PubMed İndeksli Yayınlar Koleksiyonu
Permanent URI for this collectionhttps://hdl.handle.net/11727/4810
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Item Current clinician perspective on non-vitamin K antagonist oral anticoagulant use in challenging clinical cases(2020) Turk, Ugur Onsel; Acar, Rezzan Deniz; Akgun, Taylan; Emren, Volkan; Kanat, Selcuk; Karacaglar, Emir; Kepez, Alper; Kul, Seref; Ozel, Erdem; Simsek, Evrim; Tuluce, Selcen Yakar; Tuluce, Kamil; Camm, A. John; 0000-0002-2538-1642; 32281950; ABI-6723-2020Objective: The evolution of non-vitamin K antagonist anticoagulants (NOACs) has changed the horizon of stroke prevention in atrial fibrillation (SPAF). All 4 NOACs have been tested against dose-adjusted warfarin in well-designed, pivotal, phase III, randomized, controlled trials (RCTs) and were approved by regulatory authorities for an SPAF indication. However, as traditional RCTs, these trials have important weaknesses, largely related to their complex structure and patient participation, which was limited by strict inclusion and extensive exclusion criteria. In the real world, however, clinicians are often faced with complex, multimorbid patients who are underrepresented in these RCTs. This article is based on a meeting report authored by 12 scientists studying atrial fibrillation (AF) in diverse ways who discussed the management of challenging AF cases that are underrepresented in pivotal NOAC trials. Methods: An advisory board panel was convened to confer on management strategies for challenging AF cases. The article is derived from a summary of case presentations and the collaborative discussions at the meeting. Conclusion: This expert consensus of cardiologists aimed to define management strategies for challenging cases with patients who underrepresented in pivotal trials using case examples from their routine practice. Although strong evidence is lacking, exploratory subgroup analysis of phase III pivotal trials partially informs the management of these patients. Clinical trials with higher external validity are needed to clarify areas of uncertainty. The lack of clear evidence about complex AF cases has pushed clinicians to manage patients based on clinical experience, including rare situations of off-label prescriptions.Item Design and rationale of dabigatran's stroke prevention in real life in Turkey (D-SPIRIT)(2016) Turk, Ugur Onsel; Alioglu, Emin; Tuncer, Esref; Ozpelit, Mehmet Emre; Pekel, Nihat; Tengiz, Istemihan; Cetin, Nurullah; Dalgic, Onur; Topaloglu, Caner; Bilgin, Nazile; Altin, Cihan; Ozdemirkiran, Tolga; Tuluce, Kamil; Turkoglu, Ebru Ipek; Ozpelit, Ebru; 27138311Objective: The D-SPIRIT registry is designed to investigate the safety and efficacy of dabigatran etexilate in patients with nonvalvular atrial fibrillation (NVAF) and to collect data on outcomes in clinical practice. Methods: The D-SPIRIT is a national, prospective, observational, post-marketing registry involving patients with NVAF who have been taking dabigatran etexilate therapy for stroke prevention for a minimum of 6 months prior to enrollment. The registry will collect and analyze data from routine care, enrolling up to 600 patients in 9 centers. Patients will be followed up for 2 years to evaluate effectiveness and safety. A sample size of 600 subjects is proposed based on the following assumptions; Two-sided significance level of 0.05 (1-sided significance level of 0.025), ischemic stroke incidence rate of 0.768%-1.111%, hemorrhagic stroke incidence rate of 0.109%-0.130%, transient ischemic attack incidence rate of 0.722%-0.623%, therapy discontinuation incidence rate of 40% at day 730, and duration of enrollment period of 12 months with non-uniformed enrollment rate. Ethics approval was given by Dokuz Eyll University Ethics Committee of Clinical Research (2014/54) and approved by the Turkish Ministry of Health. Conclusion: Potential results of D-SPIRIT registry will add data from clinical practice to those from the RE-LY trial to expand knowledge of dabigatran etexilate treatment in patients with NVAF.