1. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.
- Author
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Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, and Dawkins KD
- Subjects
- Aged, Angina, Unstable drug therapy, Cardiovascular Diseases mortality, Coronary Stenosis drug therapy, Europe, Female, Humans, Male, Middle Aged, Myocardial Infarction drug therapy, Myocardial Infarction epidemiology, Myocardial Revascularization statistics & numerical data, Percutaneous Coronary Intervention instrumentation, Product Surveillance, Postmarketing, Reoperation, Angina, Unstable surgery, Antineoplastic Agents therapeutic use, Coronary Stenosis surgery, Drug-Eluting Stents, Everolimus therapeutic use, Myocardial Infarction surgery
- Abstract
Aims: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population., Methods and Results: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent., Conclusions: In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.
- Published
- 2015
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