摘要
The aim of this study was to establish safety and feasibility of oral Rapamyci n at two doses -2 mg and 5 mg -in achieving low rates of repeat target lesion revascularization (TLR) in de novo native coronary artery lesions. Drug eluting stents have shown the ability to limit restenosis. Oral Rapamycin is an alterna tive strategy that can target multiple coronary lesions suitable for treatment w ith any approvedmetal stent and at potentially lower cost. The Oral Rapamune to Inhibit Restenosis (ORBIT) study is an open label study of 60 patients with de novo lesions treated with bare metal stents in up to two vessels. After a loadin g dose of 5 mg, patients received a daily dose of 2 mg (n=30) and 5 mg(n=30) for 30 days. Six month angiographic, intravascular ultrasound(IVUS), and clinical follow up were conducted. Baseline clinical and procedural characteristics were similar: 10%of patients in the 2-mg group and 30%in the 5-mg group did not complete the course; 43%in the 2-mg group and 66%in the 5-mg group had side effects. At six month follow up, late loss (0.6 ±0.5 mm vs. 0.7 ±0.5 mm; p=N S), in stent binary restenosis (7.1%vs. 6.9%; p=NS), in stent percent volume obstruction by IVUS (29%vs. 24%; p=NS), and clinically driven TLR (14.3%vs. 6.9%; p=NS) were similar in 2-mg and 5-mg groups. Oral Rapamycin for the prev ention of restenosis is safe, feasible, and associated with low rates of repeat revascularization. Although associated with certain side effects, it may be cons idered for patients undergoing multivessel stents if proven in larger randomized studies.
The aim of this study was to establish safety and feasibility of oral Rapamyci n at two doses -2 mg and 5 mg -in achieving low rates of repeat target lesion revascularization (TLR) in de novo native coronary artery lesions. Drug eluting stents have shown the ability to limit restenosis. Oral Rapamycin is an alterna tive strategy that can target multiple coronary lesions suitable for treatment w ith any approvedmetal stent and at potentially lower cost. The Oral Rapamune to Inhibit Restenosis (ORBIT) study is an open label study of 60 patients with de novo lesions treated with bare metal stents in up to two vessels. After a loadin g dose of 5 mg, patients received a daily dose of 2 mg (n=30) and 5 mg(n=30) for 30 days. Six month angiographic, intravascular ultrasound(IVUS), and clinical follow up were conducted. Baseline clinical and procedural characteristics were similar: 10%of patients in the 2-mg group and 30%in the 5-mg group did not complete the course; 43%in the 2-mg group and 66%in the 5-mg group had side effects. At six month follow up, late loss (0.6 ±0.5 mm vs. 0.7 ±0.5 mm; p=N S), in stent binary restenosis (7.1%vs. 6.9%; p=NS), in stent percent volume obstruction by IVUS (29%vs. 24%; p=NS), and clinically driven TLR (14.3%vs. 6.9%; p=NS) were similar in 2-mg and 5-mg groups. Oral Rapamycin for the prev ention of restenosis is safe, feasible, and associated with low rates of repeat revascularization. Although associated with certain side effects, it may be cons idered for patients undergoing multivessel stents if proven in larger randomized studies.
