November 2022 | Issue 67
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Profile:
Joseph Bavaria Low-risk TAVI trends
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Renal denervation’s rocky road runs on as mixed trial results dent recent optimism More than eight years after results of the SYMPLICITY HTN-3 trial led the authors of a New England Journal of Medicine (NEJM) editorial to observe that the “renal denervation train” had reached a “grinding halt”, recent months have seen investigators express renewed optimism that the treatment may be back on track as a promising treatment option for hypertension.
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his comes amid a flurry of new data from renal denervation trials released at both the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT; 16–19 September, Boston, USA) and the American Heart Association (AHA) annual scientific sessions (5–7 November, Chicago, USA). On the heels of the latest tranche of data, Medtronic has announced submission of the final module of the premarket approval (PMA) package for its Symplicity Spiral renal denervation system to the US Food and Drug Administration (FDA) for final review and approval. At AHA 2022, David Kandzari (Piedmont Heart Institute, Atlanta, USA) delivered six-month results from the full cohort of the SPYRAL HTN-ON MED trial. The trial investigated the blood pressure-lowering effect and safety of renal denervation with Medtronic’s radiofrequency (RF)-based Symplicity Spyral system in hypertensive patients prescribed up to three antihypertensive medications. A total of 337 patients were enrolled at 42 sites across the USA, Europe, Japan, Australia, and Canada, and were randomised 2:1 to renal denervation (n=205) versus sham control (n=132). “The ON MED study demonstrated significant
The ON MED study demonstrated significant reductions in office-based blood pressure, the David most commonly Kandzari used measure in clinical practice” reductions in office-based blood pressure, the most commonly used measure in clinical practice,” said Kandzari, the trial’s lead principal investigator, adding that researchers also saw reductions in absolute blood pressure that were consistent with earlier renal denervation studies. However, Kandzari’s presentation revealed that 24-hour ambulatory systolic blood pressure declined with
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renal denervation, but did not differ from the sham group, meaning that the trial’s primary endpoint was not met. Offering some explanation as to why this may have occurred, Kandzari commented that more than 80% of patients in the ON MED expansion group experienced follow-up during the COVID-19 pandemic, and compared with patients enrolled before the pandemic, significant differences in baseline 24-hour ambulatory systolic blood pressure were observed that may reflect changes in patient behaviour and lifestyle during the pandemic. Additionally, patients treated with the sham procedure increased the amount of medication they were taking compared to those treated with renal denervation. “These factors likely contributed to the smaller than expected differences in ambulatory systolic blood pressure”, Kandzari said. The trial met its primary safety endpoint, aligning with previous safety results on the therapy. In a press release that followed the release of the trial’s results at AHA, Medtronic said that in addition to the consistent absolute drops in blood pressure that have been demonstrated across trials from its SPYRAL HTN global clinical programme, long-term data have “demonstrated the durability and ‘always on’ effect of renal denervation as a treatment strategy”. The SPYRAL HTN global clinical programme includes the SPYRAL HTN-OFF MED pivotal trial and the currently-enrolling SPYRAL AFFIRM study, alongside the global SYMPLICITY registry. Long-term results from SMPLICITY HTN-3 were presented at TCT 2022 by Deepak L Bhatt (Brigham and Women's Heart and Vascular Center and Harvard Medical School, Boston, USA). Despite the trial's primary endpoint failure at six months, the long-term data pointed towards significantly greater reductions in office systolic blood pressure, albeit with commentators attaching some caution to the interpretation of the result, due to the crossover of patients later on in the study. Cardiovascular News, May 2014 Continued on page 3
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“Definitive” data show PCI fails to reduce death, heart failure hospitalisation in patients with severe left ventricular dysfunction Percutaneous coronary intervention (PCI) does not reduce allcause mortality or heart failure hospitalisation in patients with severe left ventricular dysfunction and extensive coronary artery disease, late-breaking research presented at the annual congress of the European Society of Cardiology (ESC 2022; 26–29 August, Barcelona, Spain) has shown. THIS WAS THE HEADLINE FINDING of the Revascularization for ischemic ventricular dysfunction—REVIVEDBCIS2—trial, a long-anticipated randomised trial of PCI versus optimal medical therapy for severe ischaemic cardiomyopathy. Led by researchers in the UK, results of the trial, which have been published in the New England Journal of Medicine (NEJM), are intended to fill a gap in randomised evidence to determine the benefit of PCI in this patient population. Presentation of the REVIVED-BCIS2 trial results was among the biggest attractions of the four-day ESC congress, and Divaka Perera’s (King’s College London, London, UK) presentation of the primary endpoint— which showed virtually identical rates of allcause death or heart failure hospitalisation for PCI and optimised medical therapy—elicited audible surprise among attendees at a full-tocapacity hot line trial session on day two of the event. “Coronary artery disease is the most common cause of heart failure and for this reason it has long been assumed that treating the coronary artery disease would be a good treatment for heart failure,” REVIVEDBCIS2 investigator Perera commented in his presentation, adding that despite a lack of randomised trial evidence to support PCI in severe stable left ventricular function, the procedure is “frequently” performed in this context. Furthermore, the use of PCI is supported as a Class 2a recommendation within current European revascularisation guidelines, Perera noted, adding that Continued on page 4