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Diabetes And
   Multivessel Disease

             Dr. Dev Pahlajani
              MD,FACC,FSCAI
Chief of Interventional Cardiology, Breach
          Candy Hospital, Mumbai



              www.cardiositeindia.com
DIABETES EPIDEMIOLOGY

         www.cardiositeindia.com
The Diabetes Epidemic
•      About 150 million diabetic patients worldwide, expected
       to double by 2025
•      One million new patients diagnosed in the US each year
•      Prevalence in Europe ~5% to ~7%, expected to double
       in next 25 years.

                         UK                     3.1
                Netherlands                           3.6
                        Italy                                                                 7.1
                   Germany                                   4.2
                     France                              4.0
                    Belgium                                  4.1
                       0.0          2.0                4.0                    6.0                      8.0
    0-5% in Western Europe                            (%)
    5-8% in Southern Europe

                                                                    Amos AF et al. Diabetic Medicine 1997; 17: S7-S85
                                                              Mak KH et al. European Heart Journal 2003; 24: 1087-1103
                                                                          IDF (International Diabetes Federation - 2000)
                                    www.cardiositeindia.com
WORLD CAPITAL OF DIABETES
India was the expected world capital of DM
China has overtaken India to wrest the title of the
‘diabetes capital of the world', going by the latest figures
revealed by the 5th edition of Diabetes Atlas
At 90.0 million, China today has the largest number of
people with diabetes.
India follows with about 61.3 million
The third on the list is far behind – United States at 23.7
million.
                        www.cardiositeindia.com
Global Burden of Diabetes
Top 10 Countries With Diabetics (20-79 Years Of Age)


Country                  2011               Country            2031
                         [Millions]                            [Millions]
China                    90.0               China              129.7
India                    61.3               India              101.2
USA                      23.7               USA                29.6
Russian Federation       12.6               Brazil             19.6
Brazil                   12.4               Bangladesh         16.8
Japan                    10.7               Mexico             16.4
Mexico                   10.3               Russian Federation 14.1
Bangladesh               8.4                Egypt              12.4
Egypt                    7.3                Indonesia          11.8
Indonesia                7.3                Pakistan           11.4
                                www.cardiositeindia.com
Multivessel disease in Diabetes
Balloon Era

BMS Era

DES Era




               www.cardiositeindia.com
Bypass Angioplasty
Revascularization Investigation
         (BARI) Trial



           www.cardiositeindia.com
BYPASS ANGIOPLASTY REVASCULARISATION
         INVESTIGATION (BARI)
 New Engl Jour Of Med 1996 (335): 217-225
 Comparison of Coronary Bypass Surgery with Angioplasty in
  Patients with Multivessel Disease
 914 assigned to CABG
 915 assigned to PTCA
 Similar
    Demographic Features
    Angiography Findings
    EF
 Equally Distributed Co morbid Features


                         www.cardiositeindia.com
BARI: 5 Year Mortality
Diabetic vs. Non-Diabetic Patients
                  Non-CV death      CV death
                 40
                          34
                 30       10
 Mortality (%)




                 20       24                 19
                                             10
                                                                    9             10
                 10
                                                                    4              5
                                                                                   5
                                             9
                                                                    5              5
                  0
                         PTCA            CABG                      PTCA          CABG
                                 Diabetics                          Non-diabetics


                                         www.cardiositeindia.com
                                                                   Circulation 1997; 96: 1761-1769
BARI study: Mortality in Diabetic Patients
o Benefit only in CABG patients with internal mammary
  artery
o Greatest difference seen in diabetics treated with insulin

o Difference due to a reduced mortality in patients with a
  subsequent AMI




        “Diabetics with multi-vessel disease
              should undergo CABG”
                      www.cardiositeindia.com
BARI Registry: No Difference in Long-term Outcome in
Diabetics Treated by PTCA or CABG
                   “PTCA is a safe alternative to CABG in diabetics when they are
                                          properly selected”
CABG Patients                                               PTCA Patients
                       100                      Registry (85.8)                       100                       Registry (86.1)

                        80                  Randomized (84.4)                          80                 Randomized (80.9)
    Survival (%)




                                                                   Survival (%)
                        60                                                             60

                        40                                                             40
                                     Unadjusted p=0.57                                          Unadjusted p<0.01
                        20            Adjusted p=0.66                                  20        Adjusted p=0.16

                         0                                                              0
                   0         1   2     3   4    5      6    7                     0         1   2     3   4     5    6    7
  No. of patients                                                No. of patients
  Registry 625                       590       569         436    Registry 1189                 1124          1091       769
  Random. 914                        860       814         590    Random. 915                       842        790       579

                                                     www.cardiositeindia.comF et al, Circulation 2000;101:2795
                                                                        Feit
Cumulative Number of Subsequent Revascularization
  Procedures per 100 Patients by Randomization


                                    PCI
                                    CABG       PCI




                                                 CABG




       www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
Overall Survival by Randomized
Treatment Stratified by Diabetes Status




                         The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
         www.cardiositeindia.com
Overall Survival and Survival Free of Q-
 Wave MI by Randomized Treatment




            www.cardiositeindia.com   The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
Rates of Survival and Freedom from Major Cardiovascular
        Events, According to PCI and CABG Strata.




               www.cardiositeindia.com   Source: The BARI 2D Study Group. N Engl J Med 2009;360:2503-2515 .
10-Year Survival Rates for Patients According
  to Subgroups Based on Characteristics at
                 Study Entry




          www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
Percent of Surviving Patients With Stable or
  Unstable Angina at Each Follow-Up by
              Randomization




                                     The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
           www.cardiositeindia.com
Freedom From Cardiac Death and Freedom From
Cardiac Death or Any MI by Randomized Treatment




         www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
Diabetes is a Predictor of Late Loss
                               %
                    LL             D
Trial              mm              M                                        Late Loss vs. % of Diabetics in Bare (non-DES)
Sirius-Ctrl/8mo.          1    28.2                                                          Stent Study

Ravel-Ctrl/6mo.          0.8       21
                                                                           30
Venus-6mo            0.97      23.4                                                                           1
                                                                                                              0.98
                                                                           25
Velvet-6mo               0.7   10.7                                                                    0.830.97 1.19
                                                                                                      0.8 0.93




                                             % of Diabetics in the study
Vision-6mo           0.83          23                                      20
                                                                                                         0.9
Penta-6mo                0.9   18.5                                        15                                                Series1
                                                                                                 0.6
Multi-Link-ISAR2                                                                               0.54
                                                                           10                       0.7
   -6mo              0.93          22
BX ISAR2             1.19      22.2                                         5

Bstent                                                                      0
    Heprincoated     0.54      12.2                                             0        0.5              1            1.5
Deliver Bare         0.98      26.8                                                     Late Loss in mm.

