Short‐Term Risk of Bleeding During Heparin Bridging at Initiation of Vitamin K Antagonist Therapy in More Than 90 000 Patients With Nonvalvular Atrial Fibrillation Managed in Outpatient Care

Abstract

BackgroundSeveral studies have recently examined the risks of bleeding and of ischemic stroke and systemic embolism associated with perioperative heparin bridging anticoagulation in patients with nonvalvular atrial fibrillation. However, few studies have investigated bridging risks during vitamin K antagonist initiation in outpatient settings.Methods and ResultsA retrospective cohort study was conducted on individuals starting oral anticoagulation between January 2010 and November 2014 for nonvalvular atrial fibrillation managed in outpatient care and identified from French healthcare insurance. Bleeding and ischemic stroke and systemic embolism events were identified from the hospitalization database. Adjusted hazard ratios with 95% CI were estimated using Cox models during the first and 2 following months of anticoagulation. Of 90 826 individuals, 30% had bridging therapy. A total of 318 (0.35%) cases of bleeding and 151 (0.17%) ischemic stroke and systemic embolism cases were identified during the first month of follow‐up and 231 (0.31%) and 122 (0.16%) during the 2 following months, respectively. At 1 month of follow‐up, the incidence of bleeding was higher in the bridged group compared with the nonbridged group (0.47% versus 0.30%; P<0.001), and this increased risk persisted after adjustment for covariates (hazard ratio=1.60; 95% CI, 1.28–2.01). This difference disappeared after the first month of treatment (0.93; 0.70–1.23). No significant difference in the occurrence of ischemic stroke and systemic embolism was observed either at 1 month of follow‐up or later.ConclusionsAt vitamin K antagonist initiation for nonvalvular atrial fibrillation managed in ambulatory settings, bridging therapy is associated with a higher risk of bleeding and a similar risk of arterial thromboembolism compared with no bridging therapy.

Oral anticoagulation therapy use in patients with atrial fibrillation after the introduction of non-vitamin K antagonist oral anticoagulants: findings from the French healthcare databases, 2011–2016

“…These patterns of NOAC use contrast with the other patterns concomitantly observed in this study, such as the high level of concomitant prescription of antiplatelet agents and parenteral anticoagulants or, to a lesser extent, NOAC use in non-approved indications such as prosthetic heart valves that are both associated with an increased risk of bleeding 58–60…”

Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline

“…36 Furthermore, observational studies reported that patients who had received VKA alone had a significantly lower risk of bleeding events, compared with patients treated with LMWH followed by OAC. 50–53…”

“…36 Furthermore, observational studies reported that patients who had received VKA alone had a significantly lower risk of bleeding events, compared with patients treated with LMWH followed by OAC. [50][51][52][53] Recommendations. In patients with non-valvular AF and previous ischemic stroke or TIA, we suggest avoiding routine bridging therapy prior to anticoagulation with vitamin K antagonists or non-vitamin K antagonist oral anticoagulants for secondary prevention of all events.…”

“…Several studies found that patients who had received OACs alone had a significantly lower risk of bleeding events than patients treated with fulldose LMWH followed by OAC. [50][51][52][53] The results of these studies should not be applied in a generalised manner because patients who received LMWH were more likely to have dysphagia and perhaps be at inherently greater risk of adverse outcomes.…”

Relative impact of hospital and surgeon procedure volumes on primary total hip arthroplasty revision: a nationwide cohort study in France

“…We retrospectively used the French National Health Insurance Information System (Système National d'Informations Inter-régimes de l'Assurance Maladie [SNIIRAM]), from which relevance and accuracy for pharmacoepidemiology studies have been validated [19] , [20] , [21] , [22] , [23] , [24] and used in many published studies [13] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] . The French National Health Insurance is compulsory; it comprehensively covers the entire French population.…”