EMBRACE

ClinicalTrials.gov ID NCT07602790

Official Title

Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery Disease
 

Background

Hypertension remains one of the most important modifiable risk factors for cardiovascular morbidity and mortality worldwide. Despite the availability of multiple antihypertensive drug classes and evidence-based treatment strategies, a substantial proportion of patients continue to have inadequately controlled blood pressure. Poor blood pressure control is particularly common among patients with multivessel coronary artery disease and is associated with increased adverse cardiovascular outcomes, including myocardial infarction, stroke, heart failure, progression of renal dysfunction, and increased mortality.

Renal sympathetic nerve activity plays a central role in the pathophysiology of hypertension through modulation of renal blood flow, sodium and water retention, renin release, and systemic sympathetic tone. Renal denervation is a catheter-based procedure designed to disrupt renal sympathetic afferent and efferent nerves by delivering energy to the renal artery wall. Multiple randomized clinical studies have demonstrated that renal denervation can reduce blood pressure in patients with uncontrolled hypertension, with sustained effects during follow-up and an acceptable safety profile when performed using contemporary devices and techniques.

Patients with multivessel coronary artery disease undergoing percutaneous coronary intervention represent a particularly relevant population in which blood pressure control is of critical importance. In many cases, coronary revascularization is performed as a staged procedure, with an initial index PCI followed by a planned staged PCI to complete revascularization of remaining significant coronary lesions. This staged approach allows for optimization of patient safety and procedural efficiency, particularly in patients with complex coronary anatomy or a high ischemic burden.

Study Design

The EMBRACE study is a prospective, randomized, controlled, multicenter clinical investigation designed to evaluate the benefit of renal denervation in patients with multivessel coronary artery disease undergoing staged percutaneous coronary intervention.

Eligible patients are adults with multivessel coronary artery disease undergoing staged PCI who have hypertension defined as persistent elevation of office systolic blood pressure despite treatment with two or more antihypertensive medications. Following confirmation of eligibility and completion of the index PCI, patients who remain eligible prior to the planned staged PCI are randomized in a 1:1 allocation ratio to receive renal denervation in addition to standard care or standard care alone.

Renal denervation is performed using a commercially available catheter-based renal denervation system according to the manufacturer's instructions for use. The procedure may be performed during the staged PCI procedure or as a standalone intervention, depending on procedural planning and investigator judgment. All patients continue to receive guideline-directed medical therapy for hypertension and coronary artery disease throughout the study.

Patients randomized to the control group undergo staged PCI and continue standard medical therapy without renal denervation.