1. PCI vs CABG IN CSAPCI vs CABG IN CSA
DR VINIT KUMAR
2. CSACSA
Stable coronary artery disease is generallyStable coronary artery disease is generally
characterized by episodes of reversiblecharacterized by episodes of reversible
myocardial demand/supply mismatch,myocardial demand/supply mismatch,
related to ischaemia or hypoxia, which arerelated to ischaemia or hypoxia, which are
usually inducible by exercise, emotion orusually inducible by exercise, emotion or
other stress and reproducible—but, whichother stress and reproducible—but, which
may also be occurring spontaneously.may also be occurring spontaneously.
4. Evolution of CABG
1818
Heberden coins
the term “angina
pectoris”
1950
Vineburg
reroutes IMA
into heart
muscle
1953
Gibbon performs
1st
successful
open heart
surgery using a
cardio-pulmonary
bypass machine
1957/8
Bailey/Longmire
report successful
coronary
revascularization
on a beating heart
1962
Sabiston
attempts to
suture an SVG
into coronary
circulation
1968
Favaloro 1st
surgeon to
perform bypass
surgery (SVG)
1999
Diegler et al
publish OPCAB
technique
1958
Sones discovers
the diagnostic
coronary
angiogram
1996
Greenspun et al
and Benetti et al
publish MIDCAB
technique
2000
Falk et al publish
TECAB technique
2003
Shrivastava
et al publish
ThoraCAB
technique
1876
Hammer
diagnoses the
first cardiac
infarct in a living
human
1910
Carrell presents
a paper
describing
coronary artery
bypass
2005
Updated
ACC/AHA/SCAI
guidelines:
CABG remains
the standard of
care for
3VD/LM
disease
5. Evolution of PCI
1844
Bernard coins the
term “cardiac
catheterization”
1929
Forssmann
peforms the 1st
human cardiac
catheterization
1958
Sones discovers
the diagnostic
coronary
angiogram
1962
Ricketts and
Abrams use the
percutaneous
approach in
coronary arteries
1964
Dotter
introduces
transluminal
angioplasty
1977
Gruentzig
peforms the 1st
PTCA
1967
Judkins perfects
the transfemoral
approach
1986
Sigwart and Puel
implant the 1st
coronary stent
1994
1st
coronary stent
approved by the
FDA 2003
FDA approval of
1st
DES
2006
FDA panel on
the safety of
DES
Today
Increasing
real-world use
of PCI in LM
and 3VD
2002
CE Mark on 1st
DES
6. CABGCABG PCIPCI
+
Angina reliefAngina relief
+
Reduced reinterventionReduced reintervention
+
Complex anatomyComplex anatomy
+
CompleteComplete
revascularizationrevascularization
+
Mortality benefit in selectedMortality benefit in selected
patient groupspatient groups
Potential high costsPotential high costs
InvasiveInvasive
+
Initially cost effectiveInitially cost effective
+
Fast recoveryFast recovery
+
Reduced acuteReduced acute
complicationscomplications
+
Least invasiveLeast invasive
Increased restenosisIncreased restenosis
Repeat revascularizationRepeat revascularization
CABG is standard of care in patients
with left main & multivessel disease
Historical Pros & Cons
7. Why is CABG better than PCI?Why is CABG better than PCI?
PCI treats an isolatedPCI treats an isolated
lesion in the proximallesion in the proximal
vessel.vessel.
CABG bypasses theCABG bypasses the
proximal 2/3 of theproximal 2/3 of the
vessel, where thevessel, where the
current lesioncurrent lesion andand
future threateningfuture threatening
lesionslesions occuroccur..
This advantage ofThis advantage of
CABG will persist,CABG will persist,
even if Stenteven if Stent
restenosis is ZERO.restenosis is ZERO.
Gersh and Frye NEJM , May
2005
8. CABGCABG
PCIPCI
Evolution of Revascularization
+
Improved techniqueImproved technique
+
Improved stentImproved stent
designdesign
+
DESDES
+
Improved guidewiresImproved guidewires
+
Off pump techniqueOff pump technique
+
Less invasive approachLess invasive approach
+
Increased arterialIncreased arterial
revascularizationrevascularization
+
Optimal perioperativeOptimal perioperative
carecare
?
