非心源性轻至中度缺血性卒中患者双联与单联抗血小板治疗的真实世界比较：一项倾向匹配分析。
Real-world comparison of dual versus single antiplatelet treatment in patients with non-cardioembolic mild-to-moderate ischemic stroke: A propensity matched analysis.
作者信息
Foschi Matteo, Ornello Raffaele, D'Anna Lucio, De Matteis Eleonora, De Santis Federico, Barone Valentina, Viola Marilina, Mosconi Maria Giulia, Rosin Diletta, Romoli Michele, Tassinari Tiziana, Cenciarelli Silvia, Censori Bruno, Zedde Marialuisa, Diomedi Marina, Petruzzellis Marco, Inchingolo Vincenzo, Cappellari Manuel, Candelaresi Paolo, Bavaro Alessandra, Cavallini Anna, Piscaglia Maria Grazia, Terruso Valeria, Pezzini Alessandro, Frisullo Giovanni, Muscia Francesco, Zini Andrea, Leone Ruggiero, Palmieri Carmela, Cupini Letizia Maria, Marcon Michela, Tassi Rossana, Sanzaro Enzo, Papiri Giulio, Viticchi Giovanna, Orsucci Daniele, Falcou Anne, Diamanti Susanna, Tarletti Roberto, Nencini Patrizia, Rota Eugenia, Sepe Federica Nicoletta, Caputi Luigi, Volpi Gino, La Spada Salvatore, Beccia Mario, Mastrangelo Vincenzo, Invernizzi Paolo, Pelliccioni Giuseppe, De Angelis Maria Vittoria, Bonanni Laura, Ruzza Giampietro, Caggia Emanuele Alessandro, Russo Monia, Tonon Agnese, Acciarri Maria Cristina, Anticoli Sabrina, Roberti Cinzia, Scaglione Gaspare, Pistoia Francesca, Alessi Chiara, De Boni Antonella, Sanna Alessandra, Chiti Alberto, Barbarini Leonardo, Masato Maela, Del Sette Massimo, Passarelli Francesco, Bongioanni Maria Roberta, De Michele Manuela, Ricci Stefano, Valente Mariarosaria, Gigli Gian Luigi, Merlino Giovanni, Paciaroni Maurizio, Guarino Maria, Sacco Simona
机构信息
Department of Biotechnological and Applied Clinical Sciences (DISCAB), University of L'Aquila, L'Aquila, Italy.
Department of Brain Sciences, Imperial College London, London, UK.
出版信息
Int J Stroke. 2025 Apr;20(4):438-449. doi: 10.1177/17474930241302991. Epub 2024 Dec 16.
BACKGROUND
Short-term dual antiplatelet treatment (DAPT) is superior to single antiplatelet treatment (SAPT) for secondary prevention in non-cardioembolic minor ischemic stroke and high-risk transient ischemic attack (TIA). As the real-world use of DAPT is broader than in trials, it is important to clarify its benefit/risk profile in a diverse population.
METHODS
Post hoc analysis of prospectively collected data from the READAPT cohort and three prospective stroke registries including patients with mild-to-moderate (National Institute of Health Stroke Scale (NIHSS) score 0-10) ischemic stroke receiving early DAPT or SAPT. The primary effectiveness outcome was 90-day return to pre-stroke neurological functioning using modified Rankin Scale (mRS) score. Secondary effectiveness outcomes were 90-day mRS shift, new ischemic stroke/TIA, vascular and all-cause death, 24 h early neurological improvement or deterioration. The safety outcome was 90-day intracranial hemorrhage.
RESULTS
We matched 1008 patients treated with DAPT and 1008 treated with SAPT. Compared to SAPT, patients treated with DAPT showed higher likelihood of 90-day primary effectiveness outcome (87.5% vs. 84.4%, risk difference 3.1% (95% confidence interval (CI): 0.1%-6.1%); p = 0.047, risk ratio 1.03 (95% CI: 1.01-1.07); p = 0.043) and higher rate of 24-h early neurological improvement (25.3% vs. 15.4%, risk difference 9.9% (95% CI: 6.4%-13.4%); p < 0.001, risk ratio 1.65 (95% CI: 1.37-1.97); p < 0.001). No differences were observed for other study outcomes. Subgroup analysis confirmed benefit of DAPT over SAPT for primary effectiveness outcome in patients with moderate stroke, those treated with intravenous thrombolysis, and those who received antiplatelet loading dose.
CONCLUSION
Our findings suggest that DAPT use might be safe and more effective than SAPT even in the real world and in patients who do not strictly fulfill the criteria of landmark large clinical trials.
背景
在非心源性轻度缺血性卒中和高危短暂性脑缺血发作（TIA）的二级预防中，短期双重抗血小板治疗（DAPT）优于单一抗血小板治疗（SAPT）。由于DAPT在现实世界中的应用比在试验中更广泛，因此有必要在不同人群中阐明其获益/风险情况。
方法
对前瞻性收集的来自READAPT队列和三个前瞻性卒中登记处的数据进行事后分析，这些数据包括接受早期DAPT或SAPT治疗的轻度至中度（美国国立卫生研究院卒中量表（NIHSS）评分0 - 10）缺血性卒中患者。主要有效性结局是使用改良Rankin量表（mRS）评分在90天时恢复到卒中前神经功能状态。次要有效性结局包括90天mRS评分变化、新发缺血性卒中/TIA、血管性死亡和全因死亡、24小时早期神经功能改善或恶化。安全性结局是90天颅内出血。
结果
我们匹配了1008例接受DAPT治疗的患者和1008例接受SAPT治疗的患者。与SAPT相比，接受DAPT治疗的患者90天主要有效性结局的可能性更高（87.5%对84.4%，风险差异3.1%（95%置信区间（CI）：0.1% - 6.1%）；p = 0.047，风险比1.03（95%CI：1.01 - 1.07）；p = 0.043），24小时早期神经功能改善率更高（25.3%对15.4%，风险差异9.9%（95%CI：6.4% - 13.4%）；p < 0.001，风险比1.65（95%CI：1.37 - 1.97）；p < 0.001）。其他研究结局未观察到差异。亚组分析证实，在中度卒中患者、接受静脉溶栓治疗的患者以及接受抗血小板负荷剂量治疗的患者中，DAPT在主要有效性结局方面优于SAPT。
结论
我们的研究结果表明，即使在现实世界中以及在未严格符合标志性大型临床试验标准的患者中，使用DAPT可能比SAPT更安全、更有效。
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