BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.

In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

ObjectivesTo evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis.SettingMulticentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India.Participants995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up.InterventionsPercutaneous coronary intervention with Supraflex SES,Primary and secondary outcome measuresThe primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months.ResultsAt 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm.ConclusionsThe FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

Aim: The TAXCO study was designed to compare the degree of neointimal coverage and the prevalence of malapposition at 6 months subsequent to implantation of ultrathin biodegradable polymer-coated sirolimus-eluting stents (SES) and durable polymer-coated everolimus-eluting stents (EES) of thin strut thickness using optical coherence tomography (OCT). Methods: The TAXCO study included a total of 42 patients who gave consent and underwent OCT examination between August 2017 and September 2017. Of 42, five patients' OCT examinations were of insufficient quality for quantitative analysis. Thus, the OCT analysis group consisted of 37 patients. Among them, 16 patients were treated with Xience (Abbott Vascular) and 21 with Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), 6 (±1) months earlier at our institution. The OCT was performed using a C7 Dragonfly™ imaging catheter (St. Jude Medical Inc.). All OCT images were analyzed at an independent core laboratory (Cardiovascular Research Center, São Paulo, Brazil) by analysts who were blinded to patient and procedural information. Results: A total of 763 crosssections (6,882 struts) were analyzed in Xience group, and 1,127 crosssections (9,968 struts) in Tetriflex group. At 6 months, on per-lesion basis, no significant differences were observed between Xience group and Tetriflex group in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137) and malapposed struts (0.05 ± 0.2 vs. 0.21 ± 0.69, p = .302). Strut-level neointimal thickness also did not differ between Xience group and Tetriflex group (0.18 ± 0.12 vs. 0.14 ± 0.08 mm, p = .286). Conclusion: This OCT study found no significant difference in strut coverage and neointimal thickness at 6 months after implantation of biodegradable polymer-coated Tetriflex, when compared with durable polymer-coated Xience.

Aims To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). Methods and results In the MASTER DAPT trial, 3383 patients underwent noncomplex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events (NACE; composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium [BARC] 3 or 5 bleeding events); major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 BARC bleeding. NACE and MACCE did not differ with abbreviated versus standard DAPT among patients with complex (hazard ratio [HR]: 1.03, 95% confidence interval [CI]: 0.69–1.52, and HR: 1.24, 95% CI: 0.79–1.92, respectively) and noncomplex PCI (HR: 0.90, 95% CI: 0.71–1.15, and HR: 0.91, 95% CI: 0.69–1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3 or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2,816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3 or 5 was lower with abbreviated DAPT. Conclusion In HBR patients free from recurrent ischemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity.