Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial.
BACKGROUND
Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated.


OBJECTIVE
To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent.


METHODS
This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003.


METHODS
Patients were randomly assigned to receive a sirolimus-eluting stent (129 patients) or an uncoated stent having an identical architecture and radiographic appearance (128 patients).


METHODS
The primary end point was the 8-month binary in-segment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events.


RESULTS
The mean (SD) reference diameter of the treated segment was 2.2 (0.28) mm; the lesion length, 11.84 (6.15) mm. After 8 months, the binary in-segment restenosis rate was 53.1% (60/113) in the patients receiving an uncoated stent and 9.8% (12/123) in those receiving a sirolimus-eluting stent (relative risk [RR], 0.18; 95% confidence interval [CI], 0.10-0.32; P<.001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events (12/129 [9.3%] vs 40/128 [31.3%]; RR, 0.30; 95% CI, 0.15-0.55; P<.001) mainly because of a reduction in target lesion revascularization (9/129 [7%] vs 27/128 [21.1%]; RR, 0.33; 95% CI, 0.14-0.70; P = .002) and myocardial infarction (2/129 [1.6%] vs 10/129 [7.8%]; RR, 0.20; 95% CI, 0.01-0.93; P = .04).


CONCLUSIONS
The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.
Ardissino
Diego
D
Division of Cardiology, Ospedale Maggiore, University of Parma, Italy. cardiologia.parma@ao.pr.it
Cavallini
Claudio
C
Bramucci
Ezio
E
Indolfi
Ciro
C
Marzocchi
Antonio
A
Manari
Antonio
A
Angeloni
Giulia
G
Carosio
Giuseppe
G
Bonizzoni
Erminio
E
Colusso
Stefania
S
Repetto
Monica
M
Merlini
Piera Angelica
PA
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
D007166:Immunosuppressive Agents; D020123:Sirolimus