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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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