EuroPCR 2012 research highlights: A slideshow presentation
EuroPCR 2012 research highlights:A slideshow presentation
EuroPCR 2012 Research Highlights EuroPCR 2012, the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), took place in Paris on May 15-18. Key trials and presentations at the sessions included: FAME II: Fractional flow reserve (FFR) pinpoints stable CAD patients who fare worse with optimal medical therapy (OMT) SIMPLICITY HTN 2: New renal-denervation systems debut amid excitement and caution COMFORTABLE-AMI: Bioerodable polymer DES trumps bare metal in STEMI Ethica Award 2012: This years recipient Dr Martin Leon TAVI: TAVI to treat surgical valve failure shows potential, with caveats TAVI: TAVI numbers rise in Europe as reimbursement, expertise expands SOURCE XT: Next-generation transcatheter aortic valve looks good in 30-day registry data PARTNER A: Stroke is down in new TAVI analyses Master Live Demonstrations: Complex cardiovascular interventions and new techniques COMPARE II: Nobori biolimus stent matches everolimus stents in all- comers
FAME II FAME II: FFR pinpoints stable CAD patients who fare worse with OMT Results: Patients with stable coronary artery disease (CAD) in whom fractional flow reserve (FFR) identifies at least one "hemodynamically significant" stenosis face more than a 10-times-higher risk of urgent revascularization if they are initially treated with optimal medical therapy (OMT) rather than PCI. That difference in urgent revascularizations was what led to the premature halting of FAME II last fall. The new findings should help physicians single out which stable CAD patients will, in fact, do better with PCI than OMT and vice versa. The data set is preliminary: the primary end point of the study was a composite of death, MI, and urgent revascularization, and those results have not yet been calculated."In this preliminary data set of the FAME II trial, in patients with stable CAD and at least one hemodynamically significant stenosis(FFR<0.80) in at least one major epicardial artery, OMT alone was associated with a significantly larger number of urgent revascularizationsthan FFR-guided PCI plus OMT," said Dr Bernard De Bruyne (OLV Clinic, Aalst, Belgium). By contrast, "in patients with stable CADwithout invasively documented ischemia-inducing lesions (FFR>0.80) OMT alone was associated with a very favorable clinical outcome. If[the angiogram] is perfectly normal, no need for FFR," he explained. "If you have a patient with typical symptoms and one critical lesion onthe angiogram, corresponding to the ECG, again, no need for FFR. But for all the others—and there are very often one or two lesions forwhich you dont know what to do—then for these lesions FFR might be helpful, and it might change the approach to the patient with CAD orsuspected CAD, which means these patients might actually take a shortcut to the lab, bypassing all of the noninvasive stuff."See: FAME II: FFR pinpoints stable CAD patients who fare worst with OMT
SIMPLICITY HTN 2 New renal-denervation systems debut amid excitement and caution Results: Upwards of 20 other companies, according to Dr Ron Waksman (Washington Hospital, DC), are busy developing competing systems, some of which were featured in a EuroPCR session devoted to emerging technologies. One year after garnering the "innovation award" at EuroPCR 2011, renal denervation—poised to depose TAVI as the hottest thing in interventional cardiology— had its own color-coded track in the EuroPCR2012 program, with debates, live cases, program-building tips, and preliminary results from animal and first-in-human studies with devices still in development. The Symplicity system (Medtronic) is the far-and- away front runner, having demonstrated average office-based BP drops of 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, with 84% of patients having had a ≥10-mm-Hg drop in systolic blood pressure from baseline. Leading the rest of the pack is St Judes EnligHTN system, which received CE Mark on the opening day of the meeting.Dr Stephen Worthley (Royal Adelaide Hospital, Australia) presented 30-day results in 47 resistant-hypertension patients treated with the multielectrode,RF-ablation–based system. Mean office BP changes at one month in EnligHTN 1 were -28 systolic and -10 diastolic (p<0.0001 from baseline), with 78%of patients having systolic BP drops of ≥10 mm Hg. In terms of safety, no serious complications were seen in the renal artery or at the access site in theEnligHTN study; minor procedure-related events included four hematomas, three vasovagal responses to sheath removal, and two postproceduretransient bradycardias."You need enthusiasm to develop new things, and in hypertension we havent seen an innovation in decades," said Dr Thomas Lüscher (UniversityHospital Zürich, Switzerland). "So just the possibility that you would be able to have a persistent treatment effect by a procedure that helps severehypertension patients and maybe in the future even the option to cure hypertension is very exciting indeed. But I agree its a dream at this point. I think weneed the SYMPLICITY HTN 3 trial, which hopefully will confirm what the other studies have shown."See: New renal-denervation systems debut amid excitement, caution
COMFORTABLE-AMI Bioerodable polymer DES trumps bare metal in STEMI Results: The COMFORTABLE-AMI study suggests use of a bioerodable polymer, biolimus-eluting stent (BES) in patients with ST-elevation MI (STEMI) can radically reduce the rate of major adverse cardiac events (MACE) at one year. It is estimated that only 24 patients would need to be treated with BES to avoid one major event. The major driver of this benefit was a reduction in both target vessel reinfarction and target lesion revascularization. "None of the previous trials enrolling STEMI patients have shown a safety advantage with respect to myocardial infarction," said Dr Lorenz Räber (Berne University Hospital, Switzerland). "HORIZONS AMI showed a benefit in terms of efficacy, but not in safety." See: COMFORTABLE-AMI: Bioerodable polymer DES trumps bare metal in STEMI
Ethica Award 2012 This years recipient: Dr Martin Leon The Ethica Award is bestowed yearly on a leader in interventional cardiology who "has significantly contributed to the field of cardiovascular intervention as a teacher, scientist, care provider, and pioneer." Dr Patrick Serruys presented this years distinction to Dr Martin Leon from Columbia University in New York. Dr Leon said he was "honored and moved to receive the most prestigious honor an interventional cardiologist can receive." Previous winners include Valentin Fuster, Bernard De Bruyne and Nico Pijls, Alain Cribier and Philipp Bonhoeffer, Martin Kaltenbach, Seung- Jung Park, Renu Virmani, Julio Palmaz, Frederich Mohr, Bernard Meier, Antonio Colombo, and Run-Lin Gao. See: Life and Times of Leading Cardiologists with Dr Rob Califf. Guest: Dr Martin Leon EuroPCR 2012 Year of the Textbook Final Programme Paris 2012 p. 29 Ethica Award: And the winner is . . .
