The 'all comer' coroflex please drug-eluting stent registry in europe and asia e an overall and transcontinental assessment of the 10-month major adverse cardiac events

Matthias Leschke, Vo Thanh Nhan, Matthias Waliszewski, Vicente Palacios, Iván Horváth, Vladimir A. Ivanov, Damras Tresukosol, Panicos Avraamides, André Schneider, Martin Unverdorben

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Abstract

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 signifi- cantly 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 < 0. 001) driven by a six times higher TLR rate.

Original languageEnglish
Pages (from-to)453-461
Number of pages9
JournalIndian Heart Journal
Volume64
Issue number5
DOIs
Publication statusPublished - Sep 2012

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Keywords

  • Drug-eluting stent
  • MACE
  • Percutaneous coronary intervention
  • Predictor
  • Risk factors

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Leschke, M., Nhan, V. T., Waliszewski, M., Palacios, V., Horváth, I., Ivanov, V. A., Tresukosol, D., Avraamides, P., Schneider, A., & Unverdorben, M. (2012). The 'all comer' coroflex please drug-eluting stent registry in europe and asia e an overall and transcontinental assessment of the 10-month major adverse cardiac events. Indian Heart Journal, 64(5), 453-461. https://doi.org/10.1016/j.ihj.2012.08.002