Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Contemporary Use of Laser During Percutaneous Coronary Interventions: Insights from the Laser Veterans Affairs (LAVA) Multicenter Registry.

BACKGROUND: The contemporary use and outcomes of excimer laser coronary atherectomy (ELCA) in percutaneous coronary intervention (PCI) are not well described. METHODS: We examined the baseline clinical and angiographic characteristics and procedural outcomes of 130 target lesions in 121 consecutive PCIs (n = 116 patients) in which ELCA was performed at three United States Department of Veterans Affairs (VA) medical centers between 2008 and 2016. RESULTS: Mean age was 68.5 ± 9 years and 97% of the patients were men. Patients had high prevalence of diabetes mellitus (63%), prior coronary artery bypass graft surgery (41%), and prior myocardial infarction (60%). The most common target vessel was the left anterior descending (32%), followed by the right coronary artery (30%), circumflex artery (20%), and saphenous vein graft (12%). The target lesions were highly complex, with moderate/severe calcification in 62% and in-stent restenosis in 37%. The most common indication for ELCA was balloon-uncrossable lesions (43.8%), followed by balloon-undilatable lesions (40.8%) and thrombotic lesions (12.3%). Use of ELCA was associated with high technical success rate (90.0%) and procedural success rate (88.8%), and low major adverse cardiac event (MACE) rate (3.45%). Mean procedure time was 120 min (interquartile range [IQR], 81-191 min), air kerma radiation dose was 2.76 Gy (IQR, 1.32-5.01 Gy), and contrast volume was 273 mL (IQR, 201-362 mL). CONCLUSION: In a contemporary multicenter United States registry, ELCA was commonly used in highly complex lesions and was associated with high technical and procedural success rates and low incidence of MACE.