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
N1 - Published on behalf of the European Society of Cardiology. All rights reserved. � The Author(s) 2019. For permissions, please email: [email protected].
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 bare-metal 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: -0.63?mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11?mm2, 95% CI: -2.27 to 0.04, P?=?0.07).CONCLUSION: Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13?months, vascular healing in treated culprit lesions was almost complete irrespective of stent type.CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00962416.
AB - AIMS: The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal 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: -0.63?mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11?mm2, 95% CI: -2.27 to 0.04, P?=?0.07).CONCLUSION: Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13?months, vascular healing in treated culprit lesions was almost complete irrespective of stent type.CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00962416.
U2 - 10.1093/eurheartj/ehz074
DO - 10.1093/eurheartj/ehz074
M3 - Article
C2 - 30851032
SN - 0195-668X
VL - 40
SP - 1909
EP - 1919
JO - European Heart Journal
JF - European Heart Journal
IS - 24
ER -