http://www.theheart.org/editorial-program/1128553.do The 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium took place in Washington. Key trials presented at the meeting include: PARTNER, ZILVER PTX, ISAR-TEST 4,SORT-OUT 4, COMPARE,SPIRIT IV, HORIZONS-AMI, BIOFREEDOM, PROTECT-AF, CAP and Robotically assisted PCI

1. TCT 2010 research highlights:
A slideshow presentation

2. TCT 2010 Research Highlights
The 22nd annual Transcatheter Cardiovascular Therapeutics (TCT)
scientific symposium took place in Washington, DC September 21-25,
2010.
Key trials presented at the meeting include:
PARTNER: Transcatheter valves slash deaths and hospitalizations
compared with standard care.
ZILVER PTX: Paclitaxel-eluting peripheral stent bests bare-metal stents in
largest randomized peripheral endovascular trial ever.
ISAR-TEST 4 and SORT-OUT 4: Everolimus-eluting stent holds its own
against Cypher stent.
COMPARE and SPIRIT IV: Two-year results confirm the superiority of the
everolimus-eluting Xience V stent over two iterations of the paclitaxel-
eluting Taxus stent.
HORIZONS-AMI: Final follow-up at three years cements earlier findings.
BIOFREEDOM: Polymer-free biolimus stent reduces late lumen loss
compared with Taxus.
PROTECT-AF and CAP: WATCHMAN updates point to better safety,
enduring efficacy with LAA closure device for stroke.
Robotically assisted PCI: The first-in-human report showed that
robotically assisted PCI is safe and feasible.

3. PARTNER (Placement of Aortic Transcatheter Valve Trial)
Results: Survival was markedly higher and the risk of a
composite end point of death or repeat hospitalization was
reduced for patients with severe aortic disease unable to
undergo surgery who were treated with a novel percutaneous
valve, the Sapien transcatheter valve, compared with those
treated with standard therapy, including balloon valvuloplasty.
Risk of stroke and of vascular complications was higher in the
transcatheter aortic-valve implantation (TAVI) group.
"[The findings] show a clear benefit for the device at an
acceptable price," said Dr Craig Smith (Columbia University,
New York, NY), co- primary investigator for the trial. That price--
the strokes and vascular injuries--were "not unexpected," based
on previous studies, he added. "
See Transcatheter valves slash deaths, hospitalizations vs
standard care: PARTNER and Digesting PARTNER: Physicians
react with superlatives to TAVI results for more informtation.

4. Dr Alain G Cribier honored with TCT Career Achievement Award
This year's TCT Career Achievement Award was given to Dr
Alain G Cribier, from the Charles Nicolle Hospital in Rouen,
France. Dr Cribier worked for more than 20 years to help find a
therapeutic solution for patients with aortic disease unable to
undergo surgery. He conducted the first transcatheter aortic-
valve implantation in 2002.
As well as receiving the Career Achievement Award, Dr Cribier
was rewarded for his efforts by the results of PARTNER, which
highlighted the positive outcomes of his years of hard work.

5. ZILVER PTX
Results: The Zilver PTX (Cook Group) paclitaxel-eluting
peripheral stent beat both percutaneous transluminal angioplasty
(PTA) and provisional bare-metal stenting in a randomized trial of
479 patients with moderate to severe symptomatic
femoropopliteal artery disease with an average lesion length of
6.6 cm. About half the patients were diabetic. After one year,
83.1% of the stented segments treated with the Zilver PTX were
still patent, compared with only 32.8% of the vessels in the PTA-
treated patients (p<0.01). Even when only the optimal PTAs were
considered, the Zilver PTX still performed much better than PTA,
83.1% compared with 65.3% (p<0.01).
"[This] is a very important trial and potentially now
groundbreaking in terms of how we can conceive of superficial
femoral artery disease and popliteal treatment going forward,"
said study investigator Dr William Gray (New York Presbyterian
Hospital, NY.
See Zilver PTX bests bare-metal stents in largest randomized
peripheral endovascular trial ever for more information.

