TCT 2012 research highlights:

A slideshow presentation

TCT 2012 Research Highlights

TCT 2012 took place in Miami, FL, on October 22-26. Key trials and

presentations at the sessions included:

PFO Closure in RESPECT and PC Trial: Both trials missed their

primary end points

FAME II: FFR-guided PCI is cost-effective

ADVANCE: TAVI mortality with CoreValve still falling

TAVR: TAVR experiences identifying risks for stroke, LBBB, and

perivalvular leak

TRILOGY-ACS: Prasugrel bests clopidogrel in TRILOGY-ACS

angiography cohort

Live cases: High-definition transmission of live cases from around

the world

DESSOLVE I and II: Positive results with bioabsorbable polymer-based SES

PARTNER B: Comorbidities influence three-year survival with Sapien TAVI

ISAR DESIRE 3: Drug-eluting balloon is best option for restenosis of limus-eluting stents

MASTER: Mesh-covered stent results in more complete ST-segment resolution in STEMI

Career Achievement Award: The TCT 2012 award recipient was: Dr Renu Virmani

ADAPT-DES: Low response to clopidogrel does not increase mortality risk

STEMI-RADIAL: Radial- tops femoral-access PCI in treatment of STEMI patients

POST: Ischemic conditioning after PCI shows no benefit in STEMI patients

RESPECT and PC Trial

PFO-closure studies RESPECT and PC Trial miss primary end

point

Results: RESPECT and the PC Trial missed their primary end points.

Both trials assessed whether a patent foramen oval (PFO) closure

device could reduce the risk of recurrent stroke in patients who had

experienced cryptogenic stroke.

In the RESPECT trial, the 46.6% reduction in the risk of stroke was

not statistically significant when assessed in the ITT analysis.

However, when the investigators analyzed the data among patients

treated per protocol, the 63.4% reduction in stroke was statistically

significant, as was the 72.7% reduction in stroke when analyzed by

patients who actually received the device.

In the PC Trial, 414 patients were randomized to treatment with the transcatheter Amplatzer PFO occluder (St Jude Medical) or

medical therapy. Results indicated that closing the PFO failed to reduce the primary end point of death from any cause, nonfatal

stroke, transient ischemic attack, and peripheral embolism. There was an 80% reduction in the risk of stroke, but this reduction did not

reach statistical significance.

"We conclude from these data and other data that in carefully selected patients with a history of cryptogenic stroke and PFO that this

provides evidence of a benefit in stroke risk reduction from closure with this particular device over medical management alone," said

Dr John Carroll (University of Colorado, Denver). "The primary analysis, which was the intention to treat, was borderline and formally

not statistically significant, but trended toward superiority, while the secondary analysis suggested that this is a superior treatment."

See: PFO-closure trials RESPECT and PC miss primary end point

FAME II

FAME II: FFR-guided PCI is cost-effective

Results: A cost-effectiveness analysis of the St Jude-sponsored

FAME II trial shows that fractional-flow-reserve (FFR)-guided

PCI is a cost-effective alternative to optimal medical

management in stable patients with flow-limiting coronary

lesions. The FAME II trial was stopped last year after the

interim analysis showed that patients randomized to PCI were

much less likely to need an urgent revascularization than

patients randomized to optimal medical therapy.

"Based on COURAGE, people have argued that up-front optimal medical therapy should be achieved before proceeding to

PCI, but what we showed in FAME II was that if you can identify ischemia-producing lesions and isolate those, patients

[with those lesions] benefit from PCI up front as compared with optimal medical therapy, by decreasing urgent

revascularization and improving quality of life," said Dr William Fearon (Stanford University, CA).

See: FAME II: FFR-guided PCI is cost-effective

ADVANCE

ADVANCE: TAVI mortality with CoreValve still falling

Results: One-year results from the ADVANCE study of the

Medtronic CoreValve confirm that mortality rates with

transcatheter aortic-valve implantation (TAVI) have dropped

steadily since the device's earliest clinical trials. ADVANCE

includes 1015 TAVI patients treated between March 2010 and

July 2011 at 44 centers in 12 European countries. The mortality

rates seen in ADVANCE compare very favorably with the 24.2%

one-year all-cause mortality in the TAVI patients in the

PARTNER A pivotal trial of the Edwards Sapien TAVI system.

