Are the Results of Randomized Controlled Trials on Anticoagulation in Patients With Atrial Fibrillation Generalizable to Clinical Practice?

Abstract

Patients who undergo anticoagulation for atrial fibrillation in actual clinical practice differ from those in randomized trials, but have similar rates of stroke and major bleeding. The risk of minor bleeding is higher and may require more intensive monitoring in practice.

Cost-Effectiveness of Genotype-Guided Warfarin Dosing for Patients With Atrial Fibrillation

“…21 During subsequent periods patients taking warfarin were assumed to have bleeding events at a rate of 1.2% per year, based on data from a recent systematic review. 23 Minor bleeding events were assumed to occur at a rate 6.25 times the major bleed rate based on an analysis of trial and observational study data. 23 Patients who have a bleeding event were assumed to discontinue warfarin therapy and to have bleeds at a rate 0.45 times that of warfarin-treated subjects, based on data from a recent meta-analysis.…”

“…23 Minor bleeding events were assumed to occur at a rate 6.25 times the major bleed rate based on an analysis of trial and observational study data. 23 Patients who have a bleeding event were assumed to discontinue warfarin therapy and to have bleeds at a rate 0.45 times that of warfarin-treated subjects, based on data from a recent meta-analysis. 24 Because not all patients with warfarin-associated bleeding will discontinue treatment, we conducted a secondary analysis assuming that such patients would continue treatment.…”

“…We estimated the cost of CYP2C9 and VKORC1 genotyping at $475, based on current pricing [23][24][25] and added $100 for phlebotomy and recordkeeping. 26 To assess the effect of reductions in cost due to future technological advances, we also considered a total cost of $200 in a sensitivity analysis.…”

Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

“…Estimations of its frequency range from 0.3 to 4.6% per year (1,2). The absolute rate of ICH in patients older than age 60 years who are treated with conventional intensities of anticoagulation ranges from 0.3 to 1% per year, and 60% of cases are fatal (3).…”

Differences among Clinical Classification Schemes for Predicting Stroke in Atrial Fibrillation: Implications for Therapy in Daily Practice

“…Other factors that could have an influence in the low prescription of anticoagulation in our study are physicians' distrust in the validity of clinical trials that support these CCSs, 30 the uncertainty about whether the CCSs' benefits are applicable to clinical practice, 31 or their reticence to initiate anticoagulation for older patients, 16,27,30,32 despite the available evidence. 33 In addition to this, in some cases, the emergency physicians could be following the recommendations of local clinical practice guides, and the rate of anticoagulation would vary as much as 13% to 100%, depending on the guideline used. 34 Finally, the type of NVAF had an impact on the prescription pattern: anticoagulation was more frequently indicated in patients with paroxysmal NVAF than in those with persistent or permanent NVAF.…”