Cypher More Effective for Long Lesions
The rate of in-segment restenosis was 77% lower among patients with long native coronary lesions treated with sirolimus-eluting stents (Cypher, Cordis/Johnson & Johnson) compared with patients treated with paclitaxel-eluting stents (Taxus, Boston Scientific).
Results of the LONG-DES II trial were presented by Seung-Jung Park, MD, an interventional cardiologist at the University of Ulsan College of Medicine in South Korea.
At six-month follow-up, patients in the sirolimus-eluting stent arm had a 3.3% rate of in-segment restenosis compared with 14.6% in the paclitaxel-eluting stent group (P < .0001) (see Figure).
The binary restenosis rate was also significantly lower in the sirolimus-eluting stent group in all locations except the proximal edge.
Angiographic results
Minimal lumen diameter and diameter stenosis were both significantly better in the sirolimus-eluting stent group at six-month angiographic follow-up. In-segment minimal lumen diameter was 2.13 mm in the sirolimus-eluting stent group and 1.87 mm in the paclitaxel-eluting stent group (P < .001). Diameter stenosis in-segment was 20.1% in the sirolimus-eluting stent group and 31.4% in the paclitaxel-eluting stent group (P < .001).
Clinical outcomes
Clinical follow-up was performed at nine months. Rates of death and myocardial infarction did not differ significantly between the two groups. However, target lesion revascularization was significantly lower in the sirolimus-eluting stent group at 2.4%, compared with 7.2% in the paclitaxel-eluting stent group (P = .012). Similarly, target vessel revascularization was 3.2% in the sirolimus-eluting stent group vs. 7.6% in the paclitaxel-eluting stent group (P = .03).
Researchers conducted several subgroup analyses to assess the impact of factors such as diabetes mellitus and multiple stents on angiographic restenosis and found no significant effect. “In all subgroup analyses, Cypher was better,” Park said.
Trial design
LONG-DES I had suggested a benefit with sirolimus over paclitaxel. The LONG-DES II trial enrolled 500 patients from five clinical centers in South Korea.
Patients had coronary lesions at least 25 mm in length. They were randomized in a one-to-one ratio to receive either sirolimus-eluting stents or paclitaxel-eluting stents.
All patients received aspirin at 200 mg daily and clopidogrel (Plavix, Sanofi/Synthelabo) at a loading dose of 300 mg followed by 75 mg daily.
The mean age of the patient cohort was approximately 61 years, and about 65% were men. Hypertension was present in more than half of the cohort and diabetes mellitus was noted in about one - third.
Clinicians treated the left anterior descending lesion about 60% of the time. There was a near 100% device success rate in both groups.
The mean length of the stented segment was approximately 41 mm in both groups, and clinicians used a mean of 0.86 stents per patient.
Angiographic follow-up was available for between 82% and 84% of the patients, and clinical follow-up was available for 98% to 99.6% in both groups.