Monday, June 5, 2023
EuroPCR 2012, the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), took place in Paris on May 15-18.
Key trials presented at the sessions include:
FAME II: Fractional flow reserve pinpoints stable CAD patients who fare worse with optimal medical therapy
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 year's recipient: Dr. Martin Leon
TAVI: TAVI to treat surgical valve failure shows potential, with caveats
TAVI: TAVI numbers rise in Europe as reimbursement, expertise expand
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: FFR Pinpoints Stable CAD Patients Who Fare Worse With OMT
Patients with stable coronary artery disease (CAD) in whom fractional flow reserve (FFR) identifies at least 1 "hemodynamically significant" stenosis face more than a 10-times-higher risk for urgent revascularization if they are initially treated with optimal medical therapy (OMT) rather than percutaneous coronary intervention (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 do better with PCI vs OMT and vice versa. The dataset is preliminary; the primary endpoint of the study was a composite of death, myocardial infarction (MI), and urgent revascularization, and those results have not yet been calculated.
"In this preliminary dataset of the FAME II trial, in patients with stable CAD and at least 1 hemodynamically significant stenosis (FFR ≤ 0.80) in at least 1 major epicardial artery, OMT alone was associated with a significantly larger number of urgent revascularizations than FFR-guided PCI plus OMT," said Dr. Bernard De Bruyne (OLV Clinic, Aalst, Belgium). By contrast, "in patients with stable CAD without 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 1 critical lesion on the angiogram, corresponding to the ECG, again, no need for FFR. But for all the others -- and there are very often 1 or 2 lesions for which you don't know what to do -- then for these lesions FFR might be helpful, and it might change the approach to the patient with CAD or suspected CAD, which means these patients might actually take a shortcut to the lab, bypassing all of the noninvasive stuff."
SIMPLICITY HTN 2: New Renal-Denervation Systems Debut Amid Excitement and Caution
Upwards of 20 companies, according to Dr. Ron Waksman (Washington Hospital, Washington, DC), are busy developing competing renal denervation 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 transcatheter aortic valve implantation (TAVI) as the hottest thing in interventional cardiology -- had its own color-coded track in the EuroPCR 2012 program. The Symplicity system (Medtronic) is the far-and-away front runner, having demonstrated average office-based BP drops of 32/12 mm Hg at 6 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 this pack is St Jude's EnligHTN system, which received CE marking on the opening day of the meeting. Dr. Stephen Worthley (Royal Adelaide Hospital, Adelaide, Australia) presented 30-day results in 47 resistant-hypertension patients treated with the multielectrode, RF-ablation–based system. Mean office BP changes at 1 month in EnligHTN 1 were -28 systolic and -10 diastolic (P < .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.
"You need enthusiasm to develop new things, and in hypertension we haven't seen an innovation in decades," said Dr. Thomas Lüscher (University Hospital Zürich, Zürich, Switzerland). "So just the possibility that you would be able to have a persistent treatment effect by a procedure that helps severe hypertension patients, and maybe in the future even the option to cure hypertension, is very exciting indeed. But I agree that it's a dream at this point. I think we need the SYMPLICITY HTN 3 trial, which hopefully will confirm what the other studies have shown."
COMFORTABLE-AMI: Bioerodable Polymer DES Trumps Bare Metal in STEMI
The COMFORTABLE-AMI study suggests that 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 1 year. It is estimated that only 24 patients would need to be treated with BES to avoid 1 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, Berne, Switzerland). "HORIZONS AMI showed a benefit in terms of efficacy, but not in safety."
Ethica Award 2012: This Year's 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 year's 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.
TAVI to Treat Surgical Valve Failure Shows Potential, With Caveats
The largest series to date looking at TAVI to treat the failure of a surgically implanted prosthetic has found high rates of survival at 1 year, but also enough safety signals so that investigators are cautioning against widespread use of the practice. Bioprosthetic surgical valves tend to fail 10-15 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 valve (Edwards Lifesciences) were used to treat the failed surgical valves, with no differences in terms of the underlying cause of valve failure between the 2 types of TAVI devices.
"The valve-in-valve procedure, although feasible, is technically demanding, includes several safety concerns, and should probably be reserved for highly experienced centers," said Dr. Danny Dvir (Rabin Medical Center, Petah Tikva, Israel) during the late-breaking clinical trial sessions. That said, the procedure in most patients is "clinically effective," and at least out to 1 year, patient survival is equivalent to -- if not better than -- that seen in other TAVI cohorts, where patients are undergoing native valve replacement.