Orbit                    0.6   13.3
                               www.cardiositeindia.com
Arterial Revascularization
Therapies Study (ARTS) Trial



          www.cardiositeindia.com
ARTS I
   The primary objective of ARTS I was to compare intra-
    coronary stenting to bypass surgery in patients with
    multivessel disease


    Effectiveness was measured in terms of Major Cardiac
    and Cerebrovascular Events (MACCE) – free survival at
    one year


                          www.cardiositeindia.com
ARTS I – Patient Flow
STENT                                                          CABG

 600                   INTENTION TO TREAT                      605
  1     Medical Treatment only Medical Treatment only           3

                Cross–over                      Cross-over
        3 consent withdrawal           8 consent withdrawal
        2 LM disease                   8 exclusion criteria
  6                                                             19
        1 inappropriate selection      1 miscommunication
                                       1 QMI on waiting list
                                       1 UAP on waiting list
        3 urgent CABG                  2 PTCA
 13     10 elective CABG               within hosp stay         2
        within hosp stay
 580    Successful treatment according to randomisation         581
(97%)                                                          (96%)
                           www.cardiositeindia.com
ARTS I
MACCE (30 day follow-up)

                              CABG                       Stent
                              (605)                      (600)
Death                  8+3*           1.8%          9            1.5%
CVA                    7+1 *          1.3%          5            0.8%
AMI (Q)                13+4*          2.8%         15+1*         2.7%
Re-CABG                  2            0.3%          12           2.0%
Re-PTCA                  3            0.5%          10           1.7%
Total                   41            6.8%          52           8.7%
*
 Events prior to assigned treatment
                         www.cardiositeindia.com
The Stent Era: ARTS I Study
• Less favorable long-term outcome with stenting in DM
• 1-year mortality rate: 6.4% vs. 3.1%
• Reduced rate of revascularization compared to balloon PTCA

                            100
  Event-free survival (%)




                            95
                            90
                            85                                                                88.4%
                                                                                              84.4%
                            80
                            75
                                                                                              76.2%
                            70
                            65                                                                63.4%
                             60
                            0       60        120          180           240         300         360
                                              Days after randomization
CABG: Non Diabetes                       CABG: Diabetes
Stent: Non Diabetes                      Stent: Diabetes                 Abizaid A. Circulation 2001;104:533
                                               www.cardiositeindia.com
ARTS I DIABETICS

Death/CVA/MI/CABG/RE- PTCA

DIABETIC SUBGROUP
 Repeat revascularization was higher in diabetic patients
  randomized to the stent arm vs. CABG(42.9% VS 10.9%)
 Compared to non diabetic patients(27.5% vs 8.4%)
 Based on the available evidence, surgery should continue
  to be viewed as the preferred therapy for diabetic
  patients with multivessel disease when using bare metal
  stents.

                      www.cardiositeindia.com    JACC, 2005, 46, 575-81
ARTS I DIABETICS




    www.cardiositeindia.com
ARTS Trial (CABG v. PCI)
                                    Three year follow-up

                          100                                               PCI
Event Free Survival (%)




                           80   99.5%    97.5%          97.2%               CABG 96.3%
                                98.5%    97.2%          96.4%                       95.5%
                           60

                           40

                           20
                                                                           p=0.08 Log Rank
                                 Death                                     p=0.09 Fisher
                            0
                           0    150   300   450       600      750         900    1050       1200

                                            Days since randomization
                                                 www.cardiositeindia.com
ARTS Trial (CABG v. PCI)
                                       Three year Follow-up
                          100
Event Free Survival (%)




                                                                               CABG
                           80
                                                                               PCI
                           60
                                 96.0%   91.2%        89.8%                      88.8%
                           40    95.5%   90.3%        89.2%                      87.0%

                           20
                                 Death AMI CVA                           p=0.58 Log Rank
                                                                         p=0.62 Fisher
                            0
                           0    150   300   450    600      750          900    1050   1200

                                            Days since randomization

                                               www.cardiositeindia.com
ARTS Trial (CABG v. PCI)
                                       Three year Follow-up
                          100    95.7%
Event Free Survival (%)




                                         87.8%
                           90                           85.0%
                                                                                 83.6%
                                 91.8%
                                                                                 CABG
                           80
                                         73.5%

                           70                          69.5%
                                                                                 65.7%

                           60                                                     PCI
                                                                           p=0.005 Log Rank
                                 Death AMI CVA CABG Re-PCI                 p=0.006 Fisher
                           50
                           0    150   300   450      600      750          900   1050     1200

                                            Days since randomization

                                                 www.cardiositeindia.com
ARTS Trial (CABG v. PCI)
Three year Follow-up (Diabetic subgroup)
                           100                                                        CABG
 Event Free Survival (%)




                            90                                                         92.7%


                            80                                                        Death, AMI, CVA
                                                                                        PCI = CABG
                            70
                                                                                       61.6%
                            60                                                  PCI
                                  CABG Re-PCI                         p=0.0001 Log Rank
                            50                                        p<0.0001 Fisher


                            0    150   300   450    600      750          900    1050     1200

                                             Days since randomization

                                                www.cardiositeindia.com
ARTS I DIABETICS
Death/CVA/MI/CABG/RE- PTCA

DIABETIC SUBGROUP

• Repeat revascularization was higher in diabetic patients
  randomized to the stent arm vs. CABG(42.9% VS 10.9%)
• Compared to non diabetic patients(27.5% vs 8.4%)
• Based on the available evidence, surgery should
  continnue to be viewed as the preferred therapy for
  diabetic patients with multivessel disease when using
  bare metal stents.

                      www.cardiositeindia.com      JACC, 2005, 46, 575-81
ARTS II

PRIMARY OBJECTIVE
   To compare the effectiveness of coronary stent
    implantation using the Sirolimus drug eluting Bx Velocity™
    stent with that of surgery as observed in ARTS I


   Effectiveness will be measured in terms of Major Cardiac
    and Cerebrovascular Events (MACCE) – free survival at 30
    days and six months




                        www.cardiositeindia.com
Sirolimus Coating Modulates neointima
   in 30-Day Porcine Coronary Model




   Control                         + Sirolimus

             www.cardiositeindia.com
ARTS II: Study Design
   Single arm, multicenter trial
   607 patients in 45 centers from 19 countries
   Main goal of the ARTS II trial is to demonstrate non-
    inferiority in clinical effectiveness and cost-effectiveness with
    the CYPHER® stent compared to the previous results of the
    ARTS I trial
          ARTS II                                ARTS I

                                                Randomization


          CYPHER      ®               CABG                  CROWN™ &
            (n=607)                    (n=605)             CrossFlex LC™
                                                                 (n=600)
                          Serruys P. et al., JACC 2005 (Sunday March 6th); Oral Presentation.
                             www.cardiositeindia.com
ARTS-II Trial
                                              Historical Controls from ARTS I: 1202
607 patients with multivessel                  patients with multivessel coronary
      coronary lesions                                       lesions
             26.2% diabetic                                     18.2% diabetic
                                                            28% 3 vessel disease
          54% 3 vessel disease
                                                             7.5% type C lesions
          13.9% type C lesions
                                                                           Bare Metal
                                                    CABG                     Stent
     Sirolimus-eluting stent
                                                                        2.8 stents per patient
         3.7 stents per patient
                                                                         Avg total length: 48
        Avg total length: 73 mm                      n = 602                     mm
                n = 607
                                                                               n = 600
                                  Endpoints:

    Primary       – Major adverse cardiac and cerebrovascular events (MACCE),
    including               death, cerebrovascular event, myocardial infarction,
    and revascularization,              at 1 year for the comparison of CABG treated
    patients in the ARTS I trial                   with sirolimus-eluting stent patients
    in the ARTS II trial

