This article is more than 5 years old. Information may no longer be current.
The Take Home: EuroPCR
This May, more than 12,000 attendees convened at the Palais de Congrés in Paris for the EuroPCR meeting. The annual event set an international stage for some of the most talked-about and potentially transformative technologies in the field of interventional cardiology being developed and researched today.
Cardiology Today’s Intervention was at the meeting and spoke with several experts on some of the most cutting-edge technologies presented. Among them were Cardiology Today’s Intervention Editorial Board members Dominick J. Angiolillo, MD, PhD, of the University of Florida College of Medicine-Jacksonville, and Ashok Seth, MD, with Fortis Escorts Heart Institute, New Delhi, India; European Association of Percutaneous Cardiovascular Interventions representatives Christoph K. Naber, MD, PhD, with Essen University Hospital, Germany, and Andreas Baumbach, MD, with Bristol Heart Institute, United Kingdom; Society for Cardiovascular Angiography and Interventions Past-President Larry S. Dean, MD, with the University of Washington School of Medicine, Seattle, Wash.; and Marco A. Costa, MD, of the University Hospitals Case Medical Center, Cleveland, and Krishna J. Rocha-Singh, MD, FACC, FAHA, with the Prairie Vascular Institute, St. John’s Hospital, Springfield, Ill.
Late-Breaking Data: DESolve Nx
Ashok Seth
Seth: The DESolve Nx study adds to our present knowledge in that it was a roughly 130-patient study looking at 6-month late loss and showed that the late loss with the DESolve scaffold (Elixir Medical) was low (0.21 ± 0.34 mm). The other important aspect was that there was a low incidence of complications (6-month MACE, 3.25%). That provides us with important data, which were good enough to get a CE mark for the DESolve scaffold. As an interventional cardiologist, it’s nice to have another absorbable scaffold available despite the data being preliminary. However, for Absorb Bioresorbable Vascular Scaffold (Abbott Vascular), we have angiographic data on 110 patients and it is still the most studied absorbable stent with optical coherence tomography, IVUS and CTA at multiple time frames over years, providing tremendous insights into performance, safety and efficacy. The 800-patient, single-arm, multicenter ABSORB EXTEND trial has enrolled close to 700 patients and will be finishing soon, which will give us robust safety and efficacy data in more “real-world” patients and the ABSORB FIRST post-marketing registry is on the way.
Andreas
Baumbach
Baumbach: DESolve is a well-constructed stent. It appears to have very good mechanical parameters, radial strength and acute results. Compared with what we have seen so far with the one system that has been widely used (Absorb), the DESolve stent erodes within a year, much faster than Absorb, which takes 3 years. However, 1 year is still after the time a scaffold is absolutely needed, so it will likely do the job. This is exciting because you can then start to assess the benefits of the disappeared stent much earlier. So, this is very exciting first clinical data, and I look forward to seeing larger cohorts testing this device.
Late-Breaking Data: BIOFLOW-II
Seth: An ideal stent could be one with a cobalt chromium thin strut platform, a biodegradable polymer and a limus drug. All of these components get incorporated into this Orsiro stent (Biotronik). The hypothesis with a stent like this is that the biodegradable polymer will gradually degrade over 1 to 2 years leaving behind a bare-metal stent. This would have potential long-term advantages of low rates of very late stent thrombosis, low restenosis rates and the ability to withdraw or cease dual antiplatelet therapy, if required.
In the BIOFLOW-II study, researchers demonstrated that compared with the Xience Prime (Abbott), this new Orsiro stent had identical low late loss (in stent: Orsiro, 0.10 ± 0.32 vs. Xience Prime, 0.11 ± 0.29; P=.99; in segment: Orsiro, 0.09 ± 0.35 vs. Xience Prime, 0.09 ± 0.33; P=.86). The important aspect is that the good results of Xience, in terms of short- and long-term safety and efficacy, provide us with robust 5-year data of extremely low stent thrombosis rates, making it very difficult to design a study that would be able to show the superiority of any new stent concepts and its potential advantage. BIOFLOW-II had a very select inclusion criteria looking at late loss, but needs a powerful clinical endpoint. However, the next study, which has been completed and is an all-comer study powered for clinical endpoints, I suspect will demonstrate noninferiority toward Xience. It would be extremely difficult to demonstrate superiority of the potential advantages even in an all-comers study. So even if proven to be noninferior, the potential advantages may make this stent an attractive and favored option in “real-world” patients.
