Key result
Oral rapamycin cuts 6-month in-stent binary restenosis ~55% vs. placebo.
Why the study?
The efficacy of oral rapamycin at reducing 6-month restenosis after bare metal stent implantation was not established.
Does oral rapamycin reduce 6-month angiographic restenosis in patients after bare metal stent implantation?
RCT (n=108)
single-blind
1:1
Does oral rapamycin reduce 6-month angiographic restenosis in patients after bare metal stent implantation?
Relative Risk: 0.45 (95% CI 0.24–0.84)
Absolute Event Rate: 14.3% vs 32.1%
p-value: p=0.015
A 1-month course of oral rapamycin significantly reduces 6-month angiographic restenosis and intravascular ultrasound volume obstruction after bare metal stent implantation.
Supports oral rapamycin after bare metal stenting to reduce restenosis; extends systemic mTOR inhibition beyond local drug delivery.
OBJECTIVES: To establish the efficacy of oral rapamycin at a dose of 2 mg for 1 month at reducing the 6-month restenosis rate after the implantation of bare metal stents. METHODS: A prospective, 1:1 randomized, single-blind, placebo-controlled study was conducted in 108 consecutive patients assigned immediately after stent implantation to oral rapamycin (4 mg loading dose followed by 2 mg daily for 30 days) or a placebo. RESULTS: Rapamycin was maintained in 98% of patients. Angiographic in-stent binary restenosis was 14.3% in the rapamycin group versus 32.1% in the placebo group, with a relative risk (RR) of 0.45 (95% CI 0.24-0.84, p = 0.015). The rapamycin blood concentration at 15 days correlated with binary restenosis (p = 0.044). The volume obstructions found by intravascular ultrasound for the rapamycin and the placebo groups were 18.1+/-10.7 and 27.1+/-15.7% (p = 0.002), respectively. Major adverse cardiac events at a 5-year follow-up were 31.5% for the rapamycin group and 50.0% for the placebo group (RR 0.63, 95% CI 0.39-1.01, p = 0.078). CONCLUSIONS: Oral rapamycin significantly reduces the incidence of restenosis at follow-up compared to a placebo.We believe these findings deserve further testing in larger trials.
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Cernigliaro et al. (2009) conducted an RCT in Restenosis after bare metal stent implantation (n=108). Oral rapamycin vs. Placebo was evaluated on Angiographic in-stent binary restenosis at 6 months (RR 0.45, 95% CI 0.24-0.84, p=0.015). Oral rapamycin significantly reduced 6-month angiographic in-stent binary restenosis compared to placebo (14.3% vs 32.1%; RR 0.45; 95% CI 0.24-0.84; P=0.015).
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