SOLACI | Latin American Society of Interventional Cardiology

The GLOBAL SYMPLICITY Registry is the largest study, with the longest followup, of real-world patients (real world data) presenting high blood pressure, treated with renal denervation.

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Time in Target Range (TTR), estimates the time a patient needs to control their blood pressure, and is an independent predictor of cardiovascular events.

The aim of this registry, open, multicenter, and observational, was to assess the impact of improved TTR after radiofrequency renal denervation on cardiovascular outcomes, and estimate cardiovascular reduction associated to improved blood pressure control.

3077 consecutive uncontrolled hypertensive patients, treated with the Symplicity™ (Flex o Spyral) radiofrequency renal denervation system, were included and followed up to 3 years. Cutoff values for TTR were office <140 mmHg and 24-hour ambulatory blood pressures <130 mmHg.

Mean age was 60±12 years, office BP was 166 mmHg ±25 and ambulatory BP was 154±19 mmHg; patients were treated with 4.9±1.7 antihypertensive medication classes. Office blood pressure saw a reduction vs. baseline of -13.2 at 6 months, -14 at one year, -15.3 at two years and -16.7 at 3 years (P<0.001). This progressive benefit was also seen in the ambulatory branch, with reduced hypertension values regardless the number of antihypertensives (p=0.007).

TTR significantly and progressively increased at followup: 28.2% at 3 months vs. 34.9% at 3 years. As regards safety outcomes, there was a small number of events: creatinine elevation >50% in 1.3%, chronic kidney disease, advance stage, in 1.9% and the presence of new renal stenosis (>70%) in 0.3% of cases.

When looking at MACE, patients with TTR >50% presented fewer events compared against TTR 0-50% (2.9% vs 6.2%; P<0.0001). 10% TTR increase was associated to 16% MACE reduction.