Duke Clinical Research Institute, Duke University, Durham, North Carolina, and Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada (D.S.C.).
Duke-National University of Singapore Medical School, Singapore (K.Z.).
Ann Intern Med. 2022 Sep;175(9):1230-1239. doi: 10.7326/M21-4653. Epub 2022 Aug 16.
Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation.
To determine the optimal strategy for stroke prevention conditional on a patient's individual risks for ischemic stroke and bleeding.
Decision analysis with a Markov model.
Evidence from the published literature informed model inputs.
Women and men with nonvalvular AF and without prior stroke.
Lifetime.
Clinical.
LAAO versus warfarin or direct oral anticoagulants (DOACs).
The primary end point was clinical benefit measured in quality-adjusted life-years.
RESULTS OF BASE-CASE ANALYSIS: The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHADS-VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHADS-VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs.
Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data.
Clinical effectiveness data were drawn primarily from studies on the Watchman device.
Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO.
None.
左心耳封堵术（LAAO）是一种有选择地应用于伴有心房颤动（AF）的患者替代口服抗凝剂的潜在方法。与抗凝剂相比，LAAO 降低了大出血风险，但与抗凝相比，其发生缺血性卒中的风险尚不确定。
确定根据患者缺血性卒中和出血风险的个体情况，预防卒中的最佳策略。
决策分析与马尔可夫模型。
文献发表的证据为模型输入提供信息。
无瓣膜性房颤且无既往卒中的女性和男性。
终生。
临床。
LAAO 与华法林或直接口服抗凝剂（DOAC）相比。
主要终点是通过质量调整生命年来衡量的临床获益。
AF 患者的卒中风险和出血风险决定了 LAAO 是否优于抗凝剂。合并风险有利于 LAAO 用于高出血风险，但在更高的卒中风险下，这种获益变得不太确定。例如，在 HAS-BLED 评分为 5 时，在 CHADS-VASc 评分为 2 至 5 的情况下，LAAO 在模型模拟的 80%以上的情况下占优势。在较低的出血风险（HAS-BLED 评分 0 至 1）下，LAAO 在 QALYs 中获益的概率（>80%）仅限于卒中风险较低的患者（CHADS-VASc 评分 2）。由于 DOAC 出血风险低于华法林，因此 LAAO 的净获益不如 DOAC 确定。
使用 ORBIT 出血评分代替 HAS-BLED 评分，以及 LAAO 临床疗效数据的替代来源，结果仍然一致。
临床疗效数据主要来自 Watchman 装置的研究。
尽管 LAAO 可作为伴有高出血风险的 AF 患者预防卒中的抗凝剂替代方法，但 LAAO 的总体获益取决于个体患者的卒中风险和出血风险的组合。这些结果表明，需要足够低的卒中风险才能使 LAAO 受益。作者认为，这些结果可以改善选择 LAAO 患者时的共同决策。
无。
