EuroPCR 2018: Stable CAD, Functional Tests, and Renal Denervation Take Center Stage

PARIS, France—If it’s worth doing, do it well: that might be the best way to sum up both the message and the meat of this year’s EuroPCR program. The meeting kicks off here next week, and according to the EuroPCR chair, the overall theme of this year’s gathering is “to insist on best practices,” something that is true for coronary as well as structural heart interventions.

“There are a number of components to this,” William Wijns, MD (Lambe Institute for Translational Medicine and Cúram, Galway, Ireland), told TCTMD, “but one is optimal drug-device interaction, and the other is to make sure that both pre- and postprocedure best practices are taken care of as part of the care pathway.”

That theme informs a number of the “Hot Line/Late-Breaking Trial” sessions in this year’s program—a whopping 12 such sessions in total. As with last year’s program, however, just two of them have been booked for the Main Arena.

PCI Decision-Making in Stable Angina

The first, midday Tuesday, May 22, kicks off with new data from one of the biggest newsmakers of 2017: ORBITA. Lead investigator Rasha Al-Lamee, MBBS (Imperial College London, England), will lead off with a physiology-stratified analysis of the impact of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) on the efficacy of coronary angioplasty in the randomized, sham-controlled trial of PCI versus best medical therapy in patients with stable coronary artery disease.

The ORBITA analysis, which came up during a recent “controversies” session at the SCAI 2018 meeting last month, is bound to keep the “best practices” debate alive, yet “ORBITA is only part of this,” Wijns told TCTMD. “The entire session is going to be incredible. The question really, during that session, is whether PCI impacts on outcomes in stable coronary disease beyond the quality of life benefits of revascularization, whether there is any impact on death or MI. This is looked at from a number of angles.”

To that end, the five other trials in this grouping are focused on what Wijns termed “stable coronary syndromes” and in particular, the value of functional tests. The GZ-FFR trial is a randomized controlled trial of PCI versus optimal medical therapy in patients with “grey-zone” values on FFR. FAME 2 investigators will release 5-year results of their trial (3-year results were presented at TCT 2017), while Swedish researchers have delved into the SCAAR database to investigate long-term survival among patients with stable angina who underwent PCI with or without pressure wire guidance.

Highlighted by Wijns, a fifth study in this session pools data from FAME 2, DANAMI3-PRIMULTI, and Compare-Acute, looking specifically at the nonculprit lesions in these trials and the correlation between functional results and death/MI in patients randomized to PCI or medical therapy. This, said Wijns, “should carry a lot of weight” given the combined power of this analysis to consider hard events.

Finally, in a sixth presentation that departs somewhat from the other five, Patrick Serruys, MD (Imperial College London), is presenting SYNTAX III REVOLUTION, a “heart team” comparison between noninvasive CT angiography plus FFRCT and invasive angiography plus FFR/iFR in complex stable CAD. Depending on how the “decision trees” compare between these two approaches, “I think this could be a major step forward in the direction of noninvasive CT-based diagnosis, potentially replacing the invasive diagnostic angiogram in a proportion of patients,” Wijns said.

As part of this spotlight session, Michael Haude, MD, PhD (Städtische Kliniken Neuss, Germany), will present a “PCR statement on PCI for stable CAD.”

Renal Denervation Returns

The second Main Arena Hot Line session takes place Wednesday morning, May 23, and combines two studies of renal denervation with two studies on new coronary stents. Leading off, David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA), will present 6-month results from SPYRAL HTN-ON MED, the companion to last year’s “OFF MED” trial. Three-month results from the 80-patient OFF MED study, released at the European Society of Cardiology Congress 2017 last fall, showed that renal denervation using the Symplicity Spyral multielectrode catheter (Medtronic) resulted in greater declines in 24-hour systolic pressure and 24-hour diastolic pressure than a sham procedure in patients with untreated mild-to-moderate hypertension.

