Hypertension,as the most common cardiovascular disease,has high prevalence,low awareness,and poor control rates.Due to the limitations of pharmacotherapy,renal denervation(RDN)has emerged in the past decade as a novel interventional therapy for hypertension.Over a decade of evidence-based medical research has demonstrated the efficacy and safety of this technique in lowering blood pressure.Currently,a major challenge in RDN trials is the unavoidable adjustments of antihypertensives required to control blood pressure,which interfere with the efficacy of RDN.Whether the failed cases like Simplicity HTN-3 of six month and REQUIRE trials or trials of SPYRAL and RADIANCE series,the results indicate that the assessment of RDN clinical trials must include changes in antihypertensive drug burdens.Since both antihypertensives and interventional procedures influence blood pressure levels,adjustments in antihypertensives must be considered when evaluating the RDN.We also need to address a major clinical question of whether patients can reduce or even discontinue medication after RDN.SMART study introduced the predefined"Medication Burden Index"and applied the control rate of target office systolic blood pressure(OSBP)and change in antihypertensives drug burden as a composite endpoint for the clinical trial,which demonstrated that RDN,as an adjunctive therapy,significantly reduced patients'drug burden while achieved target OSBP control.Future RDN trials should fully consider the impact of drug burden,clearly define blood pressure parameters,and identify the target population.Additionally,design of RDN trials would become more diverse,including efficacy endpoints that better answer important clinical questions per guideline,various ablation energies,readout of efficient ablaton during RDN,and proper control groups.
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