Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis

• Published in: Journal of the American College of Cardiology 2006-04, Vol.47 (8), p.1522-1529
• Main Authors: Rodriguez, Alfredo E., Granada, Juan F., Rodriguez-Alemparte, Máximo, Vigo, Cesar F., Delgado, Juan, Fernandez-Pereira, Carlos, Pocovi, Antonio, Rodriguez-Granillo, Alfredo M., Schulz, Daryl, Raizner, Albert E., Palacios, Igor, O’Neill, William, Kaluza, Grzegorz L., Stone, Gregg
• Format: Article
• Language: English
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2005.12.052

Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis: The Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study Alfredo E. Rodriguez, Juan Granada, Máximo Rodriguez-Alemparte, Cesar F. Vigo, Juan Delgado, Carlos Fernandez-Pereira, Antonio Pocovi, Alfredo M. Rodriguez-Granillo, Daryl Schulz, Albert Raizner, Igor Palacios, William O’Neill, Greg Kaluza, Gregg Stone, for the ORAR II Investigators One hundred patients were randomized to either oral rapamycin (6-mg loading dose given before intervention, followed by 3 mg/day for 14 days) or no therapy after the implantation of a coronary stent. The primary study end point was incidence of angiographic binary restenosis and late loss at nine months. The secondary end points were target lesion revascularization, target vessel revascularization, and incidence of major adverse cardiovascular events at one year. At nine months, the in-segment binary restenosis and in-segment late loss were significantly reduced in the oral rapamycin group (p = 0.001). At one year, the oral rapamycin group also had a significantly lower incidence of target vessel revascularization, target lesion revascularization, and major adverse cardiovascular events. The purpose of this study was to assess the role of oral rapamycin in decreased restenosis after bare metal stent implantation. Small observational studies suggest that the administration of oral rapamycin reduces angiographic restenosis after bare metal stent implantation. Between September 2003 and September 2004, 100 patients were randomized to either oral rapamycin (6-mg loading dose given 2.7 h before intervention followed by 3 mg/day for 14 days) plus diltiazem 180 mg/day or no therapy after the implantation of a coronary bare metal stent design. The primary study end point was incidence of angiographic binary restenosis and late loss at nine months. The secondary end points were target lesion revascularization, target vessel revascularization, and incidence of major adverse cardiovascular events at 1 year. Angiographic follow-up was completed in 87% of patients. In the rapamycin group, the drug was well tolerated (26% minor side effects) and was maintained in 96% of patients. At 9 months, the in-segment binary restenosis was reduced by 72% (11.6% rapamycin vs. 42.8% no-therapy group, p = 0.001) and the in-stent binary restenosis was reduced by 65% (12% rapamycin vs. 34.6% no-therapy group, p = 0.009). The in-segment late loss was also