Dataset Information

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

ABSTRACT:

Background

The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations.

Aims

This study aimed to investigate the 5-year clinical results of the EBC TWO Trial.

Methods

A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation.

Results

The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34).

Conclusions

In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions.

Clinicaltrials

gov: NCT01560455.

SUBMITTER: Arunothayaraj S

PROVIDER: S-EPMC10333921 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

Arunothayaraj Sandeep S Behan Miles W MW Lefèvre Thierry T Lassen Jens F JF Chieffo Alaide A Stankovic Goran G Burzotta Francesco F Pan Manuel M Ferenc Miroslaw M Hovasse Thomas T Spence Mark S MS Brunel Philippe P Cotton James M JM Cockburn James J Carrié Didier D Baumbach Andreas A Maeng Michael M Louvard Yves Y Hildick-Smith David D

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20230516

<h4>Background</h4>The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations.<h4>Aims</h4>This study aimed to investigate the 5-year clinical results of the EBC TWO Trial.<h4>Methods</h4>A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. ...[more]

PMID: 37946522

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Project description:BackgroundIn patients with complex true coronary bifurcation lesions (CBLs), Crush or Culotte stenting has been the commonest approaches of percutaneous coronary intervention (PCI). However, the optimal one remains in debate.MethodsA systematic review and meta-analysis of cohort studies searched from PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese National Knowledge Infrastructure (CNKI), VIP information database, and WangFang Data Information Site, to compare the long-term safety and efficacy of PCI with Crush versus Culotte in patients with CBLs. The primary end point was target lesion revascularization (TLR) and secondary end points were a composite of major adverse cardiac events (MACE) including cardiac death (CD), myocardial infarction (MI), stent thrombosis (ST), and target vessel revascularization (TVR) by PCI or bypass surgery, and each individual component at long-term follow-up. Furthermore, omitting each study in turn was used to sensitivity analysis for high heterogeneity of studies.ResultsA total of 7 studies were included to perform a meta-analysis, 3 randomized trials and 4 observational studies with 2211 patients, 1281 treated with Crush and 930 with Culotte. There was no significant difference in TLR and MACE between Crush and Culotte [RR 0.76, 95% CI (0.48-1.23), I = 57%; RR 0.78, 95% CI (0.47-1.29), I = 83%, respectively]. ST tended to be lower in patients treated with Crush [RR 0.61, 95% CI (0.37-1.01), I = 23%]. CD and MI were comparable between the 2 groups [RR 0.80, 95% CI (0.43-1.49), I = 0%; RR 0.74, 95% CI (0.49-1.13), I = 32%, respectively]. TVR was also associated with the similar risk [RR 0.76, 95% CI (0.49-1.16), I = 60%]. However, high heterogeneity was detected for TLR, MACE, and TVR, and the source of heterogeneity was DKCRUSH-III study by Chen, SL.ConclusionsIn the treatment of coronary bifurcation lesions, TLR and MACE were not significant difference between the Crush and Culotte groups, but TLR and MACE were also regarded as high heterogeneity mainly due to better outcomes achieved by DK Crush and there was a trend toward lower ST in the Crush group. Crush, particularly DK Crush, may be superior to conventional Culotte for treatment of CBLs.Prospero registration numberCRD42018111868.

Dataset Information

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

Background

Aims

Methods

Results

Conclusions

Clinicaltrials

Publications

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

Similar Datasets

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