TCT 2011 research highlights:

A slideshow presentation

TCT 2011 Research Highlights

The Transcatheter Cardiovascular Therapeutics (TCT) 2011 took place in

San Francisco, CA, from November 7 through November 11, 2011.

Key trials/topics presented at the sessions include:

STACCATO: A study comparing the transapical approach for transcatheter

aortic-valve implantation (TAVI) against conventional aortic-valve replacement

surgery was stopped due to an increase in adverse events in the TAVI arm

PARTNER A (QoL and Efficacy): A quality-of-life assessment in a trial

comparing the transfemoral vs transapical route in high-risk, surgery-eligible

patients showed substantial QoL benefits via the transfemoral route

TCT 2011 Keynote Address: The future of humankind by Michio Kaku, PhD

Longitudinal stent compression: A panel of specialists discussed this issue

and concluded that this phenomenon is rare and can be avoided and that stent

design should be revised

BRIDGE: Continuous cangrelor may safely wean ACS patients off oral antiplatelets

TRIGGER PCI: Platelet function not always a useful guide to antiplatelet therapy

TCT 2011 Career Achievement Award: Dr Eric Topol

RIFLE STEACS: Lower risk of MACCE with radial-access PCI in STEMI patients

ADVISE (FFR): New pressure measurement does not require adenosine and equals FFR

TCT 2011 Inspirational Address and TCT 2011 Thomas J Linnemeier Spirit of Interventional Cardiology Young Investigator Award

"Third-gen" stents: Two experimental drug-eluting stents, Synergy and Cre8, have shown positive results in early phase trials.

PARTNER B: Transcatheter valves at two years continue to support the role of TAVR as the standard of care for symptomatic patients with aortic

stenosis who are not surgical candidates

TWENTE: Zotarolimus stent matches everolimus drug-eluting stent

TCT 2011 Geoffrey O Hartzler Master Clinical Operator Award: Dr Horst Sievert

View our complete TCT coverage here.

STACCATO

A study comparing the transapical approach for

transcatheter aortic-valve implantation (TAVI) against

conventional aortic-valve replacement surgery

Results: The STACCATO trial was designed three years ago

and included elderly patients with valvular aortic stenosis who

could be treated with surgery or transapical TAVI. Based on

data from a surgery registry, they anticipated a surgical-event

rate—defined as a composite of 30-day all-cause mortality,

major stroke, and/or renal failure—of 13.5% and an estimated

event rate in the TAVI arm of 2.5%. The study was stopped due

to an increase in adverse events in the TAVI arm after the

inclusion of 70 patients.

"There is no doubt there are patients who can't be operated on, and they should be treated with TAVI," said Dr Leif

Thuesen. "But the patient who can be operated on—here, we should be very, very cautious. It's the operable patients, the

low-risk patients; they should not have the TAVI procedures, but that's what is happening. We had one patient, for instance,

who did not want the conventional operation, so he had the TAVI procedure in Canada. That's how it is. Indications are

slipping."

See: STACCATO: Transapical TAVI in surgery-eligible patients stopped due to adverse events

PARTNER A (QoL and cost-efficacy data)

A quality-of-life (QoL) assessment in a trial comparing the

transfemoral vs transapical route in high-risk, surgery-

eligible patients

Results: New QoL data show that high-risk, surgery-eligible

patients treated via a transfemoral route in PARTNER A

reported substantial QoL benefits compared with surgery in the

early weeks postprocedure. This was not the case for patients

treated via a transapical route.

"For patients eligible only for the transapical approach, there was no benefit of transcatheter aortic-valve replacement over

surgical aortic-valve replacement at any time point, and in fact, QoL tended to be better with surgical replacement both at

one and six months," said Dr David Cohen.

See: PARTNER QoL data hint transapical TAVI falls short of aortic-valve surgery

TCT 2011 Keynote Address: The future of humankind

The renowned theoretical physicist, futurist, and author Dr Michio

Kaku presented the keynote address, "The future of humankind,"

on Wednesday, November 9, 2011, in the main arena of the Moscone

Center.

His humanistic approach propels audiences into the future with

thought-provoking insights about science and society and optimistic

but realistic observations about the human condition combined with

sage guidance for our own evolution and enlightenment.

See: Keynote Speaker: Michio Kaku, PhD

Longitudinal stent compression

Interventional cardiologists hashed over the emerging issue of

longitudinal stent compression, with the bulk of experts

concluding that this phenomenon is rare, grabbing undue

attention, and in many cases avoidable with meticulous

technique. Most agreed, however, that stent design may play a

factor in making some stents more vulnerable than others.

