UH among the first health systems in the U.S. to use faster acting, genetically engineered version of the clot-busting tPA drug
-- Patients arriving at a University Hospitals’ emergency room or other facilities with acute ischemic stroke symptoms occurring in the last four and a half hours are now being treated with a faster-acting drug to dissolve the clot. This change promises to expedite logistics for those who need to be transferred to a different UH location for more advanced stroke care, as in emergent mechanical thrombectomy and clot retrieval. The change went into effect at the majority of UH hospitals on June 7, after months of preparation and training.
Dissolving blood clots (thrombolysis) has been a mainstay of care for acute ischemic stroke since the 1990s, when several clinical trials conducted by the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group demonstrated its efficacy and safety.
“Until recently, IV thrombolysis was done with Alteplase,” said Amrou Sarraj, MD, Director of UH Neurological Institute Stroke Systems. “But Tenecteplase has recently garnered momentum as an alternative to Alteplase.”
Tenecteplase takes just five seconds to administer as a bolus (a single dose of the drug) in a patient’s vein. In contrast, Alteplase is administered as an IV drip over a period of an hour.
“This change expedites the treatment delivery and potentially helps with other logistic issues, especially for patients requiring transfer for higher level of care,” Dr. Sarraj said. “It enables a strategy of ‘give and go’ rather than ‘drip and ship’ strategy with Alteplase.”
Tenecteplase also has chemical properties that make it a more attractive option for ischemic stroke patients, Dr. Sarraj said. It has a higher affinity for fibrin in the clot, which means the clot can be dissolved more effectively. This advantage is especially significant for patients with a clot in one of the larger arteries of the brain.
“There is mounting data that Tenecteplase is non-inferior in strokes overall, but superior in strokes with large vessel occlusion, with doubling the early reperfusion in those patients,” Dr. Sarraj said. “Tenecteplase is especially useful for patients being considered for thrombectomy procedure, as shown in the EXTEND IA TNK trial.”
In clinical trials, Tenecteplase has been shown to have equivalent efficacy and safety profile to Alteplase, with larger benefits in patients with large artery occlusion. The EXTEND-IA TNK trial, for example, demonstrated higher rates of dissolved clots and better clinical outcomes with Tenecteplase, as compared to Alteplase. A meta-analysis of randomized controlled trials demonstrated the non-inferiority of Tenecteplase in terms of improvement in functional status with similar risk of bleeding in the brain. Recently presented at European Stroke Organization Conference, the AcT trial successfully demonstrated non-inferiority of Tenecteplase as compared to Alteplase in a stand-alone trial with a non-inferiority design. In addition, the TASTEa trial in Australia demonstrated smaller ischemic lesions on brain imaging when Tenecteplase was used in ambulances. Current American Heart Association/American Stroke Association guidelines also recommend Tenecteplase as a reasonable alternative for patients who are being considered for a clot retrieval procedure.
On the strength of this evidence, UH Neurological Institute decided the time was right to make the switch from Alteplase to Tenecteplase, Dr. Sarraj said.
“University Hospitals has always been at the forefront of the revolutions in the medical field, providing up to date medical care to the patients of Northeast Ohio,” he said. “Given our policy of highest levels of care made available to all our patients, we decided to implement this change across the system. This is a huge step forward that would not have been possible without efforts, planning and support from stroke department at UH Cleveland Medical Center and stroke teams and our emergency medicine colleagues at all over the system, as well as tremendous help from the legal and IT department. The team from UH Cleveland Medical Center trained others across the whole system. We are happy to provide this latest medical advance for our patients.”