Introduction:
Common IV rt-PA exclusion criteria may limit its use. The SMART criteria expand eligibility by reducing exclusions and can increase thrombolysis rates. However, applicability of SMART criteria to non-specialized centers is uncertain. We hypothesized that it is safe and efficacious to use SMART criteria in a wide range of hospital settings.
Methods:
Retrospective study of 539 consecutive acute ischemic stroke (AIS) patients receiving IV rt-PA using SMART criteria. Patients receiving IV rt-PA at a Comprehensive Stroke Center (CSC; n=267) versus Outlying Spoke Hospital (OSH; n=272) prior to transfer to the CSC were compared. There were 35 OSH (25-500+ beds) encompassing 120,000 sq miles in Northern California. The CSC neurologist was consulted by telephone (64%) or telemedicine (36%) in all cases. Primary outcomes were symptomatic intracranial hemorrhage (sICH) rate and favorable discharge outcome (mRS ≤ 1). Secondary measures were mortality and number of common rt-PA contraindications.
Results:
OSH patients were younger, had lower baseline mRS, and were clinically more severe. 90% had contraindications to rt-PA, the most common being mild symptoms (49%) and age ≥ 80 (37%). CSC had more contraindications than OSH patients (median (2(1-3) vs. 1(1-2), p < 0.001). Favorable outcome (45% vs. 37%; OR, 0.7[95% CI, 0.5-1.1]), sICH rate (2.6% vs. 5.1%; OR, 2.0[95% CI, 0.8-5.1]), and mortality (9% vs. 14%; OR, 1.6[95% CI, 0.95-2.8]) were not significantly different between groups. After baseline factor adjustment, OSH rt-PA treatment was not associated with increased sICH (adjusted OR, 0.6[95% CI, 0.2-2.0]) or reduced favorable outcome (adjusted OR, 0.97[95% CI, 0.5-1.8]).
Conclusion:
Generalized application of SMART criteria is safe and effective. Current rt-PA criteria may unnecessarily exclude patients from thrombolysis and need revision.
Introduction:
IV rt-PA guidelines exclude therapeutically anticoagulated or thrombocytopenic patients. These exclusion criteria may limit thrombolytic therapy to patients who might benefit, especially with the increased use of novel oral anticoagulants (NOACs). The objective of this study is to determine if IV rt-PA is safe, especially in this patient population.
Methods:
Retrospective analysis of IV rt-PA treated patients receiving oral anticoagulation (warfarin (INR
>
1.7)), novel oral anticoagulant (NOAC), therapeutic heparin, low-molecular weight heparin (LMWH), or with thrombocytopenia (platelets < 100K). Patients were treated using SMART criteria (consent obtained for off label rt-PA use). Safety was evaluated by symptomatic intracerebral hemorrhage (sICH) rate ≤36hr after treatment.
Results:
81 patients were identified. 35 patients received therapeutic warfarin and 1 had coagulopathy (unclear etiology); mean INR=2.2 (range 1.7-3). 5 received therapeutic IV heparin, 6 full dose (1 mg/kg BID) LMWH, and 22 therapeutic NOACs. 12 had thrombocytopenia (mean platelet count 77K). There was a consistent increase in NOAC use in this cohort; 25% of the patients were taking NOACs from 2012-14, increasing to 71% from 2015-17. Out of all patients, 7 received intra-arterial (IA) rt-PA, and 8 thrombectomy. There were 3 sICH (3.75%), none in patients taking NOACs; for all sICHs there were mitigating factors that contributed (undiagnosed malignancy, adjunctive IA rt-PA, incorrect time of onset). Two developed hematoma at the catheter site with no clinical effect.
Conclusions:
These data suggest that IV rt-PA can be safely administered in therapeutically anticoagulated and thrombocytopenic patients, and sICH rates were similar to the NINDS cohort. The use of IV rt-PA in these patients may increase eligibility for acute stroke therapy, particularly where IA therapy is unavailable. Furthermore, preliminary results for patients taking NOACs indicate a good safety profile in this growing subpopulation.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.