TCT 2010 research highlights:

A slideshow presentation

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.

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.

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.

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.

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

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.

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.

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

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.

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.

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.

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.

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

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.

For more information

TCT 2010 Conference Coverage on

theheart.org

Medscape TCT 2010

TCT

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.

theheart.org is the leading online source of independent cardiology news.

We are the top provider of news and opinions for over 100 000 physicians.

Become a member of http://www.theheart.org

Become a fan on Facebook: http://www.facebook.com/theheartorg

Follow us on Twitter: http://www.twitter.com/theheartorg