    Secondary – MACCE at 30 days, 6 months, 3 and 5 years.
                  – Total cost at 30 days
                  – Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5
                    years          www.cardiositeindia.com                                 ACC 2005
ARTS II – Diabetic population (MACCE
at 1y)
                                           ARTS II            ARTS I (CABG)           ARTS I (PCI)
  Hierarchical MACCE up to 1 year
                                           (n=159)               (n=96)                 (n=112)



                                                   }                      }
Death (%)                                    2.5                    3.1                    6.3
CVA (%)                                      0.0        3.1         5.2       10.4         1.8
MI (%)                                       0.6                    2.1                    6.3
(re) CABG (%)
(re) PCI (%)
                                             3.1
                                             9.4   } 12.5           1.0
                                                                    3.1   } 4.1            8.0
                                                                                           14.3
Any MACCE (%)                                15.7                  14.6                    36.6


 Significant difference in MACCE (p=<0.001) between ARTS II
  and ARTS I (PCI)
 No significant difference in MACCE (p=0.86) between ARTS II
  and ARTS I (CABG)

                                    www.cardiositeindia.com    Morice M-C. EuroPCR 2005.
ARTS II - MACCE up to 1 year*
                                       ARTS II            ARTS I (CABG)           ARTS I (PCI)
  Hierarchical MACCE up to 1 year
                                       (n=607)               (n=602)                (n=600)



                                                }                       }
Death (%)                                 1.0                     2.7                   2.7
CVA (%)                                   0.8       3.0           1.8       8.0         1.8
MI (%)                                    1.2                     3.5                   5.0
(re) CABG (%)
(re) PCI (%)
                                          2.0
                                          5.4   } 7.4             0.7
                                                                  3.0   } 3.7           4.7
                                                                                        12.3
Any MACCE (%)                            10.4                11.6                       26.5




                        More extensive disease in ARTS II
         (% diabetes, 3-vessel involvement, lesions/patients) than ARTS I



                                        www.cardiositeindia.com
         * Complete follow-up in 97%                        Morice M-C. EuroPCR 2005.
ARTS II : Event free survival
At one year, there was no difference in event-free survival between the
ARTS II SES group and the ARTS I CABG group. However, the ARTS II
group showed significantly higher rates of survival free from cardiac
death, MI, and reintervention than the ARTS I bare metal stent group. The
groups were not significantly different in the primary endpoint of survival
free from MACCE.

    ARTS II : DES               ARTS I : BMS               ARTS I : CABG

100

 80
             P = < 0.001
 60                                     P = 0.003
                                                             P = 0.46
                                      91.5
                  90.7

                         92.0
           96.9




                                             78.1
 40

                                                    95.9




                                                                    73.7
                                                             89.5




                                                                           88.5
 20

   0

        Survival free from          Survival free from       Survival free from
        Death/CVE/MI                reintervention           MACE
                                www.cardiositeindia.com
ARTS II study




  www.cardiositeindia.com
ARTS II – Diabetic population

                                      ARTS II            ARTS I (CABG)           ARTS I (PCI)
Lesion characteristics             patients (159)         patients (96)          patients (112)
(main differences)                 lesions (568)          lesions (290)          lesions (309)
Lesion length > 20mm (%)               15                       6                         6
Calcified lesion (%)                   33                      15                         13
Type C lesions (%)                     17                       8                         7
# of lesions > 50% DS               3.6 ± 1.3              3.0 ± 1.1                   2.9+1.2
# of treated lesions                3.2 ± 1.2              2.8 ± 0.8                   2.5+1.1
Procedural characteristics
# of stents implanted               3.6 ± 1.5                   -                      3.0 ± 1.5
Total stent length (mm)                74                       -                         53
Range                                12-179                     -                      14-165

     More extensive disease in ARTS II diabetic patients than ARTS I CABG


                               www.cardiositeindia.com     Morice M-C. EuroPCR 2005.
ARTS – 5 Yrs Outcome Major Adverse Cardiac Events
 At 5 Years In Patients Without Diabetes Stratified
               According To Treatment
                STENT                        BYPASS
                NON-DIABETIC                 NON-DIABETIC                                  STENT VS
                N = 488                      N = 509                 RELATIVE RISK         CABG
                N (%)                        N (%)                   (95% CI)              p VALUE
(RE) CABG 46 (9.4)              5 (1.0)                 9.60 (3.85 – 23.95)     < 0.001


(RE) PTCA 105 (21.5) 41 (8.1)                2.67 (1.90 – 3.75)      < 0.001


ANY REVASC-          134 (27.5) 43 (8.4)                3.25 (2.36 – 4.48)      < 0.001
ULARISATION


ANY MACCE            189 (38.7) 108 (21.2) 1.83 (1.49 – 2.23)        < 0.001
                                                                                     P. W. SERRUYS
                                           www.cardiositeindia.com                   JACC 2005
ARTS II : Summary
• Among patients with multivessel coronary lesions, patients
  treated with sirolimus eluting stents had significantly lower rates
  of MACCE compared with a historical registry of similar patients
  treated with bare metal stents and rates of MACCE statistically
  equivalent to patients from the same registry treated with CABG.
• The majority of the differnce in MACCE between the ARTS II and
  ARTS I BMS groups was driven by the increased need for repeat
  revascularization in the bare metal stent group. The ARTS II group
  had equal rates of revascularization to the ARTS I CABG group,
  despite having increased length and complexity of lesions.
• While this historical registry comparison is promising and
  statistical measures were used to adjust for co-founding
  variables, a randomized trial is needed to adequately determine
  the superiority of one therapy over another.
                           www.cardiositeindia.com
Short & Long Term Results After
Multivessel Stenting In Diabetic
Patients


              www.cardiositeindia.com
Short & Long Term Results After
Multivessel Stenting In Diabetic Patients
•   Prospective data base of CRF 1993-1999
•   689 consecutive patients
•   1639 stents
•   501 (1200 lesions) – no DM
•   102 (235 lesions) oral agents
•   86 (204 lesions) insulin



                                                 R. MEHRAN
                       www.cardiositeindia.com   JACC 2004
MULTISTENTING IN DIABETICS
IN-HOSPITAL OUTCOMES OF PATIENTS /
LESIONS NO DM    NIDDM   IDDM
               (N= 560/1428)     (N = 114/284)           (N = 81/213)   p VALUE


ANGIOGRAPHIC
SUCCESS (%)    99.8              99.0                    100            0.47


ABRUPT
CLOSURE (%)    1.3               0.4                     0              0.13


QMI (%)        0                 0                       0              NA


NON QMI (%)    27                28                      21             0.51
                                                                             R. MEHRAN
                               www.cardiositeindia.com                       JACC 2004
MULTIVESSEL STENTING IN DIABETICS
           1.0

           0.9
           0.8
           0.7
SURVIVAL




           0.6
           0.5
                           No DM                              P < 0.001
           0.4
                       DM treated with oral agent
           0.3
                       DM treated with Insulin
           0.2
           0.1
           0
                 0   100            200             300      400
                                       TIME IN DAYS                       R. MEHRAN ET AL
                                   www.cardiositeindia.com                JACC 2004, 43, 1348
MULTIVESSEL STENTING IN DIABETICS
                      1.0

