The main results evaluating the effect of intensive versus standard blood pressure control on major adverse cardiovascular events in patients with atrial fibrillation are pending presentation.
RCT (n=1,676)
Open-label, blinded outcome assessed
Randomized
Yes
Does intensive blood pressure control reduce the composite of cardiovascular death, stroke, myocardial infarction, and heart failure hospitalization in high-risk patients with atrial fibrillation?
The CRAFT trial is a randomized controlled trial designed to evaluate whether intensive blood pressure control (home SBP <120 mmHg) improves cardiovascular outcomes compared to standard control in high-risk patients with atrial fibrillation, with main results pending.
Abstract Background and aims CRAFT was an investigator-conducted, international, multicenter, open-label, blinded outcome assessed, randomized controlled trial to determine the effectiveness of intensive long-term blood pressure (BP) control on the prevention of major adverse cardiovascular events in patients with AF (ClinicalTrials.gov NCT04347330). Methods Eligible adults were ‘high-risk’ AF, with another CV risk factor (age ≥65 years, history of ischemic stroke/TIA, systemic embolism, diabetes, or coronary, peripheral artery, or chronic kidney disease) and a resting office SBP 140-179mmHg (or home 125-154mmHg) on ≤3 antihypertensive drugs. Participants who successfully completed a 2-week run-in phase were randomized to intensive (home SBP 120mmHg) or standard BP (home SBP 135mmHg) BP control according to standardized protocols. The primary outcome was a hierarchical time/event composite of centrally adjudicated CV death, stroke, myocardial infarction, and heart failure hospitalization, compared using the win-ratio approach, where 1600 patients with a mean 3-years follow-up was estimated to provide 80% power to detect an effect size of 1.5. Results Of 2109 patients who entered the run-in phase, 1676 (mean age 69 yr; male 60%) were randomized at 145 sites in China and 12 sites in Japan during 2020-2024. During a mean follow-up of 2.7 person-years, the mean between-group DSBP was 8mmHg (121mmHg intensive vs. 129mmHg control). The main results are to be presented. Conclusions CRAFT will provide evidence as to whether more-intensive long-term BP control, as compared to contemporaneous recommended BP management (SBP 130mmHg) in AF, provides greater benefits for secondary prevention in this high-risk patient group. Conflict of interest
Anderson et al. (Fri,) conducted a rct in Atrial Fibrillation (n=1,676). Intensive blood pressure control vs. Standard blood pressure control (target home SBP <135 mmHg) was evaluated on Hierarchical time/event composite of centrally adjudicated CV death, stroke, myocardial infarction, and heart failure hospitalization. The main results evaluating the effect of intensive versus standard blood pressure control on major adverse cardiovascular events in patients with atrial fibrillation are pending presentation.