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The Take Home: EuroPCR
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Image: Brian Ellis
In May, the annual EuroPCR meeting was held, attracting more than 12,200 attendees to the Palais des Congrés in Paris. Cardiology Today’s Intervention was in attendance and spoke with several experts on the late-breaking data presented, including Editorial Board member Dominick J. Angiolillo, MD, PhD, of University of Florida, Jacksonville; Felix Mahfoud, MD, of the University of Saarland, Homburg/Saar, Germany; William Wijns, MD, PhD, FESC, EuroPCR Course Director and Chairman of PCR; and Paul D. Williams, MD, with James Cook University Hospital, Middlesbrough, U.K.
SYMPLICITY HTN-3 Substudy
Mahfoud: A substudy of the SYMPLICITY HTN-3 trial was presented at EuroPCR. In the analysis, the investigators found the following multivariate positive predictors of systolic BP change at 6 months among patients receiving renal denervation (Symplicity, Medtronic): baseline office systolic BP >180 mm Hg (P<.0001); total number of attempts (P=.04); and aldosterone antagonist use (P=.002). Vasodilator use (P=.005) was associated with nonresponse. Additionally, about 80% of patients in both the sham and renal denervation arms were on stable medication regimens for at least 2 weeks prior to inclusion, and roughly 40% of patients had medication changes between baseline and primary efficacy endpoint assessment. Interestingly, researchers also found that change in office systolic BP at 6 months for black patients was –15.5 mm Hg for renal denervation vs. –17.8 mm Hg in the sham procedure (P=.641), whereas the reductions in non-black patients were –15.2 mm Hg in the renal denervation arm vs. –8.6 mm Hg in the sham arm (P=.012).
Felix Mahfoud
It becomes clear from these data that we underestimated the complexity of the patient population and the role of the procedure. It is important to concentrate on the creation of an effective lesion in terms of the number of ablations and circumferential denervation. We are still in the phase where we are figuring out where the sweet spots are in terms of where to target the sympathetic nervous system in the renal arteries. But it’s also clear that the data from SYMPLICITY HTN-3 are very different from what we are doing in clinical practice. In the Global SYMPLICITY Registry, for example, there are very few patients who have been treated with four or fewer ablations per site. I would say we are more actively denervating in terms of number of ablations and we are going more distal in the renal artery and even into the branches if they are large enough. It is interesting to understand that there is a clear signal in these data, and that carries important information for us in routine practice, indicating that the concept of renal denervation is working, which is reassuring.
SAPIEN 3
Williams: In the SAPIEN 3 trial, investigators enrolled 150 patients from 16 sites in Europe and North America to determine the safety and efficacy of the Sapien 3 valve (Edwards Lifesciences). At 30 days, the primary endpoint was reported in 4.7% of patients, stroke was 2.7% and major vascular complications were 6%. The rate of no/trace paravalvular aortic regurgitation was 72.4%, mild aortic regurgitation was 24.1% and moderate aortic regurgitation was 3.4%. There were no observed cases of severe aortic regurgitation in either group.
Paul D. Williams
These data are similar to what we’ve experienced in the six Sapien 3 cases performed at our center to date. Sapien 3 is a smaller device than Sapien XT, and the delivery system is now 14F with the smaller valves. We’ve had cases that wouldn’t have been possible with the XT valve, including very small iliac peripheral vascular disease; previously, this wouldn’t have been listed for the transfemoral approach, as we would have had to perform via the transapical or transaortic route. So far, only one patient from our center had a small amount of aortic regurgitation and the rest had none. That is a substantial improvement compared with the XT device. In terms of delivery, the Sapien 3 valve is a little bit easier to use, featuring modifications to the handle that allow you to put a bit more flex on the tip of the catheter, which is good for horizontal aortas and more unfavorable aortic anatomy.
EUROMAX Substudy
Angiolillo: Results of the EUROMAX substudy showed that the primary endpoint of death or major bleeding was significantly lower in the bivalirudin (Angiomax, The Medicines Company) group compared with patients treated with heparin plus routine use of a glycoprotein IIb/IIIa inhibitor (5.1% vs. 7.4%; P=.0425), as well as those treated with bailout use of a glycoprotein IIb/IIIa inhibitor (5.1% vs. 9.8%; P=.0006).
Dominick J. Angiolillo
To date, we have very consistent data coming from the EUROMAX and HORIZONS-AMI trials, but we also have conflicting findings from the HEAT-PPCI trial presented at the American College of Cardiology Scientific Sessions this year by our colleagues in Liverpool. There are significant differences in trial design — such as HEAT-PPCI being a single-center study — that can contribute to these findings. The HEAT-PPCI trial does have its merits because it was a very large study performed in an all-comer patient population in which antithrombotic treatment regimens commonly utilized by the investigators in their practice were considered for the randomized comparison. In both arms there was a bailout strategy of glycoprotein IIb/IIIa use and the investigators were unable to confirm a benefit of bivalirudin vs. heparin, as there was a lower risk of ischemic events in the heparin arm with no differences in bleeding. These are data that need to be further digested. But this analysis of the EUROMAX trial does continue to support the role of bivalirudin in primary PCI.
OCTAVIA
Wijns: The prospective, multicenter, controlled, investigator-driven OCTAVIA trial sought to determine whether gender-related differences in STEMI pathophysiology and vascular response in current-generation DES can be observed in vivo in 140 age-matched men and women with STEMI who underwent primary PCI with an everolimus-eluting stent (Xience Prime, Abbott Vascular). Through the use of optical coherence tomography, the researchers found no significant differences between genders in ruptured plaque (men, 50% vs. women, 48.4%; P=.56), non-ruptured plaque/erosion (men, 25% vs. women, 25%; P=.86) and spontaneous dissection (men, 0% vs. women, 3.1%; P=1). At 9 months, strut coverage was reported in 92.5% of men and 90.9% of women (P=.89).
Before this study, I was living with the idea that erosion was more frequent in women and that is not the case. The study also showed that erosion is more frequent than we had anticipated. We like to think that most of the acute events — unstable angina or STEMI — are triggered by fissure and plaque rupture, and this study showed that it occurs about 25% of the time for both men and women, so it is more important than we think. The trial also found no difference in terms of the mechanisms between genders, but we still have some of the differences that have been highlighted before in women, such as smaller vessels and the fact that women tend to come for diagnosis older than men, therefore may have more extensive plaque burden.