6. ISAR-TEST 4 and SORT-OUT 4
Results: The ISAR-TEST 4 trial showed that the newer-
generation everolimus-eluting Xience V stent (Abbott) had
comparable clinical outcomes out to two years compared with the
sirolimus-eluting stent Cypher (Cordis). And SORT-OUT 4
investigators showed the Xience V stent was statistically
noninferior to Cypher for the reduction of major adverse cardiac
events (MACE) at nine months.
"A lot of the time, the SORT-OUT investigators come up with the
same questions and present similar data, perhaps using similar
methodology," said Dr Robert Byrne, the lead investigator of the
ISAR-TEST 4 study, during a press conference at the TCT. "Most
of the time, we come to the same conclusion. Here, in these two
studies, we both fail to detect any significant clinical difference
between the two stents, Cypher and Xience."
See Blinding me with Xience: Everolimus-eluting stent holds its
own against Cypher stent

7. Live case demonstrations
High-definition live cases were transmitted from sites spanning
18 locations around the globe.
These included: the CardioVascular Center in Frankfurt,
Germany; the Cardiovascular Institute and Fu Wai Hospital in
Beijing, China; the Instituto Cardiovascular de Buenos Aires in
Argentina; the John Radcliffe Hospital in Oxford, UK; the
Quebec Heart and Lung Institute, QC; the Baptist Cardiac and
Vascular Institute, in Miami, FL; the Duke Heart Center in
Durham, NC; the New York-Presbyterian Hospital/Columbia
University Medical Center, NY; the Rush Center for Congenital
and Structural Heart Disease at the Rush University Medical
Center in Chicago, IL; and Scripps Green Hospital in La Jolla,
CA.

8. COMPARE and SPIRIT IV
Results: In COMPARE, an investigator-initiated, all-
comers trial, researchers showed that the everolimus-
eluting stent remained superior to the Taxus Liberté
stent, with significant differences in the composite end
point of death, nonfatal MI, and target vessel
revascularization (TVR) observed at two years.
The SPIRIT IV investigators also showed sustained
benefit of the Xience V stent over the older Taxus
Express stent. At two years, treatment with the
everolimus-eluting stent resulted in a relative 30%
reduction in target lesion failure, a composite end point
reflecting cardiac death, target vessel MI (TVMI), or
ischemia-driven target lesion revascularization (TLR).
"The other revelation is that the very late stent-thrombosis rates with the Xience V are low, either with or without extended
dual antiplatelet therapy," said SPIRIT IV investigator Dr Dean Kereiakes (The Christ Hospital, Cincinnati, OH). "Our trial
had 72% of patients taking dual antiplatelet therapy at two years, while their trial [COMPARE] had just about 10% of the
Xience V cohort on dual therapy at two years. Either way, the very late stent-thrombosis rates were very low with the
Xience V stent. Not so in the Taxus arm."
See COMPARE and SPIRIT IV: "Durable, progressive relative benefit" of Xience V over Taxus for more information.

9. HORIZONS AMI (Harmonizing Outcomes With Revascularization
and Stents in Acute Myocardial Infarction)
Results: At three years, major bleeding remained statistically
lower in the bivalirudin patients compared with the
unfractionated heparin (UFH)/GP IIb/IIIa inhibitor group. Both
all-cause mortality and cardiac mortality, which were
significantly lower in bivalirudin patients at one year, remained
lower at three years, with event rates widening slightly over
time. In the drug-eluting- vs bare-metal-stent randomization, the
reduction in repeat target lesion revascularization (TLR) seen at
one year persisted at three years, both in patients who had
undergone angiography and in those who had not. Rates of
major adverse cardiac events and of all other clinical end points
were no different between the two groups
In his concluding remarks, principal investigator Dr Gregg Stone emphasized the enduring reduction in major bleeding,
reinfarction, cardiac mortality, and all-cause mortality in the bivalirudin-treated patients, as well as the 40% reduction in
TLR among patients randomized to the paclitaxel stent. He also drew attention to the high rates of stent thrombosis seen in
the trial-ranging from 4% to 5% in all study groups-despite the fact that patients tended to maintain the same level of dual
antiplatelet therapy.
See LESSON I: HORIZONS-AMI: Final follow-up cements earlier finding

10. BIOFREEDOM
Results: After one year, the novel polymer-free biolimus A9-eluting
stent was statistically noninferior to the paclitaxel-eluting stent in
patients with coronary artery disease in terms of in-stent late lumen
loss, and trending toward superiority, report investigators.
According to study investigator Dr Eberhard Grube, the hope is
that the polymer-free biolimus A9-eluting stent can reduce late
adverse events attributed to the polymer, such as stent thrombosis,
and potentially reduce the duration of dual antiplatelet therapy.
See BIOFREEDOM: Polymer-free biolimus stent reduces late
lumen loss compared with Taxus for more information.

