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BACKGROUND The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied. METHODS We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedurerelated bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, −14.3 percentage points; 95% CI for noninferiority, −25.0 to −3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, −3.9 percentage points; 95% CI for noninferiority, −11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). CONCLUSIONS In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.

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Aims:To classify and quantify post-expansion irregularities in durable polymer-based coatings of drugeluting stents (DES). Methods and results: Taxus Liberté™, Endeavor Sprint™, Endeavor Resolute™ and Xience V™ DES (three samples of each) were explored by light microscopy and scanning electron microscopy (SEM) following expansion at 14 atm in water. Incidence and size of irregularities were measured during thorough quantitative examinations of a 360 SEM images. DES types examined showed a significant difference in the incidence of irregularities (p<0.0001; 6.6±4.2/image at 60-fold magnification) with typical patterns specific for each DES. All types showed areas with bare metal-aspects, but incidence, shape, and size differed largely: Sprint showed the largest areas. Cracks were only found in Sprint and Resolute, while wrinkles were seen exclusively in Taxus Liberté and Xience V (p<0.0001). The coating of each DES type showed some inhomogeneity of distribution, but the incidence differed (p<0.0001) and was least in Taxus Liberté, which, on the other hand, was the only DES that showed webbing with large bare-metal exposure. Conclusions: The incidence and size of various coating irregularities on different types of DES varied widely. These data may be considered in ongoing discussions on the differences between DES and may serve as reference to compare novel DES. Abbreviations DESdrug-eluting stent SEM scanning electron microscopy BMS bare metal stent Methods DES samples examinedWe examined four types of DES which all share the presence of a durable-polymer component.

In this observational study, the guideline-recommended ticagrelor-based primary DAPT regimen was associated with an increased event risk in consecutive ACS patients treated with newer-generation DES.