Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV
Indulis Kumsārs, Niels Ramsing Holm, Matti Niemelä, Andrejs Ērglis, Kari Kervinen, Evald Høj Christiansen, Michael Mæng, Andis Dombrovskis, Vytautas Abraitis, Aleksandras Kibarskis, Thor Trovik, Gustavs Latkovskis, Dace Sondore, Inga Narbute, Christian Juhl Terkelsen, Markku Eskola, Hannu Romppanen, Mika Laine, Lisette Okkels Jensen, Mikko Pietilä, Pål Gunnes, Lasse Hebsgaard, Ole Fröbert, Fredrik Calais, Juha Hartikainen, Jens Aarøe, Jan Ravkilde, Thomas Engstrøm, Terje K. Steigen, Leif Thuesen, Jens Flensted Lassen
Abstract
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.