Background and Objectives: In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional cutting balloon angioplasty(CBA) for the treatment of patients with in-stent restenosis. This study is designed to assess if drug-eluting stent is a more effective treatment of instent restenosis than conventional CBA. Methods: Randomized trial conducted among 104 patients with angiographically significant in-stent restenosis in 3 tertiary centers from January 1, to December 31, 2004. Interventions After pretreatment with 100 mg of aspirin plus 75 mg of clopidogrel for at least 3 days before intervention, all patients were randomly assigned to 1 of 2 treatment groups: sirolimus stent, or cutting balloon angioplasty (40 patients, 42 lesions in sirolimus and 64, 70 lesions in CBA group). Main Outcome Measures: Primary end point: angiographic restenosis (diameter stenosis ���50%) at 6-month follow-up angiography based on ���in-segment��� analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups. Results: Follow-up angiography was performed in 94 (90%) of 104 patients and 102 (91%) of 112 lesions. The incidence of angiographic restenosis was 26.6% (17/64) in the cutting balloon angioplasty group, 7.9% (3/38) in the sirolimus stent group (P=.032). When compared with sirolimus stent, receiving a CBA had a relative risk (RR) of angiographic restenosis of 4.22 (95% confidence interval [CI], 1.15-15.53). The incidence of target vessel revascularization was 15.6% (10/64) in the CBA group, 0% (0/40) in the sirolimus stent group.
Conclusions: In patients with in-stent restenosis, a strategy based on sirolimus-eluting stent is superior to conventional CBA for the prevention of recurrent restenosis.