Background and purpose: Randomized controlled trials (RCTs) proved the efficacy of short-term dual antiplatelet therapy (DAPT) in secondary prevention of minor ischemic stroke or high-risk transient ischemic attack (TIA). We aimed at evaluating effectiveness and safety of short-term DAPT in real-world, where treatment use is broader than in RCTs.Methods: READAPT (REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack) (NCT05476081) was an observational multicenter real-world study with a 90-day follow-up. We included patients aged 18+ receiving short-term DAPT soon after ischemic stroke or TIA. No stringent NIHSS and ABCD2 score cut-offs were applied but adherence to guidelines was recommended. Primary effectiveness outcome was stroke (ischemic or hemorrhagic) or death due to vascular causes, primary safety outcome was moderate-to-severe bleeding. Secondary outcomes were the type of ischemic and hemorrhagic events, disability, cause of death, and compliance to treatment.Results: We included 1920 patients; 69.9% started DAPT after an ischemic stroke; only 8.9% strictly followed entry criteria or procedures of RCTs. Primary effectiveness outcome occurred in 3.9% and primary safety outcome in 0.6% of cases. In total, 3.3% cerebrovascular ischemic recurrences occurred, 0.2% intracerebral hemorrhages, and 2.7% bleedings; 0.2% of patients died due to vascular causes. Patients with NIHSS score <= 5 and those without acute lesions at neuroimaging had significantly higher primary effectiveness outcomes than their counterparts. Additionally, DAPT start >24 h after symptom onset was associated with a lower likelihood of bleeding.Conclusions: In real-world, most of the patients who receive DAPT after an ischemic stroke or a TIA do not follow RCTs entry criteria and procedures. Nevertheless, short-term DAPT remains effective and safe in this population. No safety concerns are raised in patients with low-risk TIA, more severe stroke, and delayed treatment start.
Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack / De Matteis, Eleonora; Ornello, Raffaele; De Santis, Federico; Foschi, Matteo; Romoli, Michele; Tassinari, Tiziana; Saia, Valentina; Cenciarelli, Silvia; Bedetti, Chiara; Padiglioni, Chiara; Censori, Bruno; Puglisi, Valentina; Vinciguerra, Luisa; Guarino, Maria; Barone, Valentina; Zedde, Marialuisa; Grisendi, Ilaria; Diomedi, Marina; Bagnato, Maria Rosaria; Petruzzellis, Marco; Mezzapesa, Domenico Maria; Di Viesti, Pietro; Inchingolo, Vincenzo; Cappellari, Manuel; Zenorini, Mara; Candelaresi, Paolo; Andreone, Vincenzo; Rinaldi, Giuseppe; Bavaro, Alessandra; Cavallini, Anna; Moraru, Stefan; Querzani, Pietro; Terruso, Valeria; Mannino, Marina; Pezzini, Alessandro; Frisullo, Giovanni; Muscia, Francesco; Paciaroni, Maurizio; Mosconi, Maria Giulia; Zini, Andrea; Leone, Ruggiero; Palmieri, Carmela; Cupini, Letizia Maria; Marcon, Michela; Tassi, Rossana; Sanzaro, Enzo; Paci, Cristina; Viticchi, Giovanna; Orsucci, Daniele; Falcou, Anne; Diamanti, Susanna; Tarletti, Roberto; Nencini, Patrizia; Rota, Eugenia; Sepe, Federica Nicoletta; Ferrandi, Delfina; Caputi, Luigi; Volpi, Gino; Spada, Salvatore La; Beccia, Mario; Rinaldi, Claudia; Mastrangelo, Vincenzo; Di Blasio, Francesco; 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; Manobianca, Giovanni; Scaglione, Gaspare; Pistoia, Francesca; Fortini, Alberto; De Boni, Antonella; Sanna, Alessandra; Chiti, Alberto; Barbarini, Leonardo; Caggiula, Marcella; Masato, Maela; Del Sette, Massimo; Passarelli, Francesco; Roberta Bongioanni, Maria; Toni, Danilo; Ricci, Stefano; Sacco, Simona. - In: EUROPEAN STROKE JOURNAL. - ISSN 2396-9881. - (2024). [10.1177/23969873241255250]
Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack
Pezzini, AlessandroMembro del Collaboration Group
;
2024-01-01
Abstract
Background and purpose: Randomized controlled trials (RCTs) proved the efficacy of short-term dual antiplatelet therapy (DAPT) in secondary prevention of minor ischemic stroke or high-risk transient ischemic attack (TIA). We aimed at evaluating effectiveness and safety of short-term DAPT in real-world, where treatment use is broader than in RCTs.Methods: READAPT (REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack) (NCT05476081) was an observational multicenter real-world study with a 90-day follow-up. We included patients aged 18+ receiving short-term DAPT soon after ischemic stroke or TIA. No stringent NIHSS and ABCD2 score cut-offs were applied but adherence to guidelines was recommended. Primary effectiveness outcome was stroke (ischemic or hemorrhagic) or death due to vascular causes, primary safety outcome was moderate-to-severe bleeding. Secondary outcomes were the type of ischemic and hemorrhagic events, disability, cause of death, and compliance to treatment.Results: We included 1920 patients; 69.9% started DAPT after an ischemic stroke; only 8.9% strictly followed entry criteria or procedures of RCTs. Primary effectiveness outcome occurred in 3.9% and primary safety outcome in 0.6% of cases. In total, 3.3% cerebrovascular ischemic recurrences occurred, 0.2% intracerebral hemorrhages, and 2.7% bleedings; 0.2% of patients died due to vascular causes. Patients with NIHSS score <= 5 and those without acute lesions at neuroimaging had significantly higher primary effectiveness outcomes than their counterparts. Additionally, DAPT start >24 h after symptom onset was associated with a lower likelihood of bleeding.Conclusions: In real-world, most of the patients who receive DAPT after an ischemic stroke or a TIA do not follow RCTs entry criteria and procedures. Nevertheless, short-term DAPT remains effective and safe in this population. No safety concerns are raised in patients with low-risk TIA, more severe stroke, and delayed treatment start.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.