Divergence Between Clinical Trial Evidence and Actual Practice in Use of Dual Antiplatelet Therapy After Transient Ischemic Attack and Minor Stroke-Reference-Cited by-同舟云学术

Divergence Between Clinical Trial Evidence and Actual Practice in Use of Dual Antiplatelet Therapy After Transient Ischemic Attack and Minor Stroke

Published:2023-05 Issue:5 Volume:54 Page:1172-1181
ISSN:0039-2499
Container-title:Stroke
language:en
Short-container-title:Stroke

Author:

De Matteis Eleonora¹^ORCID,De Santis Federico¹^ORCID,Ornello Raffaele¹,Censori Bruno²^ORCID,Puglisi Valentina²^ORCID,Vinciguerra Luisa²^ORCID,Giossi Alessia²,Di Viesti Pietro³,Inchingolo Vincenzo³,Fratta Giovanni Matteo³,Diomedi Marina⁴^ORCID,Bagnato Maria Rosaria⁴^ORCID,Cenciarelli Silvia⁵^ORCID,Bedetti Chiara²⁵^ORCID,Padiglioni Chiara⁵,Tassinari Tiziana⁶^ORCID,Saia Valentina⁶^ORCID,Russo Alessandro⁶,Petruzzellis Marco⁷^ORCID,Mezzapesa Domenico Maria⁷^ORCID,Caccamo Martina⁷^ORCID,Rinaldi Giuseppe⁸,Bavaro Alessandra⁸^ORCID,Paciaroni Maurizio⁹^ORCID,Mosconi Maria Giulia⁹^ORCID,Foschi Matteo¹¹⁰^ORCID,Querzani Pietro¹⁰,Muscia Francesco¹¹^ORCID,Gallo Cassarino Serena¹¹,Candelaresi Paolo¹²^ORCID,De Mase Antonio¹²^ORCID,Guarino Maria¹³^ORCID,Cupini Letizia Maria¹⁴^ORCID,Sanzaro Enzo¹⁵^ORCID,Zini Andrea¹⁶^ORCID,La Spada Salvatore¹⁷,Palmieri Carmela¹⁸,Sepe Federica Nicoletta¹⁹,Beretta Simone²⁰^ORCID,Paci Cristina²¹^ORCID,Caggia Emanuele Alessandro²²,De Angelis Maria Vittoria²³,Bonanni Laura²⁴^ORCID,Volpi Gino²⁵,Tassi Rossana²⁶^ORCID,Pistoia Francesca¹^ORCID,Scoditti Umberto²⁷^ORCID,Tonon Agnese²⁸^ORCID,Viticchi Giovanna²⁹^ORCID,Ruzza Giampietro³⁰,Nencini Patrizia³¹^ORCID,Cavallini Anna³²^ORCID,Toni Danilo³³^ORCID,Ricci Stefano⁵^ORCID,Sacco Simona¹^ORCID,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

Affiliation:

1. Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.).

2. Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.).

3. Department of Neurology, Casa sollievo della sofferenza, San Giovanni Rotondo, Italy (P.D.V., V.I., G.M.F.).

4. Department of Systems Medicine, Tor Vergata University Hospital, Rome, Italy (M.D., M.R.B.).

5. Department of Neurology, Città di Castello Hospital, Italy (S.C., C.B., C. Padiglioni, S.R.).

6. Department of Neurology, Santa Corona Hospital, Pietra Ligure, Italy (T.T., V.S., A.R.).

7. Department of Neurology and Stroke Unit “F. Puca,” AOU Consorziale Policlinico, Bari, Italy (M. Petruzzellis, D.M.M., M.C.).