TAVR
Naber: There were several presentations of interesting data involving new transcatheter valves at this year’s EuroPCR. The one I found of most interest was the SOURCE XT post-approval study, which included nearly 2,700 patients with severe aortic stenosis who were treated with the 18F Sapien XT valve (Edwards Lifesciences). At 1-year follow-up, patients had low rates of cardiac (10.8%) and all-cause (19.5%) mortality. These are the best ever survivor rates for critically ill patients. With these data, we can now clearly say that transcatheter valves are an established therapy and here to stay.
Christoph K. Naber
REPRISE II was another trial that assessed a transcatheter valve (Lotus valve; Boston Scientific), but in this case reported 30-day outcomes. Patients with severe calcific aortic stenosis considered high risk for surgical valve replacement (n=60) had a substantially reduced mean aortic gradient (11.3 ± 5.2 mm Hg vs. 47.5 ± 17.2 mm Hg) and increased effective orifice area (1.7 ± 0.4 cm2 vs. 0.6 ± 0.2 cm2) as a result of treatment with the valve. Importantly, device mortality was low (1.7%) and there was no embolization, ectopic valve deployment or need to implant a transcatheter aortic valve (TAV) in a TAV. Aortic regurgitation was negligible and clinical event rates were consistent with those reported for other valves.
The Lotus valve is an interesting and appealing concept. In fact, I see it as a good engineering idea in that it features an adaptive seal designed to minimize paravalvular leak and is fully retrievable and recapturable. It appears so far to be associated with no major concern, but we have very limited data.
So, with these and other study results, it is clear that we will soon have other players in the transcatheter valve field besides the established ones, Sapien and CoreValve (Medtronic).
Larry S. Dean
Dean: The results of the ADVANCE trial assessing the CoreValve transcatheter valve are remarkable for a high procedure success rate and an acceptable mortality of 4.5% at 30 days with the device. Follow-up at 1 year showed a mortality of 17.9% and a trend suggesting that moderate-to-severe aortic regurgitation following TAVR impacted mortality. This adds to the concern noted in the PARTNER trial that residual aortic regurgitation impacts patient outcome. However, it remains hypothesis generating, and additional data will be required to more fully understand this finding. Also noted was that 29% of patients required placement of a permanent pacemaker at 1 year, which is quite high and is approximately fivefold higher than what was seen in the PARTNER trial. Results from the US CoreValve pivotal trial are eagerly awaited, which may or may not confirm the high rates of pacemaker insertion using the CoreValve.
Marco A. Costa
Costa: In the DISCOVER CE mark trial, the Direct Flow Medical transcatheter aortic valve system, which features a double-ring design, was shown to lead to a 99% freedom from all-cause mortality rate at 30 days in patients with severe aortic stenosis considered high risk for surgery. Additionally, 99% of patients experienced mild or less aortic regurgitation after being treated with the valve, while 73% experienced none/trace aortic regurgitation. These are very encouraging preliminary results for the valve, which will likely be part of the portfolio of valves we’ll have in the future. It’s still to be decided whether it is the final device, but it introduces the concept of polymer-based technology that is much needed because conformability of the aortic annulus is a very important problem we have with non-polymeric technologies. This valve could be a blockbuster. But if the design comes at the cost of more challenging delivery then it balances out. So it has to be technically feasible and operator independent.
