TY - JOUR
T1 - The European bifurcation club Left Main Coronary Stent study
T2 - A randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN)
AU - Hildick-Smith, David
AU - Egred, Mohaned
AU - Banning, Adrian
AU - Brunel, Philippe
AU - Ferenc, Miroslaw
AU - Hovasse, Thomas
AU - Wlodarczak, Adrian
AU - Pan, Manuel
AU - Schmitz, Thomas
AU - Silvestri, Marc
AU - Erglis, Andreis
AU - Kretov, Evgeny
AU - Lassen, Jens Flensted
AU - Chieffo, Alaide
AU - Lefèvre, Thierry
AU - Burzotta, Francesco
AU - Cockburn, James
AU - Darremont, Olivier
AU - Stankovic, Goran
AU - Morice, Marie Claude
AU - Louvard, Yves
N1 - Publisher Copyright:
© 2021 Published on behalf of the European Society of Cardiology. All rights reserved.
PY - 2021/10/1
Y1 - 2021/10/1
N2 - Background: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. Methods and results: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. Conclusions: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. Study registration: http://clinicaltrials.gov NCT02497014.
AB - Background: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. Methods and results: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. Conclusions: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. Study registration: http://clinicaltrials.gov NCT02497014.
KW - Angina
KW - Bifurcation
KW - Coronary artery
KW - Left main stem
KW - Stents
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U2 - 10.1093/eurheartj/ehab283
DO - 10.1093/eurheartj/ehab283
M3 - Article
C2 - 34002215
AN - SCOPUS:85110687189
VL - 42
SP - 3829
EP - 3839
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 37
ER -