They also are in line with the one-year results from the

SOURCE registry with Sapien, where one-year survival was

76.1% in the overall cohort.

"We have learned a lot with regard to the procedure. We're preventing complications, and this affects long-term survival in

a positive way," said Dr Axel Linke (University of Leipzig Heart Center, Germany). "There is more room to grow with

adjustment of devices. The next generations will address paravalvular leaks, and we've seen that paravalvular leaks affect

mortality. I hope that when we're as good as conventional surgery at 30 days [and reduce paravalvular leaks], we'll be as

good as conventional surgery at one year."

See: ADVANCE: TAVI mortality with CoreValve still falling

TAVR

TAVR experiences identifying risks for stroke, LBBB, and perivalvular leak

Results: With experiences in transcatheter aortic-valve replacement (TAVR) growing

worldwide, new data are emerging to identify various predictors of adverse clinical outcomes,

including the risk of cerebrovascular events, left bundle branch block (LBBB), and perivalvular

aortic regurgitation. Published data suggest that the 30-day stroke risk with TAVR is

approximately 3.5%. The incidence of acute and subacute cerebrovascular events is 2.7%

and 2.4%, respectively. Also, 30% of patients with no prior conduction disturbances develop

LBBB following TAVI with a balloon-expandable valve.

Data on perivalvular regurgitation and its impact on clinical outcomes from the FRANCE 2 registry of 2769 patients show

that 15% of patients had moderate to severe aortic regurgitation (grade >2) following successful TAVR. The presence of

aortic regurgitation was associated with a twofold increase in the risk of death at one year. At one year, the rate of death

among patients with aortic regurgitation grade >2 was 25% compared with 10% among patients with mild or no aortic

regurgitation.

"Postprocedure aortic regurgitation after TAVR is a major issue," said Dr Eric van Belle (Hôpital Cardiologique, Lille,

France), "and it could be avoided, especially when there is no significant aortic regurgitation at baseline or when a

nonfemoral-artery approach is used. For balloon- and self-expandable devices, the benefit of the nonfemoral artery

approach on the rate of aortic regurgitation suggests that a good axial control of the device at the time of the delivery is

key to reduce the rates of aortic regurgitation."

See: TAVR experiences identifying risks for stroke, LBBB, and perivalvular leak

TRILOGY-ACS

Prasugrel bests clopidogrel in TRILOGY-ACS angiography

cohort

Results: Results from the TRILOGY-ACS angiographic cohort

indicate that ACS patients randomized to prasugrel following

coronary angiography had significantly lower rates of major

cardiovascular events compared with patients treated with

clopidogrel. The results run counter to the results observed in

the overall study. In TRILOGY-ACS, one of the few studies to

focus on high-risk patients with ACS who are medically

managed without revascularization, the newer antiplatelet agent

prasugrel failed to show a reduction in the primary end point of

major cardiovascular events compared with clopidogrel.

"I think angiography identifies a population of patients with ACS in whom we're sure they have active coronary disease

driving their event," said Dr Stephen Wiviott (Brigham and Women's Hospital, Boston, MA). "In order to get into the trial, if

you had angiography, you had to demonstrate that you had significant coronary lesions. There are many people who come

into the hospital who have ST-segment changes or positive troponin, and when we take them to the cath lab they don't

have significant coronary lesions. I think the angiography creates a purer coronary-based population."

See: Prasugrel bests clopidogrel in TRILOGY-ACS angiography cohort

Live cases

Live cases in high definition

High-definition live cases were transmitted from 20 locations

around the globe, offering unique learning opportunities to

attendees. Topics included: left main and bifurcation, chronic

total occlusion, transcatheter valve therapies, iliac and

superficial femoral artery, renal/aortic/mesenteric, multivessel,

and diffuse disease, complex and unusual coronary disease,

carotid and neurointervention, and adult congenital disease

interventions.

Taped cases were also available, on topics such as unusual

interventions, imaging and physiology, TAVR, endovascular

interventions, nonvalvular structural heart interventions,

coronary interventions, and vascular drug-delivery

breakthroughs.

