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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-B...

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Zeitschriftentitel: Open Heart
Personen und Körperschaften: 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
In: Open Heart, 7, 2020, 1, S. e000947
Format: E-Article
Sprache: Englisch
veröffentlicht:
BMJ
Schlagwörter:
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
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 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
spellingShingle 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
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
Cardiology and Cardiovascular Medicine
author_sort kumsars, indulis
spelling 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 2053-3624 BMJ Cardiology and Cardiovascular Medicine http://dx.doi.org/10.1136/openhrt-2018-000947 <jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01496638">NCT01496638</jats:ext-link>.</jats:p></jats:sec> 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 Open Heart
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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_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_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 Cardiology and Cardiovascular Medicine
url http://dx.doi.org/10.1136/openhrt-2018-000947
publishDate 2020
physical e000947
description <jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01496638">NCT01496638</jats:ext-link>.</jats:p></jats:sec>
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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, 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
container_issue 1
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description <jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01496638">NCT01496638</jats:ext-link>.</jats:p></jats:sec>
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spelling 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 2053-3624 BMJ Cardiology and Cardiovascular Medicine http://dx.doi.org/10.1136/openhrt-2018-000947 <jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01496638">NCT01496638</jats:ext-link>.</jats:p></jats:sec> 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 Open Heart
spellingShingle 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, 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, Cardiology and Cardiovascular Medicine
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
title_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
topic Cardiology and Cardiovascular Medicine
url http://dx.doi.org/10.1136/openhrt-2018-000947