Abstract 12261: Reduced Subclinical and Clinical Atherosclerosis by a Treat-to-Target Intervention of Cardiovascular Risk Factors in Rheumatoid Arthritis: Results of the francis, a Randomized Clinical Trial.

Introduction: Patients with Rheumatoid Arthritis (RA) have an increased risk for cardiovascular disease (CVD) compared to the general population. No long term intervention trials on CVD risk factors in RA have been published so far, and a debate on the efficacy of controlling traditional risk factors in RA is ongoing. Methods: In this open-label randomised controlled trial, RA patients <70 years without prior CVD or diabetes mellitus were randomized to either a treat-to-target approach (according to pre-specified treatment targets) or usual care regarding traditional CVD risk factors. The primary outcome was defined as change in carotid intima media thickness (cIMT) as a marker for subclinical atherosclerosis and the secondary outcome was a composite of cardiovascular events. Results: A total of 320 patients underwent randomization and 218 completed 5 years follow-up (115 for treat-to-target group and 103 for usual care). Mean (± SD) baseline cIMT in the treat-to-target group was 0.570 ± 0.108 vs. 0.569 ± 0.113 mm (p=0.91) for usual care. The primary outcome reached statistical significance showing decreased progression of cIMT in those allocated to the treat-to-target intervention compared to usual care (0.029 ± 0.081 vs. 0.056 ± 0.103 mm; p=0.034). There was no difference in antihypertensive treatment between groups, however more patients in the treat-to-target group received statin treatment compared to usual care (48.3% vs. 21.4%; p<0.001), resulting lower LDL-C level (2.5 ± 0.8 vs. 3.1 ± 0.6 mmol/L; p<0.001). Cardiovascular events occurred in 1.3% of the patients in the treat-to-target group vs. 4.7% in those receiving usual care (p=0.048), leading to an absolute risk reduction of 3.4%. The numbers needed to treat to prevent one single cardiovascular event over 5 years was 30, which is much lower than in most secondary prevention CVD intervention trials using anti-hypertensives or lipid lowering therapy in non-RA populations. Conclusions: Intensive treat-to-target intervention of traditional CVD risk factors for primary prevention in RA is efficient. These data underscore the urgency for cardiovascular risk management programs in RA and provide for the first time support for implementation of current guidelines targeting traditional risk factors. [ABSTRACT FROM AUTHOR]