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.
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).
Kandzari
David E
DE
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA. kandzari.david@scrippshealth.org
Rao
Sunil V
SV
Moses
Jeffrey W
JW
Dzavik
Vladimir
V
Strauss
Bradley H
BH
Kutryk
Michael J
MJ
Simonton
Charles A
CA
Garg
Jyotsna
J
Lokhnygina
Yuliya
Y
Mancini
G B John
GB
Yeoh
Eunice
E
Buller
Christopher E
CE
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
D007166:Immunosuppressive Agents; D020123:Sirolimus