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Cardiovasc Revasc Med ; 19(4): 429-432, 2018 06.
Article in English | MEDLINE | ID: mdl-29174500

ABSTRACT

OBJECTIVES: To report long-term results of a novel sirolimus-eluting stent with biodegradable polymer BACKGROUND: Newer generation drug-eluting stents are characterized by thin struts, improved platform design and highly biocompatible polymer carrying the antiproliferative drug. The RapstromTM stent, sharing these features, showed promising outcomes in preclinical models and in a first-in-man trial. METHODS: The present study is a multicenter, non-randomized post-market registry, including patients with de novo coronary artery disease treated with implantation of one or more Rapstrom stents. Primary endpoint of the study was the rate of major adverse cardiac events (MACE) at three-year follow-up. RESULTS: 1073 patients were enrolled, with a high prevalence of diabetes (35%) and acute coronary syndrome at presentation (82%); at three-year follow up, MACE rate was 14.8%, with a low incidence of definite or probable stent thrombosis (0.75%). CONCLUSIONS: These data confirm the good clinical performance of the Rapstrom stent, supporting the concept that the combination of thin struts and biodegradable polymer is associated with positive clinical outcomes.


Subject(s)
Absorbable Implants , Acute Coronary Syndrome/surgery , Cardiovascular Agents/administration & dosage , Coronary Stenosis/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Sirolimus/administration & dosage , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/epidemiology , Cardiovascular Agents/adverse effects , Comorbidity , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/epidemiology , Coronary Thrombosis/epidemiology , Humans , Incidence , Percutaneous Coronary Intervention/adverse effects , Prevalence , Product Surveillance, Postmarketing , Prosthesis Design , Registries , Risk Factors , Sirolimus/adverse effects , Time Factors , Treatment Outcome
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