Sirolimus and Paclitaxel Coronary Stents Compared in Clinical Practice

January 1, 2011—In Catheterization and Cardiovascular Interventions, Niklas Millauer, MD, et al published findings from a study that sought to compare the long-term clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in routine clinical practice (2011;77:5–12).

The background of the study is that although SES have been shown to more effectively reduce neointimal hyperplasia than PES, uncertainty prevails whether this difference translates into differences in clinical outcomes outside randomized controlled trials with selected patient populations and protocol-mandated angiographic follow-up.

As detailed by the investigators, the study was composed of 904 consecutive patients who underwent implantation of a drug-eluting stent between May 2004 and February 2005. Of these, 467 patients with 646 lesions received SES, and 437 patients with 600 lesions received PES. Clinical follow-up was obtained at 2 years without intervening routine angiographic follow-up. The primary endpoint was a composite of death, myocardial infarction (MI), and target vessel revascularization.

At 2 years, the primary endpoint was less frequent with SES (12.9%) than PES (17.6%, HR = 0.7; 95% CI, 0.5–0.98; P = .04). The difference in favor of SES was largely driven by a lower rate of target lesion revascularization (TLR; 4.1% vs 6.9%; P = .05), whereas rates of death (6.4% vs 7.6%; P = .49), MI (1.9% vs 3.2%; P = .21) and definite stent thrombosis (0.6% vs 1.4%; P = .27) were similar for both stent types. The benefit regarding reduced rates of TLR was significant in nondiabetic patients (3.6% vs 7.1%; P = .04) but not in diabetic patients (5.6% vs 6.1%; P = .8), according to the study.

The investigators concluded that SES more effectively reduced the need for repeat revascularization procedures than PES when used in routine clinical practice. They noted that the beneficial effect is maintained up to 2 years and may be less pronounced in diabetic patients.