RT Journal Article
SR Electronic
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: the Nordic-Baltic Bifurcation Study IV
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e000947
DO 10.1136/openhrt-2018-000947
VO 7
IS 1
A1 Indulis Kumsars
A1 Niels Ramsing Holm
A1 Matti Niemelä
A1 Andrejs Erglis
A1 Kari Kervinen
A1 Evald Høj Christiansen
A1 Michael Maeng
A1 Andis Dombrovskis
A1 Vytautas Abraitis
A1 Aleksandras Kibarskis
A1 Thor Trovik
A1 Gustavs Latkovskis
A1 Dace Sondore
A1 Inga Narbute
A1 Christian Juhl Terkelsen
A1 Markku Eskola
A1 Hannu Romppanen
A1 Mika Laine
A1 Lisette Okkels Jensen
A1 Mikko Pietila
A1 Pål Gunnes
A1 Lasse Hebsgaard
A1 Ole Frobert
A1 Fredrik Calais
A1 Juha Hartikainen
A1 Jens Aarøe
A1 Jan Ravkilde
A1 Thomas Engstrøm
A1 Terje K Steigen
A1 Leif Thuesen
A1 Jens F Lassen
A1 ,
YR 2020
UL http://openheart.bmj.com/content/7/1/e000947.abstract
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.