Journal Article

Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack

Paci, Cristina, Acciarri, Maria Cristina, Foschi, Matteo, Moraru, Stefan, Beccia, Mario, Bonanni, Laura, Terruso, Valeria, Palmieri, Carmela, Sanzaro, Enzo, Toni, Danilo, Mezzapesa, Domenico Maria, Nencini, Patrizia, Petruzzellis, Marco, Invernizzi, Paolo, Cappellari, Manuel, Padiglioni, Chiara, Vinciguerra, Luisa, Bedetti, Chiara, Ferrandi, Delfina, Pelliccioni, Giuseppe, Cenciarelli, Silvia, Cavallini, Anna, Mosconi, Maria Giulia, Leone, Ruggiero, Cupini, Letizia Maria, De Boni, Antonella, Orsucci, Daniele, Tonon, Agnese, Passarelli, Francesco, Marcon, Michela, Pezzini, Alessandro, tini, Alberto, Frisullo, Giovanni, De Angelis, Maria Vittoria, Russo, Monia, Mastrangelo, Vincenzo, Falcou, Anne, Zini, Andrea, Caggiula, Marcella, Manobianca, Giovanni, Zedde, Marialuisa, Chiti, Alberto, Barbarini, Leonardo, Barone, Valentina, Rota, Eugenia, Ornello, Raffaele, Paciaroni, Maurizio, Romoli, Michele, Bavaro, Alessandra, Diamanti, Susanna, Caputi, Luigi, Diomedi, Marina, Sepe, Federica Nicoletta, Sacco, Simona, De Santis, Federico, Roberti, Cinzia, Di Viesti, Pietro, Roberta Bongioanni, Maria, Zenorini, Ma

2024

Overview

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.

• Publisher: Oxford University Press
• Subject: Ischemia / Stroke / Transient ischemic attack