Renal Denervation
Rocha-Singh: One-year data from the EnligHTN trial demonstrated that patients treated with the EnligHTN renal denervation catheter experienced a mean systolic BP reduction of –27 mm Hg when measured in an office setting. Among the patients, 80% responded to therapy, which was defined as BP reduction ≥10 mm Hg when measured during an office visit.
Krishna J.
Rocha-Singh
If you compare the mean systolic BP reductions observed in this trial with those observed in the trials assessing the Symplicity (Medtronic) and Vessix (Boston Scientific) renal denervation catheters, you find that in patients with severe treatment resistant hypertension on approximately five anti-hypertension medications, a similar trend begins to emerge: If you start at the same systolic BP (178-182 mm Hg), a successful renal denervation appears to result in a 6- to 12-month reduction in systolic BP between 25 mm Hg and 28 mm Hg. This trend may relate to the pathophysiology and biology of ablating efferent and afferent renal nerves with radiofrequency energy. I anticipate that a discussion will evolve over the next year or so as more data emerges with radiofrequency energy as to whether we are witnessing the emergence of a “class effect” among these radiofrequency devices. In the coronary stent world, some cardiologists believe that technical evolution of drug-eluting stents has reached a plateau and they have become commodities. Obviously, we can’t say that about renal denervation as of yet because we don’t have the breadth and extent of effectiveness and safety follow-up data, but you do start to see the same systolic BP effect at 6 and 12 months. Perhaps longer-term (2-3 year) follow-up data may differentiate these radiofrequency devices based on durability of BP effect and safety. Other points of device differentiation will relate to ease-of-use, total ablation time, which relates to patient discomfort, and French size of the system. The EnligHTN catheter will likely be iterated because it is an 8F system and most US cardiologists are probably more comfortable with guidewire-based systems, particularly in difficult anatomies.
Drug-Coated Stents
Dominick J.
Angiolillo
Angiolillo: The currently enrolling LEADERS FREE trial will look at the idea of whether a drug-coated stent (BioFreedom BA9, Biosensors International) can reduce the duration of dual antiplatelet therapy. The more than 2,400 patients in the trial will receive one DAPT regimen of aspirin 100 mg to 160 mg once daily (OD) indefinitely and clopidogrel (Plavix, Sanofi-Aventis) 75 mg OD (or another P2Y12 inhibitor) for 1 month only. The obvious advantages of reducing DAPT duration are the possibility of minimizing the risk of bleeding caused by prolonged DAPT treatment and improving patient adherence. I do feel we need to be cautious with this concept, however, because there is a plethora of data supporting the role of prolonged DAPT in the setting of ACS. The PEGASUS trial, in fact, will be looking at the impact of going beyond 12 months DAPT in patients with a prior ACS, and will involve 21,000 patients. The design was based on robust, hypothesis-generating data from prior trials. So here we are going in two directions: One is that of “treating the stent” and thus trying to reduce duration of DAPT without safety concerns (namely stent thrombosis); and the other is that of “treating the patient” by prolonging DAPT to prevent overall ischemic recurrences. Therefore, while technical advances are critical in this field and similar trials are indeed needed, we should be cautious with interpreting the data, which may not necessarily be applicable to “all comers” undergoing PCI and potentially underpowered to fully address safety and efficacy concerns.
Disclosure: Angiolillo has received consulting fees/honorarium from Abbott Vascular, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Evolva, Merck, PLx Pharma, Sanofi-Aventis and The Medicines Company; payment for participation in review activities from Johnson & Johnson, St. Jude Medical and Sunovion, and institutional payments for grants from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Evolva, GlaxoSmithKline, Otsuka, Sanofi-Aventis and The Medicines Company; and has other financial relationships with the James and Esther King Biomedical Research Program. Baumbach reports no relevant financial disclosures. Costa was a consultant for Direct Flow Medical. Dean receives research support from Edwards Lifesciences. Naber has consulted for/received honorarium from Edwards Lifesciences. Rocha-Singh is a consultant for and on steering committees of Boston Scientific and Medtronic, and is a consultant for Cardiosonic. Seth is a consultant for Abbott Vascular.