31475798 OR Ticagrelor in Patients with Stable Coronary Disease and Diabetes Dotaz Zobrazit nápovědu
BACKGROUND: Patients with stable coronary artery disease and diabetes mellitus who have not had a myocardial infarction or stroke are at high risk for cardiovascular events. Whether adding ticagrelor to aspirin improves outcomes in this population is unclear. METHODS: In this randomized, double-blind trial, we assigned patients who were 50 years of age or older and who had stable coronary artery disease and type 2 diabetes mellitus to receive either ticagrelor plus aspirin or placebo plus aspirin. Patients with previous myocardial infarction or stroke were excluded. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria. RESULTS: A total of 19,220 patients underwent randomization. The median follow-up was 39.9 months. Permanent treatment discontinuation was more frequent with ticagrelor than placebo (34.5% vs. 25.4%). The incidence of ischemic cardiovascular events (the primary efficacy outcome) was lower in the ticagrelor group than in the placebo group (7.7% vs. 8.5%; hazard ratio, 0.90; 95% confidence interval [CI], 0.81 to 0.99; P = 0.04), whereas the incidence of TIMI major bleeding was higher (2.2% vs. 1.0%; hazard ratio, 2.32; 95% CI, 1.82 to 2.94; P<0.001), as was the incidence of intracranial hemorrhage (0.7% vs. 0.5%; hazard ratio, 1.71; 95% CI, 1.18 to 2.48; P = 0.005). There was no significant difference in the incidence of fatal bleeding (0.2% vs. 0.1%; hazard ratio, 1.90; 95% CI, 0.87 to 4.15; P = 0.11). The incidence of an exploratory composite outcome of irreversible harm (death from any cause, myocardial infarction, stroke, fatal bleeding, or intracranial hemorrhage) was similar in the ticagrelor group and the placebo group (10.1% vs. 10.8%; hazard ratio, 0.93; 95% CI, 0.86 to 1.02). CONCLUSIONS: In patients with stable coronary artery disease and diabetes without a history of myocardial infarction or stroke, those who received ticagrelor plus aspirin had a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus aspirin. (Funded by AstraZeneca; THEMIS ClinicalTrials.gov number, NCT01991795.).
- MeSH
- Aspirin škodlivé účinky terapeutické užití MeSH
- cévní mozková příhoda epidemiologie prevence a kontrola MeSH
- diabetes mellitus 2. typu komplikace farmakoterapie mortalita MeSH
- dvojitá slepá metoda MeSH
- incidence MeSH
- infarkt myokardu epidemiologie prevence a kontrola MeSH
- inhibitory agregace trombocytů škodlivé účinky terapeutické užití MeSH
- Kaplanův-Meierův odhad MeSH
- kombinovaná farmakoterapie škodlivé účinky MeSH
- krvácení chemicky indukované epidemiologie mortalita MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- nemoci koronárních tepen komplikace farmakoterapie mortalita MeSH
- senioři MeSH
- ticagrelor škodlivé účinky terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
Diabetes mellitus 2 typu (DM2T) je nezávislým rizikovým faktorom koronárnej aterosklerózy a akútnych koronárnych syndrómov (AKS). Protidoštičková (antiagregačná) liečba tvorí v súčasnosti základ farmakologickej liečby AKS, ako aj základ farmakologickej prevencie budúcich ischemických príhod u pacientov so stabilnou koronárnou chorobou srdca, vrátane pacientov podstupujúcich elektívne perkutánne intervencie (PCI). Viaceré práce však poukázali na možné zlyhanie tejto liečby, ktoré je priamo asociované s DM2T. Uvedená skutočnosť viedla k zavedeniu nových, potentných antagonistov ADP-receptorov do klinickej praxe, ktoré rozšírili možnosti protidoštičkovej liečby u pacientov s DM2T a AKS (prasugrel, tikagrelor a kangrelor), či u pacientov s DM2T podstupujúcich elektívne PCI (kangrelor). Táto práca sumarizuje moderné trendy protidoštičkovej liečby u pacientov s DM2T.
Type 2 diabetes mellitus (T2DM) is an independent risk factor of coronary atherosclerosis, including acute coronary syndromes (ACS). Antiplatelet (antiaggregant) therapy forms currently the basis of pharmacological treatment of ACS, and also the basis of pharmacological prevention of future ischemic events in patients with stable coronary artery disease, including those undergoing elective percutaneous coronary interventions (PCI). However, there are several reports pointing on a possible failure of this therapy which could be directly associated with T2DM. In fact, these observations lead to the introduction of novel potent ADP receptor blockers which enriched the possibilities of antiplatelet therapies in patients with T2DM and ACS (prasugrel, ticagrelor and cangrelor); and also in those undergoing elective PCI (cangrelor). This paper summarizes the modern antiplatelet strategies in patients with T2DM.