Presenters included:

Dr Paul Williams (Manchester Heart Centre, UK)

Dr Simon Walsh (Belfast Health and Social Care Trust,

Northern Ireland)

Dr John Ormiston (Mercy Angiography, Auckland, New

Zealand)

Panelists included:

Dr Tullio Palmerini (Istituto di Cardiologia, Bologna, Italy)

Dr Peter C Smits (Maasstad Ziekenhuis, Rotterdam, the Netherlands)

Dr Gregg Stone (Columbia University, New York, NY)

Dr Louis Cannon (Northern Michigan Hospital Heart and Vascular Institute, Petoskey, MI)

Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA)

See: Hype or hazard? Longitudinal stent compression hashed out at TCT

BRIDGE

Continuous cangrelor may safely wean ACS patients off

oral antiplatelets

Results: The BRIDGE trial showed that continuous infusion of

cangrelor, an investigational P2Y12 platelet inhibitor, allowed

patients with acute coronary syndromes or coronary stents to

go off oral dual-antiplatelet therapy safely in advance of CABG

surgery in a modest-sized placebo-controlled phase 2 study.

"This is the first time we have a trial assessing, in a prospective, randomized, double-blind fashion, the use of a novel

[antiplatelet] agent that has the ideal properties for bridging. And the trial clearly shows that we are able to achieve and

sustain adequate levels of P2Y12 inhibition during the preoperative stage, with overall favorable safety signals," said Dr

Dominick Angiolillo.

See: BRIDGE to surgery: Cangrelor may safely wean ACS patients off oral antiplatelets

TRIGGER-PCI

Platelet function not always a useful guide to antiplatelet

therapy

Results: Investigators who explored platelet-function testing for

guiding antiplatelet therapy in a low-risk PCI population, who

earlier this year had announced that their trial was prematurely

halted due to futility, presented available main data. In the

TRIGGER-PCI trial, 423 patients (out of a planned 2150)

receiving PCI for stable CAD who had high on-treatment

platelet reactivity levels were assigned to therapy with

prasugrel or clopidogrel. Clinical events were few, probably

because the trial's patients were unusually low risk. As

anticipated, prasugrel suppressed the high platelet-reactivity

levels that are known to persist on clopidogrel. The generally

good outcomes in both randomization groups suggest that

choosing prasugrel over clopidogrel based on platelet-function

testing isn't likely to make much of a clinical difference in such

low-risk patients.

"High on-clopidogrel platelet reactivity was observed less

frequently than expected," acknowledged Dr Dietmar Trenk.

See: TRIGGER-PCI enlightens: Platelet function not always

useful as guide to antiplatelet therapy

TCT 2011 Career Achievement Award

On the morning of Wednesday, November 9, 2011, Dr Martin B

Leon presented the TCT 2011 Career Achievement Award to Dr

Eric J Topol. The award is presented annually to a pioneer in

the field of interventional cardiology medicine.

Dr Topol spearheaded the discovery of multiple genes that

increase a person's risk of heart attacks and pioneered the

development of critical heart-care therapies now used in daily

practice—therapies such as clot busters, antiplatelet agents,

and angioplasty devices. He has led more than 15 international,

multicenter research trials involving 40 countries and more than

200 000 patients. He is also a leader in the movement to

modernize medical treatment through wireless digital innovative

technologies.

Dr Topol is also the editor-in-chief of theheart.org.

See: TCT 2011 program (page 102)

RIFLE STEACS

Results: The RIFLE STEACS study included 1001 patients with

STEMI randomized to radial- or femoral-access PCI. The

primary composite end point included bleeding and MACCE, a

composite known as the net adverse clinical event (NACE) rate.

At 30 days, the overall NACE rate was 21.0% in the femoral-

access PCI group and 13.6% in the radial-access group, a

statistically significant difference (p=0.003). The MACCE rate—

a composite of cardiac death, MI, target lesion

revascularization, and stroke—was also significantly reduced:

11.4% in the femoral-access group and 7.2% in the radial-

access group (p=0.029). The reduction in MACCE was driven

by a significant reduction in cardiac death, which was 5.2% in

the radial-access group and 9.2% in the femoral—access group

(p=0.20).

"This is a strong message of the study, an important reduction [in cardiac death]," said Dr Enrico Romagnoli. He added

that the radial approach was an independent predictor of improved outcomes. Investigators say the findings show that the

radial-access approach should no longer be considered a substitute for the femoral approach but instead should become

the primary recommended access site for STEMI and other acute coronary syndromes.

See: RIFLE STEACS: Lower risk of MACCE with radial-access PCI in STEMI patients

ADVISE (FFR)

Results: In the ADVISE trial, a new technology that analyzes

pressure inside the vessel without the use of adenosine

provides intracoronary pressure measurements similar to

fractional flow reserve (FFR). Investigators say the technology

should have increased applicability in more patients, especially

those who are unable to tolerate adenosine, and can improve

work flow in the catheterization lab.

"It's exactly the same as FFR, there's no change, except we've managed to stabilize our resistance using a mathematical

algorithm rather than having to give a drug to do the same thing," said lead investigator Dr Justin Davies. "We know now

from clinical trials that we do a lot better if we don't make our judgments based on visual estimations of stenosis but

actually make an assessment based on the pressure drop across the whole length of the artery."

See: ADVISE: New pressure measurement does not require adenosine, equals FFR

TCT 2011 Inspirational Address and TCT 2011 Thomas J. Linnemeier Spirit of Interventional Cardiology Young Investigator Award

On the morning of Thursday, November 10 2011, Dr Shigeru

Saito presented the TCT 2011 Inspirational Address: A story of

despair, hope, and recovery in Japan.

