RESUMO
BACKGROUND AND AIMS: In the COMPASS trial, low-dose rivaroxaban with aspirin improved cardiovascular outcomes in patients with atherosclerotic cardiovascular disease (ASCVD). We aimed to assess the potential clinical implications of this therapy in a generalizable population. METHODS AND RESULTS: A retrospective cohort of adults with ASVCD was formed using healthcare administrative databases in Alberta, Canada (population 4.4 million). Patients with a new diagnosis between 2008 and 2019 formed the epidemiological cohort (n = 224,600) and those with long-term follow-up (>5 years) formed the outcomes cohort (n = 232,460). The primary outcome of major adverse cardiovascular events (MACE) was assessed and categorized based on the COMPASS trial eligibility. In the outcomes cohort, 77% had only coronary artery disease, 15% had only peripheral artery disease, and 8% had both. Of those, 37% met the COMPASS trial eligibility criteria, 36% met exclusion criteria and 27% did not meet inclusion criteria. Over a median of 7.8 years, the COMPASS exclusion group demonstrated the highest rate of MACE (5.9 per 100 person-years), following by the eligible group and the group that did not meet COMPASS inclusion criteria (3.1 and 1.4 per 100 person-years respectively). The expected net clinical benefit of antithrombotic therapy in the eligible group was 5.6 fewer events per 1000 person-years. CONCLUSIONS: In a real-world population of 4.4 million adults, there are roughly 20,000 new cases of ASVCD diagnosed yearly, with â¼40% being eligible for the addition of low-dose rivaroxaban therapy to antiplatelet therapy. The theoretical implementation of dual antithrombotic treatment in this population could result in a substantial reduction in cardiovascular morbidity and mortality.
RESUMO
BACKGROUND: We assessed the prevalence and pregnancy outcomes of pre-existing diabetes mellitus (pre-DM) and gestational diabetes mellitus (GDM) in Alberta, Canada, 2005-11. METHODS: 327 198 singleton and 5552 twin pregnancies resulting in live births or stillbirths were included. The odds ratios of adverse outcomes were evaluated comparing pre-DM with no diabetes and GDM with no diabetes, controlling for maternal characteristics. RESULTS: Diabetes complicated 6.3% of pregnancies, with 88% being GDM. In singleton pregnancies, pre-DM and GDM were associated with increased risks of pre-eclampsia (adjusted odds ratio [aOR] = 3.38 and 1.83, respectively), cesarean delivery (aOR 2.53, 1.55), spontaneous preterm (aOR 4.20, 1.71), and labor-induced preterm (aOR 3.82, 2.00) in the mother, and macrosomia (aOR 2.11, 1.30), shoulder dystocia (aOR 1.54, 1.32), congenital anomalies (aOR 1.61, 1.20), and neonatal intensive care unit (NICU) admissions (aOR 3.81, 1.60) in the infants. In addition, pre-DM was associated with an increased likelihood of stillbirth (aOR 3.73) and neonatal death (aOR 2.00) compared with non-diabetic pregnancies. In twin pregnancies, pre-DM was associated with increased risks of spontaneous (aOR 3.54) and labor-induced (aOR 3.57) preterm births, large for gestational age (LGA) infants (aOR 3.73), congenital anomalies (aOR 3.05) and NICU admissions (aOR 2.91); GDM was associated with an increased risk of pre-eclampsia (aOR 1.54), cesarean delivery (aOR 1.57), and LGA infants (aOR 1.63). CONCLUSIONS: Pre-existing diabetes confers higher risks than GDM. Diabetes is associated with adverse outcomes in singleton and twin pregnancies, and the increased risks are generally similar or less in twins, probably due to their higher "baseline" risks and closer clinical monitoring.
