Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease Insights From the COMPASS Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F20%3A43920037" target="_blank" >RIV/00216208:11120/20:43920037 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/20:N0000094

Výsledek na webu

<a href="https://doi.org/10.1161/CIRCULATIONAHA.120.046448" target="_blank" >https://doi.org/10.1161/CIRCULATIONAHA.120.046448</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/CIRCULATIONAHA.120.046448" target="_blank" >10.1161/CIRCULATIONAHA.120.046448</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease Insights From the COMPASS Trial

Popis výsledku v původním jazyce

Patients with established coronary artery disease (CAD) or peripheral artery disease (PAD) often have diabetes mellitus. These patients are at high risk of future vascular events. In a prespecified analysis of the COMPASS trial, we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes versus without diabetes in preventing major vascular events. The primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction (MI), or stroke. Secondary endpoints included all-cause mortality and all major vascular events (cardiovascular death, MI, stroke, or major adverse limb events including amputation). The primary safety endpoint was a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding. There were 10,341 patients with diabetes and 17,054 without diabetes in the overall trial. There was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin (N=9,152) versus placebo plus aspirin (N=9,126) in patients both with (N=6,922) and without (N=11,356) diabetes for the primary efficacy endpoint (HR 0.74, p=0.002 and HR 0.77, p=0.005, respectively, p=0.77) and all-cause mortality (HR 0.81, p=0.05 and HR 0.84, p=0.09, respectively, p=0.82). However, though the absolute risk reductions appeared numerically larger in patients with versus without diabetes, both subgroups derived similar benefit (2.3% vs 1.4% for the primary efficacy endpoint at 3 years, Gail-Simon qualitative p&lt;0.0001; 1.9% vs 0.6% for all-cause mortality, p=0.02; 2.7% vs 1.7% for major vascular events, p&lt;0.0001). Since the bleeding hazards were similar among patients with and without diabetes, the prespecified net benefit for rivaroxaban appeared particularly favorable in the former group (2.7% vs 1.0%, Gail-Simon qualitative p=0.001). In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral endpoints in patients with and without diabetes. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes, including a three-fold greater reduction in all-cause mortality. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.

Název v anglickém jazyce

Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease Insights From the COMPASS Trial

Popis výsledku anglicky

Patients with established coronary artery disease (CAD) or peripheral artery disease (PAD) often have diabetes mellitus. These patients are at high risk of future vascular events. In a prespecified analysis of the COMPASS trial, we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes versus without diabetes in preventing major vascular events. The primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction (MI), or stroke. Secondary endpoints included all-cause mortality and all major vascular events (cardiovascular death, MI, stroke, or major adverse limb events including amputation). The primary safety endpoint was a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding. There were 10,341 patients with diabetes and 17,054 without diabetes in the overall trial. There was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin (N=9,152) versus placebo plus aspirin (N=9,126) in patients both with (N=6,922) and without (N=11,356) diabetes for the primary efficacy endpoint (HR 0.74, p=0.002 and HR 0.77, p=0.005, respectively, p=0.77) and all-cause mortality (HR 0.81, p=0.05 and HR 0.84, p=0.09, respectively, p=0.82). However, though the absolute risk reductions appeared numerically larger in patients with versus without diabetes, both subgroups derived similar benefit (2.3% vs 1.4% for the primary efficacy endpoint at 3 years, Gail-Simon qualitative p&lt;0.0001; 1.9% vs 0.6% for all-cause mortality, p=0.02; 2.7% vs 1.7% for major vascular events, p&lt;0.0001). Since the bleeding hazards were similar among patients with and without diabetes, the prespecified net benefit for rivaroxaban appeared particularly favorable in the former group (2.7% vs 1.0%, Gail-Simon qualitative p=0.001). In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral endpoints in patients with and without diabetes. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes, including a three-fold greater reduction in all-cause mortality. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2020

Kód důvěrnosti údajů

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

Název periodika

Circulation

ISSN

0009-7322

e-ISSN

—

Svazek periodika

141

Číslo periodika v rámci svazku

23

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

14

Strana od-do

1841-1854

Kód UT WoS článku

000545970000009

EID výsledku v databázi Scopus

2-s2.0-85085938239