TAVI to treat surgical valve failure TAVI to treat surgical valve failure shows potential, with caveats Results: The largest series to date looking at transcatheter aortic-valve implantation (TAVI) to treat the failure of a surgically implanted prosthetic has found high rates of survival at one year, but enough in the way of safety signals that investigators are cautioning against widespread use of the practice. Bioprosthetic surgical valves tend to fail 10 to 15 years after the initial implantation, and reoperations are often in high-risk patients who are typically elderly, with multiple comorbidities. Both the CoreValve (Medtronic) and Sapien (Edwards Lifesciences) were used to treat the failed surgical valves, with no differences in terms of the underlying cause of valve failure between the two types of TAVI devices."The valve-in-valve procedure, although feasible, is technically demanding, includes several safety concerns, and shouldprobably be reserved for highly experienced centers," said Dr Danny Dvir (Rabin Medical Center, Israel) during the late-breaking clinical-trial sessions. That said, the procedure in most patients is "clinically effective" and at least out to one year,patient survival is equivalent to—if not better than—that seen in other TAVI cohorts, where patients are undergoing native valvereplacement.See:TAVI to treat surgical valve failure shows potential, with caveats
TAVI numbers rise in Europe TAVI numbers rise in Europe as reimbursement and expertise expands Results: New data are offering a fresh snapshot of just how quickly the number of TAVI procedures is increasing in Europe and where these are taking place. Since the first devices were approved in Europe in 2007, Germany has led the continent in implantations: by 2011, German hospitals had implanted a full 43% of all TAVI devices in Europe, the same proportion it held in 2010. In a distant second place was France, with 13% of procedures, followed by Italy and the UK/Ireland, with 10% and 7%, respectively. Presenting the data, Dr Nicolo Piazza (German Heart Center, Munich) noted that for Europe as a whole, TAVI procedures have more than tripled in recent years, from 4498 in 2009, rising to 14 599 in 2010 and to 18 372 in 2011. The average implantation rate for Europe was 40.9 per million inhabitants in 2011, up from 32.6 in 2010.Broken down by nation, only a handful of countries showed significant increases from one year to the next: Germanys rate per million rosefrom less than 80 in 2010 to 96 in 2011, Austrias rose from 50 to 76, Denmarks rate rose from less than 40 to 60, and Norways doubledfrom about 12 to 25 per million. Other countries, like Switzerland and the Netherlands, remained more static, at just under 80 and justunder 50 per million, respectively, in both years.See: TAVI numbers rise in Europe as reimbursement, expertise expands
SOURCE XT Next-generation transcatheter aortic valve looks good in 30-day registry data Results: Early data from the SOURCE XT registry on high-risk patients treated with the Sapien XT (Edwards Lifesciences) transcatheter aortic valve show that this next-generation TAVI device is safe with either the transapical- or transfemoral-access approach. One-month data from 2706 patients in SOURCE XT were the subject of several presentations at EuroPCR2012. Mortality in the 1694 patients implanted with the Sapien XT via the transfemoral approach was 4.3%, among the lowest rates ever reported in a registry of transfemoral TAVI patients. The one-month mortality for the 906 patients implanted with the Sapien XT via the transapical approach was 9.9%, and the mortality rate for all of the non–transfemoral-access routes combined—there were also 98 transaortic and eight subclavian patients—was 9.7%. Paravalvular leak was low in both the transapical and transfemoral groups. There was no paravalvular leak or only a trace of a leak in nearly 65% of the transfemoral group and 79% of the transapical group. Moderate to severe leaks were seen in only 5.8% and 3.5% of the transfemoral and transapical groups, respectively."Knowing that paravalvular leakage is a predictor of mortality in the long term, that is a very positive message from this valve," said Dr OlafWendler (Kings College Hospital, London, UK). "With this excellent performance and low incidence of paravalvular leakage, we would expectto see even better outcomes [than weve seen with older models of the valve] at the one-year [follow-up]. The hypothesis, based on what datawe have, is that transfemoral is less traumatic than transapical, and thats why, although we dont have hard data on this, by making thedecision for transfemoral first, one is not doing something wrong," he said. "The transfemoral-first approach is working, but we dont have hardscientific data to say that transfemoral is better than transapical in patients where both access modes are feasible."See: Next-generation transcatheter aortic valve looks good in 30-day registry data
