Efficacy and safety of sacubitril/valsartan in chronic Type B aortic dissection combined with mild hypertension

Abstract Background Optimal antihypertensive medication for chronic Type B aortic dissection remains undecided. This study compared the efficacy and safety of sacubitril/valsartan with valsartan to determine suitable antihypertensive drug combinations Methods In this single-center, open-label, randomized, controlled trial, patients with chronic Stanford type B aortic dissection and mild hypertension were randomized to receive sacubitril/valsartan 100/200 mg or valsartan 80/160 mg. The primary endpoint was the reduction in mean sitting systolic blood pressure (msSBP) at Week 8 in patients with sacubitril/valsartan versus valsartan. Key secondary endpoints included changes in 1) mean sitting diastolic blood pressure (msDBP); 2) pulse pressure; and 3) mean ambulatory blood pressure for 24-hour, daytime, and nighttime. Safety assessments included adverse events and serious adverse events. This trial was registered with the Chinese Clinical Trial Registry, identifier: ChiCTR2300073399. Results A total of 315 patients completed the study. Sacubitril/valsartan provided a significantly greater reduction in msSBP than valsartan at Week 8 (between-treatment difference: −5.1 mm Hg [95% confidence interval (CI) −5.8 to −4.5], P < 0.001). Reductions in msSBP, msDBP, and pulse pressure as well as the mean ambulatory blood pressure for 24-hour, daytime, and nighttime, were significantly greater in sacubitril/valsartan compared with valsartan (all P < 0.001). No excessive episodes of adverse events occurred in the sacubitril/valsartan group. Conclusion Sacubitril/valsartan and valsartan reduced BP compared with baseline values. However, sacubitril/valsartan improved blood pressure control to a greater extent than valsartan. It may offer a new treatment option for patients with mild hypertension and chronic Type B aortic dissection.