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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

David E. Kandzari, MD, FACC^_*,_*, Sunil V. Rao, MD, FACC, Jeffrey W. Moses, MD, FACC, Vladimir Dzavik, MD, FACC, Bradley H. Strauss, MD, PhD, FACC^||, Michael J. Kutryk, MD, FACC^¶, Charles A. Simonton, MD, FACC^#, Jyotsna Garg, MS, Yuliya Lokhnygina, PhD, G.B. John Mancini, MD, FACC^_**, Eunice Yeoh, BSc^_**, Christopher E. Buller, MD, FACC for the ACROSS/TOSCA-4 Investigators

^_* Scripps Clinic, Division of Cardiovascular Diseases, La Jolla, California
Duke Clinical Research Institute, Durham, North Carolina
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
University Health Network, University of Toronto, Toronto, Ontario, Canada
^|| Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
^¶ Roy and Ann Foss Interventional Cardiology Program, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
^# Carolinas Medical Center, Charlotte, North Carolina
^_** University of British Columbia, Vancouver, British Columbia, Canada
Vancouver Health Sciences Center, Vancouver, British Columbia, Canada

^_* Reprint requests and correspondence: Dr. David E. Kandzari, S1056, 10666 North Torrey Pines Road, La Jolla, California 92037 (Email: kandzari.david{at}scrippshealth.org).

Objectives: 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).

Key Words: total coronary occlusion • sirolimus-eluting stent • drug-eluting stent • fracture

Abbreviations and Acronyms   DES = drug-eluting stent(s)   SES = sirolimus-eluting stent(s)   TCO = total coronary occlusion(s)   TLR = target lesion revascularization

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