Hindawi Publishing Corporation Thrombosis Volume 2012, Article ID 867121, 10 pages doi:10.1155/2012/867121 Review Article Dabigatran for Stroke Prevention in Nonvalvular Atrial Fibrillation: Answers to Challenging “Real-World” Questions Jorge Ferreira,1 Daniel Ferreira,2 Miguel Viana-Baptista,3, 4 Paulo Bettencourt,5 Rui Cernadas,6 and Francisco Crespo7 1 Servi¸co de Cardiologia, Hospital de Santa Cruz, Avenida Prof. Reinaldo dos Santos, 2790-134 Carnaxide, Portugal 2 Servi¸co de Cardiologia, Hospital da Luz, Avenida Lus´ıada 100, 1500-650 Lisboa, Portugal 3 CEDOC, Faculdade de Ciˆencias M´edicas, Universidade Nova de Lisboa, Rua da Junqueira 126, 1349-019 Lisboa, Portugal 4 Servi¸co de Neurologia, Hospital Egas Moniz, 1349-019 Lisboa, Portugal 5 Servi¸co de Medicina Interna, Hospital de Sa˜o Joa˜o, Al. Prof. Hernaˆni Monteiro, 4200-319 Porto, Portugal 6 Unidade de Sau´de Familiar da Aguda, Avenida Padre Guilherme 21, 4405-010 Arcozelo, Portugal 7 Hospital de Torres Vedras, Rua Dr. Ricardo Belo, 2560-324 Torres Vedras, Portugal Correspondence should be addressed to Jorge Ferreira, jorge ferreira@netcabo.pt Received 15 December 2011; Revised 28 February 2012; Accepted 29 February 2012 Academic Editor: Edith Nutescu Copyright © 2012 Jorge Ferreira et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Dabigatran etexilate is a novel, oral, reversible, direct thrombin inhibitor that constitutes a major breakthrough for stroke prevention in patients with nonvalvular atrial ﬁbrillation (AF). Dabigatran was the ﬁrst new oral anticoagulant approved in Europe and became available in Portugal, for stroke prevention in nonvalvular AF, earlier than in most European countries. This paper is the joint eﬀort of a panel of experts from diﬀerent specialties and provides information on the use of dabigatran, in anticipation of the challenges that will come with increased usage. 1. Introduction Dabigatran etexilate (designated as dabigatran from here onwards) and other new oral anticoagulants (OACs) consti- tute a major breakthrough for stroke prevention in patients with nonvalvular atrial ﬁbrillation (AF). They have been shown to be an alternative to vitamin K antagonists (VKAs) that does not require routine laboratory control. Dabigatran (Pradaxa , Boehringer Ingelheim, Ingelheim, Germany) is a reversible direct thrombin inhibitor and, in the RE-LY trial (Randomized Evaluation of Long-term anticoagulation therapY), a phase III study, 150 mg bid was more eﬀective in terms of stroke prevention in nonvalvular AF than VKA, whereas 110 mg bid was as eﬀective as VKA, with a lower risk of bleeding [1]. Soon after the completion of this trial, the US Food and Drug Administration (FDA) approved dabigatran 150 mg bid and 75 mg bid (for patients with a creatinine clearance of 15 to 30 mL/min) [2]. Subsequently, the European Medicines Agency approved the doses of 150 mg bid and 110 mg bid (for patients aged at least 80 years, with an elevated risk of bleeding or receiving verapamil) [3] as an alternative to warfarin for stroke and systemic embolism (SE) reduction in patients with nonvalvular AF. The American College of Chest Physicians (ACCP) Guidelines on Antithrombotic Therapy and Prevention of Thrombosis (9th ed) suggest dabigatran 150 mg twice daily rather than adjusted-dose VKA for patients with nonvalvular AF [4]. Moreover, recent quantitative beneﬁt-harm and economic analyses in the UK support regulatory decisions that dabigatran oﬀers a positive beneﬁt to harm ratio when compared to warfarin [5]. Despite considerable variation among diﬀerent coun- tries, stroke has been appointed as the second leading cause of death worldwide [6]. Portugal was ranked the highest among Western European countries in terms of stroke mortality [7], and available data suggests that stroke not only continues to be the leading cause of death in this country [8], but also that its incidence is comparatively higher (crude annual incidence 3.05 and 2.69 per 1000 for rural and urban populations, resp.; corresponding rates adjusted to European