Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack
Authors: 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 
Published: June 2024

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.