Background: Despite recommendations in the guidelines and consensus documents, there has been no randomized controlled trial evaluating oral anticoagulation (OAC) alone without antiplatelet therapy (APT) in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after coronary stenting. Methods: This study was a prospective, multicenter, open-label, noninferiority trial comparing OAC alone to combined OAC and single APT among patients with atrial fibrillation beyond 1 year after stenting in a 1:1 randomization fashion. The primary end point was a composite of all-cause death, myocardial infarction, stroke, or systemic embolism. The major secondary end point was a composite of the primary end point or major bleeding according to the International Society on Thrombosis and Haemostasis classification. Although the trial was designed to enroll 2000 patients during 12 months, enrollment was prematurely terminated after enrolling 696 patients in 38 months. Results: Mean age was 75.0±7.6 years, and 85.2% of patients were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients. The mean CHADS 2 score was 2.5±1.2. During a median follow-up interval of 2.5 years, the primary end point occurred in 54 patients (15.7%) in the OAC-alone group and in 47 patients (13.6%) in the combined OAC and APT group (hazard ratio, 1.16; 95% CI, 0.79–1.72; P =0.20 for noninferiority, P =0.45 for superiority). The major secondary end point occurred in 67 patients (19.5%) in the OAC-alone group and in 67 patients (19.4%) in the combined OAC and APT group (hazard ratio, 0.99; 95% CI, 0.71–1.39; P =0.016 for noninferiority, P =0.96 for superiority). Myocardial infarction occurred in 8 (2.3%) and 4 (1.2%) patients, whereas stroke or systemic embolism occurred in 13 (3.8%) and 19 (5.5%) patients, respectively. Major bleeding occurred in 27 (7.8%) and 36 (10.4%) patients, respectively. Conclusions: This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. Because patient enrollment was prematurely terminated, the study was underpowered and inconclusive. Future larger studies are required to establish the optimal antithrombotic regimen in this population. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01962545.
Background: The optimal cutoff value of fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFR CT ) remains unclear. Methods: The current study population consisted of 93 patients with 139 vessels, who had suspected coronary artery disease by computed tomography angiography and underwent invasive FFR. We evaluated diagnostic performance of FFR CT according to different FFR CT cutoff values and FFR CT ranges with invasive FFR ≤0.80 as the reference standard. Results: In per-vessel analysis, median invasive FFR was 0.85 (interquartile range, 0.75–0.90), and 57 out of 139 vessels (41%) showed hemodynamically significant stenosis (≤0.80). Median FFR CT was 0.77 (interquartile range, 0.66–0.84; mean difference [invasive FFR-FFR CT ], 0.06±0.11). Per-vessel accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 73%, 95%, 59%, 61%, and 94% for the cutoff value of FFR CT ≤0.80, 81%, 86%, 78%, 73%, and 89% for FFR CT ≤0.75, and 83%, 74%, 89%, 82%, and 83% for FFR CT ≤0.70, respectively. Per-vessel accuracy across the different ranges of FFR CT ≤0.60, 0.61 to 0.70, 0.71 to 0.80, 0.81 to 0.90, and >0.90 with the cutoff value of FFR CT ≤0.80 were 95%, 74%, 32%, 93%, and 100%, respectively. Setting a gray zone of FFR CT 0.71 to 0.80 provided high positive predictive value (82%; n=42/51) in the range of FFR CT ≤0.70 and high negative predictive value (94%; n=48/51) in FFR CT >0.80. Conclusions: This study suggested that referral to invasive coronary angiography should be considered individually in the range of FFR CT 0.71 to 0.80, whereas dichotomous decision could be made in FFR CT ≤0.70 and >0.80. Future prospective studies evaluating clinical outcomes are needed to establish optimal FFR CT -based diagnostic algorithm.
Background The detailed causes of death in non–ST-segment–elevation myocardial infarction (NSTEMI) have not been adequately evaluated compared to those in ST-segment elevation myocardial infarction (STEMI). Methods The study population was 6,228 AMI patients who underwent percutaneous coronary intervention (STEMI: 4,625 patients and NSTEMI: 1,603 patients). The primary outcome was all-cause death. Results Within 6 months after AMI, the adjusted mortality risk was not significantly different between NSTEMI patients and STEMI patients (HR: 0.83, 95%CI: 0.67–1.03, P = 0.09). Regarding the causes of death within 6 months after AMI, mechanical complications more frequently occurred in STEMI patients than in NSTEMI patients, while proportions of post resuscitation status on arrival and heart failure were higher in in NSTEMI patients than in STEMI patients. Beyond 6 months after AMI, the adjusted mortality risk of NSTEMI relative to STEMI was not significantly different. (HR: 1.04, 95%CI: 0.90–1.20, P = 0.59). Regarding causes of death beyond 6 months after AMI, almost half of deaths were cardiovascular causes in both groups, and breakdown of causes of death was similar between NSTEMI and STEMI. Conclusion The mortality risk within and beyond 6 months after AMI were not significantly different between STEMI patients and NSTEMI patients after adjusting confounders. Deaths due to post resuscitation status and heart failure were more frequent in NSTEMI within 6 months after AMI.
care for this population; 5-7 however, those randomized trials enrolled only selected patients who were suitable for both treatment options of CABG and PCI. There is a scarcity of studies assessing the prevalence of patients ineligible for CABG and their long-term outcomes after PCI, although the number of patients who have to receive PCI because of surgical ineligibility might be increasing in the current aging society. 8-10 Therefore, we sought to evaluate the prevalence of surgical ineligibility and its clinical effect on long-term outcomes in patients with TVD or LMCAD in real-world clinical practice.
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