title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors: Guy's and St. Thomas' National Health Service Foundation Trust, London, United Kingdom.
authors: Martyn R
authors: MR
authors: Thomas
authors: Ralf
authors: R
authors: Birkemeyer
authors: Peter
authors: P
authors: Schwimmbeck
authors: Victor
authors: V
authors: Legrand
authors: Raul
authors: R
authors: Moreno
authors: Carlo
authors: C
authors: Briguori
authors: Nikos
authors: N
authors: Werner
authors: Ezio
authors: E
authors: Bramucci
authors: Imre
authors: I
authors: Ungi
authors: Gert
authors: G
authors: Richardt
authors: Paul L
authors: PL
authors: Underwood
authors: Keith D
authors: KD
authors: Dawkins
mesh_terms: D000368:Aged; D000789:Angina, Unstable / Q000188:drug therapy / Q000601:surgery*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality; D023921:Coronary Stenosis / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation; D011358:Product Surveillance, Postmarketing; D012086:Reoperation
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus