Stent hits another wall in intracranial stenosis stroke

In a trial in China, intracranial angioplasty failed again for a less severe intracranial atherosclerotic stenosis (ICAS) stroke. However, a separate analysis did leave a glimmer of hope that IV antiplatelet therapy prior to thrombectomy helped ICAS-eligible candidates.

Echoing the results of previous trials, patients in the CASSISS trial developed transient ischemic Onset (TIA) or nondisabling stroke had no benefit in preventing future events.

The addition of stents to medical therapy did not reduce the primary outcome of stroke or death within 30 days or stroke beyond 30 days to 1 year in eligible arterial areas (8.0% vs 7.2% after medical therapy alone) , HR 1.10, 95% CI 0.52 -2.35).

ICAS is a major cause of stroke, and it disproportionately affects relatively young blacks, Asians, and Hispanics. Stroke survivors with ICAS are at greater risk of recurrent events, so the 380-person CASSISS trial published in JAMA aims to improve stenting success

“Despite reducing perioperative complication rates by reviewing surgeons and surgical sites and optimizing patient selection, findings suggest no clinical benefit from adding stents to medical treatment of symptomatic patients” patients with severe intracranial atherosclerotic stenosis,” Jiao’s team concluded.

This conclusion is supported by similarly neutral results for secondary endpoints including 2- and 3-year eligible arterial-regional stroke. More importantly, 3-year mortality even The stent group was numerically inferior, although not statistically significant (4.4% vs 1.3%, HR 3.75, 95% CI 0.77-18.13).

Based on findings previously presented at the International Stroke Conference, now in JAMA as well.

In a trial also from China, tirofiban did not reduce disability at 90 days compared with placebo as measured by the modified Rankin scale. Qingwu Yang, PhD, of Xinqiao Hospital and the Second Affiliated Hospital of Chongqing Army Medical University, China, and colleagues report that highly selective non-peptide platelet glycoprotein IIb/IIIa inhibitors also did not have any advantage in any secondary endpoint after thrombectomy.

The researchers said their findings do not support intravenous tirofiban prior to endovascular thrombectomy in acute ischemic stroke, with one possible exception.

“In subgroup analyses, point estimates of tirofiban versus placebo raise the possibility that tirofiban may be associated with lower levels of disability in stroke patients due to large-artery atherosclerosis, although The interaction test did not reach statistical significance,” Yang and colleagues said. Confirmatory trials are warranted in this population, they say.

An editorial led by Craig Anderson, MD, of the George Institute for Global Health in Sydney, Australia, observed that the majority of the RESCUE BT cohort with large atherosclerosis had ICAS.

“[A] Any further study of a targeted approach using tirofiban or other potent antiplatelet drugs in ICAS would benefit from a better understanding of atherosclerosis and thrombus formation, the importance of thrombus components .

Tirofiban is currently FDA-approved for the treatment of acute coronary syndrome only. In stroke, there is a variety of evidence for antiplatelet drugs. Yang’s team noted that another ongoing Chinese trial, the ongoing RESCUE BT 2, is investigating the results of tirofiban in non-large vessel occlusive stroke.

Both Jiao and Yang’s teams caution that their respective studies may have limited general applicability to populations outside China.

However, the editorial suggested that this may not be the case.

“Despite the relatively long workflow time and low use of intravenous thrombolysis, the outcomes of endovascular surgery in China are comparable to those in Western countries. Although the prognosis of ICAS varies by age, background risk factors and the effectiveness of medical management, but the evidence from these two trials is broadly general,” argue Anderson and colleagues.

CASSISS had 358 individuals eligible for the primary analysis (mean age 56.3 years, 73.5% male). Eligible individuals had TIA or nondisabling, nonperforator-area ischemic stroke due to severe intracranial stenosis (70%-99% occlusion). Patients who presented with ischemic symptoms within 3 weeks of study entry were excluded. Randomization resulted in a balance of stent placement and control group characteristics.

RESCUE BT included 948 thrombectomy candidates who were randomized (mean age 67 years, 41.2% women) after their last known 24-hour visit. The characteristics of rofiban and placebo recipients were well balanced. The tirofiban group received study drug as a bolus dose of 10 μg/kg followed by a continuous infusion of 0.15 μg/kg/min for up to 24 hours.