ABSTRACT
BACKGROUND@#Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.@*METHODS@#Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.@*RESULTS@#At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.@*CONCLUSIONS@#In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.
ABSTRACT
OBJECTIVE: The aim of this study was to introduce the experience in treatment of acute ST segment elevation myocardial infarction(STEMI), saphenous vein graft(SVG), Chronic total occlusion(CTO),In-stent restenosis(ISR)and diffuse calcification lesions by excimer laser coronary atherectomy(ELCA). METHODS: Twenty-two patients were enrolled through our center from November 2016 to May 2017 and ELCA was performed on 22 lesions.The clinical and procedure endpoints were recorded. RESULTS: All the lesions were successfully crossed with laser catheterand and finally were performed by ELCA. Five cases(22.7%)with STEMI, ten cases(45.5%) with SVG lesions,five cases with ISR and other cases were CTO(4.5%) and Calcification(4.5%) lesions.Seventeen patients underwent balloon dilatation and successful implantation of drug-eluting stents(DES) and one patients was treated with drug-eluting balloon(DEB).the procedual and clinical success rates were 100%. At 6.6±2.7 months follow-up, there were no major adverse cardiac events(MACEs) and ELCA relatedcomplications recorded. Conclution This limited evdiences showed that treatment of complex coronary lesions by excimer laser coronary atherectomy may be a Safe and effective choice.It can be further popularized in complex coronary artery disease.
ABSTRACT
Objective To asess the primary percutaneous coronary intervention(PPCI) strategies of culprit vessel with two lesions in ST-segment elevation myocardial infarction(STEMI) patients and their prognosis.Methods The study retrospectively reviewed 418 patients with STEMI undergoing PPCI in the General Hospital of Shenyang Military Region from January 1st to June 30th in 2015 and 75 patients were included. According to whether the non-infarct-related lesions(N-IRL) being treated or not,the patients were identified as both IRL and N-IRL being treated(the research group,n=33) or the culprit lesion(or infarct-related lesion,IRL) being treated only(control group,n=42). The endpoint was major adverse cardiocascular event(MACE) which was a composite of death from cardiac causes,nonfatal myocardial infarction,target vessel revascularization(TVR) and hospitalization with angina or heart failure.Results The study endpoint betwwen the two groups showed no statistical differences in MACE(P=0.446). Multivariate Cox regression analysis showed that age, diameter of N-IRL were predictive factors of MACE. When N-IRL located beyond the culprit lesion, the research group showed higher risk of MACE(P=0.022) and TVR(P=0.039).Conclusions The non-infarct-related lesions of patients with STEMI undergoing PPCI may be left for conventional medical treatment. It may be reasonable to choose drug therapy for distal N-IRL and to choose PCI for proximal N-IRL.