EuroPCR 2015 Takes on TAVR, PCI Optimization, and More

PARIS, France—EuroPCR 2015, held May 19-22, featured findings that spanned numerous subfields, from TAVR to complete revascularization and various hot topics in PCI. Additional presentations focused on interventions for PAD and other indications.

Many Paths to Better PCI

On the heels of recent studies backing complete revascularization as superior to culprit-only PCI in STEMI patients with multivessel disease, data from PRAGUE-13 suggest that the 2 strategies produce equivalent results. Estimated outcomes for the primary endpoint of all-cause mortality, nonfatal MI, and stroke—and its components—were similar through approximately 6 years.

In an interview with TCTMD, Roxana Mehran, MD, of Mount Sinai Hospital (New York, NY), said that the issue of complete revascularization has generated a lot of interest.

“What’s different about PRAGUE-13,” she noted, “is that the decision wasn’t made at the time of primary PCI.” Instead, procedures in the complete revascularization arm were staged, occurring 3 to 40 days after the initial intervention. Dr. Mehran predicted that the COMPLETE trial, slated to enroll nearly 4,000 patients, may provide more definitive answers. “Until we get those results, I remain cautiously optimistic [that] complete revascularization will make a difference,” she commented.

Another prominent topic was imaging guidance.

No fewer than 3 Hot Line presentations addressed the question of how optical coherence tomography (OCT) might inform PCI. The ILUMIEN I trial found that OCT, when used on top of FFR and angiography, results in a trend toward lower MACE and an unexpected reduction in periprocedural MI at 30 days. ILUMIEN II found that the degree of stent expansion is similar for procedures conducted under OCT vs IVUS guidance, while early results from OPINION suggested similar procedural outcomes with the 2 technologies.

“We were impressed [in ILUMIEN I] by the fact that in a large number of patients, the physicians did change their planning regarding the procedure after they had seen the OCT information,” said study investigator William Wijns, MD, PhD, of Cardiovascular Center Aalst (Aalst, Belgium).

Dr. Wijns, a course director of EuroPCR, told TCTMD in an interview that clinicians can already feel free to use OCT or other imaging, such as IVUS, when there are angiographic findings that are worrisome or cannot be explained. “There are other situations where there is a consensus that imaging will add to the procedure—for instance, understanding the mechanism of restenosis or confirming that the deployment of a stent in the left main is adequate,” he noted. “What we need to establish for the future is to what extent OCT guidance will improve outcomes long term and which patients might benefit.”

Another study, FFR_CT RIPCORD, demonstrated that the addition of CT-based FFR screening to angiography alone for measuring the functional significance of coronary lesions causes interventional cardiologists to change management plans for one-third of patients who present with chest pain.

“This was really a proof of concept,” stressed Dr. Mehran. What is interesting, she related, is that only about half of lesions that were 70% to 90% obstructed on CT angiography were actually ischemic according to FFR_CT.

In addition, 15-year follow-up from DEFER, the first randomized trial of FFR screening, showed no difference in outcomes between stenting and deferred PCI of nonischemic lesions in patients with stable angina. Patients in whom PCI was delayed had a reduction in long-term risk of MI.

DEFER occurred “way back when, when we were first using pressure wires and looking at ischemia-driven revascularization. Of course, the field has come forward in so many wonderful ways…, and we’ve learned so much,” Dr. Mehran said. “What was great about this study is that 15 years later, we can see the results.”

Most important, she noted, is that mortality was similar regardless of strategy. The increase in MI on the “performance” side, she added, “isn’t to say that it is unsafe to do PCI, but rather that it is safe to leave things alone.”

While much has changed in PCI over the past 15 years, Dr. Mehran said, this study still “feeds into the continued evidence that we… should be performing PCI on ischemic patients. Our revascularization should be ischemia guided and not just oculostenotic.”

Progress Documented in TAVR

TAVR, meanwhile, continues to evolve. Research released at EuroPCR provided insight into real-world outcomes, improved technologies, and expanded patient populations.

One trial found that intermediate-risk patients with aortic stenosis in Europe and Canada had a low mortality rate of 1% at 30 days after implantation with the newest-generation Sapien 3 valve (Edwards Lifesciences). In addition, a subanalysis of PARTNER II showed that TAVR with Sapien 3 results in a low risk of paravalvular regurgitation with nominal oversizing; researchers said that the degree of oversizing needed to avoid more than moderate leak seems to be less than seen with previous Sapien generations.

