http://www.theheart.org/editorial-program/1312625.do "The Transcatheter Cardiovascular Therapeutics (TCT) 2011 took place in San Francisco and the key trials/topics presented at the sessions include: STACCATO, PARTNER A (QoL and Efficacy), TCT 2011 Keynote Address, BRIDGE, TRIGGER PCI, TCT 2011 Career Achievement Award, RIFLE STEACS, ADVISE (FFR),PARTNER B and TWENTE"

1. TCT 2011 research highlights:
A slideshow presentation

2. 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.

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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)

10. 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

11. 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

12. 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)

13. 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

14. 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

15. 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

16. 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)

17. For more information
Complete TCT 2011 coverage on
theheart.org
TCT 2011
Cardiovascular Research Foundation

18. 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.

19. More slideshows
ESC 2011 research highlights
HRS 2011 research highlights
EuroPCR 2011 research highlights
ACC 2011 research highlights

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