TY - JOUR

T1 - Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch

T2 - the Nordic-Baltic Bifurcation Study IV

AU - Kumsars, Indulis

AU - Holm, Niels Ramsing

AU - Niemelä, Matti

AU - Erglis, Andrejs

AU - Kervinen, Kari

AU - Christiansen, Evald Høj

AU - Maeng, Michael

AU - Dombrovskis, Andis

AU - Abraitis, Vytautas

AU - Kibarskis, Aleksandras

AU - Trovik, Thor

AU - Latkovskis, Gustavs

AU - Sondore, Dace

AU - Narbute, Inga

AU - Terkelsen, Christian Juhl

AU - Eskola, Markku

AU - Romppanen, Hannu

AU - Laine, Mika

AU - Jensen, Lisette Okkels

AU - Pietila, Mikko

AU - Gunnes, Pål

AU - Hebsgaard, Lasse

AU - Frobert, Ole

AU - Calais, Fredrik

AU - Hartikainen, Juha

AU - Aarøe, Jens

AU - Ravkilde, Jan

AU - Engstrøm, Thomas

AU - Steigen, Terje K

AU - Thuesen, Leif

AU - Lassen, Jens F

AU - Nordic Baltic bifurcation study group

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020

Y1 - 2020

N2 - Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration number: NCT01496638.

AB - Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration number: NCT01496638.

KW - Aged

KW - Angioplasty, Balloon, Coronary/adverse effects

KW - Coronary Artery Disease/diagnostic imaging

KW - Coronary Stenosis/diagnostic imaging

KW - Drug-Eluting Stents

KW - Female

KW - Humans

KW - Latvia

KW - Lithuania

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/etiology

KW - Prospective Studies

KW - Risk Factors

KW - Scandinavian and Nordic Countries

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1136/openhrt-2018-000947

DO - 10.1136/openhrt-2018-000947

M3 - Journal article

C2 - 32076558

VL - 7

JO - Open Heart

JF - Open Heart

SN - 2398-595X

IS - 1

M1 - e000947

ER -