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The REALITY Trial: A Randomized Controlled Trial

Marie-Claude Morice, MD; Antonio Colombo, MD; Bernhard Meier, MD; Patrick Serruys, MD, PhD; Corrado Tamburino, MD; Giulio Guagliumi, MD; Eduardo Sousa, MD, PhD; Hans-Peter Stoll, MD; for the REALITY Trial Investigators

JAMA. 2006;295:895-904.

Context  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.

Design  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.

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

Patients  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.

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

Main Outcome Measures  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).

Conclusion  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.

Clinical Trial Registration  ClinicalTrials.gov Identifier: NCT00235092

Author Affiliations: Institut Cardiovasculaire Paris Sud, Massy, France (Dr Morice); Centro Cuore Colombus and San Raffaele Hospital, Milan, Italy (Dr Colombo); University Hospital, Bern, Switzerland (Dr Meier); Erasmus Medical Center, Rotterdam, the Netherlands (Dr Serruys); Ferrarotto Hospital, Catania, Italy (Dr Tamburino); Azienda Ospedaliera Ospedali Riuniti di Bergamo, Italy (Dr Guagliumi); Instituto Dante Pazzanese, Sao Paulo, Brazil (Dr Sousa); and Cordis Clinical Research Europe, Waterloo, Belgium (Dr Stoll).

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