Article ; Online: Thrombolysis after dabigatran reversal: A nation-wide Italian multicentre study, systematic review and meta-analysis.
2022 Volume 8, Issue 1, Page(s) 117–124
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 ...
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. |
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MeSH term(s) | Humans ; Dabigatran/adverse effects ; Antithrombins/adverse effects ; Ischemic Stroke/complications ; Brain Ischemia/drug therapy ; Thrombolytic Therapy/adverse effects ; Stroke/drug therapy ; Anticoagulants/therapeutic use ; Intracranial Hemorrhages/chemically induced ; Observational Studies as Topic ; Multicenter Studies as Topic |
Chemical Substances | Dabigatran (I0VM4M70GC) ; Antithrombins ; Anticoagulants |
Language | English |
Publishing date | 2022-10-29 |
Publishing country | England |
Document type | Meta-Analysis ; Systematic Review ; Journal Article |
ZDB-ID | 2851287-X |
ISSN | 2396-9881 ; 2396-9873 |
ISSN (online) | 2396-9881 |
ISSN | 2396-9873 |
DOI | 10.1177/23969873221131635 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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