1. BASKET-PROVE
Late Cardiac Death and MI Associated
With Late Stent Thrombosis in Large
Vessel Stenting After 1st or 2nd
Generation DES Compared to BMS
- the BASKET PROspective Evaluation Examination -
(BASKET-PROVE)
C.Kaiser , M. Pfisterer
on behalf of the BASKET-PROVE Investigators
supported by the Basel Cardiovascular Research Foundation
and the Swiss National Foundation for Research,
no industry sponsorship/involvement
Register ISRCTN 72444640

2. Presenter Disclosure Information
C. Kaiser, MD
BASKET-PROVE
FINANCIAL DISCLOSURE:
Advisory Board: Eli Lilly Switzerland, Daiichi-Sankyo
Switzerland, Astra Zeneca Switzerland
Speakers Bureau: Biotronik Switzerland, Abbott Vascular
Switzerland, Eli Lilly Switzerland, Daiichi-Sankyo Switzerland
M.Pfisterer, MD
BASKET-PROVE
FINANCIAL DISCLOSURE:
Advisory Board: Hoffmann La Roche Switzerland, Pfizer
Switzerland, Eli Lilly Switzerland
Speakers Bureau: Abbott, Biotronik, Boston Scientific, Cordis,
Medtronic Eli Lilly, Daiichi-Sankyo, Sanofi Aventis, Switzerland,

3. BASKET-PROVE
Background
Cardiac death /MI
0.14 0.14
Cumulative death / MI
Cumulative death / MI
0.12 0.12
0.10 0.10 p=0.16 DES
Overall
0.08 0.08
BMS BMS
0.06 0.06
p=0.009
0.04 0.04
0.02 DES 0.02 DES BMS
p=0.30
0.00 0.00
0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36
Follow-up (months) Follow-up (months)
•BASKET-Trial Small Vessels
(n=268)
0.20 0.20
Cumulative death / MI
Cumulative death / MI
BMS
0.15 0.15 BMS
- 2003-2004 0.10 0.10
DES
- single center 0.05 0.05
p=0.005
BMS
DES
- n= 826 0.00
p=0.08 0.00
DES p=0.57
0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36
- DES vs. BMS Follow-up (months) Follow-up (months)
- unselected patients
Large vessels
0.14 0.14
- 3-year outcome
Cumulative death / MI
Cumulative death / MI
(n=558)
0.12 0.12
0.10 0.10 p=0.70
DES DES
0.08 0.08
0.06 0.06
0.04 0.04
DES p=0.006
0.02 BMS 0.02
p=0.01 BMS
0.00 0.00 BMS
0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36
Follow-up (months) Follow-up (months)
--> DES: LATE CARDIAC DEATH/MI INCREASED IN LARGE VESSELS
Eur Heart J 2009; 30:16-24

4. BASKET-PROVE
Hypothesis
⇒ In large vessels, compared to BMS, 1st generation DES
- provide only a small reduction in TVR
- may increase late cadiac death/MI
AIMS
⇒ First aim: to prove or refute this hypothesis in an
adequately sized prospective multicenter trial
⇒ Second aim: to evaluate whether a similar risk-
benefit relation would also be found for 2nd
generation DES

5. BASKET-PROVE
Study Design I
Prospective, randomized, 11-center, 4-country study
Intention to-treat analysis
Inclusion 2’314 patients in need of >3.0mm stents
irrespective of indication for PCI
(March 2007 until May 2008)
Randomization 1:1:1 to
1st generation SES (Cypher select ®)
vs
Cobalt-Chromium BMS (Vision ®)
vs
2nd generation EES (Xience V ®)

6. BASKET-PROVE
Study Design II
Exclusions shock, In-stent restenosis, stent thrombosis, unprotected LM
or SVG, planned surgery < 12 months, increased bleeding
risk/oral anticoagulation, vessels >4mm, no compliance
Follow-up - after 12 and 24 months
- angio for clinical indication only
- ASS and Clopidogrel for 12 months in all patients
Endpoints: - 1° EP: Cardiac death / MI up to 24 months
a) SES vs BMS b) EES vs BMS [c) SES vs EES]
- 2° EP: Late cardiac death / MI (7-24 months) =“safety”
TVR (non-MI-related) =“efficacy”
death, cardiac death, MI, stent thrombosis, MACE
,

7. BASKET-PROVE
Patient Flow Chart
Included into study (n) 2‘314
Randomization to
stent used SES EES BMS
Intention to-treat
population 775 774 765
Protocol violators 7 4 7
Withdrew consent 7* 7* 7*
Lost < 1 year visit 8* 5* 3*
Lost >1<2 year visit 9* 7* 6*
Died < 2 years 21 25 34
2 year complete FU
(97%) 751 755 749
* Censored at time of last contact

