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 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

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 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 one critical lesion on

the angiogram, corresponding to the ECG, again, no need for FFR. But for all the others—and there are very often one or two 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."

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 Jude's 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 the

EnligHTN study; minor procedure-related events included four hematomas, three vasovagal responses to sheath removal, and two postprocedure

transient bradycardias.

"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, 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 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."

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 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.

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 should

probably 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 valve

replacement.

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: 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 and just

under 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 Olaf

Wendler (King's College Hospital, London, UK). "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 one-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."

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 who'd 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, who'd 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, Rotterdam, the Netherlands).

See: Stroke down in new TAVI analyses

Master live demonstrations: Complex cardiovascular

interventions and new techniques

A master live demonstration titled "Complex Cardiovascular

Interventions and New Techniques" took place at EuroPCR2012

on Wednesday May 16th, 2012. Hosting the demonstrations, Dr

Jean Fajadet and Dr Ibrahim Al Rashdan, 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).

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 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 four-year LEADERS results, Smits noted that other studies of stents with

bioerodable polymers have taken longer than one year to show a difference in safety, since the bioerodable polymer takes six to nine

months 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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