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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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999681/ https://www.ncbi.nlm.nih.gov/pubmed/32076558 http://dx.doi.org/10.1136/openhrt-2018-000947 |
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author | Kumsars, Indulis Holm, Niels Ramsing Niemelä, Matti Erglis, Andrejs Kervinen, Kari Christiansen, Evald Høj Maeng, Michael Dombrovskis, Andis Abraitis, Vytautas Kibarskis, Aleksandras Trovik, Thor Latkovskis, Gustavs Sondore, Dace Narbute, Inga Terkelsen, Christian Juhl Eskola, Markku Romppanen, Hannu Laine, Mika Jensen, Lisette Okkels Pietila, Mikko Gunnes, Pål Hebsgaard, Lasse Frobert, Ole Calais, Fredrik Hartikainen, Juha Aarøe, Jens Ravkilde, Jan Engstrøm, Thomas Steigen, Terje K Thuesen, Leif Lassen, Jens F |
author_facet | Kumsars, Indulis Holm, Niels Ramsing Niemelä, Matti Erglis, Andrejs Kervinen, Kari Christiansen, Evald Høj Maeng, Michael Dombrovskis, Andis Abraitis, Vytautas Kibarskis, Aleksandras Trovik, Thor Latkovskis, Gustavs Sondore, Dace Narbute, Inga Terkelsen, Christian Juhl Eskola, Markku Romppanen, Hannu Laine, Mika Jensen, Lisette Okkels Pietila, Mikko Gunnes, Pål Hebsgaard, Lasse Frobert, Ole Calais, Fredrik Hartikainen, Juha Aarøe, Jens Ravkilde, Jan Engstrøm, Thomas Steigen, Terje K Thuesen, Leif Lassen, Jens F |
author_sort | Kumsars, Indulis |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6999681 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-69996812020-02-19 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 Kumsars, Indulis Holm, Niels Ramsing Niemelä, Matti Erglis, Andrejs Kervinen, Kari Christiansen, Evald Høj Maeng, Michael Dombrovskis, Andis Abraitis, Vytautas Kibarskis, Aleksandras Trovik, Thor Latkovskis, Gustavs Sondore, Dace Narbute, Inga Terkelsen, Christian Juhl Eskola, Markku Romppanen, Hannu Laine, Mika Jensen, Lisette Okkels Pietila, Mikko Gunnes, Pål Hebsgaard, Lasse Frobert, Ole Calais, Fredrik Hartikainen, Juha Aarøe, Jens Ravkilde, Jan Engstrøm, Thomas Steigen, Terje K Thuesen, Leif Lassen, Jens F Open Heart Interventional Cardiology 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. BMJ Publishing Group 2020-01-19 /pmc/articles/PMC6999681/ /pubmed/32076558 http://dx.doi.org/10.1136/openhrt-2018-000947 Text en © 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. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Interventional Cardiology Kumsars, Indulis Holm, Niels Ramsing Niemelä, Matti Erglis, Andrejs Kervinen, Kari Christiansen, Evald Høj Maeng, Michael Dombrovskis, Andis Abraitis, Vytautas Kibarskis, Aleksandras Trovik, Thor Latkovskis, Gustavs Sondore, Dace Narbute, Inga Terkelsen, Christian Juhl Eskola, Markku Romppanen, Hannu Laine, Mika Jensen, Lisette Okkels Pietila, Mikko Gunnes, Pål Hebsgaard, Lasse Frobert, Ole Calais, Fredrik Hartikainen, Juha Aarøe, Jens Ravkilde, Jan Engstrøm, Thomas Steigen, Terje K Thuesen, Leif Lassen, Jens F 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Interventional Cardiology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999681/ https://www.ncbi.nlm.nih.gov/pubmed/32076558 http://dx.doi.org/10.1136/openhrt-2018-000947 |
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