Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design
2008; Elsevier BV; Volume: 155; Issue: 4 Linguagem: Inglês
10.1016/j.ahj.2007.11.011
ISSN1097-6744
AutoresMatthias Pfisterer, Osmund Bertel, Piero O. Bonetti, Hans‐Peter Brunner‐La Rocca, Franz R. Eberli, Paul Erné, S. Galatius, Burkhard Hornig, Wolfgang Kiowski, Otmar Pachinger, Giovanni Pedrazzini, Hans Rickli, Stefano De Servi, Christoph Kaiser,
Tópico(s)Acute Myocardial Infarction Research
ResumoBased 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. To prove or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with ≥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. 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). 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.
Referência(s)