SOLACI | Latin American Society of Interventional Cardiology

This study included 219 patients with uncontrolled essential hypertension who had received at least two antihypertensive drugs. All of them underwent a renal angiography and were randomized to the renal denervation group or the control group.

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Denervation was performed using the SyMapCath I catheter and the SYMPIONEER S1 generator/stimulator.

Mean patient age was 45 years old, and 87% of subjects were male.

The composite primary endpoint was a decrease in-office systolic blood pressure below 140 mmHg for noninferiority with the control group and changes in antihypertensive drugs in both number of drugs and doses at 6 months.

In-office systolic blood pressure was approximately 159 mmHg. After denervation, it decreased on average 25.2 mmHg in those who received denervation, and 27.3 mmHg in the control group. The difference was 2.69% (95% confidence interval: 4.11% to 9.83%), reaching noninferiority with a 10-% margin.

The drug index increased in both groups, indicating the need for more medication in higher doses to achieve blood pressure control, being lower in those who underwent denervation (4.37 vs. 7.61; p = 0.003).

Drug adherence—analyzed by urinalysis—was high and similar in both groups (around 90% at 6 months).

In terms of procedural safety, no patient died and there was no severe renal artery injury in those who underwent denervation. Major adverse events were reported in 10% of those who underwent denervation vs. 9.2% (p = 0.823).