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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.

ABSTRACT: 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.

SUBMITTER: Kumsars I

PROVIDER: S-EPMC6999681 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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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.

Kumsars Indulis I Holm Niels Ramsing NR Niemelä Matti M Erglis Andrejs A Kervinen Kari K Christiansen Evald Høj EH Maeng Michael M Dombrovskis Andis A Abraitis Vytautas V Kibarskis Aleksandras A Trovik Thor T Latkovskis Gustavs G Sondore Dace D Narbute Inga I Terkelsen Christian Juhl CJ Eskola Markku M Romppanen Hannu H Laine Mika M Jensen Lisette Okkels LO Pietila Mikko M Gunnes Pål P Hebsgaard Lasse L Frobert Ole O Calais Fredrik F Hartikainen Juha J Aarøe Jens J Ravkilde Jan J Engstrøm Thomas T Steigen Terje K TK Thuesen Leif L Lassen Jens F JF

Open heart 20200119 1

<h4>Background</h4>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.<h4>Methods</h4>The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis ...[more]

PMID: 32076558

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Project description:BackgroundThe optimal side branch (SB) treatment strategy after simple crossover stenting in bifurcation lesions is still controversial.ObjectivesThe purpose of this study was to compare the long-term outcomes of a 1-stent strategy with simple crossover alone versus with an additional SB-opening procedure in patients with left main (LM) and non-LM coronary bifurcation lesions.MethodsPatients who underwent percutaneous coronary intervention with a 1-stent strategy for bifurcation lesions including LM were selected from the COBIS (Coronary Bifurcation Stenting) III registry and divided into the simple crossover-alone group and SB-opening group. Clinical outcomes were assessed by the 5-year rate of target lesion failure (a composite of cardiac death, target vessel myocardial infarction, and target lesion repeat revascularization).ResultsAmong 2,194 patients who underwent the 1-stent strategy, 1,685 (76.8%) patients were treated with simple crossover alone, and 509 (23.2%) patients were treated with an additional SB-opening procedure. Although the baseline SB angiographic disease was more severe in the SB-opening group, the final lumen diameter of the SB was larger. The 5-year observed target lesion failure rate was similar between the 2 groups (7.0% in the simple crossover vs. 6.7% in SB-opening group; hazard ratio: 0.99; 95% confidence interval: 0.66 to 1.48; p = 0.947), even in the subgroup analyses including LM (9.5% vs. 11.3%; p = 0.442) and true bifurcation (5.3% vs. 7.8%; p = 0.362). The results were not changed after an inverse probability of treatment weighting adjustment. There was no difference in the overall and SB-related target lesion revascularization rate in both groups.ConclusionsThe long-term clinical outcome of the 1-stent strategy with simple crossover alone for coronary bifurcation lesions was acceptable compared to those of additional SB-opening procedures. (Korean Coronary Bifurcation Stenting [COBIS] Registry III [COBIS III]; NCT03068494).

Project description:Background and Objectives: Little is known about the upfront two-stent strategy (U2SS) for true coronary bifurcation lesions (CBLs) in acute coronary syndrome (ACS). We aimed to present our two-year follow-up results on the U2SS by using different two-stent techniques for the true CBL with a large side branch (SB) in ACS patients, including unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI), and to identify independent predictors of the presence of major adverse cardiac events (MACEs) after intervention. Materials and Methods: The study included 201 consecutive ACS patients with true CBLs who underwent percutaneous coronary intervention (PCI) using U2SS from October 2015 to March 2018. Clinical outcomes at follow-up were assessed. MACE was defined as a composite of cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). Results: 31.3% of the patients had an UA, 46.3% had an NSTEMI, and 22.4% had an STEMI. CBL was most frequently located in the left anterior descending (LAD)/diagonal artery (59.2%). In total, 71.1% of the patients had a Medina classification (1,1,1). Overall, 62.2% of cases were treated with mini-crush stenting. Clopidogrel was given in 23.9% of the patients; 71.1% of the patients received everolimus eluting stent (EES); and 11.9% received a sirolimus eluting stent (SES). Final kissing balloon inflation was carried out in all patients, with an unsatisfactory rate of 5%. A proximal optimization technique sequence was successfully carried out in all patients. The MACE incidence was 16.9% with a median follow-up period of 2.1 years. There were seven cardiac deaths (3.5%). The TLR rate was 13.4% (n = 27), with PCI treatment in 16 patients, and coronary artery bypass grafting treatment in 11 patients. After multivariate penalized logistic regression analysis (Firth logistic regression), clopidogrel use (odds ratio (OR): 2.19; 95% confidence interval (CI): 0.41-2.51; p = 0.007) and SES use (OR: 1.86; 95% CI: 0.31-2.64; p = 0.014) were independent predictors of the presence of MACE. Conclusion: U2SS is feasible and safe for the true CBLs with large and diseased SB in ACS patients, and is related to a relatively low incidence of MACE. Clopidogrel use and SES use may predict the MACE development in ACS patients treated using U2SS.

Dataset Information

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.

Publications

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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