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 - 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
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 - complex coronary lesions
KW - coronary bifurcations
KW - drug eluting stents
UR - http://www.scopus.com/inward/record.url?scp=85078475367&partnerID=8YFLogxK
U2 - 10.1136/openhrt-2018-000947
DO - 10.1136/openhrt-2018-000947
M3 - Journal article
C2 - 32076558
SN - 2053-3624
VL - 7
JO - Open Heart
JF - Open Heart
IS - 1
M1 - e000947
ER -