The ‘all comer’ Coroflex Please drug-eluting stent registry in Europe and Asia – An overall and transcontinental assessment of the 10-month major adverse cardiac events
| Autor: | Matthias Waliszewski, Matthias Leschke, Vo T. Nhan, Vladimir A. Ivanov, Panicos Avraamides, André Schneider, Damras Tresukosol, Martin Unverdorben, Vicente Palacios, Iván Horváth |
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| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Male
medicine.medical_specialty lcsh:Diseases of the circulatory (Cardiovascular) system Asia Time Factors Medical device Myocardial ischemia medicine.medical_treatment Treatment outcome Myocardial Infarction Myocardial Ischemia lcsh:Surgery Comorbidity MACE Prosthesis Design Risk Assessment law.invention Percutaneous coronary intervention Randomized controlled trial law Humans Medicine Prospective Studies Registries Aged Chi-Square Distribution business.industry Coronary Thrombosis Incidence Drug-Eluting Stents lcsh:RD1-811 Middle Aged medicine.disease Europe Treatment Outcome Risk factors Drug-eluting stent lcsh:RC666-701 Emergency medicine Original Article Female Medical emergency Cardiology and Cardiovascular Medicine business Risk assessment Mace Predictor |
| Zdroj: | Indian Heart Journal, Vol 64, Iss 5, Pp 453-461 (2012) |
| ISSN: | 0019-4832 |
| Popis: | Background: Randomized trials assess the potential of a medical device in well defined indications while “all comer studies” reveal the device performance in the real clinical environment. Aims: This ‘all comers’ registry assessed the 10-month outcome of the Coroflex® Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events. Methods: The Coroflex® Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses. Results: Of the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p |
| Databáze: | OpenAIRE |
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