Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban: The Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

Study Questions:

What are the clinical characteristics of patients treated with rivaroxaban for stroke prevention in atrial fibrillation (AF), who experienced intracranial hemorrhage (ICH) events?

Methods:

In the ROCKET AF trial, rivaroxaban (15-20 mg daily adjusted for renal function) was compared to warfarin for stroke prevention in 14,264 patients with AF at moderate-high risk of stroke. In this post-hoc analysis, factors associated with ICH events were explored in patients treated with either warfarin or rivaroxaban.

Results:

ICH events occurred in 172 patients (1.2% overall) with a rate of 0.67%/year. Patients experiencing ICH events had a case fatality rate of 49%. Independent predictors of ICH included race, age, reduced serum albumin, reduced platelet count, prior stroke or transient ischemic attack, and an increased diastolic blood pressure. Patients randomized to rivaroxaban therapy and patients with a history of congestive heart failure had a reduced risk of ICH. Using the predictive elements described above, the PANWARDS scoring system was developed with good ability to predict ICH risk over a 2.5-year period (C-index 0.69).

Conclusions:

The authors concluded that ICH events, while relatively infrequent, were highly fatal in anticoagulated patients. The development of the PANWARDS scoring system has good predictive ability to identify anticoagulated patients at risk for ICH events.

Perspective:

This post-hoc analysis of the ROCKET AF study details the clinical characteristics associated with ICH events in patients treated with either warfarin or rivaroxaban for stroke prevention in AF. This study describes a new scoring system (PANWARDS) for prediction of ICH risk. This new scoring system adds to the currently available scoring systems for predicting overall major bleeding risk (e.g., HAS-BLED) and ischemic stroke risk (e.g., CHA2DS2-VASc). Although not yet validated in patients taking other oral anticoagulants, such as dabigatran and apixaban, the new scoring system is applicable to a large number of patients treated with either warfarin or rivaroxaban for stroke prevention in AF. However, usability of the scoring system is limited due to the continuous nature of the variables, which limits a provider’s ability to recall them from memory or to apply the scoring system without a reference tool.

Clinical Topics: Anticoagulation Management, Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Novel Agents, Acute Heart Failure

Keywords: Vitamin K, Risk, Stroke, Ischemic Attack, Transient, Morpholines, Platelet Count, Thiophenes, Warfarin, Pyrazoles, Blood Pressure, Blood Coagulation, Serum Albumin, Intracranial Hemorrhages, beta-Alanine, Benzimidazoles, Heart Failure, Embolism, Factor Xa, Pyridones


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