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

Martyn R. Thomas, Ralf Birkemeyer, Peter Schwimmbeck, Victor Legrand, Raul Moreno, Carlo Briguori, Nikos Werner, Ezio Bramucci, Imre Ungi, Gert Richardt, Paul L. Underwood, Keith D. Dawkins

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1267-1271
Number of pages5
JournalEuroIntervention
Volume10
Issue number11
DOIs
Publication statusPublished - Mar 1 2015

Keywords

  • Coronary stenosis
  • Drug-eluting stents
  • Everolimus
  • Observational study

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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