Background and objective Predictors of symptomatic haemorrhagic transformation (s-HT) of cerebral ischaemia after intravenous recombinant tissue-plasminogen activator (rt-PA) were identified in studies using CT scans. We evaluated whether MRI can identify other predictors.
Method We analysed predictors of s-HT in a cohort of consecutive patients who received intravenous rt-PA for cerebral ischaemia after MRI at baseline. We used receiver operating characteristic curves considering an area under the curve (AUC) of 0.70 or higher as indicating acceptable discrimination.
Results Of 944 patients, 49 patients (5.2%) developed s-HT. Clinical factors independently associated with s-HT were age (adjusted OR (adjOR) 1.03 for 1 year increase; 95% CI 1.01 to 1.05), excessive alcohol consumption (adjOR 3.13; 95% CI 1.32 to 7.42), recent transient ischaemic attack (adjOR 2.88; 95% CI 1.04 to 7.95) and baseline national institutes of health stroke scale score (adjOR 1.06 for 1 point increase; 95% CI 1.02 to 1.10). MRI predictors were vascular hyperintensities (adjOR 3.89; 95% CI 1.50 to 10.08), old infarcts (adjOR 2.01; 95% CI 1.11 to 3.66) and volume of diffusion-weighted imaging (DWI) abnormality (adjOR 1.02 for 1 cm3 increase; 95% CI 1.01 to 1.03). The only variable with an acceptable discrimination was volume of DWI abnormality (AUC 0.72; 95% CI 0.64 to 0.79), a value of 4 cm3 predicting s-HT with a 78% sensitivity and 58% specificity. Variables that can be assessed only with MRI did not predict s-HT.
Conclusion Although the volume of DWI abnormality predicts s-HT, other imaging characteristics that can only be assessed with MRI were not significantly associated with s-HT.
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FC and GK contributed equally.
Contributors FC: analysed the data, drafted the manuscript, revised the manuscript for intellectual content. GK: analysed the data, revised the manuscript for intellectual content. AD: analysed the data, drafted the manuscript for intellectual content. BC: interpreted the data, revised the manuscript for intellectual content. SM: interpreted the data, revised the manuscript for intellectual content. ND-P: interpreted the data, revised the manuscript for intellectual content. HH: interpreted the data, revised the manuscript for intellectual content. CC: interpreted the data, revised the manuscript for intellectual content. J-PP: designed and conceptualised the study, revised the manuscript for intellectual content. DL: designed and conceptualised the study, analysed the data, drafted the manuscript for intellectual content, final approval of the manuscript.
Funding Institut National de la Santé et de la Recherche Médicale (U1171).
Competing interests ND-P and HH reports participation in drug trials with Boehringer-Ingelheim (honoraria paid to the hospital). CC reports participation in symposia organised by Boehringer-Ingelheim and Pfizer, advisory board by BMS (honoraria paid to ADRINORD), drug trials with Boehringer-Ingelheim, Servier, Astra-Zeneca, Biogen (honoraria paid to the hospital), vice president of the European Stroke Organisation (unpaid), member of DSMBs for institutional trials (unpaid): ATTEST 2 (UK), FIV-HeMA (France). Research support from the French Ministry of Health (A3ICH). DL reports participation in symposia organised by Boehringer Ingelheim, Bayer, BMS and Pfizer (honoraria paid to Adrinord), drug trials with Boehringer-Ingelheim (honoraria paid to the hospital), vice editor of the European Stroke Journal (honoraria paid to Adrinord), vice president of the scientific committee of the Fondation de Recherche sur les AVC (unpaid) and member of the scientific committee of the Servier Institute (unpaid). Member of DSMBs for institutional trials (unpaid): INCH (Germany), TARDIS (UK), and TO-ACT (the Netherlands). Research support from a grant of the University of Heidelberg (Germany) for the ECASS4 trial.
Patient consent for publication Not required.
Ethics approval The registry was approved by the ethical committee of Lille in 2003 and the study classified as observational (CCPPRB, Comité consultatif de protection des personnes dans la recherche biomédicale). After 2010, all patients were prospectively included in the OPHELIE observational registry (ClinicalTrials.gov Identifier n° NCT01614080) that needed a new approval by French health authorities and relevant ethical committee (Comité de Protection des Personnes Nord Ouest IV Lille, France, 9 March 2010, registration number 10.677).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available.
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