Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Silent brain infarcts (n=83). Intervention: Low-dose aspirin vs. Placebo or no therapy. Primary outcome: Combined incidence of ischemic stroke, TIA, and new silent brain infarcts (p=0.103).

Ilaria Maestrini; Marta Altieri; Laura Clemente; Edoardo Vicenzini; Patrizià Pantano; Eytan Raz; Mauro Silvestrini; Leandro Provinciali; Isabella Paolino; Carmine Marini; Matteo Di Giuseppe; Tommasina Russo; Francesco Federico; Cristiana Coppola; Maria Pia Prontera; Domenico Maria Mezzapesa; V. Lucivero; Lucilla Parnetti; Paola Sarchielli; Maria Peducci; Domenico Inzitari; Giovanna Carlucci; Carlo Serrati; Carla Zat; Anna Cavallini; Alessandra Persico; Giuseppe Micieli; Stefano Bastianello; Vittorio Di Piero

doi:10.1155/2018/7532403

Key result

Low-dose aspirin fails to reduce new cerebrovascular events or silent brain infarcts vs. control.

P=0.103
n=83

Why the study?

Does low-dose aspirin prevent new cerebrovascular events and cognitive impairment in subjects with silent brain infarcts?

Study Design

Type

RCT (n=83)

Blinding

Double-blind (for randomized cohort)

Randomization

Randomized (50 subjects) and observational (33 subjects)

Multicenter

Yes

Structured PICO

Does low-dose aspirin prevent new cerebrovascular events and cognitive impairment in subjects with silent brain infarcts?

P

Population

83 adults aged 45 years and older with at least one silent brain infarct and no previous cerebrovascular disease, followed for 4 years.

I

Intervention

Aspirin 100 mg oral enteric-coated tablet once daily for 4 years

C

Comparator

Matching placebo enteric-coated tablet or no therapy (for the non-randomized observational cohort) for 4 years

O

Outcome

Combined endpoint of ischemic stroke, transient ischemic attack (TIA), and new silent brain infarcts (SBIs) detected at MRI at 4 yearscomposite

Main Result

Absolute Event Rate: 5.6% vs 19.1%

p-value: p=0.103

Limitations

Small sample size
Enrolment method (subjects spontaneously presented for other reasons)
Strict inclusion criteria
Low consent to randomization requiring inclusion of an observational cohort
Trend towards a greater occurrence of arterial hypertension and hyperhomocysteinemia in the control group
Small size of population
Enrolment method (subjects spontaneously came to clinical observation for other reasons)
Consent to randomization hindered by general practitioners who preferred to prescribe aspirin directly

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Implication

In subjects with silent brain infarcts, low-dose aspirin showed a non-significant trend toward reducing new cerebrovascular events compared to control, though the study was severely underpowered.

Abstract

Background . We investigated low-dose aspirin (ASA) efficacy and safety in subjects with silent brain infarcts (SBIs) in preventing new cerebrovascular (CVD) events as well as cognitive impairment. Methods . We included subjects aged ≥45 years, with at least one SBI and no previous CVD. Subjects were followed up to 4 years assessing CVD and SBI incidence as primary endpoint and as secondary endpoints: (a) cardiovascular and adverse events and (b) cognitive impairment. Results . Thirty-six subjects received ASA while 47 were untreated. Primary endpoint occurred in 9 controls (19.1%) versus 2 (5.6%) in the ASA group (p=0.10). Secondary endpoints did not differ in the two groups. Only baseline leukoaraiosis predicts primary [OR 5.4 (95%CI 1.3-22.9, p=0.022)] and secondary endpoint-a [3.2 (95%CI 1.1-9.6, p=0.040)] occurrence. Conclusions . These data show an increase of new CVD events in the untreated group. Despite the study limitations, SBI seems to be a negative prognostic factor and ASA preventive treatment might improve SBI prognosis. EU Clinical trial is registered with EudraCT Number: 2005-000996-16 ; Sponsor Protocol Number: 694/30.06.04.

Discussion

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Cite This Study

Maestrini et al. (2018) conducted an RCT in Silent brain infarcts (n=83). Low-dose aspirin vs. Placebo or no therapy was evaluated on Combined incidence of ischemic stroke, TIA, and new silent brain infarcts (p=0.103). Low-dose aspirin did not significantly reduce the combined incidence of new cerebrovascular events and silent brain infarcts compared to control (5.6% vs 19.1%, p=0.103) in subjects with silent brain infarcts.

synapsesocial.com/papers/6a1814eb3275b64d0e6f7e4b https://doi.org/10.1155/2018/7532403

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Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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