Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Sep 28, 2011

Keywords

ClinConnect Summary

Background

Coronary artery stents have improved the safety and efficacy of percutaneous coronary interventions compared with balloon angioplasty alone (New Engl J Med 1994; 331:489-495). Notwithstanding, restenosis is still encountered in 20 to 30% of lesions after implantation of bare metal stents (JAMA 2000; 284:1828-36) and may require repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents with local, controlled release of therapeutic agents have addressed this problem successfully (Circulation 2003; 107:3003-7). C...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS
• • Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents
• • No limitation on the number of treated lesions, and vessels, and lesion length
• • Exclusion Criteria
• • Pregnancy
• • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material
• • Inability to provide informed consent
• • Currently participating in another trial before reaching first endpoint
• • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period