In NOTION, the first trial to randomize lower-risk patients with aortic stenosis to TAVR or surgery, the 2 procedures proved comparable in terms of all-cause death, MI, or stroke at 2 years. TAVR patients received the CoreValve device (Medtronic).

“Results were indeed stunning in terms of the safety of TAVR in [the lower-risk] population,” Dr. Wijns said. “It’s important to remember that this trial was initiated quite some time ago, so it is clear that today both the procedure and some of the devices that are being used for TAVR have improved since then. So it’s a very positive signal in the direction of treating patients who are not at the extreme spectrum of risk with TAVR rather than with surgery.”

Late-breaking trial sessions also included 2 nonrandomized studies of self-expanding valves, both old and new.

In the CoreValve ADVANCE-II Study, the overall pacemaker rate was 14.5% at 6 months in high-risk patients receiving the CoreValve device. Cases of new-onset left bundle branch block resolved over time, with 36.4% of affected patients (without pacemakers) reporting resolution by 6 months. Six-month outcomes for CoreValve Evolut R (Medtronic), noteworthy for being repositionable, also were released.

Finally, preliminary intention-to-treat data from DEFLECT III showed promise for the TriGuard neuroprotection device (Keystone Heart; Caesarea, Israel). Compared with TAVR patients treated without embolic protection, those in the TriGuard group had greater freedom from ischemic brain lesions, fewer neurological deficits, and improved cognitive function at 30 days. In addition, adverse outcomes occurred with similar frequency between the 2 groups.

“These results did raise a lot of interest, because on the one hand, we would like to improve the patient friendliness of the TAVR procedure by reducing the duration of hospitalization and perhaps skipping some of the periprocedural imaging or anesthesia, which were very useful in the early days but perhaps now that the procedure has become more standard may not be needed in all cases,” Dr. Wijns said. “On the other hand, we want to make it as successful as possible, reducing complications even further. Of course, stroke is number one on the list even though with the current [device] iterations the rates are becoming smaller.

“So there is a balancing act between making it a patient friendly and swift procedure vs including an extra intervention, like the placement of [embolic protection devices],” he noted. Beyond the periprocedural period, Dr. Wijns added, pharmacological approaches may be helpful in reducing the risk of events.

Novel Approaches to Disease, Patient Subsets

Additional studies presented at EuroPCR shed light on device-based treatment for particular subgroups. These included:

• The DEB-SFA-LONG study and the IN-PACT Global Clinical Study, which both employed the paclitaxel-coated IN.PACT Admiral balloon (Medtronic) in PAD patients with long lesions
• LIPSIA-Conditioning, in which the combination of remote ischemic preconditioning and postconditioning increased myocardial salvage for STEMI patients undergoing primary PCI
• Two trials—NEXT and SORT OUT VII—conducted in all-comers populations that assessed the potential of biodegradable-polymer DES
• The MASTER study comparing a biodegradable-polymer sirolimus-eluting stent and a BMS specifically in STEMI patients
• Three trials related to bifurcation lesions; two supported the use of provisional stenting as a first-line effort but showed that a 2-stent strategy can be safe and effective if performed correctly, while the other looked at a dedicated bifurcation stent
• PERFECT-2, which reported that balloon angioplasty offers durable symptom relief in patients with erectile dysfunction and isolated penile artery stenosis for up to 1 year
• Two studies—RESERVOIR and OCT-DES—that investigated whether new-generation DES, including a polymer-free device, might benefit patients with diabetes

Presentations at: EuroPCR; May 19-22, 2015; Paris, France.

Disclosures:

• Dr. Mehran reports receiving research grants or receiving consulting or advisory board fees from multiple pharmaceutical and other companies.
• Dr. Wijns reports that fees and honoraria on his behalf go to the Cardiovascular Research Center Aalst. He is a shareholder and non-executive board member of Argonauts Partners, Cardio3 Biosciences (now Celyad), and Genae. He has received institutional research grants from several pharmaceutical and device companies including Boston Scientific, St. Jude, and Volcano.

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• EuroPCR 2013: From Cutting-Edge Devices to the Clinical Challenges
• EuroPCR 2012: Biodegradable Devices, Imaging Take Center Stage