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

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 WindeckerCOMFORTABLE AMI Trial Investigators

61 Citations (Scopus)

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.

Original language	English
Journal	Circulation. Cardiovascular interventions
Volume	7
Issue number	3
Pages (from-to)	355-64
Number of pages	10
ISSN	1941-7640
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.113.001440
Publication status	Published - Jun 2014

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Räber, L., Kelbæk, H., Taniwaki, M., Ostojic, M., Heg, D., Baumbach, A., von Birgelen, C., Roffi, M., Tüller, D., Engstrøm, T., Moschovitis, A., Pedrazzini, G., Wenaweser, P., Kornowski, R., Weber, K., Lüscher, T. F., Matter, C. M., Meier, B., Jüni, P., ... COMFORTABLE AMI Trial Investigators (2014). Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial. Circulation. Cardiovascular interventions, 7(3), 355-64. https://doi.org/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. / Räber, Lorenz; Kelbæk, Henning; Taniwaki, Masanori et al.
In: Circulation. Cardiovascular interventions, Vol. 7, No. 3, 06.2014, p. 355-64.

Research output: Contribution to journal › Journal article › Research › peer-review

Räber, L, Kelbæk, H, Taniwaki, M, Ostojic, M, Heg, D, Baumbach, A, von Birgelen, C, Roffi, M, Tüller, D, Engstrøm, T, Moschovitis, A, Pedrazzini, G, Wenaweser, P, Kornowski, R, Weber, K, Lüscher, TF, Matter, CM, Meier, B, Jüni, P, Windecker, S & COMFORTABLE AMI Trial Investigators 2014, 'Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial', Circulation. Cardiovascular interventions, vol. 7, no. 3, pp. 355-64. https://doi.org/10.1161/CIRCINTERVENTIONS.113.001440

@article{c83123186abd4a75ac7067176ae31f27,

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

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.",

author = "Lorenz R{\"a}ber and Henning Kelb{\ae}k and Masanori Taniwaki and Miodrag Ostojic and Dik Heg and Andreas Baumbach and \{von Birgelen\}, Clemens and Marco Roffi and David T{\"u}ller and Thomas Engstr{\o}m and Aris Moschovitis and Giovanni Pedrazzini and Peter Wenaweser and Ran Kornowski and Klaus Weber and L{\"u}scher, \{Thomas F\} and Matter, \{Christian M\} and Bernhard Meier and Peter J{\"u}ni and Stephan Windecker and \{COMFORTABLE AMI Trial Investigators\}",

note = "{\textcopyright} 2014 American Heart Association, Inc.",

year = "2014",

month = jun,

doi = "10.1161/CIRCINTERVENTIONS.113.001440",

language = "English",

volume = "7",

pages = "355--64",

journal = "Circulation. Cardiovascular interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins",

number = "3",

}

TY - JOUR

T1 - Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction

T2 - two-year clinical results of the COMFORTABLE AMI trial

AU - Räber, Lorenz

AU - Kelbæk, Henning

AU - Taniwaki, Masanori

AU - Ostojic, Miodrag

AU - Heg, Dik

AU - Baumbach, Andreas

AU - von Birgelen, Clemens

AU - Roffi, Marco

AU - Tüller, David

AU - Engstrøm, Thomas

AU - Moschovitis, Aris

AU - Pedrazzini, Giovanni

AU - Wenaweser, Peter

AU - Kornowski, Ran

AU - Weber, Klaus

AU - Lüscher, Thomas F

AU - Matter, Christian M

AU - Meier, Bernhard

AU - Jüni, Peter

AU - Windecker, Stephan

AU - COMFORTABLE AMI Trial Investigators

PY - 2014/6

Y1 - 2014/6

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/84905869428

U2 - 10.1161/CIRCINTERVENTIONS.113.001440

DO - 10.1161/CIRCINTERVENTIONS.113.001440

M3 - Journal article

C2 - 24847017

SN - 1941-7640

VL - 7

SP - 355

EP - 364

JO - Circulation. Cardiovascular interventions

JF - Circulation. Cardiovascular interventions

IS - 3

ER -

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

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