EuroPCR 2014: Clinical Challenges, Novel Innovations Share the Limelight
PARIS, France—Research presented at EuroPCR 2014, held May 20-23, offered both new ways to improve on current therapies and fresh approaches to treating challenging lesions and patient subsets.
EuroPCR course director William Wijns, MD, PhD, of Cardiovascular Center Aalst (Aalst, Belgium), told TCTMD in an interview, “One theme for this year is that we tried to mix presentations of late-breaking trials with late-breaking innovations.”
For example, he said, “during the meeting we had several presentations of first-in-man interventions that are trying to repair the mitral valve or even replace it. We can see that this is an unmet need.”
Two presentations focused on novel devices for mitral valve disease. A multicenter feasibility study assessed the Cardioband device (Valtech, Paris, France), a ‘surgical-like’ ring implanted percutaneously to perform direct annuloplasty. The procedure appears to be safe and feasible, with outcomes that researchers say rival surgery. First-in-man data on the D-shaped Tiara bioprosthesis (Neovasc, Vancouver, Canada) also were positive.
Another first-in-man study outlined a new approach to treating left heart failure, demonstrating gains in functional status and quality of life. When implanted, the V-Wave device (V-Wave, Or Akiva, Israel) produces left atrial decompression through unidirectional left-to-right shunt.
Global Cooperation Featured
Other presentations showed creative takes on study design. The CENTURY II trial, which randomized more than 1,100 patients slated for PCI with DES at 58 sites in Europe, Japan, and Korea, provides an example of how to streamline approval processes across regions, Dr. Wijns said, noting, “It is global harmonization in action.”
Dr. Wijns served as co-principal investigator of the trial.
For CENTURY II, patients were stratified according to whether or not they fulfilled requirements for DES use in Japan before being randomized to receive the Ultimaster stent (Terumo; Tokyo, Japan), which releases sirolimus from an abluminal coating expected to resorb within 3 to 4 months, or the permanent-polymer everolimus-eluting Xience stent (Abbott Vascular; Santa Clara, CA).
Ultimaster proved noninferior to Xience for the primary endpoint of freedom from target lesion failure (TLF; cardiac death, target vessel MI, and clinically driven TLR) at 9 months, both in the total population and in the cohort of patients that matched Japanese regulatory requirements for DES treatment.
Evidence Base Grows for Recent Therapies
TAVR continued to generate headlines at EuroPCR. Initial 30-day results from the Sapien 3 trial demonstrated that a new lower-profile valve and delivery system (Sapien 3; Edwards Lifesciences, Irvine, CA) appear “very promising,” Dr. Wijns said. The study observed low mortality and stroke rates and few access-site complications. In addition, the UK TAVI registry found that nearly half of high-risk patients who undergo TAVR for severe aortic stenosis live at least 5 years after the procedure, with long-term survival affected not by procedural and device factors but by patient characteristics.
Dr. Wijns said that, at this point, TAVR has become an integral part of “the interventional armamentarium.”
The Iberian Registry delivered good news on percutaneous closure of the left atrial appendage performed in Portugal and Spain. Most of the stroke protection derived from the treatment does not become apparent until 1 year after treatment, the study found. Moreover, bleeding rates are also lower than would be expected based on baseline patient risk.
Various Approaches to Bifurcations Evaluated
Several late-breaking trials took on the challenging subset of bifurcation lesions. The BABILON trial found that use of a paclitaxel-eluting balloon rather than an everolimus-eluting stent to treat bifurcations appears to double the amount of late lumen loss at 9 months and triple the need for repeat revascularization at 24 months, though the differences were not significant.
In addition, 2 trials looked at dedicated bifurcation stents.
One, the COBRA study, randomized 40 patients either to receive an Axxess stent (Biosensors International, Singapore) plus 2 Biomatrix DES (Biosensors)—all of which elute biolimus A9 from an abluminal biodegradable polymer—or to undergo optimal culotte technique using the everolimus-eluting Xience Prime (Abbott Vascular, Abbott Park, IL). At 9 months, the percentage of uncovered stent struts per bifurcation segment on optical coherence tomography was similar for both strategies but numerically favored culotte/Xience. In-stent late lumen loss, meanwhile, was lower in the bifurcation core with Axxess/Biomatrix, and both strategies resulted in similar clinical outcomes at 1 year.
Updated results from the Tryton Bifurcation Trial also were presented. The study randomized 704 patients with true coronary bifurcations to a 2-stent strategy using the Tryton dedicated bifurcation BMS (Tryton Medical, Durham, NC) in the side branch and DES in the main vessel, or to the accepted strategy of DES in the main vessel plus provisional side branch stenting. At 1 year, target vessel failure (TVF) and its components all were similar between the 2 groups. Among patients with side branches ≥ 2.25 mm, Tryton did not hold a significant advantage over provisional stenting for TVF at 1 year but results, as in previously presented 9-month data, continued to numerically favor the dedicated device.
