JAMA: Intravenous tirofiban before endovascular therapy does not significantly improve clinical outcomes in patients with large vessel occlusive stroke (RESCUE BT study)

Endovascular therapy is undoubtedly the first-line treatment for acute anterior circulation large vessel occlusi.

However, whether stent thrombectomy, catheter aspiration, mechanical thrombectomy, angioplasty and other techniques are used, it is possible to damage the vascular endothelium, resulting in thrombosis , and even vascular re-occlusi.

Previous studies have reported that the probability of vascular reclosure within 24 hours after surgery is 3%-1
A feasible preventive modality is the use of antiplatelet drugs to assist endovascular thera.

Tirofiban is a non-peptide GP IIb/IIIa receptor inhibitor with high selectivity and high affinity, with small molecular weight, fast onset of action, and reversible inhibition of platelet aggregati.

In the management of acute coronary syndromes , tirofiban has been shown to be effective in reducing the risk of thrombotic events associated with P.

However, in the field of endovascular treatment of acute stroke , the role of tirofiban is rarely reported, and the only analysis is limited to retrospective, small-sample single-center observational studi.

Evidence-based support from controlled tria.

A multicenter, randomized, placebo-controlled, double-blind clinical trial of intravenous tirofiban before endovascular therapy for acute large vessel occlusion (RESCUE BT) was conducted by the Department of Neurology, Second Affiliated Hospital of Army Medical University (Chongqing Xinqiao Hospital) The team of Professor Yang Qingwu and Professor Zi Wenjie of the Medical Center cooperated with 54 hospitals across the count.

It is the first large-scale study in the world to investigate whether intravenous tirofiban can further improve the clinical outcomes of patients with acute anterior circulation large vessel occlusion receiving endovascular treatme.

Randomized controlled clinical tria.

The trial results were published in the JAMA Journal of the American Medical Association on August 9, 2022, Beijing ti.

Research Background

Stroke is the first fatal and disabling disease in Chi.

There are more than 8 million new stroke patients each year, resulting in about 15 million deat.

Acute large vessel occlusive stroke accounts for only 20%, but the fatality and disability rate is as high as 6
and their families have caused an extremely heavy social and economic burd.

The 2015 guidelines for early management of stroke at home and abroad unanimously recommend endovascular therapy as the preferred treatment for acute large vessel occlusio.

However, various endovascular treatments may damage vascular endothelial cells, trigger platelet activation, adhesion, and aggregation, leading to vascular reocclusion and other thrombotic complication.

Tirofiban is a non-peptide platelet glycoprotein IIb/IIIa receptor antagoni.

At present, many scholars have reported the role of tirofiban as an important adjuvant therapy for endovascular therapy in acute ischemic stro.

However, most studies are small sample, single-center observational studies, and there are no randomized controlled trials addressing this critical issue of great interest to clinicia.

The RESCUE BT trial focused on a major clinical issue in the current field of stroke care—whether tirofiban can reduce the severity of disability in patients with acute anterior circulation large vessel occlusive stroke receiving endovascular thera.

This trial was fully supported by Lunan Pharmaceutical Group .

, L.

, and funded by several projects such as the National Natural Science Foundation
of China and the Clinical Research Talent Training Program of the Army Military Medical Universit.

Research methods

Main inclusion criteria: age ≥18 years old; arrival at the hospital within 24 hours from the last normal time; no intravenous thrombolysis due to contraindications or family refusal; baseline NIHSS score ≤30; baseline ASPECTS ≥6; CTA, MRA Or DSA confirmed the presence of occlusion of the intracranial segment of the internal carotid artery or the M1 and M2 segments of the middle cerebral artery; after evaluation by the clinical diagnosis and treatment team, endovascular treatment was plann.

The exclusion criteria included the use of dual antiplatelet drugs within 1 week of the onset of the cerebral infarction, major surgery within 2 weeks of the onset of the onset, and thrombolytic therapy for the onset of the onset of the cerebral infarcti.

Eligible patients were stratified by NIHSS score, vascular occlusion site, and study center, and were randomly assigned to the experimental or control grou.

The experimental group received 10𝜇g/kg bolus injection of tirofiban, followed by 15𝜇g/kg/h for 24 hours; the control group received the same dose of place.

The specific technique used for intra-arterial therapy is at the discretion of the treating physician, but intra-arterial thrombolytic drugs (eg, alteplase, urokinase, study drugs, rescue drugs, or other GP IIb/IIIa) are not recommended inhibito.

For patients who have undergone rescue therapy such as balloon dilation and stent implantation, if the positive blood flow cannot be maintained after angioplasty, the rescue drug, which is the second bottle in the study kits Medicine bottle can be activat.

The specific usage is the same as the study dr.

All patients received oral antiplatelet medication at 20 hours after initiation of study dr.

At 24 hours after initiation of study drug, intravenous maintenance of study drug was terminat.

Subsequent treatment followed existing clinical guidelin.

The primary outcome measure was 90-day mRS, and the safety outcomes were symptomatic intracranial hemorrhage and 90-day mortali.

Main results:

From October 2018 to October 2021, a total of 1970 patients were screened in 55 hospitals with endovascular treatment capabilities in China, of which 950 were randomized and 2 withdrew their conse.

The main analysis included the experimental group and the control group, respective.

463 and 485 respective.

The mean age was 67 years, 42% were female , and 948 (100%) completed the trial

The two groups were well balanced at baseline, with a median baseline NIHSS score of 16 and a median baseline ASPECTS score ofNotably, according to the TOAST classification of stroke, both groups had a higher proportion of large-arterial atherosclerotic (LAA) stroke, accounting for 46% and 41%, respectively, which may be related to the characteristics of the Asian populati.

There was no significant difference in the 90-day mRS score between the tirofiban group and the placebo group , with a median (interquartile range) of 3 (1-4), with a corrected cOR value of 09 (95% CI, 87-37; P=46)
Similarly, there were no statistically significant differences betweenthe groups in the secondary outcomes of mRS score 0-2 at 90 days, successful recanalization rate at last angiography, and recanalization rate at 48 hours