http://www.theheart.org/web_slides/1185893.do A study on Basel Stent Cost-effectiveness Trial-Prospective Validation Examination (BASKET-PROVE) Designed to see whether the higher rate of late cardiac events with first-generation drug-eluting stents (DES) vs bare-metal stents seen in BASKET-LATE was real

1. BASKET-PROVE (Basel Stent Cost-
effectiveness Trial—Prospective
Validation Examination)

2. BASKET-PROVE (Basel Stent Cost-effectiveness
Trial—Prospective Validation Examination)
C Kaiser (University Hospital Basel, Switzerland)
American Heart Association 2010 Scientific Sessions
• Designed to see whether the higher rate of late cardiac events with first-
generation drug-eluting stents (DES) vs bare-metal stents seen in BASKET-
LATE was real
• Population and treatment:
2314 patients needing a coronary stent 3.0 mm in diameter or larger
Randomized to either a first-generation sirolimus-eluting stent, a bare-metal
cobalt-chromium stent, or a second-generation everolimus-eluting stent
All were prescribed aspirin and clopidogrel for at least one year postimplant
• Outcomes:
Primary end point: composite of death from cardiac causes or nonfatal MI at
two years
Main secondary end points: late events (seven to 24 months) and target
vessel revascularization (TVR)

3. BASKET-PROVE: Results
• Rates of the primary end point were statistically similar in all three groups:
2.6% in the sirolimus-eluting-stent group, 3.2% in the everolimus-eluting-stent
group, and 4.8% in the bare-metal-stent group
• There were no significant differences in the rates of late events or the rates of
death, MI, or stent thrombosis between any of the groups
• Non-MI-related TVR rates were statistically different between the DES patients and
bare-metal-stent patients (p=0.007), but not between the two DES groups:
3.7% for the sirolimus-eluting-stent group, 3.1% for the everolimus-eluting-stent
group, and 8.9% for the bare-metal-stent group

4. BASKET-PROVE: Commentary*
"In contemporaneous stenting of large coronary arteries, late safety problems with
drug-eluting stents could not be confirmed, and there was even a trend in the
opposite direction."
- Dr Christopher Kaiser
"Based on the results, this study is indeed highly reassuring in that the safety issue
that was noted in BASKET-LATE has not been confirmed here."
- Dr Marco Valgimigli
"[This trial provides evidence] against those who say that in larger vessels, you
don't need drug-eluting stents because TVR is so rare anyway."
- Dr David Holmes
*All comments from BASKET-PROVE: DES as safe as bare-metal stents in larger coronary arteries,
with less TVR (http://www.theheart.org/article/1151317.do)

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