Impact of different anticoagulation management strategies on outcomes in atrial fibrillation: Dutch and Belgian results from the GARFIELD-AF registry.

BACKGROUND: The uptake rate of non-vitamin K oral anticoagulants (NOAC) for the treatment of non-valvular atrial fibrillation (AF) was far lower in the Netherlands (NL) compared to Belgium (BE). Also, patients on VKA in NL were treated with a higher target international normalized ratio (INR) range of 2.5 to 3.5. OBJECTIVES: To explore the effect of these differences on thromboembolism (TE) and bleeding. METHODS: Data from the GARFIELD-AF registry was used. Patients with new-onset AF and ≥1 investigator-determined risk factor for stroke were included between 2010 and 2016. Event rates from 2 years of follow-up were used. RESULTS: In NL and BE, 1186 and 1705 patients were included, respectively. Female sex (42.3% vs 42.2%), mean age (70.7 vs 71.3 years), CHA2 DS2 -VASc (3.1 vs 3.1), and HAS-BLED score (1.4 vs 1.5) were comparable between NL and BE. At diagnosis in NL vs BE, 72.1% vs 14.6% received vitamin K antagonists (VKA) and 17.8% vs 65.5% NOACs, varying greatly across cohorts. Mean INR was 2.9 (±1.0) and 2.4 (±1.0) in NL and BE, respectively. Event rates per 100 patient-years in NL and BE, respectively, of all-cause mortality (3.38 vs 3.90; hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15), ischemic stroke/TE (0.82 vs 0.72; HR 1.14, 95% CI 0.62-2.11), and major bleeding (2.06 vs 1.54; HR 1.33, 95% CI 0.89-1.99) did not differ significantly. CONCLUSIONS: In GARFIELD-AF, despite similar characteristics, patients on anticoagulants were treated differently in NL and BE. Although the rate of major bleeding was 33% higher in NL, variations in bleeding, mortality, and TE rates were not statistically significant.

Effects of amlodipine and lisinopril on intima-media thickness in previously untreated, elderly hypertensive patients (the ELVERA trial).

OBJECTIVE: To compare the effects of the calcium channel blocker amlodipine and the angiotensin-converting enzyme inhibitor lisinopril on intima-media thickness (IMT) in elderly, previously untreated hypertensive individuals. DESIGN: A double-blind randomized parallel-group trial (the ELVERA trial). PATIENTS: The study population comprised 166 newly diagnosed hypertensive individuals (aged 60-75 years) with diastolic blood pressure between 95 and 115 mmHg or systolic blood pressure between 160 and 220 mmHg, or both. INTERVENTION: Patients were allocated randomly to groups to receive amlodipine 5-10 mg or lisinopril 10-20 mg for 2 years. MAIN OUTCOME MEASURES: Before and after 1 and 2 years of treatment, IMT was measured in three carotid and two femoral arterial sites by B-mode ultrasound. The primary endpoint was the change from baseline of the combined mean maximum far wall IMT of carotid and femoral arteries, evaluated by repeated measurement analysis of the treatment effect in an intention-to-treat analysis. RESULTS: After 2 years of treatment, amlodipine decreased IMT by 0.089 mm [95% confidence interval (CI) 0.144 to 0.037]. Lisinopril decreased IMT by 0.065 mm (95% CI 0.124 to 0.010). No differences between the two drugs were found (P = 0.18). Both treatment regimens achieved the greatest reduction of IMT after 1 year, with a slight increase after the second year, whereas the reduction in blood pressure was maintained. Comparing the carotid and femoral arteries, a significant treatment difference in the change from baseline in favour of amlodipine was observed in the IMT of the elastic common carotid artery (P < 0.05). The effects of the two drugs on the muscular common femoral artery were not different. CONCLUSION: In a long-term study, amlodipine and lisinopril reduce IMT to a similar extent in newly diagnosed elderly hypertensive patients. It is suggested that the two drugs have different effects on arteries that are not prone to atherosclerosis.

Effects of nifedipine on carotid and femoral arterial wall thickness in previously untreated hypertensive patients.

BACKGROUND: Experimental and clinical evidence suggests that calcium-channel blockers may retard the atherosclerotic process after long-term treatment. Whether these effects exist after intermediate-term treatment in hypertensive patients is mainly unknown. OBJECTIVE: To determine the 26-week effects of the long-acting calcium-channel blocker nifedipine on intima media thickness (IMT) in newly found hypertensive patients. DESIGN: Open-label study with blinded end-point analysis. METHODS: From a population survey, 131 previously untreated mild hypertensives (4 x systolic blood pressure between 160 and 220 mmHg and/or diastolic blood pressure between 95 and 115 mmHg) were included. Patients were treated with long-acting nifedipine 30-60 mg targeted to reach a predetermined drop in blood pressure. Prior to and after 26 weeks of treatment, IMT was measured by ultrasonography in the carotid and femoral artery. The combined mean maximal far wall IMT was used as primary endpoint. Change from baseline was evaluated by paired t-test in an intention-to-treat analysis. RESULTS: The mean maximal far wall IMT at baseline was 1.03 +/- 0.23 mm, and decreased by 0.078 mm (95% confidence interval, CI 0.044-0.111) after treatment. Regression analysis, including baseline IMT and changes of blood pressure, showed that reduction of IMT was mostly influenced by baseline IMT (p < 0.001; model R2 = 0.1). CONCLUSION: Our observations show that 26 weeks of nifedipine treatment inhibits IMT progression in these newly found hypertensive patients. This effect was mostly seen in arterial walls with highest IMT before treatment, suggesting that patients with highest cardiovascular risk benefit most of antihypertensive treatment.