What question did this study set out to answer?

To investigate whether dual antiplatelet therapy (DAPT) is noninferior to intravenous thrombolysis with alteplase in achieving excellent functional outcomes among patients with minor nondisabling acute ischemic stroke.

June 27, 2023JAMAOpen Access

Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke

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Why the study?

Intravenous thrombolysis is increasingly used in minor stroke, but whether dual antiplatelet therapy is noninferior to intravenous thrombolysis in minor nondisabling acute ischemic stroke was unknown.

Does dual antiplatelet therapy (DAPT) provide noninferior functional outcomes compared to intravenous alteplase in patients with minor nondisabling acute ischemic stroke?

Population

760 patients with acute minor nondisabling stroke at 38 hospitals in China

Comparison

Dual antiplatelet therapy vs intravenous alteplase

Design

Multicenter, open-label, blinded end point, noninferiority randomized clinical trial

Follow-up

90 days

Authors

DCDawei ChenGeneral Hospital of Shenyang Military Region YCYu CuiQingdao University ZZZhonghe ZhouAmerican Museum of Natural History

Discussion

Member takes

Implication

DAPT was associated with noninferior 90-day outcomes; leaves open whether it should replace thrombolysis in practice.

Key Points

To investigate whether dual antiplatelet therapy (DAPT) is noninferior to intravenous thrombolysis with alteplase in achieving excellent functional outcomes among patients with minor nondisabling acute ischemic stroke.
Multicenter, open-label, blinded-endpoint randomized noninferiority clinical trial (NCT03661411) conducted across 38 hospitals in China among 760 patients with acute minor nondisabling ischemic stroke (NIHSS score ≤5) presenting within 4.5 hours of symptom onset.
Participants were randomized to receive DAPT (clopidogrel 300 mg loading, then 75 mg daily plus aspirin 100 mg daily for 12±2 days, followed by guideline antiplatelet therapy to 90 days; n=393) or intravenous alteplase (0.9 mg/kg followed by standard antiplatelet therapy at 24 hours; n=367).
At 90 days, excellent functional outcome (modified Rankin Scale score 0–1) occurred in 93.8% (346/369) of the DAPT group compared with 91.4% (320/350) of the alteplase group (risk difference, 2.3% [95% CI, -1.5% to 6.2%]; crude relative risk, 1.38 [95% CI, 0.81-2.32]; lower limit of 1-sided 97.5% CI was -1.5%, P < .001 for noninferiority with margin -4.5%).
Symptomatic intracerebral hemorrhage within 90 days occurred in 0.3% (1/371) of participants in the DAPT group compared to 0.9% (3/351) in the alteplase group.

Structured PICO

Does dual antiplatelet therapy (DAPT) provide noninferior functional outcomes compared to intravenous alteplase in patients with minor nondisabling acute ischemic stroke?

Population

760 patients with acute minor nondisabling stroke (NIHSS score ≤5, with ≤1 point on the NIHSS in several key single-item scores) presenting within 4.5 hours of symptom onset, median age 64, 31.0% women, in China.

Intervention

Dual antiplatelet therapy (DAPT): 300 mg clopidogrel on day 1 followed by 75 mg daily for 12 (±2) days, plus 100 mg aspirin on day 1 followed by 100 mg daily for 12 (±2) days, and guideline-based antiplatelet treatment until 90 days.

Comparator

Intravenous alteplase (0.9 mg/kg; maximum dose, 90 mg) followed by guideline-based antiplatelet treatment beginning 24 hours after receipt of alteplase.

Outcome

Excellent functional outcome, defined as a modified Rankin Scale score of 0 or 1 (range, 0-6), at 90 days.hard clinical

In patients with minor nondisabling acute ischemic stroke presenting within 4.5 hours, DAPT is noninferior to intravenous alteplase for achieving excellent functional outcomes at 90 days.

Cite This Study

Chen et al. (2023) studied this question.

synapsesocial.com/papers/6a7d31d2a22b92c3732791bc https://doi.org/10.1001/jama.2023.7827

Topics

Dual antiplatelet therapy

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Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Topics

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