PARTNER A Stroke is down in new TAVI analyses Results: Real-world stroke rates following transcatheter aortic-valve implantation (TAVI) are likely not as high as the PARTNER A trial first suggested, and a refined understanding of just when and how these are occurring should help bring rates down even further. The rate of major stroke at 30 days was 3.8% in PARTNER A. Stroke data from 214 patients whod undergone TAVI with the Medtronic CoreValve at the Erasmus ThoraxCenter were presented. At six days, there were a total of 11 major strokes (5%), two minor strokes, and six transient ischemic attacks (TIAs). Importantly, half of the strokes occurred during the procedure, but the remainder occurred two to six days later. The major stroke rate of 5%—higher than that reported by others Thursday—may reflect the fact that the Rotterdam series includes all patients treated there, including the so-called "learning-curve" early cases. A key predictive factor in the Rotterdam cohort was new-onset atrial fibrillation, which was the strongest predictor of stroke in multivariate analyses; five patients who developed AF, whod been taking only aspirin and clopidogrel, went on to have a stroke."These findings indicate that improvements [in patient management] after TAVI are as important as if not more important than preventivemeasures during TAVI to reduce stroke," said Dr Rutger-Jan Nuis (Erasmus ThoraxCenter, Rotterdam, the Netherlands).See: Stroke down in new TAVI analyses
Master live demonstrations: Complex cardiovascularinterventions and new techniquesA master live demonstration titled "Complex CardiovascularInterventions and New Techniques" took place at EuroPCR2012on Wednesday May 16th, 2012. Hosting the demonstrations, DrJean Fajadet and Dr Ibrahim Al Rashdan, accompanied by anexpert panel discussion, offered continuous live demonstrationsfrom Clinique Pasteur (Toulouse, France) and the Chest Hospitalat the Kuwait Heart Center (Safat, Kuwait).See: EuroPCR2012 Final Programme
COMPARE II Nobori biolimus stent matches everolimus stents in all-comers Results: Results of the COMPARE II trial suggest the "next-generation" Nobori biolimus-eluting stent (BES) (Terumo) is noninferior to market- leading everolimus-eluting stents (EES; Xience V, Prime, Promus) at one year. But at least at 12-month follow-up, there is no signal that the device, which boasts a bioerodable polymer, is any safer than the stents that use a permanent polymer coating. The trial randomized 2707 "all-comers" patients 2:1 to the Nobori stent or the Xience/Promus devices, tracking a primary composite end point of cardiac death, MI, or clinically driven target vessel revascularization (TVR). At one year, the rate of this composite end point was similar, at roughly 5%, in both groups, reaching the prespecified definition of noninferiority for the Nobori. Secondary efficacy and safety end points were also no different between groups. Of note, stent-thrombosis rates, again no different between stent groups, were very low—1% or less for both definite and definite/probable stent thrombosis regardless of stent type.Dr Pieter Smits (Maasstad Ziekenhuis, Rotterdam, the Netherlands) presented the COMPARE II trial results at a late-breaking clinical-trial session. Smits acknowledged that one of the primary aims of a bioerodable polymer stent is to have a stent that shows "no stentthrombosis," based on the presumption that better endothelial healing with these stents would reduce thrombus formation. "So we arehappy that we have another stent available that shows equal safety and efficacy, but unfortunately the [stent-thrombosis] problem hasnot completely been solved," he said. Pointing to the four-year LEADERS results, Smits noted that other studies of stents withbioerodable polymers have taken longer than one year to show a difference in safety, since the bioerodable polymer takes six to ninemonths to disappear. "So there may be a difference later on, [potentially with] less very late thrombosis."See: COMPARE II: Nobori biolimus stent matches everolimus stents in all-comers
For more information Complete EuroPCR 2012 coverage on theheart.org EuroPCR 2012 Scientific Sessions
Credits and disclosures Managing Editor: Shelley Wood Managing Editor, heartwire theheart.org Kelowna, BC Disclosure: Shelley Wood has disclosed no relevant financial relationships. Contributors: Steven Rourke Manager, Editorial Programming theheart.org Montreal, QC Disclosure: Steven Rourke has disclosed no relevant financial relationships. Katherin Vasilopoulos Montreal, QC Disclosure: Katherin Vasilopoulos has disclosed no relevant financial relationships.
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