8. Department of Neurology, Di Venere Hospital, Bari, Italy (G. Rinaldi, A.B.).

9. Stroke Unit, University Hospital Santa Maria della Misericordia, Perugia, Italy (M. Paciaroni, M.G.M.).

10. Department of Neuroscience, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy (M.F., P.Q.).

11. Department of Neurology, ASST Ovest Milanese, Legnano, Italy (F.M., S.G.C.).

12. Department of Neurology and Stroke Unit, AORN Antonio Cardarelli, Naples, Italy (P.C., A.D.M.).

13. IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology, Policlinico S. Orsola-Malpighi, Bologna, Italy (M.G.).

14. Department of Neurology and Stroke Unit, S. Eugenio Hospital, Rome, Italy (L.M.C.).

15. Department of Neurology and Stroke Unit, Umberto I Hospital, Siracusa, Italy (E.S.).

16. IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology and Stroke Center, Maggiore Hospital, Bologna, Italy (A.Z.).

17. Department of Neurology, Antonio Perrino Hospital, Brindisi, Italy (S.L.S.).

18. Department of Neurology, Hospital “E. Agnelli,” Pinerolo, Italy (C. Palmieri).

19. Department of Neurology and Stroke Unit, S.S. Biagio e Arrigo Hospital, Alessandria, Italy (F.N.S.).

20. Department of Neurology, Fondazione IRCCS San Gerardo dei Tintori Monza, Italy (S.B.).

21. Neurology Unit, Ospedale Provinciale “Madonna del Soccorso,” San Benedetto del Tronto, Italy (C. Paci).

22. Department of Neurology, Giovanni Paolo II Hospital, Ragusa, Italy (E.A.C.).

23. Department of Neurology and Stroke Unit, S.S. Annunziata Hospital, Chieti, Italy (M.V.D.A.).

24. Dipartimento di Medicina e Scienze dell’Invecchiamento, Università G. d’Annunzio di Chieti-Pescara e Clinica Neurologica e Stroke Unit Ospedale Clinicizzato S.S. Annunziata di Chieti, Italy (L.B.).

25. Department of Neurology, San Jacopo Hospital, Pistoia, Italy (G. Volpi).

26. Stroke Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy (R.T.).

27. Department of Emergency-Neurology-Stroke Care, University Hospital of Parma, Italy (U.S.).

28. Department of Neurology, Ospedale Civile S.S. Giovanni e Paolo, Venezia, Italy (A.T.).

29. Clinical and Experimental Medicine Department, Marche Polytechnic University, Ancona, Italy (G. Viticchi).

30. Stroke Unit, Cittadella Hospital, Cittadella, Italy (G. Ruzza).

31. Stroke Unit, Careggi University Hospital, Florence, Italy (P.N.).

32. Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino Foundation, Pavia, Italy (A.C.).

33. Department of Human Neurosciences, University of Rome La Sapienza, Italy (D.T.).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

Reference36 articles.

1. A 5-Decade Analysis of Incidence Trends of Ischemic Stroke After Transient Ischemic Attack

2. One-Year Risk of Stroke after Transient Ischemic Attack or Minor Stroke

3. Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline

4. Canadian Stroke Best Practice Recommendations for Acute Stroke Management: Prehospital, Emergency Department, and Acute Inpatient Stroke Care, 6th Edition, Update 2018

5. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Combining Intravenous Thrombolysis and Dual Antiplatelet Treatment in Patients With Minor Ischemic Stroke: A Propensity Matched Analysis of the READAPT Study Cohort;Journal of the American Heart Association;2024-08-20

2. Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack;European Stroke Journal;2024-06-13

3. Efficacy and safety of oral factor Xa inhibitors versus vitamin-K antagonists in the early phase after acute ischemic stroke or TIA in the real-world setting: The PRODAST study;European Stroke Journal;2024-04-03

4. Cost‐Effectiveness of Increased Use of Dual Antiplatelet Therapy After High‐Risk Transient Ischemic Attack or Minor Stroke;Journal of the American Heart Association;2024-04-02

5. Stroke and high-risk TIA outcomes with reduction of treatment duration when treatment initiated in emergency rooms (SHORTER-study);International Journal of Stroke;2024-03-16