How does modern
CABG compare to PCI
in high-risk patients
eligible for both
techniques ?
Randomized Trial
10. Eras of Comparative CABG
Trials
Drug Eluting Stents
DES vs CABG (randomized)
Plain Balloon Angioplasty
POBA vs CABG
Bare Metal Stents
BMS vs CABG
Drug Eluting Stents
DES vs CABG
13. PCI Vs CABG in MVD POBA eraPCI Vs CABG in MVD POBA era
Observational studiesObservational studies
Randomised controlled trialsRandomised controlled trials
14. OBSERVATIONAL STUDIES.OBSERVATIONAL STUDIES.
CABG ass. with less mortality in long runCABG ass. with less mortality in long run
recurrent events, including angina pectoris and the needrecurrent events, including angina pectoris and the need
for repeat revascularization procedures, were morefor repeat revascularization procedures, were more
frequent in the PTCA than the CABG group,frequent in the PTCA than the CABG group,
largely as a consequence of incompletelargely as a consequence of incomplete
revascularization and restenosis.revascularization and restenosis.
15. Impact of Coronary BypassImpact of Coronary Bypass
Surgery on SurvivalSurgery on Survival
Coronary Artery Surgery Study (CASS)
16. PCI vs CABG Trial ResultsPCI vs CABG Trial Results
SummarySummary
Significant
decrease of
revascularization
expected with DES
17. BARIBARI
1829 pts. of multivessel CAD1829 pts. of multivessel CAD
Primary endpoint was allcause mortality at 5yrsPrimary endpoint was allcause mortality at 5yrs
Separate analysis of diabetic pts.Separate analysis of diabetic pts.
RESULTRESULT
No significant differences overallNo significant differences overall
the composite end point of cardiac mortality or MIthe composite end point of cardiac mortality or MI
cardiac mortality in nondiabetic patients regardless ofcardiac mortality in nondiabetic patients regardless of
symptoms,symptoms,
LV function,LV function,
number of diseased vessels, ornumber of diseased vessels, or
stenotic pLAD artery.stenotic pLAD artery.
23. BMS Vs CABG IN SVD (p-LAD)BMS Vs CABG IN SVD (p-LAD)
MASSMASS (Medicine, Angioplasty or Surgery Study, 1995) &(Medicine, Angioplasty or Surgery Study, 1995) &
Lausanne TrialLausanne Trial, 1994 (LIMA to LAD), 1994 (LIMA to LAD)
–– No difference in overall survival in both studiesNo difference in overall survival in both studies
–– In Lausanne Trial, more CABG pts were free from lateIn Lausanne Trial, more CABG pts were free from late
events such as angina at 2.5 yearsevents such as angina at 2.5 years
The RITA, subset of 45% had SVD.The RITA, subset of 45% had SVD.
Over 2 to 3 years, the rates of mortality, MI andOver 2 to 3 years, the rates of mortality, MI and
improvement in symptoms were similarimprovement in symptoms were similar
Frequent reintervention in patients treated with PTCA.Frequent reintervention in patients treated with PTCA.
24. Comparison of BMS With MinimallyComparison of BMS With Minimally
Invasive Bypass Surgery for LADInvasive Bypass Surgery for LAD
25. PCI Vs CABG in MVD - BMS eraPCI Vs CABG in MVD - BMS era
Observational studiesObservational studies
Randomised controlled trialsRandomised controlled trials
26. Northern New England DatabaseNorthern New England Database
1994-2001 N=14,4931994-2001 N=14,493
Circulation 2005;112[suppl I]:I-371-I-376.
27. New York State 1997-2000New York State 1997-2000
3-Vessel Disease N=23,0223-Vessel Disease N=23,022
Adjusted Survival
N Engl J Med 2005;352:2174-83.
