Thrombolysis after dabigatran reversal: A nation-wide Italian multicentre study, systematic review and meta-analysis

Author:

Romoli Michele1ORCID,Matteo Eleonora2,Migliaccio Ludovica3,Gentile Mauro3,Mosconi Maria Giulia4,Scura Giuseppe Maria4,Naccarato Marcello5,Colangeli Enrico6,Candelaresi Paolo7,Andreone Vincenzo7,Giammello Fabrizio8ORCID,Fortunata Musolino Rosa8,Dell’Aera Cristina8,Sepe Federica Nicoletta9,Pronello Edoardo9,Barbarini Leonardo10,Caggiula Marcella10,Rizzo Federica11,Petruzzellis Marco11,Giorli Elisa12,Zedde Maria Luisa13ORCID,Anticoli Sabrina14,Mangiardi Marilena14,Muto Mario15,Diana Francesco16,De Angelis Maria Vittoria17,Digiovanni Anna17,Concari Letizia18,La Gioia Sara19,Sessa Maria19,Biguzzi Sara1,Cordici Francesco1,Longoni Marco1,Ruggiero Maria20ORCID,Cenciarelli Silvia21,Eusebi Paolo22,Sacco Simona6ORCID,Caso Valeria4,Paciaroni Maurizio4,Ricci Stefano2,Zini Andrea3,Toni Danilo23,Giannandrea David21ORCID

Affiliation:

1. Neurology and Stroke Unit, Department of Neuroscience, Bufalini Hospital, Cesena, Italy

2. Dipartimento di Scienze Biomediche e Neuromotorie (DIBINEM), Università di Bologna, Bologna, Italy

3. IRCCS Istituto delle Scienze Neurologiche di Bologna, Neurologia e Rete Stroke Metropolitana, Bologna, Italy

4. Medicina Vascolare e d’Urgenza, Stroke Unit, Università degli Studi di Perugia, Ospedale S. Maria della Misericordia, Perugia, Perugia, Italy

5. Neurology and Stroke Unit, Department of Medical, Surgical and Health Sciences, Azienda Sanitaria Universitaria Giuliano Isontina, University of Trieste, Trieste, Italy

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

7. UOC Neurologia e Stroke Unit, Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli, Italy

8. Stroke Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy

9. Stroke Unit, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

10. UOC Neurologia- PO Vito Fazzi, Lecce, Italy

11. UOC Neurologia e Stroke Unit “F. Puca” AOU Consorziale Policlinico Bari, Bari, Italy

12. SC Neurologia, Ospedale S. Andrea, La Spezia, Italy

13. S.C Neurologia, Stroke Unit, Azienda USL, IRCCS di Reggio Emilia, Reggio Emilia, Italy

14. Stroke Unit, Head, Neck and Neuroscience Department, San Camillo Forlanini Hospital, Rome, Italy

15. UOC Neuroradiologia diagnostica ed interventistica, Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli, Italy

16. Neuroradioly, University Hospital San Giovanni di Dio e Ruggi D’Aragona, Salerno, Italy

17. Department of Neurology, SS Annunziata Hospital, Chieti, Italy

18. SC Neurologia, Azienda Ospedaliera Universitaria di Parma, Parma, Italy

19. UOC Neurologia, Stroke Unit, ASST Papa Giovanni XXIII, Bergamo, Italy

20. Neuroradiologia, Ospedale Bufalini, Cesena, Italy

21. Neurologia e Stroke Unit, Ospedale di Gubbio e Città di Castello, USL Umbria 1, Perugia, Italy

22. Umbria Regional Health Authority, Perugia, Italy

23. Stroke Unit, Emergency Department, Sapienza University of Rome, Roma, Italy

Abstract

Introduction: Recent anticoagulant intake represents a contraindication for thrombolysis in acute ischemic stroke. Idarucizumab reverses the anticoagulant effect of dabigatran, potentially allowing for thrombolysis. This nation-wide observational cohort study, systematic review, and meta-analysis evaluated the efficacy and safety of thrombolysis preceded by dabigatran-reversal in people with acute ischemic stroke. Patients and methods: We recruited people undergoing thrombolysis following dabigatran-reversal at 17 stroke centers in Italy (reversal-group), people on dabigatran treated with thrombolysis without reversal (no-reversal group), and age, sex, hypertension, stroke severity, and reperfusion treatment-matched controls in 1:7 ratio (control-group). We compared groups for symptomatic intracranial hemorrhage (sICH, main outcome), any brain hemorrhage, good functional outcome (mRS 0–2 at 3 months), and death. The systematic review followed a predefined protocol (CRD42017060274), and odds ratio (OR) meta-analysis was implemented to compare groups. Results: Thirty-nine patients in dabigatran-reversal group and 300 matched controls were included. Reversal was associated with a non-significant increase in sICH (10.3% vs 6%, aOR = 1.32, 95% CI = 0.39–4.52), death (17.9% vs 10%, aOR = 0.77, 95% CI = 0.12–4.93) and good functional outcome (64.1% vs 52.8%, aOR = 1.41, 95% CI = 0.63–3.19). No hemorrhagic events or deaths were registered in no-reversal group (n = 12). Pooling data from 3 studies after systematic review (n = 1879), reversal carried a non-significant trend for sICH (OR = 1.53, 95% CI = 0.67–3.50), death (OR = 1.53, 95% CI = 0.73–3.24) and good functional outcome (OR = 2.46, 95% CI = 0.85–7.16). Discussion and conclusion: People treated with reperfusion strategies after dabigatran reversal with idarucizumab seem to have a marginal increase in the risk of sICH but comparable functional recovery to matched patients with stroke. Further studies are needed to define treatment cost-effectiveness and potential thresholds in plasma dabigatran concentration for reversal.

Publisher

SAGE Publications

Subject

Cardiology and Cardiovascular Medicine,Neurology (clinical)

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