SAN FRANCISCO, Nov. 10, 2023 /PRNewswire/ — On October 26, 2023, SyMap Medical invited Professor Felix Mahfoud, Vice-Chair of the Working Group Interventional Hypertension Treatment of the European Society of Hypertension (ESH) and a distinguished authority in the renal denervation (RDN) field, to jointly present the 6 month pivotal trial results of renal mapping/selective RDN (msRDN) from the SMART Study (Sympathetic Mapping/Ablation of Renal nerves to Treat hypertension) at the TCT 2023 conference in San Francisco, California, U.S. There were presentations from Medtronic, Recor, and Ablative Solution in the same section.
The joint SMART Study Investigators-Felix Mahfoud presentation attracted substantial interest and admiration from the audience at the conference. The SMART Study was the first randomized, prospective, multicenter, single-blind, sham-controlled trial to investigate the safety and efficacy of msRDN in patients with uncontrolled hypertension directed at answering the question of whether antihypertensive drug burden was reduced while office systolic blood pressure was controlled to target level (<140mmHg).
The SMART Study enrolled 220 patients with uncontrolled hypertension at a 1:1 ratio into msRDN and Sham groups between November 2016 and February 2022. The study combined two efficacy endpoints at 6-months: The control rate of patients with office systolic blood pressure (OSBP)＜140mmHg (non-inferior outcome) and the change in the composite index of antihypertensive drugs (Drug Burden) in treatment versus Sham group (superior outcome).
RDN site was selected following demonstrations of increased SBP (＞5mmHg, hot spot) by intra-renal artery (RA) electrical stimulation using a novel renal stimulation, mapping/ablation system (SyMap Medical Ltd, Suzhou, China). In the left RA and right main RA, mapped sites were 8.2±3.0 and 8.0±2.7 respectively, and hot/ablated sites were 3.7±1.4 and 4.0±1.6, respectively. At 6 month, the Control Rate of office systolic blood pressure was comparable between RDN and Sham group (95.4% vs 92.8%, p=0.429), and achieved non-inferiority margin -10% (2.69%; 95% CI -4.11%, 9.83%, p＜0.001 for non-inferiority); the change in Drug Index was significantly lower in RDN group (4.37±6.65 vs 7.61±10.31, p=0.010) and superior to Sham group (-3.25; 95% CI -5.56, -0.94, p=0.003), indicating msRDN patients need significantly fewer drugs to control OSBP＜140mmHg. The study also met primary safety endpoints. The results demonstrated the safety and efficacy of renal msRDN to treat uncontrolled hypertension via only four ablations on each side of the renal main artery.
Both the academic and industrial communities are eagerly waiting for the therapy’s approval by the U.S. FDA and the incorporation of RDN therapy into the clinical practice to treat hypertension. Given this context, RDN was one of the central themes and most hotly pursued topics during the TCT conference this year. There were six RDN sessions addressing various aspects, including evidence from basic research, clinical trials, training for operators, procedural workflows, patient selection, perioperative management, interdisciplinary referrals, the establishment of RDN/hypertension centers, and prospective developments. It became apparent that RDN, as a therapy to treat uncontrolled hypertension getting into clinical practices, has emerged on the horizon.
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