Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: Randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction

Lorenz Räber*, Kyohei Yamaji, Henning Kelbæk, Thomas Engstrøm, Andreas Baumbach, Marco Roffi, Clemens Von Birgelen, Masanori Taniwaki, Aris Moschovitis, Serge Zaugg, Miodrag Ostojic, Giovanni Pedrazzini, Dimitrios Alexios Karagiannis-Voules, Thomas F. Lüscher, Ran Kornowski, David Tüller, Vladan Vukcevic, Dik Heg, Stephan Windecker

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

Aims:  The long-Term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with baremetal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.

Methods and results: We performed a 5-year clinical follow-up of 1157 patients (BES: N= 575 and BMS: N= 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25- 0.66, P > 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P > 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES:-0.63mm2, 95% CI:-1.44 to 0.39 vs. BMS-1.11mm2, 95% CI:-2.27 to 0.04, P = 0.07).

Original languageEnglish
Pages (from-to)1909-1919
Number of pages11
JournalEuropean heart journal
Volume40
Issue number24
DOIs
Publication statusPublished - 21 Jun 2019

Fingerprint

Stents
Polymers
Thrombosis
Metals
Myocardial Infarction
Confidence Intervals
Optical Coherence Tomography
Ischemia

Keywords

  • Coronary artery disease
  • Drug-eluting stent
  • Restenosis
  • ST-segment elevation myocardial infarction
  • Stent
  • Stent thrombosis

Cite this

Räber, Lorenz ; Yamaji, Kyohei ; Kelbæk, Henning ; Engstrøm, Thomas ; Baumbach, Andreas ; Roffi, Marco ; Von Birgelen, Clemens ; Taniwaki, Masanori ; Moschovitis, Aris ; Zaugg, Serge ; Ostojic, Miodrag ; Pedrazzini, Giovanni ; Karagiannis-Voules, Dimitrios Alexios ; Lüscher, Thomas F. ; Kornowski, Ran ; Tüller, David ; Vukcevic, Vladan ; Heg, Dik ; Windecker, Stephan. / Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial : Randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction. In: European heart journal. 2019 ; Vol. 40, No. 24. pp. 1909-1919.
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title = "Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: Randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction",
abstract = "Aims:  The long-Term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with baremetal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.Methods and results: We performed a 5-year clinical follow-up of 1157 patients (BES: N= 575 and BMS: N= 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95{\%} confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95{\%} CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95{\%} CI: 0.25- 0.66, P > 0.001). Definite stent thrombosis (ST) was recorded in 2.2{\%} and 3.9{\%} (HR 0.57, 95{\%} CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3{\%} vs. 1.6{\%}, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08{\%} vs. BMS 0.02{\%}, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1{\%} vs. 0.15{\%}, P > 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES:-0.63mm2, 95{\%} CI:-1.44 to 0.39 vs. BMS-1.11mm2, 95{\%} CI:-2.27 to 0.04, P = 0.07).",
keywords = "Coronary artery disease, Drug-eluting stent, Restenosis, ST-segment elevation myocardial infarction, Stent, Stent thrombosis",
author = "Lorenz R{\"a}ber and Kyohei Yamaji and Henning Kelb{\ae}k and Thomas Engstr{\o}m and Andreas Baumbach and Marco Roffi and {Von Birgelen}, Clemens and Masanori Taniwaki and Aris Moschovitis and Serge Zaugg and Miodrag Ostojic and Giovanni Pedrazzini and Karagiannis-Voules, {Dimitrios Alexios} and L{\"u}scher, {Thomas F.} and Ran Kornowski and David T{\"u}ller and Vladan Vukcevic and Dik Heg and Stephan Windecker",
year = "2019",
month = "6",
day = "21",
doi = "10.1093/eurheartj/ehz074",
language = "English",
volume = "40",
pages = "1909--1919",
journal = "European heart journal",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "24",

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Räber, L, Yamaji, K, Kelbæk, H, Engstrøm, T, Baumbach, A, Roffi, M, Von Birgelen, C, Taniwaki, M, Moschovitis, A, Zaugg, S, Ostojic, M, Pedrazzini, G, Karagiannis-Voules, DA, Lüscher, TF, Kornowski, R, Tüller, D, Vukcevic, V, Heg, D & Windecker, S 2019, 'Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: Randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction', European heart journal, vol. 40, no. 24, pp. 1909-1919. https://doi.org/10.1093/eurheartj/ehz074

Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial : Randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction. / Räber, Lorenz; Yamaji, Kyohei; Kelbæk, Henning; Engstrøm, Thomas; Baumbach, Andreas; Roffi, Marco; Von Birgelen, Clemens; Taniwaki, Masanori; Moschovitis, Aris; Zaugg, Serge; Ostojic, Miodrag; Pedrazzini, Giovanni; Karagiannis-Voules, Dimitrios Alexios; Lüscher, Thomas F.; Kornowski, Ran; Tüller, David; Vukcevic, Vladan; Heg, Dik; Windecker, Stephan.

In: European heart journal, Vol. 40, No. 24, 21.06.2019, p. 1909-1919.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial

T2 - Randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction

AU - Räber, Lorenz

AU - Yamaji, Kyohei

AU - Kelbæk, Henning

AU - Engstrøm, Thomas

AU - Baumbach, Andreas

AU - Roffi, Marco

AU - Von Birgelen, Clemens

AU - Taniwaki, Masanori

AU - Moschovitis, Aris

AU - Zaugg, Serge

AU - Ostojic, Miodrag

AU - Pedrazzini, Giovanni

AU - Karagiannis-Voules, Dimitrios Alexios

AU - Lüscher, Thomas F.

AU - Kornowski, Ran

AU - Tüller, David

AU - Vukcevic, Vladan

AU - Heg, Dik

AU - Windecker, Stephan

PY - 2019/6/21

Y1 - 2019/6/21

N2 - Aims:  The long-Term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with baremetal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.Methods and results: We performed a 5-year clinical follow-up of 1157 patients (BES: N= 575 and BMS: N= 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25- 0.66, P > 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P > 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES:-0.63mm2, 95% CI:-1.44 to 0.39 vs. BMS-1.11mm2, 95% CI:-2.27 to 0.04, P = 0.07).

AB - Aims:  The long-Term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with baremetal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.Methods and results: We performed a 5-year clinical follow-up of 1157 patients (BES: N= 575 and BMS: N= 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25- 0.66, P > 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P > 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES:-0.63mm2, 95% CI:-1.44 to 0.39 vs. BMS-1.11mm2, 95% CI:-2.27 to 0.04, P = 0.07).

KW - Coronary artery disease

KW - Drug-eluting stent

KW - Restenosis

KW - ST-segment elevation myocardial infarction

KW - Stent

KW - Stent thrombosis

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U2 - 10.1093/eurheartj/ehz074

DO - 10.1093/eurheartj/ehz074

M3 - Article

C2 - 30851032

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VL - 40

SP - 1909

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JO - European heart journal

JF - European heart journal

SN - 0195-668X

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