Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions - The REALITY trial: A randomized controlled trial

Marie Claude Morice, Antonio Colombo, Bernhard Meier, Patrick Serruys, Corrado Tamburino, Giulio Guagliumi, Eduardo Sousa, Hans Peter Stoll

Research output: Contribution to journalArticle

414 Citations (Scopus)

Abstract

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

Original languageEnglish
Pages (from-to)895-904
Number of pages10
JournalJournal of the American Medical Association
Volume295
Issue number8
DOIs
Publication statusPublished - Feb 22 2006

Fingerprint

Sirolimus
Paclitaxel
Stents
Coronary Vessels
Randomized Controlled Trials
Confidence Intervals
Latin America
Angina Pectoris
Percutaneous Coronary Intervention
Coronary Artery Bypass
Multicenter Studies
Pathologic Constriction
Metals
Myocardial Infarction
Outcome Assessment (Health Care)
Prospective Studies
Transplants
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions - The REALITY trial : A randomized controlled trial. / Morice, Marie Claude; Colombo, Antonio; Meier, Bernhard; Serruys, Patrick; Tamburino, Corrado; Guagliumi, Giulio; Sousa, Eduardo; Stoll, Hans Peter.

In: Journal of the American Medical Association, Vol. 295, No. 8, 22.02.2006, p. 895-904.

Research output: Contribution to journalArticle

Morice, Marie Claude ; Colombo, Antonio ; Meier, Bernhard ; Serruys, Patrick ; Tamburino, Corrado ; Guagliumi, Giulio ; Sousa, Eduardo ; Stoll, Hans Peter. / Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions - The REALITY trial : A randomized controlled trial. In: Journal of the American Medical Association. 2006 ; Vol. 295, No. 8. pp. 895-904.
@article{ba3993a7a54d40768d84514c1aebf393,
title = "Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions - The REALITY trial: A randomized controlled trial",
abstract = "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",
author = "Morice, {Marie Claude} and Antonio Colombo and Bernhard Meier and Patrick Serruys and Corrado Tamburino and Giulio Guagliumi and Eduardo Sousa and Stoll, {Hans Peter}",
year = "2006",
month = "2",
day = "22",
doi = "10.1001/jama.295.8.895",
language = "English",
volume = "295",
pages = "895--904",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "8",

}

TY - JOUR

T1 - Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions - The REALITY trial

T2 - A randomized controlled trial

AU - Morice, Marie Claude

AU - Colombo, Antonio

AU - Meier, Bernhard

AU - Serruys, Patrick

AU - Tamburino, Corrado

AU - Guagliumi, Giulio

AU - Sousa, Eduardo

AU - Stoll, Hans Peter

PY - 2006/2/22

Y1 - 2006/2/22

N2 - 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

AB - 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

UR - http://www.scopus.com/inward/record.url?scp=33644532583&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33644532583&partnerID=8YFLogxK

U2 - 10.1001/jama.295.8.895

DO - 10.1001/jama.295.8.895

M3 - Article

C2 - 16493102

AN - SCOPUS:33644532583

VL - 295

SP - 895

EP - 904

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 8

ER -