                      0.9
                      0.8
EVENT FREE SURVIVAL




                      0.7

                      0.6
                      0.5
                                  No DM                                    P < 0.001
                      0.4
                                  DM treated with oral agent
                      0.3
                                 DM treated with Insulin
                      0.2
                      0.1
                      0
                            0   100             200                  300         400
                                               TIME IN DAYS                            R. MEHRAN ET AL
                                           www.cardiositeindia.com                     JACC 2004, 43, 1348
Comparison of Outcome Using Sirolimus-
 Eluting Stenting in Diabetic Versus Non
   diabetic Patients With Comparison
of Insulin Versus Non-Insulin Therapy in
           the Diabetic Patients
  Ramon Kumar, MDa, Tobias T. Lee, MDa, Allen Jeremias, MDa,
  Christopher P. Ruisi, MDa, Brett Sylvia, BSa, Jorge Magallon, MDa,
   Ajay J. Kirtane, MDa, Brian Bigelow, MDa, Martin Abrahamson,
    MDb, Duane S. Pinto, MDa, Kalon K.L. Ho, MD MSca, David J.
   Cohen, MD, MSca, Joseph P. Carrozza, Jr., MDa, and Donald E.
                             Cutlip, MDa


                                                   Am J. Cardiol 2007;100:1187
                         www.cardiositeindia.com
Comparison of Sirolimus Stent in DM
  Vs NDM - Insulin VS Non Insulin
             Therapy
•   297 pts. With DM
•   115 on Insulin
•   541 Non DM
•   All received Sirolimus Stent




                      www.cardiositeindia.com   Am.J.Card.2007
CAD / Insulin TREATED & Siro Stent Outcome
             Nine-month clinical events :
        diabetic versus non diabetic patients
Events                       Diabetes Mellitus                  P Value

                            Yes                   No
                         (n = 297)             (n = 541)

MACEs               33 (11.8 %)              28 (5.6 %)         0.002

Cardiac death         5 (1.8 %)               6 (1.2 %)         0.80




                   www.cardiositeindia.com                 Am J. Cardiol 2007;100:1187
CAD / Insulin Treated & Siro Stent Outcome
Nine-month clinical events : insulin-treated patients versus
                          others
  Events                           Insulin Therapy                P Value

                                Yes                    No
                             (n = 115)              (n = 182)

  MACEs                  19 (17.5 %)              14 (8.2 %)      0.001

  Cardiac death           4 (3.7 %)                1 (0.6 %)      0.006

  MI                      9 (8.2 %)                8 (4.6 %)      0.06

  Cardiac death or MI    11 (10.1 %)               9 (5.2 %)      0.01

  TLR                    14 (13.3 %)              12 (7.1 %)      0.04

  Stent Thrombosis        3 (2.6 %)                3 (1.7 %)      0.57
                        www.cardiositeindia.com
                                                                Am J. Cardiol 2007;100:1187
Influence of DM on Outcomes-ST in
             Asian Patients
 856 with DM

 2295 no DM

 All received DES

 Death, Non fatal MI,TVR




                                                 Park et al Am.J.Card.2009,103,2079




                       www.cardiositeindia.com
40                                                                 4
                                                      Diabetes                                                          Diabetes
                                                      Non-diabetes                                                      Non-diabetes
                           30
         Event rates (%)




                                                                                 Event rates (%)
                                                                                              2
                                      Log Rank P=0.34                                                  Log Rank P=0.34
                           20
                                                                                              1
                           10


                           0                                                               0
                                  0       365    730    1095                                       0      365    730    1095
No. at Risk
                                         Follow-up (days)                No. at Risk
                                                                                                         Follow-up (days)
Diabetes                    865        730      457           195        Diabetes    865                 842         560           247
Non-diabetes               2295       2057   1339       561              Non-diabetes 2295                 22487     1520         674



              Kaplan-Meir survival curve of primary composite
                     end point and stent thrombosis
                           (definite or probable)
                                                               www.cardiositeindia.com                     Park et al Am J. Cardiol 2009, 103;646
Non-diabetics vs. insulin-treated diabetes
A                                                               Adjusted HR (95 % CI)          P value
    Death                                                            2.77 (1.55-4.95)          0.001

    MI                                                               1.01 (0.54-1.89)          0.97

    TLR                                                              1.36 (0.77-2.39)          0.29

    TVR                                                              1.72 (1.02-2.88)          0.04

    Death or MI                                                      1.66 (1.09-2.53)          0.02

    Death, MI or TVR                                                 1.65 (1.17-2.32)          0.004

    ST (decline or probable                                          0.99 (0.20-4.92)          0.99

    ST (any ARC criteria)                                            1.75 (0.77-3.96)          0.20
                               0.1           1                  10
                              Adjusted Hazard Ratio (95 % CI)

              Adjusted hazard ratios for clinical outcomes
            and stent thrombosis in diabetic patients who do
            (A) and do not (B) require insulin therapy versus
                          non-diabetic patients
                                     www.cardiositeindia.com
                                                                                Park et al Am j. Cardiol 2009, 103;646
Non-diabetics vs. Non insulin-treated diabetes
B                                                                Adjusted HR (95 % CI)   P value
    Death                                                             0.66 (0.52-1.45)   0.58

    MI                                                                1.05 (0.74-1.49)   0.79

    TLR                                                               0.94 (0.67-1.32)   0.72

    TVR                                                               1.23 (0.91-1.67)   0.18

    Death or MI                                                       0.99 (0.74-1.31)   0.92

    Death, MI or TVR                                                  1.08 (0.87-1.35)   0.47

    ST (decline or probable                                           0.62 (0.21-1.88)   0.40

    ST (any ARC criteria)                                             0.74 (0.36-1.52)   0.41
                               0.1             1                 10
                               Adjusted Hazard Ratio (95 % CI)

              Adjusted hazard ratios for clinical outcomes
            and stent thrombosis in diabetic patients who do
            (A) and do not (B) require insulin therapy versus
                          non-diabetic patients
                       www.cardiositeindia.com         Park et al Am j. Cardiol 2009, 103;646
ENDEAVOR IV - DM

    www.cardiositeindia.com
ENDEAVOR IV: Diabetics
                     Baseline Characteristics
                              Endeavor               Taxus   P value
                                (241)                (236)

Age (yrs)                         64.2                63.8    0.679
Male (%)                          59.8               61.0     0.780
History of Smoking (%)            54.4                53.8    0.926
Family History CAD (%)            43.9                42.1    0.917
Diabetes (%)                      100.0              100.0    N/A
   IDDM (%)                        33.2               27.1    0.163
Hypertension (%)                   90.5               90.7    1.000
Hyperlipidemia (%)                 83.8               90.3    0.041


                           www.cardiositeindia.com
ENDEAVOR IV - DM




    www.cardiositeindia.com   JACC Intv. 2009, 2, 967
Endeavor Clinical program
• Endeavor shows remarkable consistency in clinical outcomes


   9 month    EI n=100   EII n=591     EIICA       EIII n=   Combined
   results                             n=289       316       N=1296
   MACE (%)   2.0        7.3           10.4        7.6       7.6


