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ISCHAEMIC HEART DISEASE
Cypher versus Taxus: the fight continues ▸
The use of sirolimus-eluting and paclitaxel-eluting stents in the treatment of de novo coronary lesions has not been compared in a prospective multicentre study to date. In the REALITY trial, 1386 patients from 90 hospitals across Europe, Latin America and Asia were randomly assigned to receive either a sirolimus-eluting (n = 701) or a paclitaxel-eluting stent (n = 685). All patients had angina pectoris and one or two de novo native coronary artery lesions in vessels of between 2.25–3.00 mm in diameter. Angiographic follow up was performed at eight months and clinical follow up at 12 months. The primary end point was in-lesion binary restenosis (defined as a luminal stenosis of more than 50%) at eight months. Secondary end points included one year rates of target lesion and vessel revascularisation and a composite end point of cardiac death, Q wave or non-Q wave myocardial infarction, coronary artery bypass grafting, or repeat target lesion revascularisation. In-lesion binary restenosis at eight months occurred in 86 patients (9.6%) with a sirolimus-eluting stent and 95 patients (11.1%) with a paclitaxel-eluting stent (relative risk (RR) 0.84, 95% confidence interval (CI) 0.61 to 1.17; p = 0.31). The mean (SD) in-stent late loss was 0.09 (0.43) mm for sirolimus eluting stents versus 0.31 (0.44) mm for paclitaxel-eluting stents (difference, −0.22 mm, 95% CI −0.26 to −0.18 mm; p < 0.001). For sirolimus- versus paclitaxel-eluting stents, respectively, mean in-stent diameter stenosis was 23.1% v 26.7% (p < 0.001) and the number of major adverse cardiac events at one year was 73 (10.7%) v 76 (11.4%) (p = 0.73). The authors conclude that a longer follow up period is needed to see if the difference in late loss between the two stents translates into significant clinical outcomes. However, as an accompanying editorial by Sorin Brener of the Cleveland …