The findings support stent-retrievers as “game changers” for stroke treatment that can be applied to a wider patient population, lead author says.
The long-awaited results of the Trevo Stent-Retriever Acute Stroke (TRACK) multicenter registry confirm that that real-world use of the device measures up to what was seen in randomized controlled trials.
Postmarketing registry trials such as this one are important because they are not as selective as randomized controlled trials, lead author Osama O. Zaidat, MD (Mercy Health St. Vincent Hospital, Toledo, OH), explained to Neurovascular Exchange. “There are no strict criteria, so you are not picking the winner. There is no cherry picking.”
The goal, he said, is “to see if by approving these devices, in the hands of [anyone] anywhere, are we hurting the patients?”
For the TRACK registry, whose results were published online recently in the Journal of NeuroInterventional Surgery, 23 centers enrolled a total of 634 consecutive patients treated for acute ischemic stroke using the Trevo device (Stryker Neurovascular) between March 2013 through August 2015. Participants’ mean age was 66.1 ± 14.8 years, and their mean baseline NIHSS score was 17.4 ± 6.7. In total, 86.7% had an anterior circulation occlusion.
Outcomes approached those attained in randomized clinical trials examining use of the Trevo device, researchers said.
TRACK Registry Outcomes
|
Time from Symptom Onset to Puncture, mins |
363.1 ± 264.5 |
|
Time from Symptom Onset to Revascularization, mins |
78.8±49.6 |
|
TICI ≥ 2b |
80.3% |
|
90-Day mRS ≤ 2 |
47.9% |
|
90-Day mRS ≤ 2 (Anterior Circulation Strokes Treated Within 6 Hours Only) |
51.4% |
|
90-Day mRS ≤ 2 (TICI ≥ 2b Only) |
54.3% |
|
90-Day Mortality |
19.8% |
Independent predictors of clinical outcome were age, baseline NIHSS, use of a balloon guide catheter, revascularization, and symptomatic intracranial hemorrhage.
Suggestive of Class Effect
According to Zaidat, the findings strongly suggest that the benefits of stent retrievers are a class effect, given that the outcomes of TRACK are quite similar to those of postmarketing studies with the Solitaire device (Medtronic). While he acknowledged that the two devices have not been compared head-to-head, he noted that the considerable overlap in both study authors and operators in these trials suggests that the data are at least somewhat comparable with each other. Also, there are no statistical differences in outcomes.
The findings also imply that current American Heart Association/American Stroke Association (AHA/ASA) guidelines define appropriate patients for stent-retriever thrombectomy too narrowly, Zaidat asserted.
“We had a significant number of patients outside the AHA/ASA guidelines,” he explained. “If you look at all-comers [compared to those who met the AHA/ASA criteria], you find the outcomes are not statistically significant. So, the guidelines may be very restrictive.”
In particular, Zaidat said he believes that the 6-hour cutoff from symptom onset may not need to be followed rigidly. “We know time is important, but it’s not that important,” he said.
The current data bolster the idea that stent-retrievers are “game changers” for the interventional management of interventional stroke, Zaidat asserted. “For all comers, it’s surprising to me that the first pass rate in the TRACK registry was identical to the first pass rate in the NASA registry at 25 to 26%,” he noted, adding, “Devices have come a long way. The rate in the historical devices in IMS III achieved a final complete restoration after multiple attempts of only 4%.”
Source:
Zaidat OO, Castonguay AC, Nogueira RG, et al. TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry. J NeuroInterv Surg. 2017;Epub ahead of print.
Disclosures:
Zaidat reports receiving compensation for his involvements in Arise II, the Therapy Trial, and the STRATIS registry trial.
