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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

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  • Indulis Kumsars
  • Niels Ramsing Holm
  • Matti Niemelä
  • Andrejs Erglis
  • Kari Kervinen
  • Evald Høj Christiansen
  • Michael Maeng
  • 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 Pietila
  • Pål Gunnes
  • Lasse Hebsgaard
  • Ole Frobert
  • Fredrik Calais
  • Juha Hartikainen
  • Jens Aarøe
  • Jan Ravkilde
  • Thomas Engstrøm
  • Terje K Steigen
  • Leif Thuesen
  • Jens F Lassen
  • Nordic Baltic bifurcation study group
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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.

OriginalsprogEngelsk
TidsskriftOpen Heart
Vol/bind7
Udgave nummer1
Sider (fra-til)e000947
ISSN2053-3624
DOI
StatusUdgivet - 2020

Bibliografisk note

© 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.

ID: 62332095