28. Stenting vs Surgery for MVD Patients:Stenting vs Surgery for MVD Patients:
New York State Registry (3-yr survival %)New York State Registry (3-yr survival %)
Stent CABGStent CABG
2V No LAD 91.4 93.52V No LAD 91.4 93.5
2V non prox LAD 90.9 93.02V non prox LAD 90.9 93.0
3V non prox LAD 84.6 89.33V non prox LAD 84.6 89.3
3V prox LAD 84.5 89.33V prox LAD 84.5 89.3
( HR for 3V CABG 0.64 )( HR for 3V CABG 0.64 )
Hannan EL, NEJM, 2005
29. Absolute Survival Advantage
CABG vs BMS
• A significant survival advantage for CABG has been
demonstrated, and appears to increase with longer F.U.
Patients Source 1 year 3 years 5 Years 7 years
14,493 NNE 1.7% 3.1% 4.6% 6.3%
23,022 NY State 2.8% 4.9%
1,722 Duke 1.6% 6.8% 9.4% 6.6%
39,237 Overall 2.3% 4.3% 5.1% 6.3%
Survival Advantage of CABG vs BMS for 3 Vessel Disease
Peter K. Smith, MD Duke University
30. Death , MI , CVA and one – year mortality were similar .Death , MI , CVA and one – year mortality were similar .
In PCI group DM was the main factor for poor out comeIn PCI group DM was the main factor for poor out come
PCI was associated with a greater need for RepeatPCI was associated with a greater need for Repeat
Revascularization .Revascularization .
N Engl J Med 344:1117, 2001N Engl J Med 344:1117, 2001
Arterial RevascularizationArterial Revascularization
Therapies Study (ARTS) 1205 ptsTherapies Study (ARTS) 1205 pts
32. The ‘Stent or Surgery’ TrialThe ‘Stent or Surgery’ Trial
Longer Term Follow UpLonger Term Follow Up
Well matched between randomised groupsWell matched between randomised groups
488- PCI, 500- CABG.488- PCI, 500- CABG.
•• Mean age - 61 years Males - 79%Mean age - 61 years Males - 79%
•• LV EF (by 2D echo) - 57%LV EF (by 2D echo) - 57%
•• Diabetes - Insulin Tx 3%, Other Tx 12%Diabetes - Insulin Tx 3%, Other Tx 12%
•• 2 vessel disease - 57% 3VD - 42%2 vessel disease - 57% 3VD - 42%
At a median follow-up of 6 years, a continuing survivalAt a median follow-up of 6 years, a continuing survival
advantage was observed for patients managed withadvantage was observed for patients managed with
CABG, which is not consistent with results from otherCABG, which is not consistent with results from other
stent-versus-CABG studies.stent-versus-CABG studies.
33.
34. Mortality by subgroups at aMortality by subgroups at a
median follow-up of 6 yearsmedian follow-up of 6 years
35. A meta-analysis of 10 RCT comparingA meta-analysis of 10 RCT comparing
CABG and PTCA: 1 to 8 yr outcomesCABG and PTCA: 1 to 8 yr outcomes
The early studies (patient entry fromThe early studies (patient entry from
1987 to 1993) used balloon angioplasty as the PCI1987 to 1993) used balloon angioplasty as the PCI
technique, and the later studies (patient entry from 1994technique, and the later studies (patient entry from 1994
to 2002) used stents (BMS) as the PCI techniqueto 2002) used stents (BMS) as the PCI technique
Most RCTs comparing CABG and PCI have beenMost RCTs comparing CABG and PCI have been
conducted in populations with double-vessel disease,conducted in populations with double-vessel disease,
good LV function.good LV function.
38. CABG vs. PCI Multivessel DiseaseCABG vs. PCI Multivessel Disease
Restenosis and the need for repeat revascularizationRestenosis and the need for repeat revascularization
has been the main difference between PCI and CABG inhas been the main difference between PCI and CABG in
the majority of patients undergoing revascularization forthe majority of patients undergoing revascularization for
chronic multivessel CAD.chronic multivessel CAD.
Some predicted that DES would eliminate the soleSome predicted that DES would eliminate the sole
remaining gap between PCI and CABG.remaining gap between PCI and CABG.
This prediction may have overstated and oversimplifiedThis prediction may have overstated and oversimplified
reality.reality.
40. DES Vs CABGDES Vs CABG
ARTS-II TrialARTS-II Trial
FREEDOMFREEDOM
•• SYNTAXSYNTAX
•• CARDia (UK & Ireland)CARDia (UK & Ireland)
41.
