SPARTE Study: Normalization of Arterial Stiffness and Cardiovascular Events in Patients With Hypertension at Medium to Very High Risk

Abstract

The SPARTE study (Strategy for Preventing cardiovascular and renal events based on ARTErial stiffness; URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02617238) is a multicenter open-label randomized controlled trial with blinded end point evaluation, undertaken at 25 French research centers in university hospitals. Patients with primary hypertension were randomly assigned (1:1) to a therapeutic strategy targeting the normalization of carotid-femoral pulse wave velocity (PWV) measured every 6 months (PWV group, n=264) versus a classical therapeutic strategy only implementing the European Guidelines for Hypertension Treatment (conventional group, n=272). In the PWV group, the therapeutic strategy used preferably a combination of ACE (angiotensin-converting enzyme) inhibitor or angiotensin receptor blocker and calcium channel blockers, as well as maximal recommended doses of ACE inhibitors and angiotensin receptor blockers. The primary outcome was a combined end point including particularly stroke and coronary events. Secondary outcomes included the time-course changes in brachial office blood pressure (BP), ambulatory BP, PWV, and treatments. After a median follow-up of 48.3 months, there was no significant between-group difference in primary outcome (hazard ratio, 0.74 [95% CI, 0.40–1.38], P =0.35). In the PWV group, combinations of renin-angiotensin-system blockers and calcium channel blockers were prescribed at higher dosage ( P =0.028), office and ambulatory systolic blood pressure and diastolic blood pressure decreased more ( P <0.001 and P <0.01, respectively), and PWV increased less ( P =0.0003) than in the conventional group. The SPARTE study lacked sufficient statistical power to demonstrate its primary outcome. However, it demonstrated that a PWV-driven treatment for hypertension enables to further reduce office and ambulatory systolic blood pressure and diastolic blood pressure and prevent vascular aging in patients with hypertension at medium-to-very-high risk, compared with strict application of guidelines.