title: Clinical and angiographic outcomes with sirolimus-eluting stents in total coronary occlusions: the ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) trial.
abstract: OBJECTIVE
  We sought to examine angiographic and clinical outcomes with sirolimus-eluting stents (SES) in total coronary occlusion (TCO) revascularization.
  
  
  BACKGROUND
  Despite evaluation of drug-eluting stents beyond approved indications, few studies have evaluated their clinical benefit in TCO revascularization.
  
  
  METHODS
  Among 15 centers in North America, 200 consecutive TCO patients (78.8% >6 weeks TCO age) were enrolled for treatment with SES. The primary end point was 6-month angiographic binary restenosis within the treated segment.
  
  
  RESULTS
  Patient characteristics included: diabetes, 24.5%; prior infarction, 33.5%; and stent length, 45.9 mm median (quartile 1, 30.2 mm; quartile 2, 62.1 mm). A total of 199 patients (99.5%) were treated with SES, and procedural success was 98.0%. The 6-month binary restenosis rates were 9.5% in-stent, 12.4% in-segment, and 22.6% in-"working length" representing the entire treatment segment. Rates of 1-year target lesion revascularization, myocardial infarction, and target vessel failure were 9.8%, 1.0%, and 10.9%, respectively. Stent thrombosis occurred in 2 patients (1.0%). Using logistic regression modeling with propensity score adjustment, the absolute reduction in binary restenosis with SES compared with a historical bare-metal stent control was 37.7% (95% confidence interval [CI]: 27.2% to 48.3%, p < 0.001; odds ratio: 0.17, 95% CI: 0.09 to 0.30, p < 0.0001). Among 32 patients (16%) identified with stent fracture, target lesion revascularization was more common than patients without fracture (25.0% vs. 6.7%, p = 0.005).
  
  
  CONCLUSIONS
  Despite greater lesion complexity than prior TCO trials, percutaneous revascularization with SES appears safe and results in substantial reductions in angiographic restenosis and failed patency and a low rate of repeat revascularization. These findings support the use of SES in TCO revascularization. (The ACROSS/TOSCA Trial; NCT00378612).
authors.affiliation: Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA. kandzari.david@scrippshealth.org
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Vladimir
authors.initials: V
authors.lastname: Dzavik
authors.forename: Bradley H
authors.initials: BH
authors.lastname: Strauss
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kutryk
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
authors.forename: Jyotsna
authors.initials: J
authors.lastname: Garg
authors.forename: Yuliya
authors.initials: Y
authors.lastname: Lokhnygina
authors.forename: G B John
authors.initials: GB
authors.lastname: Mancini
authors.forename: Eunice
authors.initials: E
authors.lastname: Yeoh
authors.forename: Christopher E
authors.initials: CE
authors.lastname: Buller
mesh_terms: D000368:Aged; D016001:Confidence Intervals; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy; D023903:Coronary Restenosis / Q000188:drug therapy / Q000628:therapy*; D003331:Coronary Vessels / Q000187:drug effects* / Q000473:pathology; D054855:Drug-Eluting Stents; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D014654:Vascular Patency
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus