Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial

Lorenz Räber; Henning Kelbæk; Masanori Taniwaki; Miodrag Ostojic; Dik Heg; Andreas Baumbach; Clemens von Birgelen; Marco Roffi; David Tüller; Thomas Engstrøm; Aris Moschovitis; Giovanni Pedrazzini; Peter Wenaweser; Ran Kornowski; Klaus Weber; Thomas F Lüscher; Christian M Matter; Bernhard Meier; Peter Jüni; Stephan Windecker; COMFORTABLE AMI Trial Investigators

doi:10.1161/CIRCINTERVENTIONS.113.001440

Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial

Circ Cardiovasc Interv. 2014 Jun;7(3):355-64. doi: 10.1161/CIRCINTERVENTIONS.113.001440. Epub 2014 May 20.

Authors

Lorenz Räber¹, Henning Kelbæk¹, Masanori Taniwaki¹, Miodrag Ostojic¹, Dik Heg¹, Andreas Baumbach¹, Clemens von Birgelen¹, Marco Roffi¹, David Tüller¹, Thomas Engstrøm¹, Aris Moschovitis¹, Giovanni Pedrazzini¹, Peter Wenaweser¹, Ran Kornowski¹, Klaus Weber¹, Thomas F Lüscher¹, Christian M Matter¹, Bernhard Meier¹, Peter Jüni¹, Stephan Windecker²; COMFORTABLE AMI Trial Investigators

Collaborators

Affiliations

¹ From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (L.R., M.T., A.M., P.W., B.M., S.W.); Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark (H.K., T.E.); Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia (M.O.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Bristol Heart Institute, Bristol, United Kingdom (A.B.); Thoraxcenter Twente and Twente University, Enschede, The Netherlands (C.v.B.); Division of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Cardiocentro, Lugano, Switzerland (G.P.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Tel Aviv University, Tel Aviv, Israel (R.K.); Kantonsspital Winterthur, Winterthur, Switzerland (K.W.); Department of Cardiology, University Hospital Zurich, Zurich, Switzerland (T.F.L., C.M.M.); and Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland (P.J., S.W.).
² From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (L.R., M.T., A.M., P.W., B.M., S.W.); Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark (H.K., T.E.); Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia (M.O.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Bristol Heart Institute, Bristol, United Kingdom (A.B.); Thoraxcenter Twente and Twente University, Enschede, The Netherlands (C.v.B.); Division of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Cardiocentro, Lugano, Switzerland (G.P.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Tel Aviv University, Tel Aviv, Israel (R.K.); Kantonsspital Winterthur, Winterthur, Switzerland (K.W.); Department of Cardiology, University Hospital Zurich, Zurich, Switzerland (T.F.L., C.M.M.); and Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland (P.J., S.W.). stephan.windecker@insel.ch.

PMID: 24847017
DOI: 10.1161/CIRCINTERVENTIONS.113.001440

Abstract

Background: This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up.

Methods and results: A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio = 0.48; 95% confidence interval, 0.31-0.72; P < 0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years = 0.45; 95% confidence interval, 0.20-1.00; P = 0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P < 0.001) and target-vessel reinfarction (1.3% versus 3.4%; P = 0.023). The composite of death, any reinfarction and revascularization (14.5% versus 19.3%; P = 0.03), and cardiac death or target-vessel myocardial infarction (4.2% versus 7.2%; P = 0.036) were less frequent among BES-treated patients compared with BMS-treated patients. The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 ± 7.2 in BES- and 39.6 ± 25.2 in BMS-treated lesions (P < 0.001).

Conclusions: Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, BES continued to improve cardiovascular events compared with BMS beyond 1 year.

Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NTC00962416.

Keywords: angiography; drug-eluting stents; myocardial infarction.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Coronary Angiography
Coronary Vessels / diagnostic imaging
Death, Sudden, Cardiac / epidemiology
Drug-Eluting Stents* / adverse effects
Female
Follow-Up Studies
Humans
Incidence
Longitudinal Studies
Male
Metals*
Middle Aged
Myocardial Infarction / therapy*
Percutaneous Coronary Intervention / methods*
Polymers*
Recurrence
Sirolimus / analogs & derivatives*
Stents* / adverse effects
Treatment Outcome

Substances

Metals
Polymers
umirolimus
Sirolimus