Preventing restenosis after implantation of bare stents with oral rapamycin: a randomized angiographic and intravascular ultrasound study with a 5-year clinical follow-up.
OBJECTIVE
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.
Cernigliaro
Carmelo
C
Cardiologia Interventistica, Clinica San Gaudenzio, Novara, Italy. carmelo.cernigliaro @ fastwebnet.it
Sansa
Mara
M
Vitrella
Giancarlo
G
Verde
Alessandro
A
Bongo
Angelo Sante
AS
Giuliani
Luigi
L
Novelli
Eugenio
E
D000284:Administration, Oral; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000097:blood / Q000627:therapeutic use*; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000097:blood / Q000627:therapeutic use*; D015607:Stents; D018084:Ultrasonography, Interventional
D000903:Antibiotics, Antineoplastic; D020123:Sirolimus