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 language | English |
|---|---|
| Pages (from-to) | 1909-1919 |
| Number of pages | 11 |
| Journal | European heart journal |
| Volume | 40 |
| Issue number | 24 |
| DOIs | |
| Publication status | Published - 21 Jun 2019 |
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Keywords
- Coronary artery disease
- Drug-eluting stent
- Restenosis
- ST-segment elevation myocardial infarction
- Stent
- Stent thrombosis
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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 journal › Article › Academic › peer-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
UR - http://www.scopus.com/inward/record.url?scp=85068445039&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehz074
DO - 10.1093/eurheartj/ehz074
M3 - Article
C2 - 30851032
AN - SCOPUS:85068445039
VL - 40
SP - 1909
EP - 1919
JO - European heart journal
JF - European heart journal
SN - 0195-668X
IS - 24
ER -