title: Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions.
  
  
  BACKGROUND
  Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials.
  
  
  METHODS
  The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001).
  
  
  RESULTS
  Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35).
  
  
  CONCLUSIONS
  Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease.
authors: Division of Cardiology, St. Vincent Heart Center of Indiana, Indianapolis, Indiana.
authors: James B
authors: JB
authors: Hermiller
authors: David R
authors: DR
authors: Rutledge
authors: Vivian W
authors: VW
authors: Mao
authors: Weiying
authors: W
authors: Zhao
authors: Jin
authors: J
authors: Wang
authors: Luis
authors: L
authors: Gruberg
authors: William
authors: W
authors: Lombardi
authors: Samin K
authors: SK
authors: Sharma
authors: Mitchell W
authors: MW
authors: Krucoff
mesh_terms: D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D003331:Coronary Vessels / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: 1 year; drug-eluting stent; everolimus; small vessel