Divergence Between Clinical Trial Evidence and Actual Practice in Use of Dual Antiplatelet Therapy After Transient Ischemic Attack and Minor Stroke
Authors: De Matteis Eleonora , De Santis Federico , Ornello Raffaele , Censori Bruno , Puglisi Valentina , Vinciguerra Luisa , Giossi Alessia , Di Viesti Pietro , Inchingolo Vincenzo , Fratta Giovanni Matteo , Diomedi Marina , Bagnato Maria Rosaria , Cenciarelli Silvia , Bedetti Chiara , Padiglioni Chiara , Tassinari Tiziana , Saia Valentina , Russo Alessandro , Petruzzellis Marco , Mezzapesa Domenico Maria , Caccamo Martina , Rinaldi Giuseppe , Bavaro Alessandra , Paciaroni Maurizio , Mosconi Maria Giulia , Foschi Matteo , Querzani Pietro , Muscia Francesco , Gallo Cassarino Serena , Candelaresi Paolo , De Mase Antonio , Guarino Maria , Cupini Letizia Maria , Sanzaro Enzo , Zini Andrea , La Spada Salvatore , Palmieri Carmela , Sepe Federica Nicoletta , Beretta Simone , Paci Cristina , Caggia Emanuele Alessandro , De Angelis Maria Vittoria , Bonanni Laura , Volpi Gino , Tassi Rossana , Pistoia Francesca , Scoditti Umberto , Tonon Agnese , Viticchi Giovanna , Ruzza Giampietro , Nencini Patrizia , Cavallini Anna , Toni Danilo , Ricci Stefano , Sacco Simona , Acciarri Maria Cristina , Alessi Chiara , Angelocola Stefania Martina , Ajdinaj Paola , Barbarini Leonardo , Barone Valentina , Baruffi Maraia Cristina , Bassi Chiara , Beccia Mario , Bellavia Simone , Biscetti Leonardo , Bonaffini Novella , Bolamperti Laura , Bongioanni Maria Roberta , Brienza Marianna , Bruzzone Gian Luca , Cameriere Valentina , Campagnaro Alessandro , Cappellani Roberto , Cappellari Manuel , Caputi Luigi , Cardinali Patrizio , Coppo Lorenzo , De Boni Antonella , De Franco Ivo Giuseppe , De Luca Cristina , Diamanti Susanna , Di Blasio Francesco , Di Carmine Caterina , Di Lisi Filomena , Di Giovanni Anna , Faini Claudia , Ferrarese Carlo , Fleetwood Thomas , Fortini Alberto , Frisullo Giovanni , Galotto Debora , Genovese Antonio , Gentile Luana , Invernizzi Paolo , La Starza Sara , Letteri Federica , Manobianca Giovanni , Mannino Marina , Marcon Michela , Masato Maela , Mazzacane Federico , Menegazzo Elisabetta , Menichetti Chiara , Monaco Daniela , Naldi Federica , Nannucci Serena , Occhipinti Clorinda , Orsucci Daniele , Paolucci Silvia , Passarelli Francesco , Papiri Giulio , Pelliccioni Giuseppe , Perini Francesco , Pinto Vincenza , Potente Eleonora , Puca Emanuele , Ricciardi Maria Chiara , Roberti Cinzia , Romoli Michele , Rondelli Francesca , Rota Eugenia , Russo Monia , Sacchini Elisa , Sanna Alessandra , Scaglione Gaspare , Scalvini Andrea , Scala Irene , Scarpato Ciro , Servillo Giovanna , Sgarlata Eleonora , Silvestrini Mauro , Simonetto Marco , Spina Emanuele , Tarletti Roberto , Terruso Valeria , Tocco Pierluigi , Tudisco Laura , Valcamonica Gloria , Valente Martina , Vista Marco , Zito Antonio , Zivelonghi Cecilia 
Published: March 2023

Background:
Randomized controlled trials (RCTs) proved that short-term (21–90 days) dual antiplatelet therapy (DAPT) reduces the risk of early ischemic recurrences after a noncardioembolic minor stroke or high-risk transient ischemic attack (TIA) without substantially increasing the hemorrhagic risk. We aimed at understanding whether and how real-world use of DAPT differs from RCTs.

Methods:
READAPT (Real-Life Study on Short-Term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or TIA) is a prospective cohort study including >18-year-old patients treated with DAPT after a noncardioembolic minor ischemic stroke or high-risk TIA from 51 Italian centers. The study comprises a 90-day follow-up from symptom onset. In the present work, we reported descriptive statistics of baseline data of patients recruited up to July 31, 2022, and proportions of patients who would have been excluded from RCTs. We compared categorical data through the χ² test.

Results:
We evaluated 1070 patients, who had 72 (interquartile range, 62–79) years median age, were mostly Caucasian (1045; 97.7%), and were men (711; 66.4%). Among the 726 (67.9%) patients with ischemic stroke, 226 (31.1%) did not meet the RCT inclusion criteria because of National Institutes of Health Stroke Scale score >3 and 50 (6.9%) because of National Institutes of Health Stroke Scale score >5. Among the 344 (32.1%) patients with TIA, 69 (19.7%) did not meet the RCT criteria because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <4 and 252 (74.7%) because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <6 and no symptomatic arterial stenosis. Additionally, 144 (13.5%) patients would have been excluded because of revascularization procedures. Three hundred forty-five patients (32.2%) did not follow the RCT procedures because of late (>24 hours) DAPT initiation; 776 (72.5%) and 676 (63.2%) patients did not take loading doses of aspirin and clopidogrel, respectively. Overall, 84 (7.8%) patients met the RCT inclusion/exclusion criteria.

Conclusions:
The real-world use of DAPT is broader than RCTs. Most patients did not meet the RCT criteria because of the severity of ischemic stroke, lower risk of TIA, late DAPT start, or lack of antiplatelet loading dose.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT05476081.