42. ARTS-II TrialARTS-II Trial
Arterial Revascularization Therapies Part II: a non-Arterial Revascularization Therapies Part II: a non-
randomized comparison of contemporary PCI andrandomized comparison of contemporary PCI and
coronary artery bypass grafting (CABG) in patients withcoronary artery bypass grafting (CABG) in patients with
multi-vessel coronary artery lesionsmulti-vessel coronary artery lesions
43. Registry n = 607 MV revasc by DESRegistry n = 607 MV revasc by DES
More diabetes than ARTS 1 (26% v 18%)More diabetes than ARTS 1 (26% v 18%)
More 3 VD (54% v 28%)More 3 VD (54% v 28%)
More stents (3.7 [73mm] v 2.8 [48mm])More stents (3.7 [73mm] v 2.8 [48mm])
6 month freedom from MACCE6 month freedom from MACCE
ARTS 2 - 93.6 %ARTS 2 - 93.6 %
ARTS 1: PCI - 84.7% CABG - 94.5%ARTS 1: PCI - 84.7% CABG - 94.5%
ARTS 2ARTS 2
44. Differences between ARTS I andDifferences between ARTS I and
ARTS IIARTS II
Drug eluting stentsDrug eluting stents
ClopidogrelClopidogrel
IIb/IIIaIIb/IIIa
More aggressive lipid lowering, ?BP control andMore aggressive lipid lowering, ?BP control and
diabetes managementdiabetes management
Improved techniqueImproved technique
All could contribute to improved outcomesAll could contribute to improved outcomes
45. ARTS II – Study designARTS II – Study design
Primary endpoint: effectiveness of coronary stent
implantation using the CYPHER® Sirolimus-eluting stent with
that of surgery as observed in ARTS I measured as MACCE
free survival at 1 year.
51. FREEDOM DesignFREEDOM Design
To evaluate whether PCI with drug eluting stenting isTo evaluate whether PCI with drug eluting stenting is
more or less effective than CABG in diabetic patientsmore or less effective than CABG in diabetic patients
with multivessel disease.with multivessel disease.
52. Treated Diabetes MellitusTreated Diabetes Mellitus
Angiographically confirmed multivessel CAD andAngiographically confirmed multivessel CAD and
amenable to either PCI or CABGamenable to either PCI or CABG
Indication for revascularizationIndication for revascularization
Primary End-point-Primary End-point- MI, stroke, death.MI, stroke, death.
56. SYNTAX Trial (SYNergy between PCISYNTAX Trial (SYNergy between PCI
with TAXUS and Cardiac Surgery)with TAXUS and Cardiac Surgery)
DES vs CABG in patients with 3 vessel or left mainDES vs CABG in patients with 3 vessel or left main
diseasedisease
•• 104 sites over 3 months104 sites over 3 months
•• Primary outcome- 12mo MACCEPrimary outcome- 12mo MACCE
•• Exclusions- prior CABG or PCI, AMI at presentation, valveExclusions- prior CABG or PCI, AMI at presentation, valve
disease requiring Surgerydisease requiring Surgery
74% treated with CABG74% treated with CABG
57. 71% enrolled (N=3,075)
All Pts with de novo 3VD and/or
LM disease (N=4,337)
Treatment preference (9.4%)
Referring MD or pts. refused
informed consent (7.0%)
Inclusion/exclusion (4.7%)
Withdrew before consent (4.3%)
Other (1.8%)
Medical treatment (1.2%)
23 US Sites62 EU Sites +
SYNTAX Trial Design
*
TAXUSTM
Express2TM
Stent System
58. SYNTAX Primary Endpoint
Randomized TrialRandomized Trial
The Primary Clinical Endpoint is the 12 Month Major
Cardiovascular or Cerebrovascular Event Rate (MACCE *)
MACCE is defined as:
• All cause Death
• Cerebrovascular Event (Stroke)
• Documented Myocardial Infarction
• Any Repeat Revascularization (PCI and/or CABG)
Patients were treated with the intention of achieving
complete revascularization of all vessels at least 1.5 mm in
diameter with stenosis of 50% or more.
