What is the clinical evidence from this study?

Study design: Cohort. Population: Acute mild-to-moderate ischemic stroke (n=506). Intervention: Clopidogrel plus aspirin vs. Aspirin monotherapy (100-300 mg on day 1, then 100 mg/day). Primary outcome: Compound vascular events (composite of ischemic stroke, TIA, myocardial infarction, and moderate to severe bleeding events) (HR 0.47, 95% CI 0.25-0.87, p=0.017).

March 12, 2022Open Access

Dual versus mono antiplatelet therapy in mild‐to‐moderate stroke during hospitalization

Key Result

Clopidogrel plus aspirin significantly reduced the risk of compound vascular events (HR 0.47) compared to aspirin alone during hospitalization in patients with acute mild-to-moderate ischemic stroke.

Study Design

Type

Cohort (n=506)

Multicenter

Yes

Structured PICO

Does clopidogrel and aspirin combination therapy reduce compound vascular events in patients with acute mild-to-moderate ischemic stroke during hospitalization?

Population

506 patients with acute (within 72 h of onset) mild-to-moderate ischemic stroke.

Intervention

Clopidogrel and aspirin combination therapy added to high-intensity statin therapy (20 mg rosuvastatin or 40 mg atorvastatin).

Comparator

Aspirin monotherapy added to high-intensity statin therapy (20 mg rosuvastatin or 40 mg atorvastatin).

Outcome

Compound vascular events during hospitalization.composite

Dual antiplatelet therapy with clopidogrel and aspirin, combined with high-intensity statins, significantly reduces the risk of compound vascular events without increasing hemorrhage risk during hospitalization for acute mild-to-moderate ischemic stroke.

Main Result

Effect estimate: HR 0.47 (95% CI 0.25-0.87)

Absolute Event Rate: 7.2% vs 13.7%

p-value: p=0.017

Limitations

Antiplatelet treatment strategy was selected at clinicians' discretion rather than according to designed distribution, introducing potential bias.
Some patients with a high risk of bleeding did not receive a loading dose of clopidogrel on the first day.
Duration of dual antiplatelet therapy was not strictly in accordance with guidelines.
Outcomes were not time-defined but variable based on the length of hospitalization, which could bias findings in favor of identifying events in those with a longer hospital stay.
Only a few cases in three hospitals in a provincial capital were enrolled, limiting the generalizability of the findings.

Abstract

OBJECTIVE: Subsequent vascular events are common after acute ischemic stroke during hospitalization. This study aimed to analyze the effectiveness of combination therapy with clopidogrel and aspirin among mild-to-moderate ischemic stroke patients treated within 72 h on the basis of a high-intensity dose of statins. METHODS: In a retrospective and multicenter cohort study, acute (within 72 h of onset) mild-to-moderate stroke patients were divided into aspirin and clopidogrel-aspirin groups on the basis of a high-intensity dose of statin therapy. The primary outcome was compound vascular events during hospitalization. Cox's proportional hazards model was used to assess differences, with the study center as a random effect. RESULTS: Among the 506 patients meeting the eligibility criteria, all subjects received a high-intensity dose of statins, including 20 mg rosuvastatin or 40 mg atorvastatin while in the hospital. In an unadjusted analysis, compound vascular events occurred in 7.2% of patients in the clopidogrel-aspirin group compared with 13.7% of those in the aspirin group (p = 0.022). In a Cox proportional hazards regression analysis, clopidogrel-aspirin was associated with a lower risk of compound vascular events (hazard ratio 95% CI, 0.47 0.25-0.87; p = 0.017) and ischemic vascular events (p = 0.008). Moderate and severe hemorrhage occurred in four patients (1.07%) in the clopidogrel-aspirin group and three patients (2.30%) in the aspirin group (p = 0.626). INTERPRETATION: In this study based on high-intensity statin therapy, clopidogrel-aspirin reduced the risk of compound vascular events and did not increase the risk of hemorrhage during patients' hospitalization after mild-to-moderate ischemic stroke within 72 h.

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