Cardiovascular Intervention and Therapeutics最新文献

The outcome of percutaneous coronary intervention (PCI) compared to coronary artery bypass grafting (CABG) is still controversial for patients with left main coronary artery (LMCA) disease. This multicenter cohort study aimed to evaluate the clinical outcomes of LMCA disease patients who underwent PCI or CABG. We reviewed 875 consecutive patients diagnosed with LMCA disease between January 2009 and December 2020 who underwent coronary revascularization by PCI (n = 404) or CABG (n = 471). A one-to-one propensity score matching was employed to control the potential biases. The primary outcome was any major adverse cardiac events (MACE), which were composed of all causes of death, myocardial infarction, or stroke. Before propensity score matching, both groups significantly differed in essential baseline characteristics. Patients undergoing PCI were significantly older (age 72.4 vs. 70.5 years). They had a better baseline left ventricular function (left ventricular ejection fraction (LVEF) 59.1% vs. 55.8%). Moreover, patients in the PCI group had less coronary artery disease burden, such as less frequency of SYNTAX scores ≥ 33 (25.1% vs. 49.0%) and true left main bifurcation disease (18.6% vs. 33.1%). After propensity score analysis, 191 pairs of patients were successfully matched, and the median follow-up time was 4.5 years. A primary outcome event occurred in 8.9% of the patients in the PCI group and 15.2% in the CABG group (HR 0.70; 95% confidence interval [CI] 0.38-1.28; P = 0.253). All causes of death were lower in the PCI group than in the CABG group (8.4% vs. 13.6%; P = 0.347), but the difference was insignificant. In PCI and CABG groups, the incidence of cardiovascular death (1.6% vs. 1.1%), myocardial infarction (1.1% vs. 1.1%), and stroke (0% vs. 1.6%) were also not significantly different. However, the incidence of any revascularization and hospitalization for heart failure tended to be higher in the PCI group than in the CABG group, but the difference was not significant. In this propensity-matched study, PCI showed a statistically insignificant difference in all causes of death, myocardial infarction, or stroke compared with CABG for the treatment of LMCA disease. Furthermore, PCI showed no statistically significant difference compared to CABG in overall endpoints, including any revascularization.

The KCB01 (KIZASHI^™) is a novel cutting balloon catheter with blades integrally formed with the balloon. It is designed to overcome the drawbacks of conventional cutting balloons in terms of lesion delivery, crossability and procedural complications while maintaining the same dilation capacity. To evaluate the efficacy and safety of the KCB01, a prospective, open-label, single-arm study was conducted at nine sites in Japan on percutaneous coronary intervention-eligible patients with stenotic lesions that exhibited residual indentation even after conventional balloon dilation at nominal pressure. Seventy-six patients were enrolled between November 2022 and June 2023, and 73 eligible patients were included in the primary analysis. The mean age was 73.5 ± 7.4 years, and 79.5% of the patients were male. The target lesion characteristics included bifurcation lesions (42.5%), in-stent restenosis lesions (20.5%), and severely calcified lesions (54.8%). The primary endpoint was procedural success, defined as the KCB01 crossing the target lesion, no residual indentation, and < 50% residual stenosis rate after KCB01 dilation (assessed using quantitative coronary angiography). The angiographic images obtained during the procedure were evaluated in a core laboratory. The procedural success rate was 87.7% (95% confidence interval [CI]: 77.9-94.2), with the lower limit of the 95% CI (77.9%) exceeding the performance goal of 76.5%. Clinical success rate was achieved in 94.5% of cases (95% CI: 86.6-98.5%), with no major adverse cardiac events reported until discharge. Furthermore, no device deficiencies related to the KCB01 were observed. These results suggest the safety and efficacy of the KCB01.