Dabigatran in real-world atrial fibrillation. Meta-analysis of observational comparison studies with vitamin K antagonists.

In the RE-LY clinical trial, dabigatran presented a better effectiveness/safety profile when compared to warfarin. However, clinical trials are not very representative of the real-world setting. We aimed to assess the performance of dabigatran in real-world patients with atrial fibrillation (AF) by means of a systematic review and meta-analysis of observational comparison studies with vitamin K antagonists (VKA). We searched PubMed, Embase and Scopus databases until November 2015 and selected studies according to the following criteria: observational study performed with nonvalvular AF patients; reporting adjusted hazard ratios (HR) of clinical events in a follow-up period; for dabigatran 75 mg, 110 mg or 150 mg versus VKA. Twenty studies were selected which included 711,298 patients, 210,279 of which were treated with dabigatran and the remaining 501,019 with VKA. Ischaemic stroke incidence was of 1.65 /100 patient-years for dabigatran and 2.85/100 patient-years for VKA (HR 0.86, 95 % confidence interval of 0.74-0.99). Major bleeding rate was 3.93/100 patient-years for dabigatran and 5.61/100 patient-years for VKA (0.79, 0.69-0.89). Risk of mortality (0.73, 0.61-0.87) and intracranial bleeding (0.45, 0.38-0.52) were significantly lower in patients treated with dabigatran when compared to patients on VKA. Risk of gastrointestinal (GI) bleeding was significantly higher in patients treated with dabigatran (1.13, 1.00-1.28). No significant difference was observed in risk of myocardial infarction (0.99, 0.89-1.11). In this combined analysis of real-world observational comparison studies with VKA, dabigatran was associated with a lower risk of ischaemic stroke, major bleeding, intracranial bleeding and mortality, higher risk of GI bleeding and a similar risk of myocardial infarction.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

In the RE-LY clinical trial, dabigatran presented a better effectiveness/safety profile when compared to warfarin. However, clinical trials are not very representative of the real-world setting.

Leech-derived molecules this paper discusses, each with a full profile in the ASH compound registry:

Explore how this research connects to clinical practice

More peer-reviewed studies in Clinical Trials.

• Leech Therapy for Knee Osteoarthritis — The Landmark RCT — Michalsen et al. (2003)
• Leech-Assisted Flap Salvage — Systematic Review of 277 Cases — Whitaker et al. (2012)
• Effects of hirudotherapy on liver functions, lipid profile, and insulin sensitivity in rats with metabolic syndrome — Bilden A et al. (2026)
• Efficacy and Safety of Hirudotherapy for Improving Sperm Quality Parameters in Male Infertility: A Randomized Controlled Trial — Abtahi-Forooshani M et al. (2026)
• Reverse Sural Flap Venous Congestion Successfully Managed With Enoxaparin in a Male Patient With a Traumatic Foot Crush Injury: A Case Report — Velasco-Bustamante J et al. (2026)
• Investigation of the therapeutic effects of medicinal leech treatment on lower extremity ischemia-reperfusion injury — Ünal K et al. (2026)
• Efficacy of Medicinal Leech Therapy in Diverse Clinical Applications: A Comprehensive Study from Azerbaijan — Farzali S et al. (2025)
• HIRUDOTHERAPY IN RECONSTRUCTIVE SURGERY: CASE-REPORTS AND REVIEW — Heinz P et al. (2020)
• Hirudotherapy Efficacy and Complications in the Management of Microsurgical Breast Reconstruction: A Systematic Review — Foppiani J et al. (2024)
• Hirudotherapy in Wound Healing — Nair H et al. (2022)

Browse all ASH-analysed research →