BASKET-PROVE trial - Summary & Results

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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

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BASKET-PROVE trial - Summary & Results

  1. 1. BASKET-PROVE (Basel Stent Cost-effectiveness Trial—ProspectiveValidation Examination)
  2. 2. BASKET-PROVE (Basel Stent Cost-effectivenessTrial—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. 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. 4. BASKET-PROVE: Commentary*"In contemporaneous stenting of large coronary arteries, late safety problems withdrug-eluting stents could not be confirmed, and there was even a trend in theopposite direction." - Dr Christopher Kaiser"Based on the results, this study is indeed highly reassuring in that the safety issuethat 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, youdont 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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