Divergence Between Clinical Trial Evidence and Actual Practice in Use of Dual Antiplatelet Therapy After Transient Ischemic Attack and Minor Stroke. Issue 5 (23rd March 2023)

• Record Type: Journal Article
• 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;
• Other Names: Acciarri Maria Cristina author non-byline.; Alessi Chiara author non-byline.; Angelocola Stefania Martina author non-byline.; Ajdinaj Paola author non-byline.; Barbarini Leonardo author non-byline.; Barone Valentina author non-byline.; Baruffi Maraia Cristina author non-byline.; Bassi Chiara author non-byline.; Beccia Mario author non-byline.; Bellavia Simone author non-byline.; Biscetti Leonardo author non-byline.; Bonaffini Novella author non-byline.; Bolamperti Laura author non-byline.; Bongioanni Maria Roberta author non-byline.; Brienza Marianna author non-byline.; Bruzzone Gian Luca author non-byline.; Cameriere Valentina author non-byline.; Campagnaro Alessandro author non-byline.; Cappellani Roberto author non-byline.; Cappellari Manuel author non-byline.; Caputi Luigi author non-byline.; Cardinali Patrizio author non-byline.; Coppo Lorenzo author non-byline.; De Boni Antonella author non-byline.; De Franco Ivo Giuseppe author non-byline.; De Luca Cristina author non-byline.; Diamanti Susanna author non-byline.; Di Blasio Francesco author non-byline.; Di Carmine Caterina author non-byline.; Di Lisi Filomena author non-byline.; Di Giovanni Anna author non-byline.; Faini Claudia author non-byline.; Ferrarese Carlo author non-byline.; Fleetwood Thomas author non-byline.; Fortini Alberto author non-byline.; Frisullo Giovanni author non-byline.; Galotto Debora author non-byline.; Genovese Antonio author non-byline.; Gentile Luana author non-byline.; Invernizzi Paolo author non-byline.; La Starza Sara author non-byline.; Letteri Federica author non-byline.; Manobianca Giovanni author non-byline.; Mannino Marina author non-byline.; Marcon Michela author non-byline.; Masato Maela author non-byline.; Mazzacane Federico author non-byline.; Menegazzo Elisabetta author non-byline.; Menichetti Chiara author non-byline.; Monaco Daniela author non-byline.; Naldi Federica author non-byline.; Nannucci Serena author non-byline.; Occhipinti Clorinda author non-byline.; Orsucci Daniele author non-byline.; Paolucci Silvia author non-byline.; Passarelli Francesco author non-byline.; Papiri Giulio author non-byline.; Pelliccioni Giuseppe author non-byline.; Perini Francesco author non-byline.; Pinto Vincenza author non-byline.; Potente Eleonora author non-byline.; Puca Emanuele author non-byline.; Ricciardi Maria Chiara author non-byline.; Roberti Cinzia author non-byline.; Romoli Michele author non-byline.; Rondelli Francesca author non-byline.; Rota Eugenia author non-byline.; Russo Monia author non-byline.; Sacchini Elisa author non-byline.; Sanna Alessandra author non-byline.; Scaglione Gaspare author non-byline.; Scalvini Andrea author non-byline.; Scala Irene author non-byline.; Scarpato Ciro author non-byline.; Servillo Giovanna author non-byline.; Sgarlata Eleonora author non-byline.; Silvestrini Mauro author non-byline.; Simonetto Marco author non-byline.; Spina Emanuele author non-byline.; Tarletti Roberto author non-byline.; Terruso Valeria author non-byline.; Tocco Pierluigi author non-byline.; Tudisco Laura author non-byline.; Valcamonica Gloria author non-byline.; Valente Martina author non-byline.; Vista Marco author non-byline.; Zito Antonio author non-byline.; Zivelonghi Cecilia author non-byline.;
• Is Part Of: Stroke. Volume 54:Issue 5(2023)
• Page Start: 1172
• Page End: 1181
• Publication Date: 2023-03-23
• Subjects: aspirin -- clopidogrel -- follow-up studies -- prospective studies -- ticagrelor; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.122.041660
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : 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.