63. Cerebrovascular Events to 12 Months
0.6%
2.2%
0 6 12
10
20
0
Months Since Allocation
CumulativeEventRate(%)
P=0.003¥
Event Rate ± 1.5 SE
ITT population
¥
Fisher Exact Test
TAXUS* (N=903)CABG (N=897)
*
TAXUS®
Express®
Stent System
64. MACCE events in SYNTAX ScoreMACCE events in SYNTAX Score
CategoryCategory
low SYNTAX scores (0 to 22)
intermediate SYNTAX scores (23 to 32)
SYNTAX scores
Low- 0 to 22
Intermediate- 23 to 32
High ≥33
65. Medically Treated Diabetes and Non-Diabetic
All-Cause Death/CVA/MI and MACCE at 12 MonthsAll-Cause Death/CVA/MI and MACCE at 12 Months
ITT population
Diabetes (Medical Treatment)
N=452
Non-Diabetic
N=1348
TAXUS*CABG
Death/CVA/MI MACCE Death/CVA/MI MACCE
P=0.96 P=0.0025 P=0.08P=0.97
*
TAXUS®
Express®
Stent System
66. SYNTAX ConclusionsSYNTAX Conclusions
The primary endpoint (12-months MACCE) inThe primary endpoint (12-months MACCE) in
this noninferiority trial for PCI was not met.this noninferiority trial for PCI was not met.
Overall MACCE higher in the PCI group (17.8%Overall MACCE higher in the PCI group (17.8%
vs 12.1%) due to an excess of redovs 12.1%) due to an excess of redo
revascularization in the PCI vs CABG (13.7% vsrevascularization in the PCI vs CABG (13.7% vs
5.9%),5.9%),
Comparable safety outcomes (death, CVA, MI,)Comparable safety outcomes (death, CVA, MI,)
in CABG and PCI patients at 12 months.in CABG and PCI patients at 12 months.
Rates of symptomatic graft occlusion and stentRates of symptomatic graft occlusion and stent
thrombosis were similar.thrombosis were similar.
Significantly higher rate of CVA in the CABGSignificantly higher rate of CVA in the CABG
groupgroup
The SYNTAX score will help stratify patients forThe SYNTAX score will help stratify patients for
the appropriate revascularization optionthe appropriate revascularization option
67. • TheThe largest benefit from CABG seemslargest benefit from CABG seems
to be in patients with diabetes mellitus.to be in patients with diabetes mellitus.
• The results of this trial also suggest thatThe results of this trial also suggest that
patients with LM only, LM + 1-VD, andpatients with LM only, LM + 1-VD, and
nondiabetics may do as well with bothnondiabetics may do as well with both
CABG and PCICABG and PCI, although the trial was not, although the trial was not
powered to study these differencespowered to study these differences
individually.individually.
68. PCI vs CABG: Gap NarrowingPCI vs CABG: Gap Narrowing
BARI/CABRI: Difference between PCI andBARI/CABRI: Difference between PCI and
CABG ~ 34%CABG ~ 34%
ARTS: Reduced to ~ 14%ARTS: Reduced to ~ 14%
SYNTAX: More complex patients ~ 5.5%SYNTAX: More complex patients ~ 5.5%
differencedifference
SYNTAX score:SYNTAX score:
Score < 22, no difference PCI vs CABGScore < 22, no difference PCI vs CABG
Score 22 - 33, slight advantage for CABGScore 22 - 33, slight advantage for CABG
Score > 33, surgical candidateScore > 33, surgical candidate
SYNTAX, Serruys P, et al. ESC 2008.
69. Limitations of SYNTAXLimitations of SYNTAX
Follow-up period was only 12 months;Follow-up period was only 12 months;
Most of the patients (> 78%) were men,Most of the patients (> 78%) were men,
Patients who underwent CABG were less likelyPatients who underwent CABG were less likely
to receive optimal medical therapy(DAPT), whichto receive optimal medical therapy(DAPT), which
may have contributed to their increased risk formay have contributed to their increased risk for
stroke.stroke.
