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Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk. BAsel Stent Kosten Effektivitäts Trial - PROspective Validation examination (BASKET-PROVE)

English title Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk. BAsel Stent Kosten Effektivitäts Trial - PROspective Validation examination (BASKET-PROVE)
Applicant Kaiser Christoph
Number 116382
Funding scheme Project funding (Div. I-III)
Research institution Klinik für Kardiologie Bereich Medizin Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Clinical Cardiovascular Research
Start/End 01.04.2007 - 31.03.2010
Approved amount 260'000.00
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Keywords (6)

stent; stent thrombosis; angioplasty; coronary disease; restenosis; risk factors

Lay Summary (English)

Lead
Lay summary
1. BackgroundDrug-eluting stents (DES) are more effective than bare-metal stents (BMS) in reducing restenosis and related target vessel revascularization (TVR), mainly by limiting intimal hyperplasia with similar rates in death or non-fatal myocardial infarction (MI). However, there is growing concern that delayed endothelialization, incomplete neointimal healing or hypersensitivity reactions after DES implantation may lead to MI and death due to late stent thrombosis. In the prospective BASKET and BASKET-LATE trial. we were able to identify an excess in late cardiac death/non-fatal myocardial infarction (MI) in patients treated with DES compared to those treated with BMS. Therefore, there is a current debate, which patients should be treated safely and effectively with DES and in which ones a BMS may still be preferred in everyday practice. A more profound analysis of subgroups benefiting from DES we performed based on the overall BASKET/BASKET-LATE data. We suggested that patients with small vessel (<3,0 mm) and bypass graft stenting had a highly significant benefit of DES, not only in reduction of target vessel revascularization (TVR), but also in a reduced rate of cardiac death/non-fatal MI. In contrast, patients with large native vessel stenting seemed to have no benefit of DES and may even have late harm 2. Working Hypothesis and specific aims These recent findings and analyses are the basis for two relevant questions which will be addressed prospectively in BASKET-PROVE. The aims of BASKET-PROVE are therefore: 1) to validate findings of BASKET/BASKET-LATE and 2) to evaluate whether a stent with a lower drug-dose does not carry the same risk of late harm as a standard first generation DES.3. Experimental design / methodsProspective randomised multicenter trial with inclusion of 2000 “real world patients” (all comers, 24 hours a day, 7 days a week, irrespective of indication for PCI) with the need for large (?3,0 mm stents only) vessel stenting during 1 year. Randomization will be: A 1:1 to Cypher® (standard 1st generation DES versus Vision® (3rd generation cobalt-chromium BMS) and B) :1 to Xience® (DES with a lower dose of a “limus”-drug). 24, 36 and 60 month- follow-up for late clinical events will be clinical by questionnaire with no “routine” follow-up angiography allowed.4. Expected value of the proposed project If findings of the retrospective analysis of BASKET/BASKET-LATE are verified by this prospective study, then 1st generation DES should no longer be used in large native vessel stenting. This would reduce the late harm which includes late cardiac death, which is most relevant in view of the >6 million DES implanted per year worldwide today. The 2nd part of the study will help to understand the mechanisms of late stent thrombosis: if late clinical events related to late stent thrombosis do no longer occur with 2nd generation DES using a lower drug-dose, then late stent thrombosis is most likely due to theamount of drugs used. - Thus, these findings should have major impact on the current use of coronary stents and our understanding of possible reasons for late stent thrombosis.
Direct link to Lay Summary Last update: 21.02.2013

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Associated projects

Number Title Start Funding scheme
120029 BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous graft Angioplasty using Glycoprotein IIb/IIIa receptor inhibitors and drug-Eluting stents 01.04.2008 Project funding (Div. I-III)
140956 BAsel Stent Kosten Effektivitäts Trial - Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) 01.04.2012 Project funding (Div. I-III)

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