Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F24%3A00081572" target="_blank" >RIV/00159816:_____/24:00081572 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/24:00136685

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/abs/pii/S0140673624009681?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/abs/pii/S0140673624009681?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(24)00968-1" target="_blank" >10.1016/S0140-6736(24)00968-1</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial

Popis výsledku v původním jazyce

Background Anti-inflammatory therapy with long-term colchicine prevented vascular recurrence in coronary disease. Unlike coronary disease, which is typically caused by atherosclerosis, ischaemic stroke is caused by diverse mechanisms including atherosclerosis and small vessel disease or is frequently due to an unknown cause. We aimed to investigate the hypothesis that long-term colchicine would reduce recurrent events after ischaemic stroke. Methods We did a randomised, parallel-group, open-label, blinded endpoint assessed trial comparing long-term colchicine (0&lt;middle dot&gt;5 mg orally per day) plus guideline-based usual care with usual care only. Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible. The primary endpoint was a composite of first fatal or non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation (defined as an admission to an inpatient unit or a visit to an emergency department that resulted in at least a 24 h stay [or a change in calendar date if the hospital admission or discharge times were not available]) for unstable angina. The p value for significance was 0&lt;middle dot&gt;048 to adjust for two prespecified interim analyses conducted by the data monitoring committee, for which the steering committee and trial investigators remained blinded. The trial was registered at ClinicalTrials.gov (NCT02898610) and is completed. Findings 3154 patients were randomly assigned between Dec 19, 2016, and Nov 21, 2022, with the last follow-up on Jan 31, 2024. The trial finished before the anticipated number of outcomes was accrued (367 outcomes planned) due to budget constraints attributable to the COVID-19 pandemic. Ten patients withdrew consent for analysis of their data, leaving 3144 patients in the intention-to-treat analysis: 1569 (colchicine and usual care) and 1575 (usual care alone). A primary endpoint occurred in 338 patients, 153 (9&lt;middle dot&gt;8%) of 1569 patients allocated to colchicine and usual care and 185 (11&lt;middle dot&gt;7%) of 1575 patients allocated to usual care alone (incidence rates 3&lt;middle dot&gt;32 vs 3&lt;middle dot&gt;92 per 100 person-years, hazard ratio 0&lt;middle dot&gt;84; 95% CI 0&lt;middle dot&gt;68-1&lt;middle dot&gt;05, p=0&lt;middle dot&gt;12). Although no between-group difference in C-reactive protein (CRP) was observed at baseline, patients treated with colchicine had lower CRP at 28 days and at 1, 2, and 3 years (p&lt;0&lt;middle dot&gt;05 for all timepoints). The rates of serious adverse events were similar in both groups. Interpretation Although no statistically significant benefit was observed on the primary intention-to-treat analysis, the findings provide new evidence supporting the rationale for anti-inflammatory therapy in further randomised trials. Copyright (c) 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

Název v anglickém jazyce

Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial

Popis výsledku anglicky

Background Anti-inflammatory therapy with long-term colchicine prevented vascular recurrence in coronary disease. Unlike coronary disease, which is typically caused by atherosclerosis, ischaemic stroke is caused by diverse mechanisms including atherosclerosis and small vessel disease or is frequently due to an unknown cause. We aimed to investigate the hypothesis that long-term colchicine would reduce recurrent events after ischaemic stroke. Methods We did a randomised, parallel-group, open-label, blinded endpoint assessed trial comparing long-term colchicine (0&lt;middle dot&gt;5 mg orally per day) plus guideline-based usual care with usual care only. Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible. The primary endpoint was a composite of first fatal or non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation (defined as an admission to an inpatient unit or a visit to an emergency department that resulted in at least a 24 h stay [or a change in calendar date if the hospital admission or discharge times were not available]) for unstable angina. The p value for significance was 0&lt;middle dot&gt;048 to adjust for two prespecified interim analyses conducted by the data monitoring committee, for which the steering committee and trial investigators remained blinded. The trial was registered at ClinicalTrials.gov (NCT02898610) and is completed. Findings 3154 patients were randomly assigned between Dec 19, 2016, and Nov 21, 2022, with the last follow-up on Jan 31, 2024. The trial finished before the anticipated number of outcomes was accrued (367 outcomes planned) due to budget constraints attributable to the COVID-19 pandemic. Ten patients withdrew consent for analysis of their data, leaving 3144 patients in the intention-to-treat analysis: 1569 (colchicine and usual care) and 1575 (usual care alone). A primary endpoint occurred in 338 patients, 153 (9&lt;middle dot&gt;8%) of 1569 patients allocated to colchicine and usual care and 185 (11&lt;middle dot&gt;7%) of 1575 patients allocated to usual care alone (incidence rates 3&lt;middle dot&gt;32 vs 3&lt;middle dot&gt;92 per 100 person-years, hazard ratio 0&lt;middle dot&gt;84; 95% CI 0&lt;middle dot&gt;68-1&lt;middle dot&gt;05, p=0&lt;middle dot&gt;12). Although no between-group difference in C-reactive protein (CRP) was observed at baseline, patients treated with colchicine had lower CRP at 28 days and at 1, 2, and 3 years (p&lt;0&lt;middle dot&gt;05 for all timepoints). The rates of serious adverse events were similar in both groups. Interpretation Although no statistically significant benefit was observed on the primary intention-to-treat analysis, the findings provide new evidence supporting the rationale for anti-inflammatory therapy in further randomised trials. Copyright (c) 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30218 - General and internal medicine

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Lancet

ISSN

0140-6736

e-ISSN

1474-547X

Svazek periodika

404

Číslo periodika v rámci svazku

10448

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

125-133

Kód UT WoS článku

001272953600001

EID výsledku v databázi Scopus

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