   TLR (%)    2.0        4.6           4.8         6.3       4.9

   TVF (%)    2.0        8.0           13.1        12.0      9.7




                         www.cardiositeindia.com
www.cardiositeindia.com
www.cardiositeindia.com
ENDEAVOR IV: Diabetics vs Non-diabetics
          Clinical Results to 12 months
                                  Diabetes            Non Diabetes
                                   (477)                (1071)       P value
Death (all) - % (#)                  0.4%                1.4%        0.171
 Cardiac                            0.4%                 0.6%        1.000
MI (all) - %                        0.9%                 2.6%        0.030
 Q Wave                             0.0%                 0.3%        0.557
 Non Q Wave                         0.9%                 2.3%        0.063
Cardiac Death + All MI, %           1.3%                 3.2%        0.035
Stent Thrombosis (all), %           0.7%                 0.4%        0.444
TLR - %                             6.4%                 2.8%        0.002
TVR - %                             9.0%                 5.4%        0.012
MACE - %                            7.0%                 6.4%        0.651
TVF - %                             9.6%                 8.1%        0.367
                            www.cardiositeindia.com
ENDEAVOR IV: Diabetics
                   TVF and TLR at 12 months
             477 diabetics (30.8% of E IV patients)

            P =0.53
                                                                              Endeavor
                  10.8%        P =0.43
         8.6%                        8.9%                                     Taxus
                                                    P =0.70
                            7.4%               6.9%
                                                           5.8%
                                                                         P =0.19
et a R




                                                                     3.5%
                                                                              2.1%

         20/233   24/223    38/516   46/518    16/233      13/223    18/516   11/518

         Diabetics         Non-diabetics        Diabetics           Non-diabetics
                      TVF                                      TLR
                                 www.cardiositeindia.com
DENDEAVOR IV:
     Demographics: Diabetics vs Non Diabetics

                            Diabetics              Non-Diabetics   P value
                              (773)                    (775)

Age (yrs)                       64.0                   63.3        0.225
Male (%)                        60.4                   71.0        <0.001
History of Smoking (%)          54.1                   64.8        <0.001
Family History CAD (%)          43.3                   42.6        0.851
Diabetes (%)                    100.0                   0.0         N/A
   IRDM (%)                     30.2                    0.0        <0.001
Hypertension (%)                90.6                    76.8       <0.001
Hyperlipidemia (%)              87.0                    81.3       0.007

                         www.cardiositeindia.com
1. The Endeavor stent is safe and effective in diabetic
   patients with “workhorse lesions” (i.e., moderate lesion
   complexity) compared to patients treated with the
   TAXUS stent
2. Very long term safety surveillance will determine
   whether very late stent thrombosis has been reduced
   with the use of the Endeavor


                       www.cardiositeindia.com
Thank You!!



 www.cardiositeindia.com

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Diabetes Mellitus & Multi vessel disease-part 1

