Percutaneous coronary intervention (PCI) for coronary bifurcation lesions (CBL) represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications (1).Currently, the single stent strategy has been considered as the default approach for the treatment of CBL (2); however, the optimal therapy for Medina type 0,1,0 or 0,0,1 left main stem (LMS) bifurcation lesions remains unclear. For these lesions, precise ostial stent placement and crossover stenting technique have been proposed. Nevertheless, precise stent placement is known to be challenging, and there is no established technique for perfect ostial stent deployment despite the fact that different strategies and/or devices have been tested (3). Several studies have shown that the cross-over stenting approach is superior to the ostial stenting with a lower rate of major adverse cardiovascular event (MACE) rate during longterm clinical follow-up (4, 5). However, data indicates that this procedure may be complicated by a significant stenosis of the other major branch of the LMS even if ABSTRACT Objective: To investigate the safety and efficacy of a percutaneous revascularization strategy that is based on the use of drug-coated balloon (DCB) for the treatment of patients with acute coronary syndrome (ACS) and de novo Medina type 0,1,0 or 0,0,1 left main stem (LMS) bifurcation lesions. Methods:In this multicenter, prospective, proof-of-concept study, patients fulfilling the above criteria were enrolled and received treatment with DCB combined with provisional drug-eluting stent (DES) implantation in the proximal major branches of the LMS. Patients who declined this revascularization approach were treated with DES implantation 1-2 mm distally to the LAD or LCx ostium followed by DCB therapy for the ostial disease. The primary endpoint of the study was percent diameter stenosis (%DS) on quantitative coronary angiography post procedure as well as event rate at 8 months follow-up.Results: Thirty patients were enrolled in the study with mean age of 60.3±7.8 years, of whom 22 (73.3%) were male. Twenty-two patients were treated only with DCB and provisional DES implantation, and 8 had DES implantation followed by DCB therapy of the ostium of the LMS major branch. All the procedures were successful with no immediate complications. Lesion %DS decreased significantly post-procedure from 62.9±14.6 to 13.3±7.5, p<0.001. During the follow-up period, no major adverse cardiac events were reported. Conclusion:This proof-of-concept study indicates that ostial DCB therapy of the LMS major branches is safe and effective. Larger clinical data and longer follow-up is needed before advocating its regular use in clinical practice.

Background and ObjectivesUse of drug-coated balloon (DCB)-only strategy for revascularization of native large coronary artery lesions is on the rise. The long-term efficacy of this approach for bifurcation and non-bifurcation lesions remains unknown. We aim to assess the long-term clinical outcomes of DCB-only strategy for the treatment of de novo bifurcation and non-bifurcation lesions in large coronary arteries.MethodsThis multicenter, prospective, observational study enrolled 119 patients with de novo coronary lesions in vessels ≥2.75 mm. The primary end point was the rate of clinically driven target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR). Patients were followed up for a median of 2 years.ResultsOf 119 patients with 138 lesions, 66 patients (75 lesions) had bifurcation and 53 patients (63 lesions) had non-bifurcation lesions. Average reference vessel diameter was 3.1 ± 0.3 mm, and there was no difference in bifurcation and non-bifurcation group (3.0 ± 0.3 vs. 3.1 ± 0.3mm; p = 0.27). At 2-year follow-up, the TLF occurred in five (4.2%), TLR in four (3.4%), and target vessel revascularization (TVR) in five (4.2%) cases. The frequency of TLR and TVR was higher in the non-bifurcation group (p = 0.04 and 0.02, respectively), but there were no differences in TLF between the two groups (p = 0.17). The cumulative incidence of TLF (Kaplan–Meier estimates) was also not different in the two groups (log-rank p = 0.11).ConclusionDCB-only strategy for de novo lesions in large coronary arteries appears to be safe and effective for both bifurcation and non-bifurcation lesions. Further randomized clinical trials are warranted to confirm the value of DCB-only strategy in de novo bifurcation lesions of large vessels.

ObjectiveThe study sought to compare angiographic and clinical outcomes of new-generation drug-eluting stents (DES) versus drug-coated balloon (DCB) in patients with coronary in-stent restenosis (ISR).DesignMeta-analysis using data from randomised trial found by searches on PubMed, the Cochrane Library, ClinicalTrials.gov and websites of major cardiovascular congresses.SettingOnly randomised trials comparing DES with DCB were included.ParticipantsPatients with ISR in the included trials.InterventionsNew-generation DES versus DCB.OutcomesThe angiographic and clinical outcomes including cardiac death, all-cause death, myocardial infarction, target lesion revascularisation (TLR), target vessel revascularisation (TVR), major adverse cardiac events (MACE) and stent thrombosis were investigated.ResultsFive trials including 913 patients were eligible and included. Pooled analysis in angiographic results identified that new-generation DES were associated with higher acute luminal gain (−0.31 mm, 95% CI −0.42 to −0.20, P<0.001) and lower per cent diameter stenosis (risk ratio (RR): 0.28, 95% CI 0.02 to 0.55, P=0.04). DES significantly reduced the risk of TLR (RR: 1.96, 95% CI 1.17 to 3.28, P=0.01) compared with DCB; however, there was no statistical differences for MACE (RR: 1.21, 95% CI 0.67 to 2.17, P=0.53), myocardial infarction (RR: 1.16, 95% CI 0.55 to 2.48, P=0.69) and cardiac death (RR: 1.80, 95% CI 0.60 to 5.39, P=0.29).ConclusionsInterventions with new-generation DES appear to be associated with significant reduction in per cent diameter stenosis and TLR at short-term follow-up, but had similar MACE, myocardial infarction and cardiac death for patients with coronary ISR compared with DCB. Appropriately powered studies with longer term follow-up are warranted to confirm these findings.

BackgroundPercutaneous coronary intervention (PCI) has a well-established role in revascularization for coronary artery disease. We performed network meta-analysis to provide evidence on optimal intervention strategies for de novo lesions in small coronary arteries.Materials and methodsEnrolled studies were randomized clinical trials that compared different intervention strategies [balloon angioplasty (BA), biolimus-coated balloon (BCB), bare-metal stent (BMS), new-generation drug-eluting stent (New-DES), older generation sirolimus-eluting stent (Old-SES), paclitaxel-coated balloon (PCB), and paclitaxel-eluting stent (PES)] for de novo lesions in small coronary arteries. The primary outcome was major adverse cardiac events (MACE).ResultsA total of 23 randomized clinical trials comparing seven intervention devices were analyzed. In terms of the primary outcome, New-DES was the intervention device with the best efficacy [surface under the cumulative ranking curve (SUCRA), 89.1%; mean rank, 1.7], and the Old-SES [risk ratio (RR), 1.09; 95% confidence interval (CI), 0.45–2.64] and PCB (RR, 1.40; 95% CI, 0.72–2.74) secondary to New-DES, but there was no statistically significant difference between these three intervention devices. All DES and PCB were superior to BMS and BA for MACE in both primary and sensitivity analysis. For secondary outcomes, there was no association between all-cause mortality and myocardial infarction (MI) with any intervention strategy, and additionally, the findings of target lesion revascularization (TLR) were similar to the primary outcomes.ConclusionPaclitaxel-coated balloon yielded similar outcomes to New-DES for de novo lesions in small coronary arteries. Therefore, this network meta-analysis may provide potential support for PCB as a feasible, effective, and safe alternative intervention strategy for the revascularization of small coronary arteries.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/#recordDetails], identifier [CRD42022338433].

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