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Observational Study
. 2024 Dec;9(4):989-999.
doi: 10.1177/23969873241255250. Epub 2024 Jun 13.

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

Eleonora De Matteis  1   2 , Raffaele Ornello  1 , Federico De Santis  1 , Matteo Foschi  1 , Michele Romoli  3 , Tiziana Tassinari  4 , Valentina Saia  4 , Silvia Cenciarelli  5 , Chiara Bedetti  5 , Chiara Padiglioni  5 , Bruno Censori  6 , Valentina Puglisi  6 , Luisa Vinciguerra  6 , Maria Guarino  7 , Valentina Barone  7 , Marialuisa Zedde  8 , Ilaria Grisendi  8 , Marina Diomedi  9 , Maria Rosaria Bagnato  9 , Marco Petruzzellis  10 , Domenico Maria Mezzapesa  10 , Pietro Di Viesti  11 , Vincenzo Inchingolo  11 , Manuel Cappellari  12 , Mara Zenorini  12 , Paolo Candelaresi  13 , Vincenzo Andreone  13 , Giuseppe Rinaldi  14 , Alessandra Bavaro  14 , Anna Cavallini  15 , Stefan Moraru  15 , Pietro Querzani  16 , Valeria Terruso  17 , Marina Mannino  17 , Alessandro Pezzini  18 , Giovanni Frisullo  19 , Francesco Muscia  20 , Maurizio Paciaroni  21 , Maria Giulia Mosconi  21 , Andrea Zini  22 , Ruggiero Leone  23 , Carmela Palmieri  24 , Letizia Maria Cupini  25 , Michela Marcon  26 , Rossana Tassi  27 , Enzo Sanzaro  28 , Cristina Paci  29 , Giovanna Viticchi  30 , Daniele Orsucci  31 , Anne Falcou  32 , Susanna Diamanti  33 , Roberto Tarletti  34 , Patrizia Nencini  35 , Eugenia Rota  36 , Federica Nicoletta Sepe  37 , Delfina Ferrandi  37 , Luigi Caputi  38 , Gino Volpi  39 , Salvatore La Spada  40 , Mario Beccia  41 , Claudia Rinaldi  42 , Vincenzo Mastrangelo  42 , Francesco Di Blasio  43 , Paolo Invernizzi  44 , Giuseppe Pelliccioni  45 , Maria Vittoria De Angelis  43   46 , Laura Bonanni  47 , Giampietro Ruzza  48 , Emanuele Alessandro Caggia  49 , Monia Russo  50 , Agnese Tonon  51 , Maria Cristina Acciarri  52 , Sabrina Anticoli  53 , Cinzia Roberti  54 , Giovanni Manobianca  55 , Gaspare Scaglione  55 , Francesca Pistoia  1 , Alberto Fortini  56 , Antonella De Boni  57 , Alessandra Sanna  58 , Alberto Chiti  59 , Leonardo Barbarini  60 , Marcella Caggiula  60 , Maela Masato  61 , Massimo Del Sette  62 , Francesco Passarelli  63 , Maria Roberta Bongioanni  64 , Danilo Toni  65 , Stefano Ricci  5   66 , Simona Sacco  1
Affiliations
Observational Study

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

Eleonora De Matteis et al. Eur Stroke J. 2024 Dec.

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.

Keywords: Dual antiplatelet therapy; TIA; aspirin; clopidogrel; ischemic stroke; ticagrelor.

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Conflict of interest statement

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.

Figures

Graphical abstract
Graphical abstract
Figure 1.
Figure 1.
Consolidated standards of reporting trials diagram of enrollment in the study. DAPT: dual antiplatelet therapy; FU: follow-up.
Figure 2.
Figure 2.
Rates of any bleeding and primary effectiveness outcomes across pre-specified subgroups. BMI: body mass index; h: hours; NIHSS: National Institutes of Health Stroke Scale. *p value =0.010. **p value =0.033.
Figure 3.
Figure 3.
Cumulative hazards of the primary effectiveness outcome and any bleeding in the overall study cohort (a) and in subgroups of patients defined according to time to dual antiplatelet therapy start (b).
See this image and copyright information in PMC

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