title: The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions.
abstract: OBJECTIVE
  The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy.
  
  
  BACKGROUND
  Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients.
  
  
  METHODS
  The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success).
  
  
  RESULTS
  At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year.
  
  
  CONCLUSIONS
  Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials.
authors.affiliation: Department of Cardiology, University Hospital Bonn, Bonn, Germany. grubee@aol.com
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Peter
authors.initials: P
authors.lastname: Smits
authors.forename: Vladimir
authors.initials: V
authors.lastname: Džavík
authors.forename: Tejas M
authors.initials: TM
authors.lastname: Patel
authors.forename: Ajit S
authors.initials: AS
authors.lastname: Mullasari
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Marrianne
authors.initials: M
authors.lastname: Stuteville
authors.forename: Cécile
authors.initials: C
authors.lastname: Dorange
authors.forename: Upendra
authors.initials: U
authors.lastname: Kaul
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001208:Asia; D002170:Canada; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013019:South Africa; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus