Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation.

BACKGROUND: Testing of factor Xa inhibitors for the prevention of cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation has been limited. METHODS: We enrolled patients with atrial fibrillation and echocardiographically documented rheumatic heart disease who had any of the following: a CHA2DS2VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating a higher risk of stroke), a mitral-valve area of no more than 2 cm2, left atrial spontaneous echo contrast, or left atrial thrombus. Patients were randomly assigned to receive standard doses of rivaroxaban or dose-adjusted vitamin K antagonist. The primary efficacy outcome was a composite of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or noncardiac) or unknown causes. We hypothesized that rivaroxaban therapy would be noninferior to vitamin K antagonist therapy. The primary safety outcome was major bleeding according to the International Society of Thrombosis and Hemostasis. RESULTS: Of 4565 enrolled patients, 4531 were included in the final analysis. The mean age of the patients was 50.5 years, and 72.3% were women. Permanent discontinuation of trial medication was more common with rivaroxaban than with vitamin K antagonist therapy at all visits. In the intention-to-treat analysis, 560 patients in the rivaroxaban group and 446 in the vitamin K antagonist group had a primary-outcome event. Survival curves were nonproportional. The restricted mean survival time was 1599 days in the rivaroxaban group and 1675 days in the vitamin K antagonist group (difference, -76 days; 95% confidence interval [CI], -121 to -31; P<0.001). A higher incidence of death occurred in the rivaroxaban group than in the vitamin K antagonist group (restricted mean survival time, 1608 days vs. 1680 days; difference, -72 days; 95% CI, -117 to -28). No significant between-group difference in the rate of major bleeding was noted. CONCLUSIONS: Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of a composite of cardiovascular events or death than rivaroxaban therapy, without a higher rate of bleeding. (Funded by Bayer; INVICTUS ClinicalTrials.gov number, NCT02832544.).

Benefits and Risks of Statin Therapy in the HIV-Infected Population.

PURPOSE OF REVIEW: HIV-infected patients face an increased risk for cardiovascular disease (CVD), estimated at 1.5- to 2-fold as compared to HIV-uninfected persons. This review provides a recent (within preceding 5 years) summary of the role of statin therapy and associated role in CVD risk reduction among HIV-infected patients on anti-retroviral therapy. RECENT FINDINGS: Statins remain the preferred agents for reducing risk for CVD among HIV-infected populations based on guidance extrapolated from general population (HIV-uninfected) cholesterol treatment guidelines across different settings globally. However, HIV-infected patients are consistently under prescribed statin therapy when compared to their HIV-uninfected counterparts. The most commonly studied statins in clinical care and small randomized and cohort studies have been rosuvastatin and atorvastatin. Both agents are preferred for their potent lipid-lowering effects and their favorable or neutral pleotropic effects on chronic inflammation, renal function, and hepatic steatosis among others. However, growing experience with the newer glucuronidated pitavastatin suggests that this agent has virtually no adverse drug interactions with ART or effects on glucose metabolism-all marked additional benefits when compared with rosuvastatin and atorvastatin while maintaining comparable anti-lipid effects. Pitavastatin is therefore the statin of choice for the ongoing largest trial (6500 participants) to test the benefits of statin therapy among HIV-infected adults. Statins are underutilized in the prevention of CVD in HIV-infected populations based on criteria in established cholesterol guidelines. There is a potential role for statin therapy for HIV-infected patients who do not meet guideline criteria which will be further delineated through ongoing clinical trials.