A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.

BACKGROUND: Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. METHODS: We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. RESULTS: After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). CONCLUSIONS: In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

Phase I drug and light dose-escalation trial of motexafin lutetium and far red light activation (phototherapy) in subjects with coronary artery disease undergoing percutaneous coronary intervention and stent deployment: procedural and long-term results.

BACKGROUND: Motexafin lutetium (MLu; Antrin) is a photosensitizer that is taken up by atherosclerotic plaque and concentrated within macrophages and vascular smooth muscle cells. After photoactivation with far red light, MLu facilitates production of cytotoxic oxygen radicals that mediate apoptosis. We assessed the safety and tolerability of phototherapy (PT) with MLu in patients undergoing percutaneous coronary intervention with stent deployment. METHODS AND RESULTS: An open-label, phase I, drug and light dose-escalation clinical trial of MLu PT enrolled 80 patients undergoing de novo coronary stent deployment. MLu was administered to 79 patients by intravenous infusion 18 to 24 hours before procedure, and photoactivation was performed after balloon predilatation and before stent deployment. Clinical evaluation, serial quantitative angiography, and intravascular ultrasound were performed periprocedurally and at 6 months follow-up. MLu PT was well tolerated without serious dose-limiting toxicities, and side effects (paresthesia and rash) were minor. No adverse angiographic outcomes were attributed to phototherapy. CONCLUSIONS: This study demonstrates that coronary MLu PT seems safe, and the maximum well-tolerated MLu dose and range of tolerated light doses were identified. These data can be used in phase II efficacy trials of MLu PT for the treatment of coronary atherosclerosis or vulnerable plaque.

Clinical use of AcuNav diagnostic ultrasound catheter imaging during left heart radiofrequency ablation and transcatheter closure procedures.

BACKGROUND: AcuNav ultrasound catheter (UC) (10F, 5.5-10 MHz) has unique advantages for left heart imaging with its 4-way tip flexible maneuverability, maximal 16-cm intracardiac imaging depth, and Doppler and color flow imaging capability. METHODS: We assessed the initial use of this UC in 40 consecutive patients (34 men; age 53 +/- 11 years old). All patients were also undergoing transseptal catheterization for percutaneous catheter mapping and ablation of either left atrium (focal initiated atrial arrhythmia/fibrillation, n = 32) or left ventricle (ventricular tachycardia, n = 4), or transcatheter atrial septal defect closure (n = 4) procedures. During each procedure, the UC was placed in the right atrium, superior vena cava, or right ventricular inflow/outflow tract. RESULTS: In all patients, UC successfully guided transseptal catheterization and provided imaging of normal or aberrant anatomy of the right/left atrial (interatrial septum, fossa ovalis, appendages, 4 pulmonary vein ostia) and right/left ventricular (valves and papillary muscles) structures. UC was important in early identification procedure complications, including pericardial effusion (n = 2, detected before systematic hemodynamic deterioration) and thrombus formation on sheaths deployed in the right atrium (n = 9) and left atrium (n = 2, early elimination with management of the sheath). With Doppler and color flow imaging, UC provided effective monitoring of increased flow velocity of all ablated pulmonary vein ostia and detection of patent foramen ovale (n = 6) or residual trivial/small atrial septal defect posttransseptal catheterization (n = 2). UC was also used to successfully image and guide transcatheter closure of atrial septal defect with positioning of the cardioseal septal occluder (Nitinol Medical Technologies Inc, Boston, Mass) and color Doppler imaging of no significant residual shunt. CONCLUSION: AcuNav UC with Doppler and color flow imaging has significant use, especially during left heart ablation. Uses include guidance of transseptal and mapping/ablation catheters and closure devices, and prompt diagnosis of cardiac complications.