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Sirolimus-Eluting Stents Offer Reduced Rates of Restenosis Over Standard Stents Among Patients With Complex Coronary Lesions

Patients treated with sirolimus-eluting stents, compared to those treated with standard stents, had reduced rates of restenosis and associated clinical events, researchers report.

"In comparison with previous studies of sirolimus-eluting stents, our trial enrolled patients with more challenging conditions, including a higher frequency of cardiac risk factors, more complex lesion morphology, and longer lesions," writes Jeffrey W. Moses, MD, Lenox Hill Heart and Vascular Institute of New York, United States and colleagues. Their double-blind trial, which compared sirolimus-eluting stents with identical looking standard stents, analysed outcomes of 1058 patients with a newly diagnosed lesion in a native coronary artery for failure of the target vessel within 270 days after percutaneous coronary revascularisation.

Overall, the patients (71% male) were a mean age of 62.3 years, and 31% had previous myocardial infarction, 26% had diabetes, 74% had hyperlipidaemia, 68% had hypertension, and 20% were current smokers. Cardiac symptoms included exertional angina in 58%, angina while at rest in 23% and unstable angina in 53%. The mean lesion length of the overall group was 14.4 mm, the average reference-vessel diameter was 2.80 mm, and 56% of the treated lesions were class B2 or C according to the American College of Cardiology-American Heart Association classification. The investigators randomised 533 patients to receive the sirolimus-eluting stent and 525 to receive the standard stent. There were no significant differences in the frequency of cardiac risk factors between treatment groups.

Follow-up angiographic data available for 350 patients in the sirolimus group and 353 in the standard group showed that the frequency of binary in-stent restenosis, defined as stenosis of at least 50% of the luminal diameter, was 3.2% in the sirolimus group compared with 35.4% in the standard group. The frequency of in-segment restenosis was 8.9% in the sirolimus group and 36.3% in the standard group.

Any major adverse cardiac event was reported in 2.4% of the sirolimus group compared with 1.5% of the standard group while in-hospital but by 270 days of follow up the frequency of any major adverse cardiac event was 7.1% in the sirolimus group and 18.9% in the standard group. Target-vessel failure at 270 days post treatment occurred in 8.6% of the sirolimus treated patients compared with 21% of the patients treated with the standard stent. The rates of angiographic restenosis and target-lesion revascularisation were also significantly reduced in the sirolimus-stent treated patients with diabetes and the smallest vessels.

"The results of our clinical trial demonstrate that the sirolimus-eluting stent has achieved the delicate balance of preserved safety and improved efficacy," the authors conclude.

N Engl J Med 2003;349:1315-23.

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