PT  - JOURNAL ARTICLE
AU  - Indulis Kumsars
AU  - Niels Ramsing Holm
AU  - Matti Niemelä
AU  - Andrejs Erglis
AU  - Kari Kervinen
AU  - Evald Høj Christiansen
AU  - Michael Maeng
AU  - Andis Dombrovskis
AU  - Vytautas Abraitis
AU  - Aleksandras Kibarskis
AU  - Thor Trovik
AU  - Gustavs Latkovskis
AU  - Dace Sondore
AU  - Inga Narbute
AU  - Christian Juhl Terkelsen
AU  - Markku Eskola
AU  - Hannu Romppanen
AU  - Mika Laine
AU  - Lisette Okkels Jensen
AU  - Mikko Pietila
AU  - Pål Gunnes
AU  - Lasse Hebsgaard
AU  - Ole Frobert
AU  - Fredrik Calais
AU  - Juha Hartikainen
AU  - Jens Aarøe
AU  - Jan Ravkilde
AU  - Thomas Engstrøm
AU  - Terje K Steigen
AU  - Leif Thuesen
AU  - Jens F Lassen
ED  - ,
TI  - 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
AID  - 10.1136/openhrt-2018-000947
DP  - 2020 Jan 01
TA  - Open Heart
PG  - e000947
VI  - 7
IP  - 1
4099  - http://openheart.bmj.com/content/7/1/e000947.short
4100  - http://openheart.bmj.com/content/7/1/e000947.full
SO  - Open Heart2020 Jan 01; 7
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.