11. Poster sessions
Over 400 abstract posters were selected to be presented at the TCT.
Awards were given to the top 25.
These included:
Robotically-Assisted PCI: First-in-Human Study, Juan F Granada et
al.
Selection Criteria for Drug-Eluting vs Bare Metal Stents: The
HORIZONS-AMI Trial, Gregg W Stone et al.
Long-Term Results of Endovascular Aneurysm Repair (EVAR) vs
Open Repair in Patients with Large Abdominal Aortic Aneurysm:
Results of the UK EVAR Trial 1, Roger M Greenhalgh et al.
SYNTAX Score Reproducibility and Agreement Between Interventional Cardiologists and Core Laboratory Technician Measurements,
Philippe Genereux et al.
Correlates and Consequences of Gastrointestinal Bleeding Complicating Percutaneous Coronary Intervention, Michael A Gaglia Jr et
al.
Approach to Treat Mitral Regurgitation: Human Data and Final Percutaneous Prototype, Richard R Heuser et al.
The Impact of XIENCE V Everolimus-Eluting Stent on Health Status in On-Label and Off-Label Patients: One-Year Results from the
Xience V USA Study, David R Rutledge et al.

12. PROTECT-AF (Embolic Protection in Patients with Atrial
Fibrillation)
PROTECT-AF (Embolic Protection in Patients with Atrial Fibrillation)
Results: Extended follow-up results on the Watchman left atrial
appendage (LAA) closure device for stroke prevention in atrial-fibrillation
patients suggest that, as more time passes postimplantation, the device
continues to prevent strokes and deaths. Meanwhile, the safety issues
that first raised flags for the procedure-pericardial effusion, device
retrievals, and different types of bleeding-are, indeed, declining over time.
CAP Registry (Continued Access PROTECT AF Registry) Results: The
CHADS2 score for patients was higher in CAP, while procedure time was
reduced, implant success was greater, and the proportion of patients who
discontinued warfarin at 45 days was significantly increased.
See WATCHMAN updates point to better safety, enduring efficacy with
LAA closure device for stroke for more information.

13. Robotically assisted PCI
Results: The first-in-human report, presented at TCT 2010,
showed that robotically assisted PCI (CorPath 200, Corindus,
Natick, MA) is technically feasible, with no occurrences of major
adverse cardiac events (MACE) at 30 days, and significantly
reduced operator exposure to radiation, as well as reduced use
of contrast.
"I think some of the main issues with interventional cardiology
are the orthopedic injuries that people don't talk about, the
radiation exposure, the quality of the intervention, and contrast
use," said lead investigator Dr Juan Granada (Cardiovascular
Research Foundation, Orangeburg, NY). "What this system is
trying to do is optimize the way we do angioplasty procedures
and to decrease the risk, mainly the risk that the operator and
the personnel are exposed to."
See First-in-human study shows robotically assisted PCI safe,
feasible for more information.

14. Opinions from TCT
Topolog
PARTNER triumph takes TAVI to the next level
Private practice with Dr Seth Bilazarian
Reacting to PARTNER
Second generation drug-eluting stent, Xience V, stands out at
TCT 2010

15. TCT 2010
Over 10 000 people attended the scientific symposia, late-
breaking trials, live case presentations, "how-to-treat" theaters,
oral abstract and poster abstract sessions, the nurse and
technologist symposium, board review courses, maintenance-
of-certification session, and FDA town hall meeting at the 22nd
annual TCT meeting held in September 2010.
TCT 2011 will be held in San Francisco November 7-11.

16. For more information
TCT 2010 Conference Coverage on
theheart.org
Medscape TCT 2010
TCT

17. Credits and disclosures
Journalists
Shelley Wood
Managing Editor, heartwire
Kelowna, BC
Disclosure: Shelley Wood has disclosed no relevant financial
relationships.
Reed Miller
heartwire
Bethesda, MD
Disclosure: Reed Miller has disclosed no relevant financial
relationships.
Michael O'Riordan
heartwire
Toronto, ON
Disclosure: Michael O'Riordan has disclosed no relevant financial
relationships.
Contributor
Steven Rourke
Manager, Editorial Programming
theheart.org
Montreal, QC
Disclosure: Steven Rourke has disclosed no relevant financial
relationships.

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