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August 27, 2019; 93 (9) Article

Validation of a clinical-genetics score to predict hemorrhagic transformations after rtPA

Caty Carrera, Natalia Cullell, View ORCID ProfileNuria Torres-Águila, Elena Muiño, Alejandro Bustamante, Antonio Dávalos, Elena López-Cancio, Marc Ribó, Carlos A. Molina, Eva Giralt-Steinhauer, Carolina Soriano-Tárraga, Marina Mola-Caminal, Jordi Jiménez-Conde, Jaume Roquer, Cristófol Vives-Bauza, Rosa Díaz Navarro, Victor Obach, Juan Francisco Arenillas, Tomás Segura, Gemma Serrano-Heras, Joan Martí-Fàbregas, Marimar Freijo, Juan Antonio Cabezas, Turgut Tatlisumak, Laura Heitsch, Laura Ibañez, Carlos Cruchaga, Jin-Moo Lee, Daniel Strbian, Joan Montaner, Israel Fernández-Cadenas, on behalf of the Spanish Stroke Genetic Consortium
First published July 31, 2019, DOI: https://doi.org/10.1212/WNL.0000000000007997
Caty Carrera
From the Neurovascular Research Laboratory (C.C., A.B.), Vall d’Hebron Research Institute, Universitat Autònoma de Barcelona; Stroke Pharmacogenomics and Genetics (N.C., N.-T.A.) and Stroke Genomics and Genetics (E.M.), Fundació Docència i Recerca Mútua Terrassa; Department of Neuroscience (A.D.), Hospital Germans Trias i Pujol; Stroke Unit (E.L.-C.), Hospital Universitario Central de Asturias; Stroke Unit (M.R., C.A.M.), Hospital Universitari Vall d'Hebron; Stroke Unit, Hospital Universitari Vall d'Hebron; Department of Neurology (E.G.-S., C.S.-T., M.M.-C., J.J.-C., J.R.), Neurovascular Research Group, IMIM-Hospital del Mar; Neurobiology Laboratory (C.V.-B.), Institut d'Investigacio Sanitaria de Palma; Department of Neurology (R.D.N.), Hospital Universitari Son Espases; Department of Neurology (V.O.), Hospital Clínic i Provincial de Barcelona; Department of Neurology (J.F.A.), Hospital Clínico Universitario, University of Valladolid; Department of Neurology (T.S.) and Experimental Research Unit (G.S.-H.), Hospital Universitario de Albacete; Department of Neurology (J.M.-F.), Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau; Department of Neurology (M.F.), Hospital de Basurto; Department of Neurology (J.A.C.), Virgen del Rocío & Macarena Hospitals, IBIS, Spain; Department of Clinical Neuroscience/Neurology (T.T.), Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Sweden; Division of Emergency Medicine (L.H.), Department of Psychiatry (L.I., C.C.), and Department of Neurology (J.-M.L.), Washington University School of Medicine, St. Louis, MO; Department of Neurology (D.S.), Helsinki University Hospital, Finland; Department of Neurology (J.M.), Virgen del Rocío & Macarena Hospitals, IBIS. Vall d’Hebron Research Institute, Universitat Autònoma de Barcelona; and Stroke Pharmacogenomics and Genetics (I.F.-C.), Fundació Docència i Recerca Mútua Terrassa, Hospital Universitari Mútua de Terrassa, Stroke Pharmacogenomics and Genetics, IIB-Sant Pau, Spain.
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Natalia Cullell
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Nuria Torres-Águila
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Elena Muiño
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Alejandro Bustamante
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Antonio Dávalos
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Elena López-Cancio
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Marc Ribó
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Carlos A. Molina
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Eva Giralt-Steinhauer
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Carolina Soriano-Tárraga
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Marina Mola-Caminal
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Jordi Jiménez-Conde
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Jaume Roquer
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Cristófol Vives-Bauza
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Rosa Díaz Navarro
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Victor Obach
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Juan Francisco Arenillas
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Tomás Segura
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Gemma Serrano-Heras
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Joan Martí-Fàbregas
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Marimar Freijo
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Juan Antonio Cabezas
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Turgut Tatlisumak
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Laura Heitsch
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Laura Ibañez
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Carlos Cruchaga
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Jin-Moo Lee
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Daniel Strbian
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Joan Montaner
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Israel Fernández-Cadenas
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Validation of a clinical-genetics score to predict hemorrhagic transformations after rtPA
Caty Carrera, Natalia Cullell, Nuria Torres-Águila, Elena Muiño, Alejandro Bustamante, Antonio Dávalos, Elena López-Cancio, Marc Ribó, Carlos A. Molina, Eva Giralt-Steinhauer, Carolina Soriano-Tárraga, Marina Mola-Caminal, Jordi Jiménez-Conde, Jaume Roquer, Cristófol Vives-Bauza, Rosa Díaz Navarro, Victor Obach, Juan Francisco Arenillas, Tomás Segura, Gemma Serrano-Heras, Joan Martí-Fàbregas, Marimar Freijo, Juan Antonio Cabezas, Turgut Tatlisumak, Laura Heitsch, Laura Ibañez, Carlos Cruchaga, Jin-Moo Lee, Daniel Strbian, Joan Montaner, Israel Fernández-Cadenas, on behalf of the Spanish Stroke Genetic Consortium
Neurology Aug 2019, 93 (9) e851-e863; DOI: 10.1212/WNL.0000000000007997

