PARIS, May 19, 2023 /PRNewswire/ — On May 17th 2023, the six-month result of the SMART Study (Sympathetic Mapping/Ablation Renal nerves for Treatment of hypertension Trial; NCT02761811) was released on the Late Breaking Clinical Trial conference, reporting ground-breaking findings in the field of hypertension. With Professor Huo Yong as the leading investigator and SyMap Medical (Suzhou) Ltd. as the sponsor, the registered clinical trial studied the efficacy of the world-pioneering innovative system of SyMapCath®/SymPioneer®, which treats hypertension with renal nerve mapping/selective denervation (msRDN).
Compared to completed and ongoing RDN trials, the SMART study unprecedentedly answered two major clinical questions in RDN with a RCT research: the six-months follow-up result shows satisfactory BP control outcome (office systolic BP＜140mmHg) in 95% of patient in the msRDN group with significantly lower antihypertensive drug burden than the control group. It demonstrates that msRDN can effectively control blood pressure while greatly reducing the dosage of antihypertensive drugs.
A new technology: renal nerve mapping+selective denervation
In the SMART study, patients in the msRDN arm have eight mapped sites on unilateral renal artery on average, nearly 50% of which are “hot spots” requiring ablation (4 sites on each artery) and 39.4% of the hot spots require a second ablation (1.5 sites on each artery). Post-ablation feedback mapping ensures effective renal sympathetic denervation by indicating the necessity of a second ablation of each site. Compared to RDN systems without mapping and feedback , the innovative approach of ‘renal nerve mapping+selective denervation’ greatly enhances intraoperative feedback, thus avoiding complications caused by blind ablations and eliminating uncertainty of operation outcome.
A new endpoint: effective BP control and significant change in the composite drug index proves major benefit of msRDN
In the 6 months follow-up with a strict drug regimen, the msRDN group demonstrated effective blood pressure control. The 6-month office BP and 24h ambulatory BP lowered significantly compared to baseline, reducing ODBP by 25mmHg, ambulatory DBP by 12mmHg, 24h dynamic SBP by 10.8mmHg, and 24h dynamic DBP by 6.3mmHg. OSBP control rate of the msRDN group was 95% with significantly reduced drug burden compared to the sham group.
The result is a resounding prove that patients in the msRDN group can achieve satisfactory BP control with markedly lower anti-hypertensive drug dosage.
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SOURCE SyMap Medical