Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: study protocol and design.
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.
Pfisterer
Matthias
M
Department of Cardiology, University Hospital Basel, Basel, Switzerland. pfisterer@email.ch
Bertel
Osmund
O
Bonetti
Piero O
PO
Brunner-La Rocca
Hans Peter
HP
Eberli
Franz R
FR
Erne
Paul
P
Galatius
Soeren
S
Hornig
Burkhard
B
Kiowski
Wolfgang
W
Pachinger
Otmar
O
Pedrazzini
Giovanni
G
Rickli
Hans
H
De Servi
Stefano
S
Kaiser
Christoph
C
D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size; D015607:Stents