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

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).

• Authors: David E Kandzari, Sunil V Rao, Jeffrey W Moses, Vladimir Dzavik, Bradley H Strauss, Michael J Kutryk, Charles A Simonton, Jyotsna Garg, Yuliya Lokhnygina, G B John Mancini, Eunice Yeoh, Christopher E Buller, ACROSS/TOSCA-4 Investigators
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 2 Issue 2 Pg. 97-106 (Feb 2009) ISSN: 1876-7605 [Electronic] United States
• PMID: 19463409 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Immunosuppressive Agents
• Sirolimus

Topics

• Aged
• Confidence Intervals
• Coronary Angiography
• Coronary Artery Disease (drug therapy, metabolism, therapy)
• Coronary Restenosis (drug therapy, therapy)
• Coronary Vessels (drug effects, pathology)
• Drug-Eluting Stents
• Female
• Health Status Indicators
• Humans
• Immunosuppressive Agents (therapeutic use)
• Logistic Models
• Male
• Middle Aged
• Odds Ratio
• Prospective Studies
• Sirolimus (therapeutic use)
• Vascular Patency