Does renal denervation require cardiovascular outcome-driven data?

Hypertension is a major driver of cardiovascular disease with a prevalence of 32-34% in adults worldwide. This poses a formidable unmet challenge for healthcare systems, highlighting the need for enhanced treatment strategies. Since 2017, eight major sham-controlled randomised controlled trials have examined the effectiveness and safety of renal denervation (RDN) as therapy for BP control. Although most trials demonstrated a reduction in systolic 24-hour/daytime ambulatory BP compared to control groups, open to discussion is whether major adverse cardiovascular events (MACE)-driven RDN trials are necessary or whether the proof of BP reduction as a surrogate for better cardiovascular outcomes is sufficient. We conducted an analysis of the statistical methods used in various trials to assess endpoint definitions and determine the necessity for MACE-driven outcome data. Such comprehensive analysis provides further evidence to confidently conclude that RDN significantly reduces blood pressure compared to sham controls. Importantly, this enables the interpolation of RDN trial endpoints with other studies that report on outcome data, such as pharmacological trials which demonstrate a significant reduction in MACE risk with a decrease in BP. Moreover, limitations associated with directly evaluating outcome data further support the use of BP as a surrogate endpoint. For example, conducting lengthier trials with larger numbers of participants to ensure robust statistical power presents a substantial challenge to evaluating outcome data. Thus, in light of the crucial need to tackle hypertension, there are notable advantages of considering BP as a surrogate for outcome data.

Aortic plaque dehiscence caused by rotational atherectomy with Kokeshi phenomenon in a patient with aortic stenosis successfully treated with transcatheter aortic valve replacement.

Rotational atherectomy (RA) is an important interventional technique to facilitate effective percutaneous coronary intervention of severely calcified lesions. Despite the improved probability of better procedural outcomes during angioplasty, the use of RA is associated with an inherent risk of complications. Here, we present a case of a woman in her mid-90s with severe aortic stenosis (AS) who underwent RA facilitated angioplasty of the right coronary artery (RCA), with the procedure complicated by the Kokeshi phenomenon. Manual traction to retrieve the burr resulted in dehiscence of an aortic plaque near the ostium of the RCA. Unfortunately, the patient's risk profile precluded surgery. After a multidisciplinary discussion, a self-expanding Core Valve Evolut R prosthesis (Medtronic, Minneapolis, Minnesota, USA) was successfully implanted, with improvement in the AS and stabilisation of the aortic plaque. This is the first reported case of successful non-operative management of a mobile-aortic plaque caused by RA with a transcatheter prosthesis.