ISSN 1016-5169 | E-ISSN 1308-4488
Dabigatran for stroke prevention in real life in a sample of population from Turkey: D-SPIRIT registry [Turk Kardiyol Dern Ars]
Turk Kardiyol Dern Ars. 2021; 49(8): 630-640 | DOI: 10.5543/tkda.2021.07734

Dabigatran for stroke prevention in real life in a sample of population from Turkey: D-SPIRIT registry

Cihan Altın1, Caner Topaloğlu2, Nurullah Çetin2, Onur Dalgıç2, Veysel Yavuz3, Emin Alioğlu4, Nazile Bilgin5, Cenk Ekmekçi6, Nihat Pekel7, Mehmet Emre Özpelit7, Eşref Tunçer4, Ebru İpek Türkoğlu8, Kamil Tülüce2, Umut Kocabaş1, Kıvanç Yüksel9, Uğur Önsel Türk10
1Department of Cardiology, Başkent University School of Medicine, İzmir, Turkey
2Department of Cardiology, Karşıyaka State Hospital, İzmir, Turkey
3Department of Cardiology, Akhisar Mustafa Kirazoğlu State Hospital, Manisa, Turkey
4Department of Cardiology, Central Hospital, İzmir, Turkey
5Department of Cardiology, Menemen State Hospital, İzmir, Turkey
6Department of Cardiology, Tepecik Training and Research Hospital, İzmir, Turkey
7Department of Cardiology, İzmir Medical Park Hospital, İzmir, Turkey
8Department of Cardiology, Kemalpaşa State Hospital, İzmir, Turkey
9Department of Biostatistics, Ege University, İzmir, Turkey
10Center for Drug Research and Development and Pharmacokinetic Applications, Ege University, İzmir, Turkey

The D-SPIRIT registry is designed to investigate the safety and effectiveness of dabigatran etexilate in patients with atrial fibrillation in routine clinical practice.

D-SPIRIT is the first national, multicenter, prospective, observational, postmarketing registry that investigates the usage of dabigatran in real life. A total of 326 noveloral anticoagulant–eligible patients with atrial fibrillation who have been taking dabigatran etexilate therapy for stroke prevention at least 6 months from 9 different centers were enrolled into the registry. Patients were followed up for 2 years to evaluate the effectiveness and safety of the treatment. All adverse clinical events including bleeding, thromboembolic events, stroke, systemic embolism, transient ischemic attack, myocardial infarction, and all-cause death were recorded.

The mean age was 71.1±9.6 years, and 57.4% of the study participants were female. The mean CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack [TIA], vascular disease, age 65-74 years, sex category) score was 3.4±1.6. The cumulative adverse clinical events rate was 6.30% per year. The rate for embolic events including TIA, ischemic stroke, and peripheral embolism was 1.26% per year. The rate for major bleeding was 2.20% per year, and the mortality rate was 0.94% per year.

This registry obtained an important overview of the current safety and effectiveness of the dabigatran etexilate in Turkey. Our results indicate similar rates of thromboembolic and bleeding events with pivotal phase 3 trial and other real-life registries. However, rate of undertreatment usage of dabigatran etexilate in real life was found to be considerable.

Keywords: Dabigatran etexilate, atrial fibrillation, real life, Turkey

How to cite this article
Cihan Altın, Caner Topaloğlu, Nurullah Çetin, Onur Dalgıç, Veysel Yavuz, Emin Alioğlu, Nazile Bilgin, Cenk Ekmekçi, Nihat Pekel, Mehmet Emre Özpelit, Eşref Tunçer, Ebru İpek Türkoğlu, Kamil Tülüce, Umut Kocabaş, Kıvanç Yüksel, Uğur Önsel Türk. Dabigatran for stroke prevention in real life in a sample of population from Turkey: D-SPIRIT registry. Turk Kardiyol Dern Ars. 2021; 49(8): 630-640

Corresponding Author: Cihan Altın, Türkiye
Manuscript Language: English

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