“There is still continued interest, very much so, in the treatment of bifurcations. Although the dominant strategy is provisional [stenting], I think continued research is warranted in the direction of intentional 2-stent use of dedicated devices,” Dr. Wijns commented. “We’re moving toward a tailored approach. [This] is a theme of the entire meeting.”
Renal Denervation Revisited
In SYMPLICITY HTN-3, positive predictors of improved office systolic blood pressure (BP) in the renal denervation arm included baseline office systolic BP, total number of ablation attempts, and aldosterone adherence. But in the control arm, response was predicted by baseline office systolic BP, African-American race, and alpha-1 blocker use. Vasodilator use, associated with an increase in BP, was the only negative predictor in the study group.
Moreover, multivariable analysis of data from the Global SYMPLICITY registry indicated that higher baseline office systolic BP and the presence of 2 or more comorbidities predicted overall response to renal denervation. Within a cohort of patients that mirrored the SYMPLICITY HTN-3 trial, predictors of response included higher number of ablation attempts, male sex, and higher baseline office systolic BP, while greater numbers of baseline antihypertensive drugs were associated with non-response.
The future of renal denervation, “of course, has been challenged by the results of SYMPLICITY [HTN-3] but more research is ongoing and definitely needed,” Dr. Wijns said, predicting that personalized care may well be the answer.
“One thing emerged from the collective experience of using renal denervation,” he said, is the existence of “phenotypes” that predict response. In clinical practice, younger patients with healthy vessels and resistant hypertension seem to be good responders, Dr. Wijns explained, while older patients with more comorbidities and stiffer vessels are not likely to respond. Middle-aged patients with conditions such as sleep apnea, obesity, and diabetes fall somewhere in the middle, he added.
According to Dr. Wijns, the importance of integrating clinical experiences such as these with research findings is “one of the key educational messages of EuroPCR.”
Challenging Disease Subsets Addressed
Femoropopliteal artery disease, meanwhile, was the focus of 2 studies.
Researchers analyzed data from a Japanese post-marketing study to demonstrate that the polymer-free paclitaxel-eluting Zilver PTX stent (Cook Medical, Bloomington, IN) is being used to treat progressively more challenging lesions while maintaining safety and efficacy. Another presentation provided more information about an ultrasound system developed by CardioProlific (Redwood City, CA) to enhance arterial delivery of paclitaxel to femoropopliteal lesions, thereby reducing restenosis.
In STEMI patients, the APPOSITION IV trial showed positive findings for the Stentys self-apposing sirolimus-eluting stent (Stentys, Paris, France) compared with the balloon-expandable Resolute zotarolimus-eluting stent (Medtronic, Santa Rosa, CA). On quantitative coronary angiography, no differences were observed between the treatment arms just after the procedure for in-stent minimal and mean lumen diameter. However, in-stent mean lumen diameter was larger at both 4- and 9-month follow-up for Stentys.
Moreover, in the ADEPT trial, self-expanding BMS and paclitaxel-eluting stents (PES) fared equally well in saphenous vein graft lesions. Procedural success was observed in all PES patients and 95.8% of BMS patients, and no immediate differences were seen in lesion length, reference vessel diameter, minimum lumen diameter, or percent diameter stenosis post-PCI. At 6 months, neither in-stent late lumen loss nor binary restenosis differed between the cohorts.
Other Interventional News Presented
Also at EuroPCR 2014, a study looking at the value of noninvasive, CT-derived fractional flow reserve assessment (Siemens, Forchheim, Germany) plus CT perfusion imaging found that combining the 2 tests offers a sensitivity of 83% and specificity of 95% in identifying inducible ischemia in patients with suspected CAD.
Five-year findings from the NOBORI 2 study showed that the Nobori biolimus A9-eluting stent (Terumo, Tokyo, Japan) has favorable long-term clinical outcomes and very low rates of device-related adverse events. At 5 years, TLF (cardiac death, target vessel MI, and TLR) was 8.2% overall and higher in complex than in simple patients (9.1% vs 5.9%; P < .01).
Finally, a subanalysis of the EUROMAX trial showed that bivalirudin is superior to heparin regardless of whether STEMI patients do or do not receive glycoprotein IIb/IIIa inhibitors, and data from the PARIS registry showed that while clopidogrel cessation varies between men and women, its ill effects stem more from comorbidities than from sex differences in and of themselves.
Presentations at: EuroPCR; May 20-23, 2014; Paris, France.
- Dr. Wijns reports receiving research funding and honoraria from multiple drug and device companies as well as holding stock in Cardio3 Biosciences.