Thrombolysis Experience in Costa Rica Compared Against Individual Patient Data from two Randomized Controlled Trials.
Latin America
Matching
Randomized clinical trials
Stroke registry
Thrombolysis
Journal
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
ISSN: 1532-8511
Titre abrégé: J Stroke Cerebrovasc Dis
Pays: United States
ID NLM: 9111633
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
12
04
2022
revised:
03
06
2022
accepted:
08
06
2022
pubmed:
23
6
2022
medline:
27
7
2022
entrez:
22
6
2022
Statut:
ppublish
Résumé
We sought to compare thrombolysis outcomes from the Costa Rican Stroke Registry Program (CRSRP) with published individual patient data from NINDS and CLOTBUST-ER trials using matching and outcome modeling from randomized clinical trials (RCTs). A retrospective observational study matching subjects on baseline characteristics, from the CRSRP, the control arm of CLOTBUST-ER, and the interventional arm of NINDS trials. Day 7-10/discharge modified Rankin Score (mRS), and early mortality was compared between matched subjects. A mortality model derived from RCTs was developed, and outcomes were compared at similar baseline NIHSS scores. CRSRP symptomatic hemorrhage (SICH) rate was compared with an Ibero-American cohort (IAC). Of 540 CRSRP patients, 351 received rt-PA under 3 hours and were matched with NINDS subjects yielding 292 pairs; 161 CRSRP subjects treated within 4.5 hours were matched with CLOTBUST-ER subjects resulting in 151 pairs. The proportion of patients achieving excellent outcomes (mRS 0-1) did not differ between CRSRP and either NINDS or CLOTBUST-ER (CRSRP vs NINDS: 36.6% vs 32.9%, p=0.3; CRSRP vs CLOTBUST-ER: 26.5% vs 24.5%, p=0.8). Mortality was higher for CRSRP vs CLOTBUST-ER (7.3% vs 0.7%, p=0.006), but not vs NINDS (6.5% vs 4.5%, p=0.4). A pooled mortality model derived from 15 RCTs representing 4410 patients (R Functional outcomes and SICH of thrombolysed Costa Rican patients compared favorably with published datasets, with a potential increase in early mortality.
Identifiants
pubmed: 35732087
pii: S1052-3057(22)00293-2
doi: 10.1016/j.jstrokecerebrovasdis.2022.106599
pii:
doi:
Substances chimiques
Fibrinolytic Agents
0
Tissue Plasminogen Activator
EC 3.4.21.68
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
106599Informations de copyright
Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of conflicting interests PM is funded (2018-2023) by the US Department of State Fulbright Scholar Program to teach Information Theory and Computer Science. NIH U54MD007602 provided partial support for TAK. PM and TAK hold copyright for PPAIRS and PPREDICTS without a commercial interest. All remaining authors declare no conflict of interest.