OBJECTIVES: To evaluate the efficacy and safety of new oral anticoagulants (NOACs) in elderly adults.
DESIGN: Meta-analyses of randomized clinical trials (RCTs).
SETTING: PubMed, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched from January 1, 2001, through March 30, 2013.
PARTICIPANTS: Elderly population (= 75) in RCTs comparing NOACs (rivaroxaban, apixaban, and dabigatran) with conventional therapy.
MEASUREMENTS: Two authors reviewed the trials, and odds ratios (ORs) were calculated using a random effects model.
RESULTS: Ten RCTs included 25,031 elderly participants. Risk of major or clinically relevant bleeding was not significantly different between NOACs and conventional therapy in elderly adults (OR = 1.02, 95% confidence interval = 0.73-1.43). Similar results were observed when comparing NOACs and pharmacologically active agents. In atrial fibrillation (AF) trials, NOACs were more effective than conventional therapy in prevention of stroke or systemic embolism in an elderly population with AF. In non-AF trials, NOACs also had a significantly lower risk of venous thromboembolism (VTE) or VTE-related death than conventional therapy in elderly adults. Analysis for individual NOACs showed that the NOAC was noninferior or more effective than conventional therapy for efficacy and safety outcomes.
CONCLUSION: In participants of clinical trials aged 75 and older, NOACs did not cause excess bleeding and were associated with equal or greater efficacy than conventional therapy.
Important meta-analysis demonstrating the safety of NOACs in elderly patients and comparable or more efficacy in prevention of thromboembolism compared with warfarin.
Yes, an article that demonstrates a counterintuitive point, but one that is borne out in the studies. Works great, less likely to bleed, but doesn't answer what happens if they actually bleed.
This meta-analysis is relevant in that it supports the efficacy and safety of new oral anticoagulants in elderly / fragile people, a population that is often regarded as "too at risk" to benefit from anticoagulation when, in fact, the exact opposite is true.
The individual trials were so large that the incremental benefit of this meta-analysis is very small.
The design of this meta-analysis is flawed and no clinically relevant conclusions can be drawn from the results. Specifically all of the NOACs are lumped together as are all of the "traditional" anticoagulant therapies. The NOACs have distinct and separate mechanisms of action, pharmacokinetics/pharmacodynamics and side effect profiles and should not be lumped together simply because they are "not warfarin or heparin". Doing so may result in the statistical attenuation of beneficial or deleterious effects of a specific NOAC (the known propensity of dabigatran, for example, to increase gastrointestinal bleeding). Lumping all of the NOACs together is similar to comparing all non-penicillin antibiotics (as one entity) to penicillin.