Department of Cardiology, KardiyoRitm Cardiac Health Center, İzmir, Turkey.
Department of Cardiology, Koşuyolu Training and Research Hospital, İstanbul, Turkey.
Turk Kardiyol Dern Ars. 2020 Apr;48(3):289-303. doi: 10.5543/tkda.2020.16359.
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.
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.
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.
非维生素 K 拮抗剂类抗凝剂（NOACs）的发展改变了房颤（AF）卒中预防的前景。所有 4 种 NOAC 均已在设计良好、关键、III 期、随机、对照试验（RCT）中与剂量调整的华法林进行了比较，并已获得监管机构批准用于 AF 适应证。然而，与传统 RCT 一样，这些试验存在重要的局限性，主要与其复杂的结构和患者参与有关，这受到严格纳入标准和广泛排除标准的限制。然而，在现实世界中，临床医生经常面临复杂的、多病共存的患者，这些患者在这些 RCT 中代表性不足。本文基于 12 位以不同方式研究 AF 的科学家的会议报告，他们讨论了在关键 NOAC 试验中代表性不足的挑战性 AF 病例的管理。
召集顾问委员会小组讨论挑战性 AF 病例的管理策略。本文源自会议上病例介绍和协作讨论的总结。
本共识是由心脏病专家制定的，旨在通过从日常实践中的病例示例来确定在关键试验中代表性不足的挑战性病例的管理策略。尽管缺乏强有力的证据，但 III 期关键试验的探索性亚组分析部分为这些患者的管理提供了信息。需要具有更高外部有效性的临床试验来阐明不确定领域。缺乏关于复杂 AF 病例的明确证据促使临床医生根据临床经验管理患者，包括罕见的超适应证处方情况。
