Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries: the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination part II (BASKET-PROVE II) trial design.
BACKGROUND
In the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination (BASKET-PROVE), drug-eluting stents (DESs) had similar 2-year rates of death and myocardial infarction but lower rates of target vessel revascularization and major adverse cardiac events compared with bare-metal stents (BMSs). However, comparative clinical effects of newest-generation DES with biodegradable polymers vs second-generation DES or newest-generation BMS with biocompatible coatings, all combined with a prasugrel-based antiplatelet therapy, on 2-year outcomes are not known.


METHODS
In BASKET-PROVE II, 2,400 patients with de novo lesions in native vessels ≥3 mm in diameter are randomized 1:1:1 to receive a conventional DES, a DES with a biodegradable polymer, or a BMS with biocompatible coating. In addition to aspirin, stable patients with BMS will receive prasugrel for 1 month, whereas all others will receive prasugrel for 12 months. The primary end point will be combined cardiac death, nonfatal myocardial infarction, and target vessel revascularization up to 2 years. Secondary end points include stent thrombosis and major bleeding. The primary aim is to test (1) the noninferiority of a biodegradable-polymer DES to a conventional DES and (2) the superiority of both DESs to BMS. A secondary aim is to compare the outcomes with those of BASKET-PROVE regarding the effects of prasugrel-based vs clopidogrel-based antiplatelet therapy.


RESULTS
By the end of 2010, 878 patients (37% of those planned) were enrolled.


CONCLUSIONS
This study will test the comparative long-term safety and efficacy of newest-generation stents on the background of contemporary antiplatelet therapy in a large all-comer population undergoing large native coronary artery stenting.
Department of Cardiology, University Hospital, Basel, Switzerland.
Raban
R
Jeger
Matthias
M
Pfisterer
Hannes
H
Alber
Franz
F
Eberli
Søren
S
Galatius
Christoph
C
Naber
Giovanni
G
Pedrazzini
Hans
H
Rickli
Jan Skov
JS
Jensen
André
A
Vuilliomenet
Nicole
N
Gilgen
Christoph
C
Kaiser
D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control*; D003718:Denmark / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D010879:Piperazines / Q000627:therapeutic use*; D000068799:Prasugrel Hydrochloride; D011446:Prospective Studies; D011474:Prosthesis Design; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use; D015996:Survival Rate / Q000639:trends; D013557:Switzerland / Q000453:epidemiology; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
D010879:Piperazines; D058921:Purinergic P2Y Receptor Antagonists; D013876:Thiophenes; D000068799:Prasugrel Hydrochloride