This large, prospective, real-world analysis in 11,121 patients from 47 countries showed low bleeding and stroke rates in rivaroxaban-treated patients with AF, with low treatment discontinuation in different regions of the world. Results were broadly consistent across regions. (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation [XANTUS]; NCT01606995; Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region [XANTUS-EL]; NCT01800006; and Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia [XANAP]; NCT01750788).
BackgroundThe prospective, observational XANTUS study demonstrated low rates of stroke and major bleeding in real-world rivaroxaban-treated patients with non-valvular atrial fibrillation (NVAF) from Western Europe, Canada and Israel. XANTUS-EL is a component of the overall XANTUS programme and enrolled patients with NVAF treated with rivaroxaban from Eastern Europe, the Middle East and Africa (EEMEA) and Latin America.MethodsPatients with NVAF starting rivaroxaban for stroke prevention were consecutively recruited and followed for 1 year, at approximately 3-month intervals, or for ≥30 days after permanent rivaroxaban discontinuation. Primary outcomes were major bleeding, adverse events (AEs), serious AEs and all-cause mortality. Secondary outcomes included stroke, non-central nervous system systemic embolism (non-CNS SE), transient ischaemic attack (TIA), myocardial infarction (MI) and non-major bleeding. All major outcomes were centrally adjudicated.ResultsOverall, 2064 patients were enrolled; mean age ± standard deviation was 67.1 ± 11.32 years; 49.3% were male. Co-morbidities included heart failure (30.9%), hypertension (84.2%), diabetes mellitus (26.5%), prior stroke/non-CNS SE/TIA (16.2%) and prior MI (10.7%). Mean CHADS2, CHA2DS2-VASc and HAS-BLED scores were 2.0, 3.6 and 1.6, respectively. Treatment-emergent event rates were (events/100 patient-years, [95% confidence interval]): major bleeding 0.9 (0.5–1.4); all-cause mortality 1.7 (1.2–2.4); stroke/non-CNS SE 0.7 (0.4–1.2); any AE 18.1 (16.2–20.1) and any serious AE 8.3 (7.0–9.7). One-year treatment persistence was 81.9%.ConclusionsXANTUS-EL confirmed low stroke and major bleeding rates in patients with NVAF from EEMEA and Latin America. The population was younger but with more heart failure and hypertension than XANTUS; stroke/SE rate was similar but major bleeding lower.
This article describes the design and methodology of the POWER study (Physicians' Observational Work on Patient Education According to their Vascular Risk). POWER is an open-label multinational postmarketing study of the angiotensin II-receptor blocker eprosartan. The Systemic Coronary Risk Evaluation (SCORE) model has been used to estimate total cardiovascular risk and changes in total cardiovascular risk status during treatment for patients recruited in all countries other than Canada. Framingham Heart Study equations have been used to estimate risk in the Canadian contingent of POWER. Observations from POWER will provide insights into how clinicians try to achieve blood pressure goals within the framework of total cardiovascular risk management and how they integrate their treatment of blood pressure with other interventions. Experience during the POWER study may also help to affirm the utility, practicability and perhaps limitations of the SCORE system for estimating total cardiovascular risk and identify ways to improve the acceptance and implementation of risk estimation methods in cardiovascular primary prevention.
Background: Combined anticoagulant/antiplatelet therapy in patients with atrial fibrillation (AF) undergoing coronary stenting (PCI) is associated with increased bleeding and cardiovascular events. An outcome relevant to patients is event-free days out of hospital. Purpose: To assess whether rivaroxaban (R) treatment strategies improve out-ofhospital adverse event-free duration compared with a standard warfarin regimen in patients with AF who undergo PCI. Methods: In the PIONEER AF-PCI trial, patients with AF undergoing PCI were randomized 1:1:1 to (1) 15 mg/d R + P2Y12 inhibitor (15 mg R n=669), (2) 2.5 mg bid R + dual-antiplatelet therapy (DAPT) (2.5 mg R n=668); or (3) vitamin K antagonist warfarin (VKA) + DAPT (n=654), and followed for 1 year. We collected the days out of the hospital free of any adverse event that was severe enough to prompt hospitalization. The adverse event that prompted a hospitalization had to have resolved even though the patient was out of the hospital to be counted as an event-free day. The figure compares the cumulative distribution of eventfree days and median number of event-free days (non-parametric Kruskal-Wallis † test). The proportion of subjects exceeding a given duration of adverse event free days (AEFD) was compared using the Wilcoxon test. Results: The 2.5 mg R + DAPT strategy was associated with greater median outof-hospital event-free days compared to VKA (p<0.0001). For any AEFD on the X axis, the proportion of subjects exceeding that time was significantly different across strata overall (p<0.0001; Figure). The proportion of subjects in the 2.5mg R + DAPT arm was significantly higher than the proportion in the VKA + DAPT group (p<0.0001). 89% of subjects in the 2.5 mg R + DAPT arm experienced >100 days of AEFD vs only 81% in the VKA + DAPT arm. Likewise, 81% of subjects in the 2.5 mg R + DAPT arm exhibited >300 days of AEFD vs only 74% in the VKA + DAPT arm. There was no statistical difference comparing the 15 mg R + P2Y12 to the VKA + DAPT group (p=0.47). Cumulative distribution of AEFD by TrxConclusions: Among patients with AF undergoing PCI, a rivaroxaban-based strategy increased event-free days out of hospital compared with a VKA + DAPT strategy, a patient-centered outcome that should be considered in the assessment of net clinical benefit. Acknowledgement/Funding: This study was funded by the sponsors, Janssen Scientific Affairs, LLC and Bayer. (ESC 2016) guidelines on atrial fibrillation focused recommendations for oral anticoagulation (OAC) in patients with ≥2 non-gender CHA2DS2-VASc stroke risk factors (ie. CHA2DS2-VASc score ≥2 in males, ≥3 in females), in contrast to the 2012 guidelines (ESC 2012). The impact on stroke and/or death with the change in treatment thresholds consequent upon the change in guidelines requires evaluation. Methods: We assessed the rates of stroke and/or death, major bleeding and the net clinical benefit (NCB) in patients at low risk (CHA2DS2-VASc score 0 in males, 1 in females; no antithrombotic therapy recommended); intermediate ...
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