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Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation
Matthias Pfisterer1, Osmund Bertel, Piero O Bonetti
1Department of Cardiology, University Hospital Basel, Basel, Switzerland. pfisterer@email.ch
Insights
Very late stent thrombosis is hypothesized to occur more often with drug-eluting stents in large coronary vessels. This trial compares Cypher, Vision, and Xience stents to assess safety and efficacy in these patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- A subgroup analysis of the BASKET trial suggested very late stent thrombosis (>12 months) is more common after drug-eluting stent (DES) implantation in large native coronary arteries.
- This observation prompted the hypothesis that DES may pose a higher risk for late stent thrombosis in this specific patient population.
Purpose of the Study:
- To prospectively investigate the hypothesis that very late stent thrombosis predominantly occurs after drug-eluting stent implantation in large native coronary vessels.
- To compare the safety and efficacy of first-generation (Cypher) and second-generation (Xience) DES against cobalt-chromium bare-metal stents (Vision) in patients undergoing large native vessel stenting.
Main Methods:
- An 11-center, 4-country prospective trial randomizing 2260 patients to receive Cypher, Vision, or Xience stents (all ≥3.0 mm).
- Exclusion criteria included left main or bypass graft disease, in-stent restenosis, prior stent thrombosis, need for non-heart surgery, increased bleeding risk, or lack of compliance/consent.
- All patients receive dual antiplatelet therapy for 12 months, with primary endpoints of cardiac death/nonfatal myocardial infarction at 24 months and follow-up up to 5 years.
Main Results:
- As of June 12, 229 patients (10% of the planned total) were enrolled.
- The enrolled patient cohort exhibited baseline risks comparable to the relevant subgroup from the BASKET trial (n=588).
Conclusions:
- The study aims to elucidate the benefits or harms of first- and second-generation DES compared to cobalt-chromium bare-metal stents in patients with large native vessel stenting.
- It will also assess the impact of 12-month versus 6-month dual antiplatelet therapy on outcomes in this low-risk patient group by comparing results with similar BASKET trial patients.
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.
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