Kandzari DE, Rao SV, Moses JW, Dzavik V, Strauss BH, Kutryk MJ, Simonton CA, Garg J, Lokhnygina Y, Mancini GBJ, Yeoh E, Buller CE

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

J Am Coll Cardiol Intv 2009;2:97–106

Coronary artery disease

To test the hypothesis that compared to historical-control patients treated with bare-metal stents (TOSCA-1 study), patients treated with sirolimus-eluting stents have ≥ 50% relative reduction in the 6-month occurrence of angiographic binary restenosis within the treated segment of the target vessel

Open

6 months

402 patients (200 sirolimus-eluting stents, 202 bare-metal stents as historical control), median age 60.3 years (sirolimus-eluting stents) and 57.7 years (historical control), undergoing elective PCI for total coronary occlusion

Sirolimus-eluting stent during PCI, or bare-metal stent during PCI (historical control)

ASA and clopidogrel before PCI, followed by dual antiplatelet therapy and/or clopidogrel. Antithrombin drugs and GP IIb/IIIa inhibitors at the discretion of the physician

The primary endpoint of restenosis within the entire treated segment occurred in 22.6% of patients who received sirolimus-eluting stents and 55.2% of historical control patients receiving bare-metal stents. Compared to the historical-control group, the unadjusted relative reduction in the primary endpoint among the sirolimus-eluting stent group was 59%, the relative reduction adjusted for 5 variables (diabetes, reference vessel diameter, lesion length, age, current smoker status) was 83% (odds ratio 0.17, 95% CI 0.09–0.30; p < 0.0001), and the relative reduction adjusted for 3 variables (diabetes, reference vessel diameter, lesion length) was 84% (odds ratio 0.16, 95% CI 0.09–0.28; p < 0.0001)