TAVI Numbers Rise in Europe as Reimbursement and Expertise Expand
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; its hospitals had implanted a full 43% of all TAVI devices in Europe. In distant second place was France, with 13% of procedures, followed by Italy and the United Kingdom/Ireland, with 10% and 7%, respectively.
Presenting the data, Dr. Nicolo Piazza (German Heart Center, Munich, Germany) noted that for Europe as a whole, TAVI procedures have more than tripled in recent years, from 4498 in 2009 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: Germany's rate per million rose from less than 80 in 2010 to 96 in 2011; Austria's rose from 50 to 76; Denmark's rate rose from less than 40 to 60; and Norway's doubled from about 12 to 25 per million. Other countries, like Switzerland and The Netherlands, remained more static, at just under 80 per million and just under 50 per million, respectively, in both years.
SOURCE XT: Next-Generation Transcatheter Aortic Valve Looks Good in 30-Day Registry Data
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 EuroPCR 2012. 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 1-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 8 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. Olaf Wendler (King's College Hospital, London, United Kingdom). "With this excellent performance and low incidence of paravalvular leakage, we would expect to see even better outcomes [than we've seen with older models of the valve] at the 1-year [follow-up]. The hypothesis, based on what data we have, is that transfemoral is less traumatic than transapical, and that's why (although we don't have hard data on this) by making the decision for transfemoral first, one is not doing something wrong," he said. "The transfemoral-first approach is working, but we don't have hard scientific data to say that transfemoral is better than transapical in patients where both access modes are feasible."
PARTNER A: Stroke Is Down in New TAVI Analyses
Real-world stroke rates following 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 who had undergone TAVI with the Medtronic CoreValve at the Erasmus Thoraxcenter (Rotterdam, The Netherlands) were presented. At 6 days, there were a total of 11 major strokes (5%), 2 minor strokes, and 6 transient ischemic attacks (TIAs). Of note, half of the strokes occurred during the procedure, but the remainder occurred 2-6 days later. The major stroke rate of 5% -- higher than that reported by others on 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 (AF), which was the strongest predictor of stroke in multivariate analyses; 5 patients who developed AF, who had 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, preventive measures during TAVI to reduce stroke," said Dr. Rutger-Jan Nuis (Erasmus Thoraxcenter).
Master Live Demonstrations: Complex Cardiovascular Interventions and New Techniques
A master live demonstration, "Complex Cardiovascular Interventions and New Techniques," took place at EuroPCR 2012 on Wednesday, May 16. Dr. Jean Fajadet and Dr. Ibrahim Al Rashdan, who hosted the demonstration, accompanied by an expert panel discussion, offered continuous live demonstrations from Clinique Pasteur (Toulouse, France) and the Chest Hospital at the Kuwait Heart Center (Safat, Kuwait).
COMPARE II: Nobori Biolimus Stent Matches Everolimus Stents in All-Comers
Results of the COMPARE II trial suggest that the "next-generation" Nobori biolimus-eluting stent (BES) (Terumo) is noninferior to market-leading everolimus-eluting stents (EES; Xience V, Prime, Promus) at 1 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 randomly assigned 2707 "all-comers" patients 2:1 to the Nobori stent or the Xience/Promus devices, tracking a primary composite endpoint of cardiac death, MI, or clinically driven target vessel revascularization (TVR). At 1 year, the rate of this composite endpoint was similar in both groups at roughly 5%, reaching the prespecified definition of noninferiority for the Nobori. Secondary efficacy and safety endpoints 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 stent thrombosis," based on the presumption that better endothelial healing with these stents would reduce thrombus formation. "So we are happy that we have another stent available that shows equal safety and efficacy, but unfortunately the [stent thrombosis] problem has not completely been solved," he said. Pointing to the 4-year LEADERS results, Smits noted that other studies of stents with bioerodable polymers have taken longer than 1 year to show a difference in safety because the bioerodable polymer takes 6-9 months to disappear. "So, there may be a difference later on, [potentially with] less very late thrombosis."
Credits and Disclosures
Managing Editor:
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, British Columbia, Canada
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Contributors:
Steven Rourke
Manager, Editorial Programming
theheart.org
Montreal, Quebec, Canada
Disclosure: Steven Rourke has disclosed no relevant financial relationships.
Katherin Vasilopoulos
Montreal, Quebec, Canada
Disclosure: Katherin Vasilopoulos has disclosed no relevant financial relationships.