  • 1. Diabetes And Multivessel Disease Dr. Dev Pahlajani MD,FACC,FSCAI Chief of Interventional Cardiology, Breach Candy Hospital, Mumbai www.cardiositeindia.com
  • 2. DIABETES EPIDEMIOLOGY www.cardiositeindia.com
  • 3. The Diabetes Epidemic • About 150 million diabetic patients worldwide, expected to double by 2025 • One million new patients diagnosed in the US each year • Prevalence in Europe ~5% to ~7%, expected to double in next 25 years. UK 3.1 Netherlands 3.6 Italy 7.1 Germany 4.2 France 4.0 Belgium 4.1 0.0 2.0 4.0 6.0 8.0 0-5% in Western Europe (%) 5-8% in Southern Europe Amos AF et al. Diabetic Medicine 1997; 17: S7-S85 Mak KH et al. European Heart Journal 2003; 24: 1087-1103 IDF (International Diabetes Federation - 2000) www.cardiositeindia.com
  • 4. WORLD CAPITAL OF DIABETES India was the expected world capital of DM China has overtaken India to wrest the title of the ‘diabetes capital of the world', going by the latest figures revealed by the 5th edition of Diabetes Atlas At 90.0 million, China today has the largest number of people with diabetes. India follows with about 61.3 million The third on the list is far behind – United States at 23.7 million. www.cardiositeindia.com
  • 5. Global Burden of Diabetes Top 10 Countries With Diabetics (20-79 Years Of Age) Country 2011 Country 2031 [Millions] [Millions] China 90.0 China 129.7 India 61.3 India 101.2 USA 23.7 USA 29.6 Russian Federation 12.6 Brazil 19.6 Brazil 12.4 Bangladesh 16.8 Japan 10.7 Mexico 16.4 Mexico 10.3 Russian Federation 14.1 Bangladesh 8.4 Egypt 12.4 Egypt 7.3 Indonesia 11.8 Indonesia 7.3 Pakistan 11.4 www.cardiositeindia.com
  • 6. Multivessel disease in Diabetes Balloon Era BMS Era DES Era www.cardiositeindia.com
  • 7. Bypass Angioplasty Revascularization Investigation (BARI) Trial www.cardiositeindia.com
  • 8. BYPASS ANGIOPLASTY REVASCULARISATION INVESTIGATION (BARI)  New Engl Jour Of Med 1996 (335): 217-225  Comparison of Coronary Bypass Surgery with Angioplasty in Patients with Multivessel Disease  914 assigned to CABG  915 assigned to PTCA  Similar  Demographic Features  Angiography Findings  EF  Equally Distributed Co morbid Features www.cardiositeindia.com
  • 9. BARI: 5 Year Mortality Diabetic vs. Non-Diabetic Patients Non-CV death CV death 40 34 30 10 Mortality (%) 20 24 19 10 9 10 10 4 5 5 9 5 5 0 PTCA CABG PTCA CABG Diabetics Non-diabetics www.cardiositeindia.com Circulation 1997; 96: 1761-1769
  • 10. BARI study: Mortality in Diabetic Patients o Benefit only in CABG patients with internal mammary artery o Greatest difference seen in diabetics treated with insulin o Difference due to a reduced mortality in patients with a subsequent AMI “Diabetics with multi-vessel disease should undergo CABG” www.cardiositeindia.com
  • 11. BARI Registry: No Difference in Long-term Outcome in Diabetics Treated by PTCA or CABG “PTCA is a safe alternative to CABG in diabetics when they are properly selected” CABG Patients PTCA Patients 100 Registry (85.8) 100 Registry (86.1) 80 Randomized (84.4) 80 Randomized (80.9) Survival (%) Survival (%) 60 60 40 40 Unadjusted p=0.57 Unadjusted p<0.01 20 Adjusted p=0.66 20 Adjusted p=0.16 0 0 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 No. of patients No. of patients Registry 625 590 569 436 Registry 1189 1124 1091 769 Random. 914 860 814 590 Random. 915 842 790 579 www.cardiositeindia.comF et al, Circulation 2000;101:2795 Feit
  • 12. Cumulative Number of Subsequent Revascularization Procedures per 100 Patients by Randomization PCI CABG PCI CABG www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
  • 13. Overall Survival by Randomized Treatment Stratified by Diabetes Status The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606 www.cardiositeindia.com
  • 14. Overall Survival and Survival Free of Q- Wave MI by Randomized Treatment www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
  • 15. Rates of Survival and Freedom from Major Cardiovascular Events, According to PCI and CABG Strata. www.cardiositeindia.com Source: The BARI 2D Study Group. N Engl J Med 2009;360:2503-2515 .
  • 16. 10-Year Survival Rates for Patients According to Subgroups Based on Characteristics at Study Entry www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
  • 17. Percent of Surviving Patients With Stable or Unstable Angina at Each Follow-Up by Randomization The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606 www.cardiositeindia.com
  • 18. Freedom From Cardiac Death and Freedom From Cardiac Death or Any MI by Randomized Treatment www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
  • 19. Diabetes is a Predictor of Late Loss % LL D Trial mm M Late Loss vs. % of Diabetics in Bare (non-DES) Sirius-Ctrl/8mo. 1 28.2 Stent Study Ravel-Ctrl/6mo. 0.8 21 30 Venus-6mo 0.97 23.4 1 0.98 25 Velvet-6mo 0.7 10.7 0.830.97 1.19 0.8 0.93 % of Diabetics in the study Vision-6mo 0.83 23 20 0.9 Penta-6mo 0.9 18.5 15 Series1 0.6 Multi-Link-ISAR2 0.54 10 0.7 -6mo 0.93 22 BX ISAR2 1.19 22.2 5 Bstent 0 Heprincoated 0.54 12.2 0 0.5 1 1.5 Deliver Bare 0.98 26.8 Late Loss in mm. Orbit 0.6 13.3 www.cardiositeindia.com
  • 20. Arterial Revascularization Therapies Study (ARTS) Trial www.cardiositeindia.com
  • 21. ARTS I  The primary objective of ARTS I was to compare intra- coronary stenting to bypass surgery in patients with multivessel disease  Effectiveness was measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) – free survival at one year www.cardiositeindia.com
  • 22. ARTS I – Patient Flow STENT CABG 600 INTENTION TO TREAT 605 1 Medical Treatment only Medical Treatment only 3 Cross–over Cross-over 3 consent withdrawal 8 consent withdrawal 2 LM disease 8 exclusion criteria 6 19 1 inappropriate selection 1 miscommunication 1 QMI on waiting list 1 UAP on waiting list 3 urgent CABG 2 PTCA 13 10 elective CABG within hosp stay 2 within hosp stay 580 Successful treatment according to randomisation 581 (97%) (96%) www.cardiositeindia.com
  • 23. ARTS I MACCE (30 day follow-up) CABG Stent (605) (600) Death 8+3* 1.8% 9 1.5% CVA 7+1 * 1.3% 5 0.8% AMI (Q) 13+4* 2.8% 15+1* 2.7% Re-CABG 2 0.3% 12 2.0% Re-PTCA 3 0.5% 10 1.7% Total 41 6.8% 52 8.7% * Events prior to assigned treatment www.cardiositeindia.com
  • 24. The Stent Era: ARTS I Study • Less favorable long-term outcome with stenting in DM • 1-year mortality rate: 6.4% vs. 3.1% • Reduced rate of revascularization compared to balloon PTCA 100 Event-free survival (%) 95 90 85 88.4% 84.4% 80 75 76.2% 70 65 63.4% 60 0 60 120 180 240 300 360 Days after randomization CABG: Non Diabetes CABG: Diabetes Stent: Non Diabetes Stent: Diabetes Abizaid A. Circulation 2001;104:533 www.cardiositeindia.com
  • 25. ARTS I DIABETICS Death/CVA/MI/CABG/RE- PTCA DIABETIC SUBGROUP  Repeat revascularization was higher in diabetic patients randomized to the stent arm vs. CABG(42.9% VS 10.9%)  Compared to non diabetic patients(27.5% vs 8.4%)  Based on the available evidence, surgery should continue to be viewed as the preferred therapy for diabetic patients with multivessel disease when using bare metal stents. www.cardiositeindia.com JACC, 2005, 46, 575-81
