Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

Literature - Kandzari DE, Böhm M, Mahfoud F, et al. - The Lancet 2018; published online ahead of print

Introduction and Methods

Studies with renal denervation have shown inconsistent findings in respect to blood pressure (BP) lowering in patients with treatment resistant hypertension [1-3 ]. Recently, the SPYRAL HTN-OFF MED trial showed significant BP reduction in hypertensive patients treated with renal denervation compared to sham controls, in the absence of antihypertensive therapy [4]. The question remains though whether the effect of renal denervation persists in the presence of antihypertensive drugs.

Therefore, the SPYRAL HTN-ON MED trial was designed to asses the efficacy and safety of catheter-based renal denervation for the treatment of uncontrolled hypertension despite ongoing treatment with antihypertensive drugs. The SPYRAL HTN-ON MED trial was a multicenter, blinded, randomized, sham-controlled, proof-of-concept trial, enrolling patients with uncontrolled hypertension. Eligible adult patients had an office systolic blood pressure (SBP) between 150-180 mm Hg, an office diastolic blood pressure (DBP) of ≥90 mm Hg, and a mean 24 h ambulatory SBP between 140-170 mm Hg. Patients were on one, two, or three standard antihypertensive drugs. Adherence was assessed by urine and blood analysis and defined as detectable levels of all prescribed antihypertensive drugs at each follow-up visit. Patients were randomly assigned (1:1) to receive renal denervation or sham procedure.

The key efficacy endpoint was the BP change from baseline based on 24 h ambulatory measurements. Safety endpoints included all-cause mortality, end-stage renal disease, new renal artery stenosis larger than 70%, any significant embolic event resulting in end-organ damage, admittance to hospital for hypertensive crises not related to medication nonadherence, new myocardial infarction, new stroke, renal artery re-intervention, major bleeding, major vascular complications, dissections, perforations and increase in serum creatinine higher than 50% from screening assessment.

467 patients were enrolled in the study between July 2015 and June 2017. This analysis included the first 80 enrolled patients (renal denervation=38) and sham control (n=42).

Main results

• BP change was significantly greater at 6 months in the renal denervation group than the sham-control group (difference for office SBP –6.8 mm Hg; 95%CI –12.5 to –1.1; P=0.0205, 24 h SBP –7.4 mm Hg; 95%CI –12.5 to –2.3; P=0.0051, office DBP –3.5 mm Hg, 95%CI –7.0 to -0.0; P=0.0478 and 24 h DBP –4.1 mm Hg, 95%CI –7.8 to –0.4; P=0.0292).
• BP reduction for the renal denervation group was greater at 6 months compared with 3 months.
• Adherence to antihypertensive drugs was similar between groups at all timepoints.
• There were no safety events up to 6 months follow-up.

Conclusion

References

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