“…The reported annual rates of warfarin-associated ICH from major RCTs of AF (Atrial-Fibrillation-Investigators, 1994; SPAF-Investigators, 1994; Olsson, 2003; Albers et al, 2005; DiMarco et al, 2005; Connolly et al, 2006, 2009; Diener et al, 2010; Granger et al, 2011; Patel et al, 2011) are systematically lower compared to the rates of ICH of non-inception and inception observational studies (Landefeld and Goldman, 1989; Fihn et al, 1993; van der Meer et al, 1993; Steffensen et al, 1997; Beyth et al, 1998; Go et al, 2003; Hylek et al, 2007; Poli et al, 2009; Figure 2). A recent observational inception cohort study of patients treated with oral anticoagulation (of whom a quarter had a previous history of stroke) reported a 2.5% (95% CI 1.1–4.7%) risk of ICH at 1 year (Hylek et al, 2007).…”