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COVID-19 Could Spur Stroke Lytic Shift to Tenecteplase

— Group makes the case for staff safety, supply chain advantages

MedpageToday
A senior man in a hospital bed being attended to by a nurse

The COVID-19 pandemic could hasten the switch to tenecteplase (TNKase) from other thrombolytic therapies for stroke treatment, thanks to its workflow advantages and the need to conserve alteplase (Activase) because of its growing use in COVID-19 patients, some specialists argued.

Before the pandemic, some stroke centers had already transitioned to tenecteplase from alteplase, because it is given as a single, 5-second IV bolus that takes about 2 minutes to mix, prepare, and administer rather than the more than 1 hour for weight-based bolus and subsequent infusion of alteplase.

"The simpler tenecteplase workflow may be additionally advantageous during the COVID-19 pandemic," wrote Steven Warach, MD, PhD, of the University of Texas at Austin, and Jeffrey Saver, MD, of UCLA, in a published online in JAMA Neurology.

"Eliminating the alteplase 1-hour infusion and the dedicated second intravenous catheter that it requires reduces staff time in close proximity to the patient and removes the intravenous infusion pump that accompanies the patient through other hospital departments and wards, presenting its own set of surfaces for a virus to settle on and staff to touch," they noted.

Another reason to make the switch: recent findings suggesting that alteplase might help COVID-19 patients with acute respiratory distress syndrome. "With COVID-19-associated supply chain disruptions also occurring, some centers and regions in the world temporarily do not have access to alteplase for its ischemic stroke indication," Warach and Saver said.

Tenecteplase is recommended by guidelines as an alternative to alteplase, but is not FDA approved for use in stroke.

As such, the viewpoint authors offered several suggestions for centers making the transition from alteplase to tenecteplase:

  • Hospitals should achieve consensus across key clinical and administrative stakeholder and oversight groups, including early engagement of neurology, emergency medicine, and pharmacy departments.
  • Review the clinical trial evidence and add tenecteplase to the hospital formulary if not already available.
  • Off-label use of tenecteplase can be justified by pointing out that the standard use of alteplase for stroke at 3-4.5 hours is also off-label, but accepted based on expert consensus of the published evidence.
  • To assuage liability concerns, appropriate clinical oversight bodies should document the approval and adoption of tenecteplase as the local standard of care for stroke thrombolysis.
  • Centers should implement tenecteplase at one default dosage (0.25 mg/kg) to avoid confusion during a stroke emergency.
  • Clinicians should be told not to follow the acute MI-based prescribing information in the tenecteplase kit for a stroke patient, because dosage differs.
  • Hospitals should systematically replace alteplase with tenecteplase on their electronic health record ordering and monitoring tools.
  • Keep a clinical registry of tenecteplase stroke cases and participate in national COVID-19 stroke registries.

Overall, many systems are already moving toward tenecteplase for acute stroke, regardless of COVID-19, commented Louise McCullough, MD, PhD, of UTHealth and McGovern Medical School in Houston, who said she agreed with the points made by Warach and Saver.

Tenecteplase is a plasminogen activator with greater fibrin specificity and reduced clearance compared with alteplase, qualities that allow for single-bolus administration. Trials have shown it is noninferior to alteplase in safety and efficacy.

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    Nicole Lou is a reporter for ֱ, where she covers cardiology news and other developments in medicine.

Disclosures

Warach reported financial compensation from Genentech for chairing the Data Monitoring Committee for the TIMELESS trial of tenecteplase for acute ischemic stroke.

Saver disclosed grants and personal fees from Boehringer Ingelheim.

Primary Source

JAMA Neurology

Warach SJ, Saver JL "Stroke thrombolysis with tenecteplase to reduce emergency department spread of coronavirus disease 2019 and shortages of alteplase" JAMA Neurol 2020; DOI: 10.1001/jamaneurol.2020.2396.