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Abstract

Objective To validate the Genot-PA score, a clinical-genetic logistic regression score that stratifies the thrombolytic therapy safety, in a new cohort of patients with stroke.

Methods We enrolled 1,482 recombinant tissue plasminogen activator (rtPA)-treated patients with stroke in Spain and Finland from 2003 to 2016. Cohorts were analyzed on the basis of ethnicity and therapy: Spanish patients treated with IV rtPA within 4.5 hours of onset (cohort A and B) or rtPA in combination with mechanical thrombectomy within 6 hours of onset (cohort C) and Finnish participants treated with IV rtPA within 4.5 hours of onset (cohort D). The Genot-PA score was calculated, and hemorrhagic transformation (HT) and parenchymal hematoma (PH) risks were determined for each score stratum.

Results Genot-PA score was tested in 1,324 (cohort A, n = 726; B, n = 334; C, n = 54; and D, n = 210) patients who had enough information to complete the score. Of these, 213 (16.1%) participants developed HT and 85 (6.4%) developed PH. In cohorts A, B, and D, HT occurrence was predicted by the score (p = 2.02 × 10−6, p = 0.023, p = 0.033); PH prediction was associated in cohorts A through C (p = 0.012, p = 0.034, p = 5.32 × 10−4). Increased frequency of PH events from the lowest to the highest risk group was found (cohort A 4%–15.7%, cohort B 1.5%–18.2%, cohort C 0%–100%). The best odds ratio for PH prediction in the highest-risk group was obtained in cohort A (odds ratio 5.16, 95% confidence interval 1.46–18.08, p = 0.009).

Conclusion The Genot-PA score predicts HT in patients with stroke treated with IV rtPA. Moreover, in an exploratory study, the score was associated with PH risk in mechanical thrombectomy-treated patients.

Glossary

AF=
atrial fibrillation;
AIS=
acute ischemic stroke;
A2M=
α-2-macroglobulin;
AUC-ROC=
area under the receiver operating characteristic curve;
CI=
confidence interval;
DBP=
diastolic blood pressure;
ECASS=
European Cooperative Acute Stroke Study;
F12=
coagulation factor XII;
HI=
hemorrhagic infarct;
HT=
hemorrhagic transformation;
MAF=
minor allele frequency;
NIHSS=
NIH Stroke Scale;
OR=
odds ratio;
OTD=
onset-to-door;
OTT=
onset-to-treatment;
PH=
parenchymal hematoma;
REVASCAT=
Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours;
rtPA=
recombinant tissue plasminogen activator;
sICH=
symptomatic intracerebral hemorrhage;
SNP=
single nucleotide polymorphism

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Spanish Stroke Genetic Consortium coinvestigators are listed in appendix 2 at the end of the article.

  • Received June 6, 2018.
  • Accepted in final form April 2, 2019.
  • © 2019 American Academy of Neurology
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