Time to procedure longer for CABGTime to procedure longer for CABG
89. 18 years of age or older,18 years of age or older,
angiographically confirmed multivesselangiographically confirmed multivessel
CAD with stenosis of more than 70% ofCAD with stenosis of more than 70% of
the vessel diameter in major epicardialthe vessel diameter in major epicardial
vessels in the territories of at least twovessels in the territories of at least two
coronary arteries, and werecoronary arteries, and were
considered by the physicians andconsidered by the physicians and
surgeons, a suitable candidates for eithersurgeons, a suitable candidates for either
PCI or CABGPCI or CABG
90.
91. CONCLUSIONS
CABG does not hold any advantage overCABG does not hold any advantage over
multivessel PCI in preventing death or MImultivessel PCI in preventing death or MI
No advantage of CABG except for theNo advantage of CABG except for the
decrease in repeat revascularisationdecrease in repeat revascularisation
proceduresprocedures
PCI comparable to CABG even inPCI comparable to CABG even in
diabetics in terms of death ,MI, and strokediabetics in terms of death ,MI, and stroke
92. PCI or CABG which strategy ?
SVD : PCI
2VD
Multivessel disease : PCI as initial strategy especially in
patients with good LV function , suitable anatomy and patient
preference .
CABG : Severe LAD proximal lesion , DM LV dysfunction ,
LM lesion , Diffuse disease .
Advanced age and comorbidity : PCI is better
Younger patient < 50 y : PCI is initial strategy
93. Factors in patient selection
1. The need for mechanical revascularization as opposed to
medical treatment & risk factor modification .
2. The likelihood of success ( vessel size , calcification ,
tortuosity , side branches )
3. The risk and potential consequences of acute failure of
PCI ( Coronary anatomy % viable myocardium , LV
function .
94. 4.The likelihood of restenosis ( diabetes , prior restenosis ,
small vessel , long lesion , Total occlusion , SVG
disease) .
5. The need for complete revascularization based on the
extent of CAD , severity of ischemia ,
LV function .
6. The presence of comorbid conditions
7. Patient preference
95.
96.
97.
98.
99.
100.
101. 2013 ESC guidelines on the management of2013 ESC guidelines on the management of
stable coronary artery diseasestable coronary artery disease
The 5-year cardiac mortality rate for the total population of 1829 patients was 4.9% for CABG vs 8% for PTCA (RR=1.55; P=.022). The 5-year cardiac mortality or MI rate was 17.5% for CABG vs 20.2.% for PTCA (P=NS).
In the 1476 nondiabetic patients, the 5-year cardiac mortality rate was 4.2% for CABG vs 4.6% for PTCA (P=NS). The 5-year cardiac mortality or MI rate was 13.2% for CABG vs 12.6% for PTCA (P=NS).
Treatment comparison of 5-year cardiac mortality rates for all patients (left) and for patients without diabetes drug therapy at baseline (right) stratified by subgroup. The RRs for cardiac mortality (PTCA:CABG) with 95% CIs are shown in the filled squares and horizontal lines. The overall treatment effect is shown in the large square at the top of the plot. Estimates of RR are expressed in logarithmic scale, are based on Cox regression analyses, and may differ from the simple ratio of 5-year cardiac mortality rates. QMI indicates Q-wave MI; LAD, left anterior descending coronary artery. *, **, and *** denote significant subgroup-by-treatment interactions at the .05, .01, and .005 levels, respectively.
Internal mammary artery use
was also consistently high: SoS 97%, ART 93% (reported
arterial conduits),16 MASS II 92%, and ERACI II 89%.
P for interaction test with a proportional hazards model
A- All trial, B- MVD.
The SYNTAX primary clinical endpoint is the 12 Month major Cardiovascular or Cerebrovascular event rate (MACCE *)
MACCE is defined as:
All cause Death
Cerebrovascular Event (Stroke)
Documented Myocardial Infarction
Any Repeat Revascularization (PCI and/or CABG)
All events were CEC Adjudicated
Cerebrovascular Events to 12 months was 0.6 for TAXUS patients and 2.2 for CABG patients (p=0.003)
The composite of all cause death, cerebrovascular events and myocardial infarction in the medically treated diabetics at 12 months was similar between CABG and TAXUS patients.