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

Dual antiplatelet therapy TIA aspirin clopidogrel ischemic stroke ticagrelor

Journal

European stroke journal
ISSN: 2396-9881
Titre abrégé: Eur Stroke J
Pays: England
ID NLM: 101688446

Informations de publication

Date de publication:
13 Jun 2024
Historique:
medline: 13 6 2024
pubmed: 13 6 2024
entrez: 13 6 2024
Statut: aheadofprint

Résumé

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. 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 ABCD 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. 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.

Sections du résumé

BACKGROUND AND PURPOSE UNASSIGNED
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 UNASSIGNED
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 ABCD
RESULTS UNASSIGNED
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 UNASSIGNED
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.

Identifiants

pubmed: 38869034
doi: 10.1177/23969873241255250
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

23969873241255250

Déclaration de conflit d'intérêts

Declaration of conflicting interestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AZ reports compensation from Angels Initiative, Boehringer-Ingelheim, Daiichi Sankyo, CSL Behring, Bayer, and Astra Zeneca; and he is member of ESO guidelines, ISA-AII guidelines, and IRETAS steering committee. RO reports compensations from Novartis and Allergan, Teva Pharmaceutical Industries, Eli Lilly and Company, SS reports compensations from Novartis, NovoNordisk, Allergan, AstraZeneca, Pfizer Canada, Inc, Eli Lilly and Company, Teva Pharmaceutical Industries, H. Lundbeck A/S, and Abbott Canada; employment by Università degli Studi dell’Aquila. MPa reports compensation from Daiichi Sankyo Company, Bristol Myers Squibb, Bayer, and Pfizer Canada, Inc. DT reports compensation from Alexion, AstraZeneca, Medtronic, and Pfizer. The other authors report no conflicts.

Auteurs

Eleonora De Matteis (E)

Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Department of Brain Sciences, Imperial College London, London, UK.

Raffaele Ornello (R)

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

Federico De Santis (F)

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

Matteo Foschi (M)

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

Michele Romoli (M)

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

Tiziana Tassinari (T)

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

Valentina Saia (V)

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

Silvia Cenciarelli (S)

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

Chiara Bedetti (C)

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

Chiara Padiglioni (C)

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

Bruno Censori (B)

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

Valentina Puglisi (V)

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

Luisa Vinciguerra (L)

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

Maria Guarino (M)

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

Valentina Barone (V)

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

Marialuisa Zedde (M)

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

Ilaria Grisendi (I)

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

Marina Diomedi (M)

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

Maria Rosaria Bagnato (MR)

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

Marco Petruzzellis (M)

Department of Neurology and Stroke Unit, "F. Puca" AOU Consorziale Policlinico, Bari, Italy.

Domenico Maria Mezzapesa (DM)

Department of Neurology and Stroke Unit, "F. Puca" AOU Consorziale Policlinico, Bari, Italy.

Pietro Di Viesti (P)

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

Vincenzo Inchingolo (V)

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

Manuel Cappellari (M)

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

Mara Zenorini (M)

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

Paolo Candelaresi (P)

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

Vincenzo Andreone (V)

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

Giuseppe Rinaldi (G)

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

Alessandra Bavaro (A)

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

Anna Cavallini (A)

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

Stefan Moraru (S)

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

Pietro Querzani (P)

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

Valeria Terruso (V)

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

Marina Mannino (M)

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

Alessandro Pezzini (A)

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

Giovanni Frisullo (G)

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

Francesco Muscia (F)

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

Maurizio Paciaroni (M)

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

Maria Giulia Mosconi (MG)

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

Andrea Zini (A)

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

Ruggiero Leone (R)

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

Carmela Palmieri (C)

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

Letizia Maria Cupini (LM)

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

Michela Marcon (M)

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

Rossana Tassi (R)

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

Enzo Sanzaro (E)

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

Cristina Paci (C)

UOC Neurologia, Ospedale "Madonna del Soccorso", San Benedetto del Tronto, Italy.

Giovanna Viticchi (G)

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

Daniele Orsucci (D)

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

Anne Falcou (A)

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

Susanna Diamanti (S)

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

Roberto Tarletti (R)

SCDU Neurologia - Stroke Unit, Azienda Ospedaliero-Universitaria "Maggiore della Carità", Novara, Italy.

Patrizia Nencini (P)

Stroke Unit, Careggi University Hospital, Florence, Italy.

Eugenia Rota (E)

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

Federica Nicoletta Sepe (FN)

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

Delfina Ferrandi (D)

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

Luigi Caputi (L)

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

Gino Volpi (G)

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

Salvatore La Spada (S)

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

Mario Beccia (M)

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

Claudia Rinaldi (C)

Neurology Unit, "Infermi" Hospital, AUSL Romagna, Rimini, Italy.

Vincenzo Mastrangelo (V)

Neurology Unit, "Infermi" Hospital, AUSL Romagna, Rimini, Italy.

Francesco Di Blasio (F)

Stroke Unit, "S.Spirito" Hospital, Pescara, Italy.

Paolo Invernizzi (P)

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

Giuseppe Pelliccioni (G)

Department of Neurology, INRCA, Ancona, Italy.

Maria Vittoria De Angelis (MV)

Stroke Unit, "S.Spirito" Hospital, Pescara, Italy.
Department of Neurology and Stroke Unit, SS Annunziata Hospital, Chieti, Italy.

Laura Bonanni (L)

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.

Giampietro Ruzza (G)

Department of Neurology, Civil Hospital, Cittadella, Italy.

Emanuele Alessandro Caggia (EA)

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

Monia Russo (M)

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

Agnese Tonon (A)

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

Maria Cristina Acciarri (MC)

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

Sabrina Anticoli (S)

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

Cinzia Roberti (C)

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

Giovanni Manobianca (G)

Department of Neurology, General Regional Hospital "F. Miulli", Acquaviva delle Fonti, Italy.

Gaspare Scaglione (G)

Department of Neurology, General Regional Hospital "F. Miulli", Acquaviva delle Fonti, Italy.

Francesca Pistoia (F)

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

Alberto Fortini (A)

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

Antonella De Boni (A)

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

Alessandra Sanna (A)

Stroke Unit, AOU Sassari, Sassari, Italy.

Alberto Chiti (A)

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

Leonardo Barbarini (L)

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

Marcella Caggiula (M)

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

Maela Masato (M)

Department of Neurology, Mirano Hospital, Mirano, Italy.

Massimo Del Sette (M)

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

Francesco Passarelli (F)

Department of Neurology, Fatebenefratelli Hospital, Rome, Italy.

Maria Roberta Bongioanni (M)

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

Danilo Toni (D)

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

Stefano Ricci (S)

Department of Neurology, Città di Castello Hospital, Città di Castello, Italy.
Coordinatore Comitato Scientifico ISA-AII.

Simona Sacco (S)

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

Classifications MeSH