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Effect of Argatroban Plus Dual Antiplatelet in Branch Atherosclerosis Disease: A Randomized Clinical Trial
Jinghan Xu1, Yinglin Liu1, Huazedan Wang1
1Department of Neurology (J.X., Y. Liu, H.W., R.S., B.Z., L.H., L.G., X.D., J.W.), Chengdu Second People's Hospital, China.
Insights
Argatroban plus dual antiplatelet therapy (DAPT) significantly reduced early neurological deterioration in high-risk branch atherosclerosis disease patients. This combination therapy also improved functional outcomes at 90 days with minimal bleeding risk.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Branch atherosclerosis disease (BAD) poses a significant risk for early neurological deterioration (END).
- Identifying effective preventative strategies for END in high-risk BAD patients is crucial.
Purpose of the Study:
- To evaluate the efficacy and safety of argatroban combined with dual antiplatelet therapy (DAPT) for preventing END.
- To assess the impact of this combination therapy on functional outcomes in high-risk BAD patients.
Main Methods:
- A multicenter, randomized controlled trial was conducted involving 100 high-risk BAD patients with mild stroke.
- Patients received either argatroban plus DAPT or DAPT alone, with primary endpoints being END incidence within 7 days and excellent functional outcome at 90 days.
Main Results:
- The argatroban plus DAPT group showed a significantly lower incidence of END (20.4%) compared to the DAPT alone group (47.1%).
- Excellent functional outcomes at 90 days were achieved by 87.8% of patients in the argatroban plus DAPT group versus 68.6% in the DAPT alone group.
- Both groups experienced only one instance of minor hemorrhage.
Conclusions:
- Argatroban plus DAPT is a safe and effective treatment strategy for reducing END in high-risk branch atherosclerosis disease patients.
- This combination therapy significantly improves 90-day functional outcomes in this patient population.
Background:
Branch atherosclerosis disease (BAD) is prone to early neurological deterioration (END). The purpose of this study was to assess the efficacy and safety of argatroban plus dual antiplatelet therapy (DAPT) for preventing END in high-risk branch atherosclerosis disease patients.
Methods:
This multicenter, open-label, blinded end point, randomized controlled trial including branch atherosclerosis disease patients with mild stroke (National Institutes of Health Stroke Scale score ≤5) was conducted at 4 centers in China from May 18, 2021 to February 8, 2023. Within 48 hours after symptom onset, patients were randomly assigned to receive argatroban plus DAPT or DAPT alone in a 1:1 ratio. The primary end points were the incidence of END (National Institutes of Health Stroke Scale score increase ≥2) within 7 days and excellent functional outcome (modified Rankin Scale score of 0 to 1) at 90 days.
Results:
A total of 111 patients were randomized, with 11 excluded for specific reasons, resulting in 100 patients included in the modified intention-to-treat population. Among the 100 patients, 49 received argatroban plus DAPT and 51 received DAPT alone, 63 (63.0%) were men, and the median age was 64 (range, 55-74) years. END occurred in 20.4% (10/49) of the argatroban plus DAPT group and 47.1% (24/51) of the DAPT group (risk difference, 26.7% [95% CI, 14.1-39.2]; risk ratio, 2.31 [95% CI, 1.49-3.58]; P=0.006). At the 90-day follow-up, 87.8% (43/49) in the argatroban plus DAPT group and 68.6% (35/51) in the DAPT group achieved an excellent functional outcome (risk difference, -19.1% [95% CI, -30.3 to -8.0]; risk ratio, 0.78 [95% CI, 0.67-0.91]; P=0.025). There was 1 minor hemorrhage in each group.
Conclusions:
Argatroban plus DAPT is a safe and effective strategy to reduce END occurrence and improve 90-day functional outcome in high-risk branch atherosclerosis disease patients.
Registration:
URL: https://www.chictr.org.cn; Unique Identifier: ChiCTR21000 46487.
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