The findings coming out of #TCT2022 highlight yet again how implantable devices and interventional procedures are taking a center stage in the future of treating widespread diseases typically treated with pharmacological interventions in a primary care setting.
One of the fascinating findings released at #TCT2022 last week in Boston was out of the Radiance II trial, the renal denervation trial of the ReCOR Paradise product. Renal denervation is already approved in Europe and other countries as a treatment for hypertension, the silent killer affecting nearly half of U.S. adults – but to date, the clinical data was insufficient to make the treatment available as a standard of care in the U.S.
There are many pharmacologic approaches to treating hypertension, with five anti-hypertensive drug classes available as part of an escalating standard of care for treatment. However, as noted by one panelist, despite the extensive array of pharmacological treatment options available, hypertension continues to be a major risk factor for multiple conditions, including stroke, heart disease, and kidney disease, and it remains widespread and often poorly controlled. Given the many variables at play in hypertension, different patients require different drugs or combinations of drugs to take effect. Additionally, as clinicians, and patients, know all too well – medication adherence is often a challenge with asymptomatic diseases like hypertension, leading to suboptimal results for long-term pharmacological treatment in a majority of patients.
The Radiance II trial could represent a breakthrough in how hypertension is treated in the United States. Although previous trials had mixed or uneven results, the release of strongly positive results from this large and rigorous trial with improved trial design is a breakthrough in a few important ways.
First, it was the largest trial conducted using this technology. Second, the trial focused on a low-risk population that was not using any pharmacological interventions, which allows for an isolated view of the effect of the procedure on its own (without the antihypertensive medications that would be needed during a trial with a high-risk population), and also showcases the potential of the procedure as a first line, rather than late-stage intervention. Finally, the ReCOR Paradise ultrasound technology used in this trial is an improvement on some of the earlier designs in its ability to provide circumferential treatment.
The results shared at TCT are strongly positive in yielding significant reductions in blood pressure in just two months, which is especially exciting given the low risk profile of the trial population.
It will take several years and additional studies before these treatments will be widely available as a standard of care in the U.S., but once they do, this could signal a sea change in the first-line therapy for hypertension. The impact of this treatment at a population health level could be significant: imagine a low-risk patient is referred by their primary care physician to have this procedure at age 50. The long-term health benefits of an extra ten years of controlled hypertension for this patient, versus the mixed results that often come from low medication adherence at this stage, would be staggering in terms of long-term prevention of stroke, heart, and kidney disease.
However, enacting this new standard of care will face significant logistical hurdles in adoption, as there simply is no analog for a disease with such widespread prevalence in which an interventional procedure is a first-line treatment recommended in a primary care setting.
To make this new treatment paradigm a reality would require a referral system from primary care settings to those who can perform the procedure, and development of new facilities and capacity to accommodate the influx of patients into this interventional procedure setting.
This will be one of the first examples of putting primary care providers on the front lines for identifying and referring patients for an interventional procedure as a first-line treatment, Typically, procedures are the outcome of a referral to a specialist for a more severe case in which pharmacological treatments have failed. These issues of capacity and referral networks will likely lead to regional disparities in access to the procedure, and even if it does become the first-line standard of care, there will be nuances in which patients will get access first.
Any new innovation takes time to remodel the delivery networks and habitual treatment patterns that came before. Payment, referral networks, and large-scale care delivery in a clinic setting are all challenges to solve in finding an efficient path to market for this therapy – but if those hurdles are cleared, renal denervation could be prove to be a breakthrough treatment option that could revolutionize outcomes for millions of patients affected by one of the deadliest diseases globally.