DESSOLVE I AND II

DESSOLVE I and II: Positive results with bioabsorbable

polymer-based SES

Results: DESSOLVE II, a head-to-head comparison in a small

study of a new biodegradable polymer-based sirolimus-eluting

stent (SES), MiStent, showed the stent was superior to the

zotarolimus-eluting stent (ZES) Endeavor in terms of

preventing late lumen loss. At nine months, quantitative

angiographic data showed that the in-stent mean lumen

diameter and in-stent diameter stenosis were also significantly

better in patients treated with the novel SES.

The 18-month quantitative angiographic, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) data

in 25 patients from DESSOLVE I was also presented. Compared with eight-month data previously presented, long-term

follow-up showed that late lumen loss and neointimal obstruction as measured by IVUS were unchanged, suggesting

stability in luminal dimensions. OCT data showed excellent stent coverage.

"The drug-eluting stent returns to the phenotype of a bare-metal stent, with all the benefit that these stents provide," said

Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA). He added that these types of stents, with a biodegradable

polymer and reversion back to a bare-metal stent, represent the future workhorse stents in interventional cardiology.

See: DESSOLVE I and II: Positive results with bioabsorbable polymer-based SES

PARTNER B (three-year results)

PARTNER B: Comorbidities influence three-year survival with

Sapien TAVI

Results: Latest results from the PARTNER B trial of the Edwards

Lifesciences Sapien transcatheter aortic valve in inoperable patients

show that the mortality benefit of the device persists at least three

years and that the survival prognosis in patients undergoing

transcatheter aortic-valve implantation (TAVI) correlates to the

severity of their comorbidities at the time of implant.

The three-year PARTNER B data show that TAVI makes the biggest

difference in patients with fewer or less severe comorbidities, as

measured by baseline Society of Thoracic Surgeons (STS) score. In

patients with an initial STS score from 0 to 4.9, mortality at three

years was 100% in the control group and 33.2% in the TAVI group.

For scores from 5 to 14.9, mortality was 77.5% and 55.2% for the

control and TAVI groups, respectively, and for STS scores over 15,

the three-year mortality rates were 86.6% and 65.8%.

"These data underscore the importance of patient selection before TAVI and the need for aggressive management of

illnesses after TAVI, because when we stratified mortality according to STS score, we were quite surprised that the higher

STS scores in the standard treatment groups were somewhat irrelevant," said Dr E Murat Tuzcu (Cleveland Clinic,

OH). "We should not perceive what is accomplished with the PARTNER program only as a success with the procedure,

but rather how the program can be established with multiple disciplines."

See: PARTNER B: Comorbidities influence three-year survival with Sapien TAVI

ISAR DESIRE 3

ISAR DESIRE 3: Drug-eluting balloon is best option for

restenosis of limus-eluting stents

Results: According to results of ISAR DESIRE 3, a three-way

randomized trial, angioplasty with a paclitaxel-eluting balloon is a

better alternative for in-stent restenosis of limus-eluting stents than

either angioplasty with a regular balloon or putting in another drug-

eluting stent (DES).

Angiographic follow-up six to eight months after the procedure

showed that for the primary end point, percentage restenosis, the

remaining diameter of stenosis was 38% in the restenosed stents

treated with the paclitaxel-eluting balloon and 37.4% in the stents

treated with a paclitaxel-eluting stent (p for noninferiority=0.007). The

paclitaxel balloon and paclitaxel stent were noninferior to each other

but both superior to regular balloon angioplasty for both secondary

end points of binary restenosis and target lesion revascularization.

"Despite over a decade of experience with drug-eluting stents in real-world practice, we still don't know the optimal

treatment for restenosis in these devices," explained Dr Robert Byrne (Deutsches Herzzentrum, Technische Universität,

Munich, Germany). "We know from some smaller studies of drug-eluting-balloon therapy that this seems to be a very

promising therapy, particularly in patients with bare-metal-stent restenosis. It has the advantage of avoiding additional

stent layers, and if we can achieve good results with drug-eluting therapy comparable to that of DES without requiring

additional stent layers, that would be a very exciting prospect."