As well, Dr Gregg W Stone presented the TCT 2011 Thomas J

Linnemeier Spirit of Interventional Cardiology Young

Investigator Award.

Finalists included:

Masaki Awata MD (Kansai Rosai Hospital, Amagasaki, Japan)

Davide Capodanno MD ( Ferrarotto Hospital, Catania, Italy)

Thomas T Tsai, MD MSc (Denver VA Medical Center , Denver

CO)

Robert W Yeh MD MBA (Massachusetts General Hospital,

Boston, MA)

See: TCT 2011 Program (page 122)

Third-generation stents show promise

Results: Two experimental drug-eluting stents (DES) seeking to

overcome the shortcomings of current market-approved devices

have shown positive results in early-phase trials.

In the EVOLVE trial, the everolimus-eluting Synergy stent was

tested against the market—approved Promus Element. At six

months, late loss—the primary angiographic end point for the

study—was no different between all stent groups.

"The findings support the safety and efficacy of the novel

abluminal bioabsorbable polymer Synergy everolimus—eluting

stent in these low-risk lesions and pave the way for larger

studies," said Dr Ian Meredith.

In a second trial, the NEXT trial, a prospective, randomized controlled trial compared the polymer-free Cre8 sirolimus-

eluting stent with the paclitaxel-eluting Taxus Liberté stent in patients with simple de novo CAD and showed that the Cre8

stent had significantly lower late lumen loss at six months.

"The NEXT study results support the rationale that high-risk patients should benefit from polymer-free DES implantation,"

concluded Dr Didier Carrié (Hôpital de Rangueil, Toulouse, France).

See: "Third-generation" Synergy and Cre8 DES show promise

PARTNER B (2 years)

Results: Two-year outcomes in the PARTNER B trial, testing

transcatheter aortic-valve replacement (TAVR) using the

Sapien device against best medical care, show that survival

curves are continuing to separate and the number needed to

treat to save one life dropped from five at one year to four

patients at two. The FDA approved the Sapien valve for the US

market, based on PARTNER B results.

"Two-year data continue to support the role of TAVR as the standard of care for symptomatic patients with aortic stenosis who

are not surgical candidates," said Dr Raj R Makkar (Cedars-Sinai Medical Center, Los Angeles, CA). "There was half the

number of repeat hospitalizations in the TAVR group as in the standard-therapy group, despite the fact that there were many

more patients alive in the TAVR group at one year."

See: Transcatheter valves at two years: PARTNER B

TWENTE

Results: Another randomized controlled "real-world" trial has

demonstrated noninferiority of the Resolute zotarolimus-

eluting stent against the market-leading Xience everolimus-

eluting stent at one year.

TWENTE was designed with no limit to the number of lesions or

vessels treated and no limit to lesion length or vessel size, in a

cohort of patients with stable angina or non-ST-elevation ACS.

In all, 1391 patients were randomized to receive the Xience V

stent or the Resolute stent. At one year, rates of the primary

end point of target vessel failure—a composite of cardiac death,

target vessel-related MI, and clinically driven target vessel

revascularization (TVR)—were nearly identical in the two

groups. Rates of each end point within the composite were also

very similar. Stent-thrombosis rates, both definite/probable and

definite, were very low, and there was no difference between

groups.

"Zotarolimus-eluting Resolute stents were noninferior to everolimus [Xience V stents] in terms of safety and efficacy for

treating real-world patients with a vast majority of complex lesions and off-label indications for [drug-eluting stents] DES," said

Dr Clemens von Birgelen.

See: Zotarolimus stent matches everolimus DES in TWENTE

TCT 2001 Geoffrey O Hartzler Master Clinical Operator Award

On Friday, November 11, 2011, Dr Martin B Leon and Dr

Gregg W Stone presented the TCT 2001 Geoffrey O Hartzler

Master Clinical Operator Award to Dr Horst Sievert

(CardioVascular Center Frankfurt, Sankt Katharinen Frankfurt,

Germany).

Dr Sievert is known for his expertise in highly specialized

noncoronary interventions for patients with congenital heart

disease, carotid disease, or a high risk of stroke. Dr Sievert was

the first to close the left atrial appendage percutaneously and

has the greatest experience worldwide in catheter closure of

heart defects in adults. Over the course of his career, Dr Sievert

has personally performed more than 25 000 percutaneous

coronary interventions and 12 000 peripheral angioplasties as

well as more than 5000 structural and valvular interventions. In

addition to serving as the principal investigator of a number of

clinical trials, Dr Sievert is the author of more than 200

manuscripts and 600 abstracts in peer-reviewed journals, as

well as 100 books and book contributions. He has also

delivered more than 1000 invited lectures around the world.

See: TCT 2001 Program (page 140)

For more information

Complete TCT 2011 coverage on

theheart.org

TCT 2011

Cardiovascular Research Foundation

Credits and disclosures

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.

Journalists:

Michael O'Riordan, theheart.org

Toronto, ON

Disclosure: Michael O'Riordan has disclosed no relevant financial

relationships.

Steve Stiles, theheart.org

Fremont, CA

Disclosure: Steve Stiles has disclosed no relevant financial relationships.

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