Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack-Reference-Cited by-同舟云学术

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

Published:2024-06-13 Issue: Volume: Page:
ISSN:2396-9873
Container-title:European Stroke Journal
language:en
Short-container-title:European Stroke Journal

Author:

De Matteis Eleonora¹²,Ornello Raffaele¹^ORCID,De Santis Federico¹^ORCID,Foschi Matteo¹^ORCID,Romoli Michele³^ORCID,Tassinari Tiziana⁴,Saia Valentina⁴,Cenciarelli Silvia⁵,Bedetti Chiara⁵,Padiglioni Chiara⁵,Censori Bruno⁶,Puglisi Valentina⁶,Vinciguerra Luisa⁶,Guarino Maria⁷,Barone Valentina⁷,Zedde Marialuisa⁸,Grisendi Ilaria⁸,Diomedi Marina⁹,Bagnato Maria Rosaria⁹,Petruzzellis Marco¹⁰,Mezzapesa Domenico Maria¹⁰,Di Viesti Pietro¹¹,Inchingolo Vincenzo¹¹,Cappellari Manuel¹²,Zenorini Mara¹²,Candelaresi Paolo¹³,Andreone Vincenzo¹³,Rinaldi Giuseppe¹⁴,Bavaro Alessandra¹⁴,Cavallini Anna¹⁵^ORCID,Moraru Stefan¹⁵,Querzani Pietro¹⁶,Terruso Valeria¹⁷,Mannino Marina¹⁷^ORCID,Pezzini Alessandro¹⁸^ORCID,Frisullo Giovanni¹⁹,Muscia Francesco²⁰,Paciaroni Maurizio²¹^ORCID,Mosconi Maria Giulia²¹^ORCID,Zini Andrea²²,Leone Ruggiero²³,Palmieri Carmela²⁴,Cupini Letizia Maria²⁵,Marcon Michela²⁶,Tassi Rossana²⁷^ORCID,Sanzaro Enzo²⁸^ORCID,Paci Cristina²⁹,Viticchi Giovanna³⁰^ORCID,Orsucci Daniele³¹,Falcou Anne³²,Diamanti Susanna³³,Tarletti Roberto³⁴,Nencini Patrizia³⁵,Rota Eugenia³⁶,Sepe Federica Nicoletta³⁷,Ferrandi Delfina³⁷,Caputi Luigi³⁸,Volpi Gino³⁹,Spada Salvatore La⁴⁰,Beccia Mario⁴¹,Rinaldi Claudia⁴²,Mastrangelo Vincenzo⁴²,Di Blasio Francesco⁴³,Invernizzi Paolo⁴⁴,Pelliccioni Giuseppe⁴⁵,De Angelis Maria Vittoria⁴³⁴⁶,Bonanni Laura⁴⁷,Ruzza Giampietro⁴⁸,Caggia Emanuele Alessandro⁴⁹,Russo Monia⁵⁰,Tonon Agnese⁵¹,Acciarri Maria Cristina⁵²,Anticoli Sabrina⁵³,Roberti Cinzia⁵⁴,Manobianca Giovanni⁵⁵,Scaglione Gaspare⁵⁵,Pistoia Francesca¹,Fortini Alberto⁵⁶,De Boni Antonella⁵⁷,Sanna Alessandra⁵⁸,Chiti Alberto⁵⁹,Barbarini Leonardo⁶⁰,Caggiula Marcella⁶⁰,Masato Maela⁶¹,Del Sette Massimo⁶²,Passarelli Francesco⁶³,Roberta Bongioanni Maria⁶⁴,Toni Danilo⁶⁵,Ricci Stefano⁵⁶⁶,Sacco Simona¹^ORCID

Affiliation:

1. Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy

2. Department of Brain Sciences, Imperial College London, London, UK

3. Department of Neuroscience, Maurizio Bufalini Hospital, AUSL Romagna, Cesena, Italy

4. Department of Neurology, Santa Corona Hospital, Pietra Ligure, Italy

5. Department of Neurology, Città di Castello Hospital, Città di Castello, Italy

6. Department of Neurology, ASST Cremona Hospital, Cremona, Italy

7. IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy

8. Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy

9. Department of Systems Medicine, Tor Vergata University Hospital, Rome, Italy

10. Department of Neurology and Stroke Unit, “F. Puca” AOU Consorziale Policlinico, Bari, Italy

11. Department of Neurology, Fondazione IRCCS Casa sollievo della sofferenza, San Giovanni Rotondo, Italy

12. Department of Neuroscience, Azienda Ospedaliera Universitaria Integrata Verona, Verona

13. Department of Neurology and Stroke Unit, AORN Antonio Cardarelli, Naples, Italy

14. Department of Neurology, Di Venere Hospital, Bari, Italy

15. UO Neurologia d'Urgenza e Stroke Unit, IRCCS Mondino Foundation, Pavia, Italy

16. Department of Neuroscience, S.Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy

17. Department of Neurology, AOOR Villa Sofia-Cervello, Palermo, Italy

18. Department of Medicine and Surgery, University of Parma, Stroke Care Program, Department of Emergency, Parma University Hospital, Parma, Italy

19. Neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy

20. Department of Neurology, ASST -Ovest Milanese, Legnano, Italy

21. Department of Internal and Cardiovascular Medicine - Stroke Unit, University Hospital Santa Maria della Misericordia, Perugia, Italy

22. IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology and Stroke Center, Maggiore Hospital, Bologna, Italy

23. Department of Neurology and Stroke Unit, “M. R. Dimiccoli” General Hospital, Barletta, ASL BT, Italy

24. Medical Department, E. Agnelli Hospital - Local Health Company (ASL) TO3, Pinerolo, Italy

25. Department of Neurology and Stroke Unit, S. Eugenio Hospital, Rome, Italy

26. Department of Neurology, Cazzavillan Hospital Arzignano, Vicenza, Italy

27. Stroke Unit, Urgency and Emergency Department, Azienda Ospedaliera Universitaria Senese, Siena, Italy

28. Department of Neurology, Umberto I Hospital, Siracusa, Italy

29. UOC Neurologia, Ospedale “Madonna del Soccorso”, San Benedetto del Tronto, Italy

30. Experimental and Clinical Medicine Department, Marche Polytechnic University, Ancona

31. Unit of Neurology-San Luca Hospital, Lucca and Castelnuovo Garfagnana, Italy

32. Stroke Unit, Emergency Department, Policlinico Umberto I Hospital, Rome, Italy

33. Department of Neurology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy

34. SCDU Neurologia - Stroke Unit, Azienda Ospedaliero-Universitaria “Maggiore della Carità”, Novara, Italy

35. Stroke Unit, Careggi University Hospital, Florence, Italy

36. Department of Neurology, San Giacomo Hospital, Novi Ligure, Italy

37. Stroke Unit-Department of Neurology, SS. Biagio e Arrigo Hospital, Alessandria, Italy

38. Department of Cardiocerebrovascular diseases, Neurology-Stroke Unit-ASST Ospedale Maggiore di Crema, Crema, Italy

39. Department of Neurology, San Jacopo Hospital, Pistoia, Italy

40. Department of Neurology, Antonio Perrino Hospital, Brindisi, Italy

41. Department of Neurology, Sant'Andrea Hospital, Rome, Italy

42. Neurology Unit, “Infermi” Hospital, AUSL Romagna, Rimini, Italy

43. Stroke Unit, “S.Spirito” Hospital, Pescara, Italy

44. Departiment of Neurology, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy

45. Department of Neurology, INRCA, Ancona, Italy

46. Department of Neurology and Stroke Unit, SS Annunziata Hospital, Chieti, Italy

47. Dipartimento di Medicina e Scienze dell’Invecchiamento, Università G. d’Annunzio di Chieti-Pescara e Clinica Neurologica e Stroke Unit Ospedale Clinicizzato SS. Annunziata di Chieti, Chieti, Italy

48. Department of Neurology, Civil Hospital, Cittadella, Italy

49. Cardio-Neuro-Vascular Department, Neurology Unit, Giovanni Paolo II Hospital, Ragusa, Italy

50. Department of Neurology, St Misericordia Hospital, Rovigo, Italy

51. Department of Neurology, Ospedale Civile Ss. Giovanni e Paolo, Venice, Italy

52. Department of Neurology, A. Murri Fermo Hospital, Fermo, Italy

53. Stroke Unit, Azienda Ospedaliera San Camillo, Rome, Italy

54. Department of Neurology, San Filippo Neri Hospital, Rome, Italy

55. Department of Neurology, General Regional Hospital “F. Miulli”, Acquaviva delle Fonti, Italy

56. Internal Medicine, San Giovanni di Dio Hospital, Florence, Italy

57. Department of Neuroscience, San Bortolo Hospital, Vicenza, Italy

58. Stroke Unit, AOU Sassari, Sassari, Italy

59. Unit of Neurology, Apuane Hospital, Massa Carrara, Italy

60. Department of Neurology, Vito Fazi Hospital, Lecce, Italy

61. Department of Neurology, Mirano Hospital, Mirano, Italy

62. Department of Neuroscience, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

63. Department of Neurology, Fatebenefratelli Hospital, Rome, Italy

64. Department of Neurology, SS Annunziata Hospital, Savigliano, Italy

65. Department of Human neurosciences, University of Rome La Sapienza, Rome, Italy

66. Coordinatore Comitato Scientifico ISA-AII

Abstract

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

SAGE Publications

Link

https://journals.sagepub.com/doi/pdf/10.1177/23969873241255250

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