THRACE: Seventh Endovascular Trial Shows Benefit in Stroke

April 20, 2015

GLASGOW, Scotland — Mechanical thrombectomy after thrombolysis was superior to thrombolysis alone when initiated within 5 hours of stroke onset in patients with moderate to severe strokes due to large artery occlusion, according to intermediate results of the THRACE study.

"Our results suggest that intravenous plus intra-arterial therapy is the treatment of preference," Serge Bracard, MD, Central Hospital Nancy, France, concluded.

Dr Bracard presented the study here at the inaugural European Stroke Organisation (ESO) Conference 2015.

Dr Serge Bracard

THRACE is one of three new positive studies showing benefits of endovascular therapy in stroke patients presented at the ESOC 2015 meeting. The other two were REVASCAT and THERAPY.

These three studies add to four previous trials reported in the past few months – MR CLEAN, ESCAPE, EXTEND-IA, and SWIFT PRIME — all showing long-awaited success with endovascular therapy for acute stroke.

The THRACE trial enrolled 414 patients from 26 centers in France. They were randomly assigned during tissue plasminogen activator (tPA) perfusion if there was no or only minor neurologic improvement (<5 points on the National Institutes of Health Stroke Scale [NIHSS]). Those assigned to intervention were referred for immediate angiography, and if an appropriate clot was present it was removed by a device of choice from a regularly updated list.

Dr Bracard said the most important requirement was time. "Interventional treatment had to start within 5 hours of symptom onset and must be completed within 6 hours."

"Ours was a pragmatic study," he commented to Medscape Medical News. "We didn't have very specific inclusion criteria other than patients had to have a clot in a large artery and a moderate to severe stroke."

The current presentation reported intermediate results because not all patients have completed the 3-month follow-up. Data at 90 days are so far available on 385 patients, and the final results will not be presented until June.

The 385 patients who have completed the trial had an average age of 62 years and an average NIHSS score of 17. Most (85%) had an M1 occlusion.

Average time to thrombectomy was 255 minutes from symptom onset.

The primary endpoint — independent functional status at 3 months (modified Rankin Scale [mRS] score, 0 to 2) — was achieved in more patients in the interventional group, with an absolute difference of 12.1% that was statistically significant (P = .016).

Table. THRACE: Intermediate Results at 3 Months

Endpoint tPA Alone (n = 195) tPA Plus Endovascular Intervention (n = 190)
mRS score, 0 - 2 (%) 42.1 54.2
mRS score, 3 - 6 (%) 57.9 45.8
Death (%) 13.1 12.5
Adverse events (%) 30.3 27.4

 

A "Growing Picture"

Commenting for Medscape Medical News, Mayank Goyal, MD, from the University of Calgary, Alberta, Canada, who was involved in the SWIFT PRIME and ESCAPE trials, said the current results add to previous data.

"This is one more piece of evidence towards a growing picture that endovascular therapy works," he said. "The results are similar to what all the other trials have shown."

He cautioned that these are still preliminary results. "We don't know yet what their complication rates are, but the bottom line looks very encouraging in that it is consistent with what we have already seen."

Funded by the French Ministry of Health. Dr Bracard has disclosed no relevant financial relationships.

European Stroke Organisation (ESO) Conference 2015. Abstract 180. Presented April 19, 2015.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....