Alteplase use safe in stroke patients above 80 years also: Study

Written By : Dr.Niharika Harsha B |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2020-09-08T18:51:45+05:30 | Updated On 11 Oct 2023 4:45 PM IST

A recent study has found that Alteplase has a positive benefit-risk profile among elderly patients. The study was published in the journal, "Stroke" 2020.

Expert 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.

Intravenous Alteplase is a recombinant tissue-type plasminogen activator prescribed for thrombolytic treatment of acute ischemic stroke (AIS). It is generally administered in 3-4.5hrs after the onset of symptoms of stroke in various areas as the regulatory approval differs in different areas. Recently regulatory criteria have restricted its use to patients aged 18-80yrs.

Researchers from Germany and United Kingdom conducted pooled analyses of the randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for Acute ischaemic stroke among patients aged >80 years to support a regulatory application and to lift the upper age restriction.

The authors evaluated individual patient data from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for acute ischaemic stroke, and the European SITS-UTMOST registry database. They evaluated patients who met the existing European regulatory criteria for alteplase, excluding upper age restriction. 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).

The key findings of the study were:

• Regardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria.

• Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome and similar 90-day mortality.

• The odds of a good stroke outcome following alteplase allocation in the full RCT population were independent of age (P=0.7383).

• A good stroke outcome was reported for almost half of the patients who received alteplase in routine practice.

• Outcomes in routine practice supported those achieved in RCTs.

Thus, the researchers concluded that Alteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. They further added that Alteplase for AIS should be evaluated on an individual benefit-risk basis.

For further reading, click the following link: doi: 10.1161/STROKEAHA.119.028396

acute ischaemic strokealteplaseAlteplase use in elderlyStroke

Source : Stroke

Dr.Niharika Harsha B

BDS, MDS

Dr.Niharika Harsha B (BDS,MDS) completed her BDS from Govt Dental College, Hyderabad and MDS from Dr.NTR University of health sciences(Now Kaloji Rao University). She has 4 years of private dental practice and worked for 2 years as Consultant Oral Radiologist at a Dental Imaging Centre in Hyderabad. She worked as Research Assistant and scientific writer in the development of Oral Anti cancer screening device with her seniors. She has a deep intriguing wish in writing highly engaging, captivating and informative medical content for a wider audience. She can be contacted at editorial@medicaldialogues.in.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751