Sakakibara Fumihiro, Ueda Shinichiro, Uchida Kazutaka, Kinjo Norito, Arai Hideki, Nezu Mari, Morimoto Takeshi
Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Japan.
Hypertens Res. 2022 Jun;45(6):1028-1036. doi: 10.1038/s41440-022-00855-x. Epub 2022 Feb 17.
Outside of clinical trials, the prophylactic effect of dihydropyridine calcium channel blockers (CCBs) on ischemic events in patients with nonvalvular atrial fibrillation (NVAF) has not been confirmed. We compared the effect of dihydropyridine CCBs on ischemic events in anticoagulated NVAF patients. We conducted a multicenter historical cohort study at 71 centers in Japan. The inclusion criterion was taking vitamin K antagonists for NVAF. The exclusion criteria were mechanical heart valves and a history of pulmonary thrombosis or deep vein thrombosis. Consecutive patients (N = 7826) were registered in February 2013 and were followed until February 2017. The primary outcomes were ischemic events and ischemic strokes; the secondary outcomes were all-cause mortality, major bleeding, and hemorrhagic strokes. The mean patient age was 73 years old, and 67% of the patients were male. Seventy-eight percent of the patients had hypertension, and dihydropyridine CCBs were used by 2693 (34%) patients (CCB group). The cumulative incidences of ischemic events and ischemic strokes at 4 years in the CCB and No-CCB groups were 5.9% vs. 5.2% and 5.6% vs. 4.8%, respectively. The adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) of the CCB group for ischemic events and ischemic strokes were 1.22 (0.95-1.57) and 1.32 (1.02-1.71), respectively; the adjusted HRs (95% CIs) of the CCB group for all-cause mortality, major bleeding, and hemorrhagic strokes were 0.85 (0.69-1.04), 1.12 (0.92-1.35), and 1.08 (0.62-1.88), respectively. Dihydropyridine CCB use by anticoagulated NVAF patients significantly increased ischemic strokes in a real-world setting.
在临床试验之外，二氢吡啶类钙通道阻滞剂（CCB）对非瓣膜性心房颤动（NVAF）患者缺血性事件的预防作用尚未得到证实。我们比较了二氢吡啶类CCB对抗凝治疗的NVAF患者缺血性事件的影响。我们在日本的71个中心进行了一项多中心历史性队列研究。纳入标准是正在服用维生素K拮抗剂治疗NVAF。排除标准是机械心脏瓣膜以及有肺血栓形成或深静脉血栓形成病史。连续患者（N = 7826）于2013年2月登记入组，并随访至2017年2月。主要结局是缺血性事件和缺血性卒中；次要结局是全因死亡率、大出血和出血性卒中。患者的平均年龄为73岁，67%为男性。78%的患者患有高血压，2693例（34%）患者使用了二氢吡啶类CCB（CCB组）。CCB组和非CCB组4年时缺血性事件和缺血性卒中的累积发生率分别为5.9%对5.2%和5.6%对4.8%。CCB组缺血性事件和缺血性卒中的校正风险比（HR）（95%置信区间[CI]）分别为1.22（0.95 - 1.57）和1.32（1.02 - 1.71）；CCB组全因死亡率、大出血和出血性卒中的校正HR（95%CI）分别为0.85（0.69 - 1.04）、1.12（0.92 - 1.35）和1.08（0.62 - 1.88）。在真实世界中，抗凝治疗的NVAF患者使用二氢吡啶类CCB会显著增加缺血性卒中的发生风险。