  • 26. ARTS I DIABETICS www.cardiositeindia.com
  • 27. ARTS Trial (CABG v. PCI) Three year follow-up 100 PCI Event Free Survival (%) 80 99.5% 97.5% 97.2% CABG 96.3% 98.5% 97.2% 96.4% 95.5% 60 40 20 p=0.08 Log Rank Death p=0.09 Fisher 0 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
  • 28. ARTS Trial (CABG v. PCI) Three year Follow-up 100 Event Free Survival (%) CABG 80 PCI 60 96.0% 91.2% 89.8% 88.8% 40 95.5% 90.3% 89.2% 87.0% 20 Death AMI CVA p=0.58 Log Rank p=0.62 Fisher 0 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
  • 29. ARTS Trial (CABG v. PCI) Three year Follow-up 100 95.7% Event Free Survival (%) 87.8% 90 85.0% 83.6% 91.8% CABG 80 73.5% 70 69.5% 65.7% 60 PCI p=0.005 Log Rank Death AMI CVA CABG Re-PCI p=0.006 Fisher 50 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
  • 30. ARTS Trial (CABG v. PCI) Three year Follow-up (Diabetic subgroup) 100 CABG Event Free Survival (%) 90 92.7% 80 Death, AMI, CVA PCI = CABG 70 61.6% 60 PCI CABG Re-PCI p=0.0001 Log Rank 50 p<0.0001 Fisher 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
  • 31. ARTS I DIABETICS Death/CVA/MI/CABG/RE- PTCA DIABETIC SUBGROUP • Repeat revascularization was higher in diabetic patients randomized to the stent arm vs. CABG(42.9% VS 10.9%) • Compared to non diabetic patients(27.5% vs 8.4%) • Based on the available evidence, surgery should continnue to be viewed as the preferred therapy for diabetic patients with multivessel disease when using bare metal stents. www.cardiositeindia.com JACC, 2005, 46, 575-81
  • 32. ARTS II PRIMARY OBJECTIVE  To compare the effectiveness of coronary stent implantation using the Sirolimus drug eluting Bx Velocity™ stent with that of surgery as observed in ARTS I  Effectiveness will be measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) – free survival at 30 days and six months www.cardiositeindia.com
  • 33. Sirolimus Coating Modulates neointima in 30-Day Porcine Coronary Model Control + Sirolimus www.cardiositeindia.com
  • 34. ARTS II: Study Design  Single arm, multicenter trial  607 patients in 45 centers from 19 countries  Main goal of the ARTS II trial is to demonstrate non- inferiority in clinical effectiveness and cost-effectiveness with the CYPHER® stent compared to the previous results of the ARTS I trial ARTS II ARTS I Randomization CYPHER ® CABG CROWN™ & (n=607) (n=605) CrossFlex LC™ (n=600) Serruys P. et al., JACC 2005 (Sunday March 6th); Oral Presentation. www.cardiositeindia.com
  • 35. ARTS-II Trial Historical Controls from ARTS I: 1202 607 patients with multivessel patients with multivessel coronary coronary lesions lesions 26.2% diabetic 18.2% diabetic 28% 3 vessel disease 54% 3 vessel disease 7.5% type C lesions 13.9% type C lesions Bare Metal CABG Stent Sirolimus-eluting stent 2.8 stents per patient 3.7 stents per patient Avg total length: 48 Avg total length: 73 mm n = 602 mm n = 607 n = 600 Endpoints:  Primary – Major adverse cardiac and cerebrovascular events (MACCE), including death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial  Secondary – MACCE at 30 days, 6 months, 3 and 5 years. – Total cost at 30 days – Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years www.cardiositeindia.com ACC 2005
  • 36. ARTS II – Diabetic population (MACCE at 1y) ARTS II ARTS I (CABG) ARTS I (PCI) Hierarchical MACCE up to 1 year (n=159) (n=96) (n=112) } } Death (%) 2.5 3.1 6.3 CVA (%) 0.0 3.1 5.2 10.4 1.8 MI (%) 0.6 2.1 6.3 (re) CABG (%) (re) PCI (%) 3.1 9.4 } 12.5 1.0 3.1 } 4.1 8.0 14.3 Any MACCE (%) 15.7 14.6 36.6  Significant difference in MACCE (p=<0.001) between ARTS II and ARTS I (PCI)  No significant difference in MACCE (p=0.86) between ARTS II and ARTS I (CABG) www.cardiositeindia.com Morice M-C. EuroPCR 2005.
  • 37. ARTS II - MACCE up to 1 year* ARTS II ARTS I (CABG) ARTS I (PCI) Hierarchical MACCE up to 1 year (n=607) (n=602) (n=600) } } Death (%) 1.0 2.7 2.7 CVA (%) 0.8 3.0 1.8 8.0 1.8 MI (%) 1.2 3.5 5.0 (re) CABG (%) (re) PCI (%) 2.0 5.4 } 7.4 0.7 3.0 } 3.7 4.7 12.3 Any MACCE (%) 10.4 11.6 26.5 More extensive disease in ARTS II (% diabetes, 3-vessel involvement, lesions/patients) than ARTS I www.cardiositeindia.com * Complete follow-up in 97% Morice M-C. EuroPCR 2005.
  • 38. ARTS II : Event free survival At one year, there was no difference in event-free survival between the ARTS II SES group and the ARTS I CABG group. However, the ARTS II group showed significantly higher rates of survival free from cardiac death, MI, and reintervention than the ARTS I bare metal stent group. The groups were not significantly different in the primary endpoint of survival free from MACCE. ARTS II : DES ARTS I : BMS ARTS I : CABG 100 80 P = < 0.001 60 P = 0.003 P = 0.46 91.5 90.7 92.0 96.9 78.1 40 95.9 73.7 89.5 88.5 20 0 Survival free from Survival free from Survival free from Death/CVE/MI reintervention MACE www.cardiositeindia.com
  • 39. ARTS II study www.cardiositeindia.com
  • 40. ARTS II – Diabetic population ARTS II ARTS I (CABG) ARTS I (PCI) Lesion characteristics patients (159) patients (96) patients (112) (main differences) lesions (568) lesions (290) lesions (309) Lesion length > 20mm (%) 15 6 6 Calcified lesion (%) 33 15 13 Type C lesions (%) 17 8 7 # of lesions > 50% DS 3.6 ± 1.3 3.0 ± 1.1 2.9+1.2 # of treated lesions 3.2 ± 1.2 2.8 ± 0.8 2.5+1.1 Procedural characteristics # of stents implanted 3.6 ± 1.5 - 3.0 ± 1.5 Total stent length (mm) 74 - 53 Range 12-179 - 14-165 More extensive disease in ARTS II diabetic patients than ARTS I CABG www.cardiositeindia.com Morice M-C. EuroPCR 2005.
  • 41. ARTS – 5 Yrs Outcome Major Adverse Cardiac Events At 5 Years In Patients Without Diabetes Stratified According To Treatment STENT BYPASS NON-DIABETIC NON-DIABETIC STENT VS N = 488 N = 509 RELATIVE RISK CABG N (%) N (%) (95% CI) p VALUE (RE) CABG 46 (9.4) 5 (1.0) 9.60 (3.85 – 23.95) < 0.001 (RE) PTCA 105 (21.5) 41 (8.1) 2.67 (1.90 – 3.75) < 0.001 ANY REVASC- 134 (27.5) 43 (8.4) 3.25 (2.36 – 4.48) < 0.001 ULARISATION ANY MACCE 189 (38.7) 108 (21.2) 1.83 (1.49 – 2.23) < 0.001 P. W. SERRUYS www.cardiositeindia.com JACC 2005
  • 42. ARTS II : Summary • Among patients with multivessel coronary lesions, patients treated with sirolimus eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG. • The majority of the differnce in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions. • While this historical registry comparison is promising and statistical measures were used to adjust for co-founding variables, a randomized trial is needed to adequately determine the superiority of one therapy over another. www.cardiositeindia.com
  • 43. Short & Long Term Results After Multivessel Stenting In Diabetic Patients www.cardiositeindia.com
  • 44. Short & Long Term Results After Multivessel Stenting In Diabetic Patients • Prospective data base of CRF 1993-1999 • 689 consecutive patients • 1639 stents • 501 (1200 lesions) – no DM • 102 (235 lesions) oral agents • 86 (204 lesions) insulin R. MEHRAN www.cardiositeindia.com JACC 2004
