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Drug-eluting or bare-metal stents for large coronary vessel stenting? : the BASKET-PROVE (PROspective Validation Examination) trial : study protocol and design

Pfisterer, M. and Bertel, O. and Bonetti, P. O. and Brunner-La Rocca, H. P. and Eberli, F. R. and Erne, P. and Galatius, S. and Hornig, B. and Kiowski, W. and Pachinger, O. and Pedrazzini, G. and Rickli, H. and De Servi, S. and Kaiser, C. and Basket-Prove, Investigators. (2008) Drug-eluting or bare-metal stents for large coronary vessel stenting? : the BASKET-PROVE (PROspective Validation Examination) trial : study protocol and design. American heart journal, Vol. 155. pp. 609-614.

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Official URL: http://edoc.unibas.ch/dok/A6004240

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Abstract

BACKGROUND: Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitäts Trial (BASKET) outcome data, we hypothesized that very late (< 12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. METHODS: To prove or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with < or = 3.0-mm stents only, randomized to receive Cypher (Johnson ; Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only patients with left main or bypass graft disease, in-stent restenosis or stent thrombosis, in need of nonheart surgery, at increased bleeding risk, without compliance/consent are excluded. All patients are treated with dual antiplatelet therapy for 12 months. The primary end point will be cardiac death/nonfatal myocardial infarction after 24 months with further follow-up up to 5 years. RESULTS: By June 12, 229 patients (10% of the planned total) were included with a baseline risk similar to that of the same subgroup of BASKET (n = 588). CONCLUSIONS: This study will answer several important questions of contemporary stent use in patients with large native vessel stenting. The 2-year death/myocardial infarction-as well as target vessel revascularization-and bleeding rates in these patients with a first- versus second-generation drug-eluting stent should demonstrate the benefit or harm of these stents compared to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12- versus 6-month dual antiplatelet therapy on these outcomes.
Faculties and Departments:03 Faculty of Medicine > Departement Biomedizin > Further Research Groups at DBM > Signal Transduction (Resink/Erne)
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Kardiologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Kardiologie
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Ehemalige Einheiten Medizinische Fächer (Klinik) > Kardiologie (Pfisterer)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Ehemalige Einheiten Medizinische Fächer (Klinik) > Kardiologie (Pfisterer)
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Kardiologie > Kardiologie (Buser)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Kardiologie > Kardiologie (Buser)
UniBasel Contributors:Buser, Peter and Pfisterer, Matthias E. and Kaiser, Christoph A. and Erne, Paul and Brunner, Hanspeter
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:C.V. Mosby
ISSN:0002-8703
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:23 May 2014 08:34
Deposited On:23 May 2014 08:34

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