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The Take Home: EuroPCR
In May, more than 12,000 attendees descended on Paris for the annual EuroPCR meeting for the latest in interventional news, education and networking. Dominick J. Angiolillo, MD, PhD, Cardiology Today’s Intervention Editorial Board member and from the University of Florida, Jacksonville; David Antoniucci, MD, Cardiology Today’s Intervention Editorial Board member and from Careggi Hospital in Florence, Italy; and Spencer B. King, III, MD, from Emory Saint Joseph’s Hospital and Emory University School of Medicine, Atlanta, shared their take-home messages from this year’s meeting.
ANTITHROMBOTIC STRATEGIES
Angiolillo: At EuroPCR 2015, I chaired a Hot Line session on antithrombotic strategies. In this session we had the opportunity to learn about several studies from our colleagues in Europe, providing insights from registry data and many retrospective analyses of clinical trialresults.
Two registry studies looked at the impact of tailoring antiplatelet therapy in patients undergoing PCI. Paul W.A. Janssen, MD, presented an interesting study looking at the POPular Risk Score, which takes into account genetic markers, pharmacodynamics and clinical risk factors, and evaluated the score to determine patients who could benefit from intensified antiplatelet therapy with prasugrel (Effient, Daiichi Sankyo/Lilly). A similar concept was utilized in the RECLOSE 3 registry presented by Dr. Antoniucci, but mostly based on pharmacodynamic response.alone Both studies reached a conclusion that intensified antiplatelet therapy can reduce ischemic events; however, as acknowledged by both investigators, the data need to be confirmed in randomized clinical trials, which are currently ongoing.
Dominick J. Angiolillo
The session also featured a study of the pharmacodynamic effects within the HEAT-PPCI trial, presented by Nick Curzen, BM, PhD, FRCP. The substudy showed differences in pharmacodynamic profiles between the unfractionated heparin and bivalirudin (Angiomax, The Medicines Company) treatment arms in the study and provided some insights on why patients treated with bivalirudin also had increased risk for stent thrombosis. Somewhat discordant with the data from HEAT-PPCI were the data from the large Swedish SCAAR registry, which did not show the high rates of stent thrombosis with bivalirudin that were observed in other studies. This is, to date, the largest registry looking at clinical outcomes with bivalirudin compared with other therapies, including heparin alone or glycoprotein IIb/IIIa inhibitors, and it indicates that in real-world clinical practice stent thrombosis rates with bivalirudin are lower than those observed in clinical trials.
Photo courtesy of EuroPCR, europcr.com; printed with permission.
Francisco Costa, MD, presented an analysis of the PRODIGY trial, which evaluated how anatomical location and bleeding risk score could be drivers of differences in outcomes in patients on dual antiplatelet therapy (DAPT). More specifically, the analysis showed that patients with high anatomical risk could potentially benefit from prolonged DAPT, while patients with a high bleeding risk score actually have harm, advocating reducing the duration of DAPT in these patients. The lead investigator of the PRODIGY trial, Marco Valgimigli, MD, PhD, reported an analysis of the ZEUS trial which looked at differences in clinical outcomes between zotarolimus-eluting and bare-metal stents in patients with high bleeding risk treated with a short duration of DAPT. The results of this analysis were supportive of the benefit of a drug-eluting stent platform with short duration in this selected high-risk patient population.
The Hot Line session concluded with the presentation of the SAS (Surgery After Stenting) registry by Roberta Rossini, MD, which included data from multiple centers in Italy and looked at the impact of specific antiplatelet therapy regimens in patients undergoing cardiac and noncardiac surgery. The researchers developed a consensus statement to define the thrombotic and bleeding risk of each patient according to the different types of surgeries, and created recommendations on how to manage these patients if they were to undergo surgery. The consensus document was published in EuroIntervention last year and the recommendations were available in a downloadable app, which was used by the researchers in the setting of a prospective registry to provide guidance on the management of patients undergoing cardiac and noncardiac surgery. Overall, based on the registry results, use of this app was feasible, as it was applied in about 85% of the overall study population, which was around 1,150 patients. It also showed that the ischemic and bleeding event profiles were overall very favorable, therefore supporting the potential clinical application of this consensus statement.
NOTION, DEFLECT III
Antoniucci: Several studies were presented at EuroPCR 2015 and, in my opinion, two deserve a positive comment: the NOTION trial and the DEFLECT III trial. Both studies were randomized, multicenter trials and were conducted rigorously.
The NOTION trial compared transcatheter aortic valve replacement vs. surgery in 280 patients at low surgical risk (> 80% had STS score < 4%) using the CoreValve system (Medtronic). In Paris, the NOTION investigators presented the 2-year results. The primary endpoint was the composite of death from any cause, MI and stroke. The primary endpoint rate at 2 years was 15.8% in the TAVR group vs. 18.8% in the surgical group, showing noninferiority of TAVR to surgery in low or intermediate surgical risk patients. The incidence of all components of the primary endpoint was lower in the TAVR group as compared with surgery: CV death, 6.5% vs. 9.1%; MI, 5.1% vs. 6%; stroke, 3.6% vs. 5.4%. Different from previous studies on TAVR in high surgical risk patients, at 2 years the incidence of cardiac mortality and any cause mortality were remarkably low and confirm the tremendous impact of comorbidities on clinical outcome after TAVR that may mask the true difference in outcome between TAVR and surgery. Moreover, the study confirms the terrific experience of TAVR operators in non-frail patients. It is easy to predict that more advanced TAVR system design and increased operator experience may further improve the clinical outcome after TAVR with a decrease in the need for permanent pacemaker (40% in the NOTION trial) and in stroke rate.
David Antoniucci
The latter, as shown by the DEFLECT III trial, which compared an antiembolic protection device (TriGuard, Keystone Heart) vs. control, is a realistic target. Freedom from ischemic brain lesions on diffusion-weighted MRI was 46% higher in the antiembolic-protection group compared with controls. Antiembolic protection was associated with fewer new neurologic deficits than seen in controls as detected by neurocognitive tests, including a more than twofold increase in recovery of normal cognitive function at 30 days.
FOCUS ON EDUCATION
King: From the opening ceremony until the end, EuroPCR really concentrates on education. The meeting brings together a diverse population of practitioners from around the world, representing many countries with a wide range of interventional capabilities and practices. Here, rooms were packed with people discussing the best approaches to a problem or daily practice issues, like how to approach acute MI and the question of whether to open all arteries or just the culprit artery.
Spencer B. King
In my own personal experience, there were several sessions that I found very interesting. One was what EuroPCR calls “in-a-box” demonstrations that focus on a scenario built around a case (not a live demonstration). These are aimed at identifying problems in a specific case, having active communication with your peers, with questions and answers. I was senior advisor to one session on the use of support devices for patients with acute MI and there was discussion of all aspects of how these cases should be managed and various trials that come into play with balloon pumping and other support devices. It gives the audience the opportunity to really think through their practice. For me, the education presented at this meeting is key.
Disclosures: Angiolillo reports receiving honoraria/serving on advisory boards for Abbott Vascular, AstraZeneca, Bristol-Myers Squibb, Eli Lilly/Daiichi Sankyo, Merck, New Havens Pharmaceuticals, PLx Pharma, Sanofi and The Medicines Company; research grants from AstraZeneca, CSL Behring, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Osprey Medical and The Medicines Company; and serving on data safety monitoring boards for CeloNova, Johnson & Johnson and St. Jude Medical. Antoniucci and King report no relevant financial disclosures.