8. BASKET-PROVE
Baseline Patient Characteristics
SES EES BMS
n 775 774 765
Male (%) 74 76 77
Age (years) 66±11 66±11 67±11
Diabetes (%) 18 15 14
Hypertension (%) 62 61 65
Hypercholesterol. (%) 61 64 75
Current Smoker (%) 30 34 34
Prior MI (%) 13 10 13
Prior PCI/CABG (%) 16 15 15
Stable Angina (%) 34 35 37
UA/NSTEMI (%) 32 34 32
STEMI (%) 34 31 31
(No significant between group differences)

9. BASKET-PROVE
Baseline Vessel Disease and
Intervention
SES EES BMS
Patients (n) 775 774 765
MV- disease (%) 44 41 43
LAD treated (%) 52 53 52
Bifurcations treated (%) 8 7 9
CTO treated (%) 5 4 5
GP IIb/IIIa blockers (%) 26 28 25
# of stented lesions/pat. 1.4±0,7 1.4±0,6 1.5±0,8
# of stents/patient 1.6±0.9 1.7±1,1 1.7±1,1
total stent length/pat. (mm) 30±20 31±23 31±23
≥ 1 stent ≤ 2,5mm (%) 3 6 6
„Off-label“ use (%) 78 75 75
Les. with ang. Success (%) 98 98 98
(No significant between group differences)

10. BASKET-PROVE
1° EP (Cardiac death/MI) up to
24 Months
SES vs BMS
SES
EES
EES vs BMS
BMS
SES vs EES
NOT adjusted for multiple comparisons, time-dependent p-values !!

11. BASKET-PROVE
2° Endpoints up to 24 Months
Cardiac Death Non fatal MI
Definitive and probable Non-MI related TVR
Stent Thrombosis
Significant after adjustment for multiple comparisons
SES
EES
NOT adjusted for multiple comparisons, time-dependent p-values !! BMS

12. BASKET-PROVE
Cumulative Clinical Events After 2 Years
* p=0.005 SES vs BMS † p=0.009 SES vs BMS
* p=0.002 EES vs BMS † p=0.005 EES vs BMS
%
15
12.9†
p=ns p=ns p=ns p=ns p=ns p=ns
10.3 *
10
7.9
7.6
4.8
4.4 4.3
5 3.7
3.6
3.2 2.9 3.2
2.6 2.6
1.7 1.7 1.7
0.9
0
all-cause cardiac MI Pts. with TVR Pts. with
death death Cardiac death/ MACE
MI
P-values adjusted for multiple testing SES EES BMS

13. BASKET-PROVE
Conclusions
In contemporary stenting of large coronary arteries
> late safety problems of DES could no longer be
confirmed (trend in opposite direction!)
> both DES showed superior efficacy compared
with BMS (TVR reduction >50%)
> no difference in either safety or efficacy was
found between 2nd generation EES and 1st
generation SES (exploratory analysis)

14. BASKET-PROVE
Implications
Findings of BASKET-PROVE imply that in patients
in need of large coronary artery stenting
> DES may be used without evidence of increased late
cardiac events / late stent thrombosis
> Since BMS and DES showed similar death / MI rates
BMS may still be used - however, with a higher TVR-rate
> Since the performance of 1st and 2nd generation DES (SES
and EES) was similar
both DES may be used in these patients

15. BASKET-PROVE
The BASKET-PROVE Centers
(number of patients randomized)
University Hospital Basel,
Gentofte University Hospital, Switzerland (n=496) Cardiocentro Lugano,
Copenhagen, Denmark (n=402) C. Kaiser Switzerland (n=154)
S. Galatius G.Pedrazzini
State Hospital Lucerne, Clara Hospital Basel,
Switzerland (n= 337) Switzerland (n=132)
P. Erne B. Hornig
Triemli Hospital Zürich, Cardiovascular Center
Switzerland (n= 264) Zürich, Switzerland (n=59)
F. Eberli O. Bertel
University Hospital Innsbruck, State Hospital Chur,
Austria (n=199) Switzerland (n= 56)
H. Alber P. Bonetti
State Hospital St. Gallen, Opedale Civile, Legnano,
Switzerland (n=174) Italy (n=41)
H. Rickli PI: M. Pfisterer S. De Servi
Co-PI: C. Kaiser

16. BASKET-PROVE
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