Evidence map›Paper›PMID 32611284›Full record

SynthesisStroke2020

Alteplase for Acute Ischemic Stroke in Patients Aged >80 Years: Pooled Analyses of Individual Patient Data.

Erich Bluhmki, Thierry Danays, Gabriele Biegert, Werner Hacke, Kennedy R Lees

Abstract readMeta-Analysis
In one paragraph

Synthesis in Stroke, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Erich BluhmkiADB Building, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany and Hochschule Biberach, University of Applied Sciences, Germany (E.B.).
Thierry DanaysThe Medical Department, Boehringer Ingelheim France SAS, Reims (T.D.).
Gabriele BiegertThe Biostatistics and Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (G.B.).
Werner HackeThe Department of Neurology, University of Heidelberg, Germany (W.H.).
Kennedy R LeesThe School of Medicine, Dentistry & Nursing, University of Glasgow, United Kingdom (K.R.L.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background/purposeExpert guidelines specify no upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS) but, until recently, European regulatory criteria restricted its use to patients aged 18 to 80 years. We performed pooled analyses of randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for AIS among patients aged >80 years to support a regulatory application to lift the upper age restriction.

methodsIndividual patient data were evaluated from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for AIS, and the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome (score 0-1, modified Rankin Scale day 90 or Oxford Handicap Score day 180), were evaluated in the full RCT and registry populations, and specified age-based subgroups (≤80 or >80 years) who met existing European regulatory criteria for alteplase, excluding upper age restriction.

resultsRegardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria (246/2405 [10.2%] versus 307/1028 [29.9%], respectively). Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%];

conclusionsAlteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. Alteplase for AIS should be evaluated on an individual benefit-risk basis.

Indexed as

Administration, IntravenousAged, 80 and overBrain IschemiaDatabases, FactualFemaleFibrinolytic AgentsHumansMaleRandomized Controlled Trials as TopicStrokeTissue Plasminogen ActivatorFibrinolytic AgentsTissue Plasminogen Activatoralteplaseelderlyischemic strokerecombinant tissue-type plasminogen activatorthrombolysis

Identifiers

PMID32611284
PMCPMC7382542

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.