Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-Up Outcomes of Multicenter Randomized Controlled BEST Trial.

BACKGROUND: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease. METHODS: This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization. RESULTS: During a median follow-up of 11.8 years (interquartile range, 10.6-12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR], 1.18 [95% CI, 0.88-1.56]; P=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 [95% CI, 0.75-1.53]; P=0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 [95% CI, 0.65-1.67]; P=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 [95% CI, 1.06-3.27]; P=0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 [95% CI, 1.58-2.32]; P<0.001) were more frequent after PCI than after CABG. CONCLUSIONS: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05125367 and NCT00997828.

Effects of combination therapy with cilostazol and probucol versus monotherapy with cilostazol on coronary plaque, lipid and biomarkers: SECURE study, a double-blind randomized controlled clinical trial.

AIM: The study aim is to investigate synergistic effects of cilostazol and probucol combination therapy on coronary plaque volume and composition. METHODS: A total of 119 patients undergoing coronary stenting were treated with probucol and cilostazol combination therapy (group Ⅰ) or with cilostazol monotherapy (group Ⅱ) in a double-blind, randomized multicenter trial, and evaluated by virtual histology intravascular ultrasound (VH-IVUS) at baseline and 9-month follow-up for changes in coronary plaque volume and composition at an index intermediate lesion with luminal narrowing ≥30% and ＜70% and for neointimal hyperplasia at the stented segment. In all patients simvastatin 20 mg was started with enrollment. RESULTS: Qualifying VH-IVUS data from 91 patients were included in the final analysis. There were no significant differences between group Ⅰ and Ⅱ with respect to the primary endpoint, nominal change in normalized total atheroma volume (TAV) of the index intermediate coronary lesion (Δ-12.6±17.7 vs. -14.2±20.2 mm(3), p=0.691), or plaque composition. Plaque regression was observed in more than 70% of patients in both groups. Diabetes was the only significant independent determinant of changes in TAV (ß=0.22, p=0.037). There were greater decreases in total cholesterol (Δ-51.8±33.0 vs. -25.4±39.1 mg/dL, p＜0.001) and LDL (Δ-33.5±30.5 vs. -20.3±30.8 mg/dL, p=0.044) levels in group Ⅰ than in group Ⅱ. However, HDL cholesterol (Δ-11.2±8.5 vs. 2.7±7.7 mg/dL, p＜0.001) and apoA1 (Δ-18.2±21.4 vs. 10.0±16.5 mg/dL, p＜0.001) levels were also significantly decreased in group Ⅰ compared with group Ⅱ. CONCLUSIONS: There were no significant differences in changes in plaque volume or composition between the cilostazol and probucol combination therapy and cilostazol monotherapy group despite different impacts of the treatments on lipid biomarkers.