Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design Matthias Pfisterer, MD, FACC, FESC, FAHA, a Osmund Bertel, MD, b Piero O. Bonetti, MD, c Hans Peter Brunner-La Rocca, MD, a Franz R. Eberli, MD, d Paul Erne, MD, e Soeren Galatius, MD, f Burkhard Hornig, MD, g Wolfgang Kiowski, MD, b Otmar Pachinger, MD, h Giovanni Pedrazzini, MD, i Hans Rickli, MD, j Stefano De Servi, MD, k and Christoph Kaiser, MD a for the BASKET-PROVE Investigators l Basel, Zuerich, Chur, Lucerne, Lugano, Switzerland; Copenhagen, Denmark; Innsbruck, Austria; and Legnano, Italy Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitäts Trial (BASKET) outcome data, we hypothesized that very late (N12 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 ≥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. (Am Heart J 2008;155:609-14.) The BASKET-LATE 1 was the first study to observe in a prospective manner an excess of late clinical events related to late stent coronary thrombosis in patients treated with drug-eluting stents (DES) compared to those with bare-metal stents (BMS). In the meantime, this observation has been confirmed in a pooled analysis of the pivotal DES trials, 2 in a meta-analysis of available prospective randomized trials, 3 and in large registries. 4,5 In most of these reports looking retrospectively for late stent thrombosis, only angiographically proven events were classified as late stent thrombosis underestimating the actual number of thrombotic events because not all patients with events were catheterized and the data were not collected prospectively. To uniformly define late stent thrombosis–related events, the Academic Research Con- sortium has proposed specific definitions for late From the a Department of Cardiology, University Hospital Basel, Basel, Switzerland, b Department of Cardiology, Im Park Hospital, Zuerich, Switzerland, c Department of Cardiology, State Hospital, Chur, Switzerland, d Department of Cardiology, Triemli Hospital, Zuerich, Switzerland, e Department of Cardiology, State Hospital Lucerne, Lucerne, Switzerland, f Department of Cardiology, Gentofte University Hospital, Copenha- gen, Denmark, g Department of Cardiology, St Clara Hospital, Basel, Switzerland, h Department of Cardiology, University Hospital, Innsbruck, Austria, i Department of Cardiology, Cardio Centro, Lugano, Switzerland, j Department of Cardiology, State Hospital St Gallen, St Gallen, Switzerland, and k Department of Cardiology, Ospedale Civile, Legnano, Italy. l The BAsel Stent Kosten-Effektivitäts Trial- PROspective Validation Examination (BASKET- PROVE) Investigators are listed in Appendix A. Submitted September 7, 2007; accepted November 9, 2007. Reprint requests: Matthias Pfisterer, MD, FACC, FESC, FAHA, Department of Cardiology, University Hospital, CH-4031 Basel, Switzerland. E-mail: pfisterer@email.ch 0002-8703/$ - see front matter © 2008, Mosby, Inc. All rights reserved. doi:10.1016/j.ahj.2007.11.011