Author + information
- Received August 26, 2008
- Revision received September 30, 2008
- Accepted October 10, 2008
- Published online February 1, 2009.
- 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††,
- ACROSS/TOSCA-4 Investigators
- ↵⁎Reprint requests and correspondence:
Dr. David E. Kandzari, S1056, 10666 North Torrey Pines Road, La Jolla, California 92037
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).
Study support provided by Cordis Corporation, Warren, New Jersey (investigational device exemption number G040213). Following protocol development and trial enrollment, Dr. Kandzari later became an employee of the Cordis Corporation, a Johnson & Johnson Company. At the time of manuscript submission, he is no longer employed with Cordis, Johnson & Johnson and has no financial or equity conflict. Dr. Simonton is employed by Abbott Vascular Inc. since trial completion. Dr. Dzavik receives research grant support from the Cordis Corporation.
- Received August 26, 2008.
- Revision received September 30, 2008.
- Accepted October 10, 2008.
- American College of Cardiology Foundation