title: One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE).
abstract: OBJECTIVE
  To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinum-chromium TAXUS Element stent in a real-world setting. The PERSEUS Workhorse and Small Vessel studies showed positive results with the TAXUS Element stent in a clinical trial setting.
  
  
  RESULTS
  TE-PROVE was a prospective, open-label, multicentre, "all-comers" study which enrolled 1,014 patients at 37 European sites. Follow-up was at 30 days, six months and one year, and will continue annually up to five years. The primary endpoint was overall and stent-related target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction (MI) and target vessel revascularisation (TVR) at one year post implantation. Secondary endpoints included the components of TVF, all-cause mortality, and ARC definite/probable stent thrombosis. Follow-up was available in 97.3% (987/1,014) of patients. Patients were 75.0% male (760/1,014), mean age was 65.1±10.8 years, 25.5% had medically treated diabetes (259/1,014), and 10.7% (109/1,014) were treated for STEMI. At baseline, mean lesion length among 1,299 treated lesions was 19.8±12.0 mm and mean reference vessel diameter was 3.1±0.5 mm. At one year, the rate of TVF (primary endpoint) was 6.0% (59/987) overall; 3.7% (37/987) of TVF events were stent-related. Cardiac death was 0.7% (7/987), target vessel-related MI was 1.1% (11/987), and TVR was 4.7% (46/987). All-cause death occurred in 1.2% (12/987) of patients and ARC definite/probable ST was 0.5% (5/987).
  
  
  CONCLUSIONS
  The primary endpoint results from the TE-PROVE registry demonstrate good performance and safety for the TAXUS Element paclitaxel-eluting stent at one year in everyday clinical practice.
  
  
  BACKGROUND
  NCT01242696.
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.forename: Ian B A
authors.initials: IB
authors.lastname: Menown
authors.forename: Iván G
authors.initials: IG
authors.lastname: Horváth
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Gilbert
authors.forename: James J
authors.initials: JJ
authors.lastname: Crowley
authors.forename: Paolo
authors.initials: P
authors.lastname: Calabria
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000401:mortality; D002857:Chromium; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D005060:Europe; 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; D017239:Paclitaxel / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation; D010984:Platinum; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012086:Reoperation; D017211:Treatment Failure; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use*
chemical_list: D050257:Tubulin Modulators; D002857:Chromium; D010984:Platinum; D017239:Paclitaxel