Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial.
BACKGROUND
Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study.


OBJECTIVE
To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents.


METHODS
Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months.


METHODS
Ninety hospitals in Europe, Latin America, and Asia.


METHODS
A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries.


METHODS
Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685).


METHODS
The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization.


RESULTS
In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, -0.22 mm; 95% CI, -0.26 to -0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, -3.60%; 95% CI, -5.12% to -2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73).


CONCLUSIONS
In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00235092.
Morice
Marie-Claude
MC
Institut Cardiovasculaire Paris Sud, Massy, France. mc.morice@icps.com.fr
Colombo
Antonio
A
Meier
Bernhard
B
Serruys
Patrick
P
Tamburino
Corrado
C
Guagliumi
Giulio
G
Sousa
Eduardo
E
Stoll
Hans-Peter
HP
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D004343:Drug Implants; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D004343:Drug Implants; D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus