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Oral Treatment of Restenosis - ORAR II
Description:
The goal of the trial was to evaluate treatment with oral rapamycin in patients undergoing bare metal stenting of de novo native coronary lesions.
Study Design
Study Design:
Patients Enrolled: 100
Mean Follow Up: 1 year
Mean Patient Age: Mean age 65 years
Female: 9
Patient Populations:
De novo coronary lesion in native artery
Primary Endpoints:
Binary restenosis and late loss at angiographic follow-up
Secondary Endpoints:
Target lesion revascularization, target vessel revascularization,
Drug/Procedures Used:
Following coronary stenting, patients were treated with oral rapamycin 3 mg/day plus diltiazem 180 mg (n=50) or control (n=50). The same stent design was used in all patients. Patients underwent angiographic follow-up. The trial was conducted in Argentina.
Principal Findings:
Baseline characteristics were well-balanced between the groups, with an LAD lesions in 40% of the control group and 53% of the rapamycin group. The primary endpoint of late lumen loss on angiographic follow-up was lower in the oral rapamycin group (0.66 mm vs 1.13 mm, p=0.0002), as was the co-primary endpoint of binary restenosis (11.6% vs 45.4%, p=0.001). The rapamycin group also had larger in-segment net gain (0.97 mm vs 0.49 mm, p=0.007), larger minimum lumen diameters (2.04 mm vs 1.47 mm, p=0.0002) and smaller percent diameter stenosis (32.7% vs 55.8%, p=0.001). At one year, mortality was 4% in each group. Stroke occurred in 2% of each group and myocardial infarction in 4% of the rapamycin group and 2% of the control group (p=NS). The rapamycin group had lower rates of both target vessel revascularization (8.3% vs 38%, p<0.001) and target lesion revascularization (7.6% vs 37.2%, p<0.001).
Study drug medication use was discontinued in 3.9% of the rapamycin group. The most common adverse events were mouth ulcers (16%). Triglycerides rose in the rapamycin group from 100 at baseline to 126 at 3 week follow-up (p=0.056).
Interpretation:
Among patients undergoing bare metal stenting of de novo native coronary lesions, treatment with oral rapamycin was associated with smaller late loss and a reduction in binary restnosis and target vessel revascularization compared with control. While the results of the present study were positive, it should be noted that patients received bare metal rather than drug eluting stents, and the restenosis rates would likely be lower in the setting of drug-eluting stents. Nonetheless, oral therapy to prevent restenosis may be important for certain subgroups of patients who may not be suitable canidates for drug-eluting stents, such as those with extremely diffuse lesions or small vessels. Additionally, the cost-effectiveness of oral therapy for prevention of restenosis compared with use of drug-eluting stents is unknown.
References:
Rodriguez AE, et al. Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis. J Am Coll Cardiol 2006;47:1522-9.
Presented by Dr. Rodriguez at the 2005 Cardiovascular Research Therapeutics Sessions, Washington, DC.
Keywords: Diltiazem, Stroke, Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Drug-Eluting Stents, Sirolimus, Constriction, Pathologic, Stents, Metals, Oral Ulcer, Triglycerides
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