This study aimed to compare 1st and 2nd generation drug-eluting stents (DES) to bare-metal stents (BMS) in large vessel stenting. The BASKET-PROVE trial randomized over 2,300 patients to receive either a 1st generation sirolimus-eluting stent (SES), a 2nd generation everolimus-eluting stent (EES), or a BMS. The primary endpoint was a composite of cardiac death and myocardial infarction up to 2 years. The study found that both DES were superior to BMS in reducing the risk of the primary endpoint and repeat revascularization, with no significant differences between the DES. Late safety concerns about DES were not confirmed. The

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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