SUBGROUP ANALYSIS IN THE GLOBAL SYMPLICITY REGISTRY

Abstract

Objective: The Global Symplicity Registry (GSR) is a prospective clinical study to evaluate the long-term safety and efficacy of renal denervation. In order to better characterize the safety and efficacy profile of renal denervation, post-hoc analyses of several subgroups within GSR were conducted. Design and method: GSR enrolls patients with uncontrolled hypertension and/or conditions associated with sympathetic nervous system activation. Initially, patients were treated using the Symplicity Flex catheter and later the Symplicity Spyral catheter for renal denervation. Patients are followed for 3 years with assessment of office blood pressure (BP), 24-hour ambulatory BP, and any adverse events. Subgroups analyzed include: patients with type II diabetes mellitus (DM), obstructive sleep apnea (OSA) and current smokers. Results: To date, there are 2,583 patients enrolled in GSR at 196 centers. For the entire cohort, mean age is 60.9 ± 12.0 years, 58.1% male, 38.2% with DM, 11.5% with OSA and 9.9% current smokers. Office and 24-hour systolic BP (SBP) reductions at 3 years for the entire cohort were -16 ± 29 (n = 1093) and -9 ± 20 (n = 465) mmHg, respectively (both p < 0.0001 from baseline). Subgroup analyses found similar office SBP reductions for current smokers (-15 ± 28 mmHg, n = 94), OSA (-16 ± 28 mmHg, n = 115) and DM (17 ± 27 mmHg, n = 426), all p < 0.0001. Mean 24-hour SBP reduction was -4 ± 21mmHg for current smokers (n = 37; p = 0.22), -6 ± 21 mmHg for OSA (n = 73; p = 0.01) and -10 ± 18 mmHg for DM (n = 186; p < 0.0001). At 3 years, adverse events rates for the entire cohort were 5.4% death, 2.6% myocardial infarction (MI) and 4.3% stroke. For noted subgroups, rates of death, MI and stroke were 4.1%, 4.8% and 5.5% for current smokers; 4.9%, 4.9% and 4.9% for OSA; and 6.9%, 4.1% and 3.5% for DM, respectively. Conclusions: Post-hoc subgroup analyses show similar office SBP reductions and higher rates of MI at 3 years in patients with OSA, DM or current smokers.