  • 45. MULTISTENTING IN DIABETICS IN-HOSPITAL OUTCOMES OF PATIENTS / LESIONS NO DM NIDDM IDDM (N= 560/1428) (N = 114/284) (N = 81/213) p VALUE ANGIOGRAPHIC SUCCESS (%) 99.8 99.0 100 0.47 ABRUPT CLOSURE (%) 1.3 0.4 0 0.13 QMI (%) 0 0 0 NA NON QMI (%) 27 28 21 0.51 R. MEHRAN www.cardiositeindia.com JACC 2004
  • 46. MULTIVESSEL STENTING IN DIABETICS 1.0 0.9 0.8 0.7 SURVIVAL 0.6 0.5 No DM P < 0.001 0.4 DM treated with oral agent 0.3 DM treated with Insulin 0.2 0.1 0 0 100 200 300 400 TIME IN DAYS R. MEHRAN ET AL www.cardiositeindia.com JACC 2004, 43, 1348
  • 47. MULTIVESSEL STENTING IN DIABETICS 1.0 0.9 0.8 EVENT FREE SURVIVAL 0.7 0.6 0.5 No DM P < 0.001 0.4 DM treated with oral agent 0.3 DM treated with Insulin 0.2 0.1 0 0 100 200 300 400 TIME IN DAYS R. MEHRAN ET AL www.cardiositeindia.com JACC 2004, 43, 1348
  • 48. Comparison of Outcome Using Sirolimus- Eluting Stenting in Diabetic Versus Non diabetic Patients With Comparison of Insulin Versus Non-Insulin Therapy in the Diabetic Patients Ramon Kumar, MDa, Tobias T. Lee, MDa, Allen Jeremias, MDa, Christopher P. Ruisi, MDa, Brett Sylvia, BSa, Jorge Magallon, MDa, Ajay J. Kirtane, MDa, Brian Bigelow, MDa, Martin Abrahamson, MDb, Duane S. Pinto, MDa, Kalon K.L. Ho, MD MSca, David J. Cohen, MD, MSca, Joseph P. Carrozza, Jr., MDa, and Donald E. Cutlip, MDa Am J. Cardiol 2007;100:1187 www.cardiositeindia.com
  • 49. Comparison of Sirolimus Stent in DM Vs NDM - Insulin VS Non Insulin Therapy • 297 pts. With DM • 115 on Insulin • 541 Non DM • All received Sirolimus Stent www.cardiositeindia.com Am.J.Card.2007
  • 50. CAD / Insulin TREATED & Siro Stent Outcome Nine-month clinical events : diabetic versus non diabetic patients Events Diabetes Mellitus P Value Yes No (n = 297) (n = 541) MACEs 33 (11.8 %) 28 (5.6 %) 0.002 Cardiac death 5 (1.8 %) 6 (1.2 %) 0.80 www.cardiositeindia.com Am J. Cardiol 2007;100:1187
  • 51. CAD / Insulin Treated & Siro Stent Outcome Nine-month clinical events : insulin-treated patients versus others Events Insulin Therapy P Value Yes No (n = 115) (n = 182) MACEs 19 (17.5 %) 14 (8.2 %) 0.001 Cardiac death 4 (3.7 %) 1 (0.6 %) 0.006 MI 9 (8.2 %) 8 (4.6 %) 0.06 Cardiac death or MI 11 (10.1 %) 9 (5.2 %) 0.01 TLR 14 (13.3 %) 12 (7.1 %) 0.04 Stent Thrombosis 3 (2.6 %) 3 (1.7 %) 0.57 www.cardiositeindia.com Am J. Cardiol 2007;100:1187
  • 52. Influence of DM on Outcomes-ST in Asian Patients  856 with DM  2295 no DM  All received DES  Death, Non fatal MI,TVR Park et al Am.J.Card.2009,103,2079 www.cardiositeindia.com
  • 53. 40 4 Diabetes Diabetes Non-diabetes Non-diabetes 30 Event rates (%) Event rates (%) 2 Log Rank P=0.34 Log Rank P=0.34 20 1 10 0 0 0 365 730 1095 0 365 730 1095 No. at Risk Follow-up (days) No. at Risk Follow-up (days) Diabetes 865 730 457 195 Diabetes 865 842 560 247 Non-diabetes 2295 2057 1339 561 Non-diabetes 2295 22487 1520 674 Kaplan-Meir survival curve of primary composite end point and stent thrombosis (definite or probable) www.cardiositeindia.com Park et al Am J. Cardiol 2009, 103;646
  • 54. Non-diabetics vs. insulin-treated diabetes A Adjusted HR (95 % CI) P value Death 2.77 (1.55-4.95) 0.001 MI 1.01 (0.54-1.89) 0.97 TLR 1.36 (0.77-2.39) 0.29 TVR 1.72 (1.02-2.88) 0.04 Death or MI 1.66 (1.09-2.53) 0.02 Death, MI or TVR 1.65 (1.17-2.32) 0.004 ST (decline or probable 0.99 (0.20-4.92) 0.99 ST (any ARC criteria) 1.75 (0.77-3.96) 0.20 0.1 1 10 Adjusted Hazard Ratio (95 % CI) Adjusted hazard ratios for clinical outcomes and stent thrombosis in diabetic patients who do (A) and do not (B) require insulin therapy versus non-diabetic patients www.cardiositeindia.com Park et al Am j. Cardiol 2009, 103;646
  • 55. Non-diabetics vs. Non insulin-treated diabetes B Adjusted HR (95 % CI) P value Death 0.66 (0.52-1.45) 0.58 MI 1.05 (0.74-1.49) 0.79 TLR 0.94 (0.67-1.32) 0.72 TVR 1.23 (0.91-1.67) 0.18 Death or MI 0.99 (0.74-1.31) 0.92 Death, MI or TVR 1.08 (0.87-1.35) 0.47 ST (decline or probable 0.62 (0.21-1.88) 0.40 ST (any ARC criteria) 0.74 (0.36-1.52) 0.41 0.1 1 10 Adjusted Hazard Ratio (95 % CI) Adjusted hazard ratios for clinical outcomes and stent thrombosis in diabetic patients who do (A) and do not (B) require insulin therapy versus non-diabetic patients www.cardiositeindia.com Park et al Am j. Cardiol 2009, 103;646
  • 56. ENDEAVOR IV - DM www.cardiositeindia.com
  • 57. ENDEAVOR IV: Diabetics Baseline Characteristics Endeavor Taxus P value (241) (236) Age (yrs) 64.2 63.8 0.679 Male (%) 59.8 61.0 0.780 History of Smoking (%) 54.4 53.8 0.926 Family History CAD (%) 43.9 42.1 0.917 Diabetes (%) 100.0 100.0 N/A IDDM (%) 33.2 27.1 0.163 Hypertension (%) 90.5 90.7 1.000 Hyperlipidemia (%) 83.8 90.3 0.041 www.cardiositeindia.com
  • 58. ENDEAVOR IV - DM www.cardiositeindia.com JACC Intv. 2009, 2, 967
  • 59. Endeavor Clinical program • Endeavor shows remarkable consistency in clinical outcomes 9 month EI n=100 EII n=591 EIICA EIII n= Combined results n=289 316 N=1296 MACE (%) 2.0 7.3 10.4 7.6 7.6 TLR (%) 2.0 4.6 4.8 6.3 4.9 TVF (%) 2.0 8.0 13.1 12.0 9.7 www.cardiositeindia.com
  • 62. ENDEAVOR IV: Diabetics vs Non-diabetics Clinical Results to 12 months Diabetes Non Diabetes (477) (1071) P value Death (all) - % (#) 0.4% 1.4% 0.171 Cardiac 0.4% 0.6% 1.000 MI (all) - % 0.9% 2.6% 0.030 Q Wave 0.0% 0.3% 0.557 Non Q Wave 0.9% 2.3% 0.063 Cardiac Death + All MI, % 1.3% 3.2% 0.035 Stent Thrombosis (all), % 0.7% 0.4% 0.444 TLR - % 6.4% 2.8% 0.002 TVR - % 9.0% 5.4% 0.012 MACE - % 7.0% 6.4% 0.651 TVF - % 9.6% 8.1% 0.367 www.cardiositeindia.com
  • 63. ENDEAVOR IV: Diabetics TVF and TLR at 12 months 477 diabetics (30.8% of E IV patients) P =0.53 Endeavor 10.8% P =0.43 8.6% 8.9% Taxus P =0.70 7.4% 6.9% 5.8% P =0.19 et a R 3.5% 2.1% 20/233 24/223 38/516 46/518 16/233 13/223 18/516 11/518 Diabetics Non-diabetics Diabetics Non-diabetics TVF TLR www.cardiositeindia.com
  • 64. DENDEAVOR IV: Demographics: Diabetics vs Non Diabetics Diabetics Non-Diabetics P value (773) (775) Age (yrs) 64.0 63.3 0.225 Male (%) 60.4 71.0 <0.001 History of Smoking (%) 54.1 64.8 <0.001 Family History CAD (%) 43.3 42.6 0.851 Diabetes (%) 100.0 0.0 N/A IRDM (%) 30.2 0.0 <0.001 Hypertension (%) 90.6 76.8 <0.001 Hyperlipidemia (%) 87.0 81.3 0.007 www.cardiositeindia.com
  • 65. 1. The Endeavor stent is safe and effective in diabetic patients with “workhorse lesions” (i.e., moderate lesion complexity) compared to patients treated with the TAXUS stent 2. Very long term safety surveillance will determine whether very late stent thrombosis has been reduced with the use of the Endeavor www.cardiositeindia.com

Hinweis der Redaktion

  1. Point out the increasing number of diabetic patients. Endeavor trials also have less usage of IIbIIIa than other trials. Usage of IIbIIIa helps prevent acute and subacute stent thrombosis. Despite that Endeavor has less usage of IIbIIIa than other trials, the stent thrombosis rates are lower (total of only 4 patients to date in all trials).
  2. The angio cohort of EII shows the same TLR results as the EIII trial. Remember EIII had 87% Angio FU in all patients (282/323)