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
Thuesen L; Dombrovskis A; Terkelsen CJ; Kibarskis A; Steigen TK; Engstrom T; Laine M; Erglis A; Holm NR; Hebsgaard L; Gunnes P; Jensen LO; Kervinen K; Latkovskis G; Niemela M; Trovik T; Aaroe J; Frobert O; Calais F; Lassen JF; Ravkilde J; Romppanen H; Sondore D; Narbute I; Pietila M; Maeng M; Kumsars I; Christiansen EH; Eskola M; Abraitis V; Hartikainen J
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
Thuesen L
Dombrovskis A
Terkelsen CJ
Kibarskis A
Steigen TK
Engstrom T
Laine M
Erglis A
Holm NR
Hebsgaard L
Gunnes P
Jensen LO
Kervinen K
Latkovskis G
Niemela M
Trovik T
Aaroe J
Frobert O
Calais F
Lassen JF
Ravkilde J
Romppanen H
Sondore D
Narbute I
Pietila M
Maeng M
Kumsars I
Christiansen EH
Eskola M
Abraitis V
Hartikainen J
BMJ PUBLISHING GROUP
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2021042824277
https://urn.fi/URN:NBN:fi-fe2021042824277
Tiivistelmä
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.
Kokoelmat
- Rinnakkaistallenteet [19207]