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

J 2024

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

KELLY, Peter, Robin LEMMENS, Christian WEIMAR, Cathal WALSH, Francisco PURROY et. al.

Základní údaje

Originální název

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

Autoři

Vydání

Lancet, NEW YORK, ELSEVIER SCIENCE INC, 2024, 0140-6736

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 168.900 v roce 2022

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1016/S0140-6736(24)00968-1

UT WoS

001272953600001

Klíčová slova anglicky

vascular recurrent events; non-cardioembolic stroke; long-term colchicine

Štítky

14110132, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 5. 8. 2024 09:55, Mgr. Tereza Miškechová

Anotace

V originále

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 (05 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 0048 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 (98%) of 1569 patients allocated to colchicine and usual care and 185 (117%) of 1575 patients allocated to usual care alone (incidence rates 332 vs 392 per 100 person-years, hazard ratio 084; 95% CI 068-105, p=012). 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<005 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.

Citovat

KELLY, Peter, Robin LEMMENS, Christian WEIMAR, Cathal WALSH, Francisco PURROY, Mark BARBER, Ronan COLLINS, Simon CRONIN, Anna CZLONKOWSKA, Philippe DESFONTAINES, De Pauw ADINDA, Nicholas Richard EVANS, Urs FISCHER, Catarina FONSECA, John FORBES, Michael D HILL, Dalius JATUZIS, Janika KORV, Peter KRAFT, Christina KRUUSE, Catherine LYNCH, Dominick MCCABE, Robert MIKULÍK, Sean MURPHY, Paul NEDERKOORN, Martin DONNELL, Peter SANDERCOCK, Bernadette SCHROEDER, Gek SHIM, Katrina TOBIN, David J WILLIAMS a Christopher PRICE. Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial. Lancet. NEW YORK: ELSEVIER SCIENCE INC, 2024, roč. 404, č. 10448, s. 125-133. ISSN 0140-6736. Dostupné z: https://dx.doi.org/10.1016/S0140-6736(24)00968-1.

@article{2421656,
   author = {Kelly, Peter and Lemmens, Robin and Weimar, Christian and Walsh, Cathal and Purroy, Francisco and Barber, Mark and Collins, Ronan and Cronin, Simon and Czlonkowska, Anna and Desfontaines, Philippe and Adinda, De Pauw and Evans, Nicholas Richard and Fischer, Urs and Fonseca, Catarina and Forbes, John and Hill, Michael D and Jatuzis, Dalius and Korv, Janika and Kraft, Peter and Kruuse, Christina and Lynch, Catherine and McCabe, Dominick and Mikulík, Robert and Murphy, Sean and Nederkoorn, Paul and Donnell, Martin and Sandercock, Peter and Schroeder, Bernadette and Shim, Gek and Tobin, Katrina and Williams, David J and Price, Christopher},
   article_location = {NEW YORK},
   article_number = {10448},
   doi = {http://dx.doi.org/10.1016/S0140-6736(24)00968-1},
   keywords = {vascular recurrent events; non-cardioembolic stroke; long-term colchicine},
   language = {eng},
   issn = {0140-6736},
   journal = {Lancet},
   title = {Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial},
   url = {https://www.sciencedirect.com/science/article/pii/S0140673624009681?via%3Dihub},
   volume = {404},
   year = {2024}
}

TY  - JOUR
ID  - 2421656
AU  - Kelly, Peter - Lemmens, Robin - Weimar, Christian - Walsh, Cathal - Purroy, Francisco - Barber, Mark - Collins, Ronan - Cronin, Simon - Czlonkowska, Anna - Desfontaines, Philippe - Adinda, De Pauw - Evans, Nicholas Richard - Fischer, Urs - Fonseca, Catarina - Forbes, John - Hill, Michael D - Jatuzis, Dalius - Korv, Janika - Kraft, Peter - Kruuse, Christina - Lynch, Catherine - McCabe, Dominick - Mikulík, Robert - Murphy, Sean - Nederkoorn, Paul - Donnell, Martin - Sandercock, Peter - Schroeder, Bernadette - Shim, Gek - Tobin, Katrina - Williams, David J - Price, Christopher
PY  - 2024
TI  - Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial
JF  - Lancet
VL  - 404
IS  - 10448
SP  - 125-133
EP  - 125-133
PB  - ELSEVIER SCIENCE INC
SN  - 01406736
KW  - vascular recurrent events
KW  - non-cardioembolic stroke
KW  - long-term colchicine
UR  - https://www.sciencedirect.com/science/article/pii/S0140673624009681?via%3Dihub
N2  - 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 (05 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 0048 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 (98%) of 1569 patients allocated to colchicine and usual care and 185 (117%) of 1575 patients allocated to usual care alone (incidence rates 332 vs 392 per 100 person-years, hazard ratio 084; 95% CI 068-105, p=012). 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<005 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.
ER  -

KELLY, Peter, Robin LEMMENS, Christian WEIMAR, Cathal WALSH, Francisco PURROY, Mark BARBER, Ronan COLLINS, Simon CRONIN, Anna CZLONKOWSKA, Philippe DESFONTAINES, De Pauw ADINDA, Nicholas Richard EVANS, Urs FISCHER, Catarina FONSECA, John FORBES, Michael D HILL, Dalius JATUZIS, Janika KORV, Peter KRAFT, Christina KRUUSE, Catherine LYNCH, Dominick MCCABE, Robert MIKULÍK, Sean MURPHY, Paul NEDERKOORN, Martin DONNELL, Peter SANDERCOCK, Bernadette SCHROEDER, Gek SHIM, Katrina TOBIN, David J WILLIAMS a Christopher PRICE. Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE) : a randomised controlledtrial. \textit{Lancet}. NEW YORK: ELSEVIER SCIENCE INC, 2024, roč.~404, č.~10448, s.~125-133. ISSN~0140-6736. Dostupné z: https://dx.doi.org/10.1016/S0140-6736(24)00968-1.

Podrobný výpis o publikaci