SPYRAL HTN-ON MED, conversely, is looking at denervation versus a sham procedure in 106 patients with uncontrolled hypertension taking one to three different classes of antihypertensive medications. In this regard, SPYRAL HTN-ON MED is a closer match with the failed SYMPLICITY HTN-3 trial, which used the company’s earlier technology and also enrolled patients taking multiple blood pressure drugs—a “more difficult population,” as Wijns put it. The primary endpoint is systolic blood pressure at 6 months as measured by 24-hour ambulatory blood pressure monitoring. Kandzari is presenting results for a prespecified analysis of the first 80 patients in this study.

The second trial, RADIANCE-HTN SOLO, will be presented by Laura Mauri, MD (Brigham and Women’s Hospital and Harvard Medical School, Boston, MA), and is one of two studies underway sponsored by the manufacturer, ReCor Medical. The “SOLO” component of RADIANCE-HTN enrolled 146 patients with essential hypertension controlled on one or two antihypertensive medications or uncontrolled on up to two antihypertensive medications who were taken off their medication at the time of randomization to either renal denervation or a sham procedure. The primary efficacy endpoint in the study is mean reduction in average daytime ambulatory systolic blood pressure at 60 days.

As in the session the previous day, EuroPCR programmers have seen fit to release a special statement in response to this new renal denervation data following the presentation of the two trials, this one to be delivered by Felix Mahfoud, MD (Saarland University Hospital, Homburg, Germany).

Following the renal denervation presentations are two latest-generation coronary stent trials. The first, TARGET All-Comer, is comparing the Firehawk biodegradable-polymer, rapamycin-eluting coronary stent (MicroPort) to the Xience permanent-polymer, everolimus-eluting stent (Abbott). According to Wijns, this study “is actually quite important,” testing the first Chinese-made, latest-generation DES to be evaluated in a large outcomes trial outside of China.

“If noninferiority is met, this would really place this device in the upper league,” said Wijns. “You can imagine, if this trial is positive, for our colleagues from China, this would be major, major achievement.”

The second DES study, SORT-OUT VIII is comparing the everolimus-eluting SYNERGY stent (Boston Scientific) to the biolimus-eluting BioFlex stent (Biosensors)—both devices have proprietary bioresorbable polymers.  

Other “Hot” Sessions

The ten remaining “Hot Line/Late-Breaking Trial” sessions include two devoted to TAVI, two to bioresorbable scaffolds, two to new-generation drug-eluting metallic stents, and one each to drug-eluting balloons, mitral and tricuspid valve innovation, peripheral and stroke interventions, and a catchall of “coronary interventions.” This last includes studies of intervention timing in transient STEMI; left distal radial access; controlled coronary sinus occlusion to reduce infarct size; hemodynamic support in large MIs; bifurcations; chronic total occlusions; and thick- versus thin-strut stents.

Pointing to the TAVR sessions, Wijns highlighted new long-term durability data from NOTION as well as some important new insights into the role of cerebral protection during TAVR. The drug-eluting balloons session will also be important, he noted, since it is devoted to the use of this technology in the coronary vasculature, not the peripheral system where these devices have already carved out a niche.

Many of these sessions take their cue from the “best practices” theme, Wijns observed, pointing out that this encompasses everything from the use of the best-in-class devices to optimal imaging and medical therapy, including extensive secondary prevention.

Beyond the Hot Lines, Wijns urged meeting attendees to check out the “Out of the Box” presentations focused on up-and-coming innovations in interventional cardiology. In particular, he noted, there are several novel heart failure interventions, including new implantable devices, for managing fluid overload in this setting. Other technologies in this session are looking at CRP apheresis as a treatment option in acute MI and the “EggNest” scatter radiation protection system (Egg Medical), billed as the only passive protection system designed to protect the entire cath lab team from scatter radiation.

EuroPCR runs Tuesday through Friday at the Palais des Congrès in Paris. To keep up with all the breaking news from EuroPCR, bookmark our conference page or follow TCTMD reporters on Twitter: Caitlin Cox, Michael O’Riordan, Yael Maxwell, and Shelley Wood.