Cardiovascular News Issue 50 - August 2018

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Positive data for renal denervation reignites interest in field After two studies indicated that renal denervation lowers blood pressure both with and without antihypertensive drugs, Felix Mahfoud (Klinik für Innere Medizin III, Saarland University Hospital, Homburg, Saarland, Germany) said that the PCR board, who organise EuroPCR, was “committed to supporting the field of renal denervation”. He added that there would be further developments in the field, so interventional cardiologists should “stay tuned”.

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ahfoud’s statement, on behalf of PCR, came directly after two shamcontrolled trials were presented at EuroPCR (22–25 May, Paris, France)—with both studies suggesting that renal denervation does lower blood pressure. The first of these, SPYRAL HTN-ON MED (of which, Mahfoud was an investigator), explored the use of the Symplicity Spyral renal denervation system (Medtronic) in patients with moderate, uncontrolled hypertension who were taking one to three antihypertensive medications. A previous study with the first-generation Symplicity catheter did not demonstrate a significant reduction in blood pressure compared with a sham procedure in patients with resistant hypertension. According to Mahfoud, one of the lessons from this trial was that “we probably started with the wrong population because their hypertension was too severe and perhaps could not be treated with anything”. Presenting the SPYRAL HTN-ON MED trial at EuroPCR, David E Kandzari (Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, USA) reported that patients were included in the study if they were stable on one to three antihypertensive medications for six weeks prior to enrolment. After a second screening visit, 76 patients were randomised to renal denervation (38) or a sham procedure (38). Follow-up visits were scheduled

David E Kandzari

at one month, three month, six months, and planned 12 to 36 months after the procedure. The primary efficacy endpoint was change from blood pressure measured at baseline (at the second clinic visit) to blood pressure measured at the six-month followup visit. At six months, there was a significant decrease in 24-hour ambulatory blood pressure in terms of systolic and diastolic blood pressure in the renal denervation group compared with baseline levels. There were no significant blood pressure reductions in the sham procedure group. These findings meant that, compared with the sham procedure group, the renal denervation group had significant reductions in both 24-hour systolic blood pressure

and 24-hour diastolic blood pressure: -7mmHg (p=0.0059) and -4.3mmHg (p=0.0174), respectively. Writing in the Lancet— SPYRAL HTN-ON MED was simultaneously published in the journal to its EuroPCR presentation—Kandzari et al note that the magnitude of blood pressure decline was “clinically significant” as prior studies have shown such reductions to be associated with “lower rates of both cardiovascular events and mortality”. Kandzari told Cardiovascular News: “Irrespective of the level of blood pressure elevation, the extent of blood pressure reduction observed in this trial has clinical significance. Considering that hypertension is the worldwide leading cause of death and disability, if confirmed in larger study, such blood pressure reductions would have a substantial public health impact.” In the Lancet, the authors observe that the extent of blood pressure reduction with renal denervation “increased over followup through six months” and the reductions were present throughout the day and night. Kandzari told delegates at EuroPCR this represents an “always on” effect for renal denervation that may have particular relevance given the limitations of dosing regimens and adherence with medications. This apparent “always on” effect may be especially importance given the relative prevalence of patients in both the sham procedure group and the renal denervation group who did not adhere to their medication regimens. Overall, the study investigators report in the Lancet, individual patient adherence to medication was 60% and this was “highly Continued on page 2

Giovanni Di Rienzo: EU regulations Page 6

Juan F Granada: Profile Page 16

New ORBITA analysis finds iFR/FFR values do not predict impact of PCI on exercise time

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ew data from the ORBITA trial indicate percutaneous coronary intervention (PCI) does not significantly improve exercise time compared with a sham procedure in patients with stable disease regardless of baseline fractional flow reserve (FFR) or instantaneous wave free ratio (iFR) values. However, this analysis does show that lower FFR/iFR values predict a progressively greater benefit of PCI on stress echocardiography ischaemia. ORBITA, which was presented at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Denver, USA), prompted heated debate in the interventional cardiology community when it indicated that PCI did not provide a benefit over a sham procedure

Rasha Al-Lamee

in terms of exercise time in patients with stable disease. A key criticism of the study at the time was that it enrolled several patients who would not have undergone PCI in clinical practice—approximately, a third of patients had FFR/iFR values that were above the standard thresholds (0.80 and 0.89, respectively) for intervention—and, therefore, this may have affected the results. Presenting the new Continued on page 2


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