See: ISAR DESIRE 3: Drug-eluting balloon is best option for restenosis of limus-eluting stents

MASTER

MASTER: Mesh-covered stent results in more complete ST-segment

resolution in STEMI

Results: In the MASTER study, the MGuard device resulted in more

complete ST-segment resolution when compared with patients treated with

a conventional bare-metal stent or drug-eluting stent (DES). The study

included patients with STEMI treated at 50 clinical centers in nine

countries. In terms of clinical follow-up at 30 days, no patients treated with

the MGuard stent died, compared with four patients in the control arm

(p=0.06). There was no difference in other clinical events, including

reinfarction, target lesion revascularization, stent thrombosis, stroke, or

TIMI major or minor bleeding.

"The STEMI patients have a lot of thrombus in the artery, and the problem is that sometimes the artery is occluded or very narrow,

but it's not a stable lesion," said Dr Sigmund Silber (Heart Center, Munich, Germany). "It's highly thrombotic, so if you push a

balloon through this thrombus you have a risk of dislocating the thrombus to the peripheral vessels. There's nothing you can do

about it. Once you dislodge a thrombus and the thrombus goes downstream, there's no intervention to heal this. So you have to

prevent it."

See: MASTER: Mesh-covered stent results in more complete ST-segment resolution in STEMI

Career Achievement Award

TCT 2012 Career Achievement Award

The TCT 2012 Career Achievement Award was presented by Dr

Martin Leon to Dr Renu Virmani from the CVPath Institute.

See: TCT 2012 Final Program, p. 138

Dr Virmani's biography

http://www.cvpath.org/about/virmani/

ADAPT-DES

ADAPT-DES: Low response to clopidogrel does not

increase mortality risk

Results: New data from ADAPT-DES shows that clopidogrel

hyporesponsiveness does not predict one-year mortality in

drug-eluting-stent recipients because the increased risk of

thrombosis is offset by a lower risk of bleeding.

In light of this result, "overcoming clopidogrel

hyporesponsiveness with more potent antiplatelet agents is

therefore unlikely to improve survival unless the beneficial

effects of reducing stent thrombosis and myocardial infarction

can be uncoupled from the likely increase in bleeding with

greater platelet inhibition," said investigator Dr Thomas

Stuckey (Moses Cone Heart and Vascular Center, Greensboro,

NC), where he and Dr Gregg Stone (Columbia University, NY)

presented an analysis of the relationship between clopidogrel

hyporesponsiveness and subsequent adverse events in the

ADAPT-DES patients.

See: ADAPT-DES: Low response to clopidogrel does not

increase mortality risk

STEMI-RADIAL

Radial- tops femoral-access PCI in treatment of STEMI

patients

Results: The STEMI-RADIAL study confirms the benefit of

radial-access PCI for the treatment of STEMI patients. Among

individuals presenting to the hospital within 12 hours of STEMI,

radial-access PCI was associated with a lower rate of major

bleeding and access-site complications, as well as a significant

increase in net clinical benefit. With these positive results, the

investigators conclude that the radial artery should be the

preferred access route over the femoral artery in primary PCI.

The lone caveat, however, is that these results were obtained

by experienced radial-access operators. In this present study,

the interventional cardiologists all performed more than 80% of

their procedures via the radial artery.

"What was also interesting was that the contrast volume and

[intensive care unit] ICU stay were significantly lower in the

radial group," said lead investigator Dr Ivo Bernat (University

Hospital, Pilsen, Czech Republic) during a press conference

announcing the results.

See:

Radial- tops femoral-access PCI in treatment of STEMI patients

POST

Ischemic conditioning after PCI shows no benefit in STEMI

patients

Results: Ischemic postconditioning following PCI of ST-

segment-elevation MI patients did not improve outcomes

compared with PCI without this extra procedure in the 700-

patient randomized POST trial, at 30-day follow up. Also, no

cardioprotective effects of ischemic postconditioning appeared

in any of the prespecified subgroups. However, subsequent

postconditioning studies using contrast-enhanced MRI to

examine infarct size have shown inconsistent results.

"Previous studies showing the cardioprotective effects of

preconditioning have several limitations—they did not reflect

current standard practice patterns of primary PCI," said Dr Joo-

Yong Hahn (Samsung Medical Center, Seoul, Korea). "They

performed only direct stenting and thrombus aspiration, and

glycoprotein IIb/IIIa inhibitors were either not used or used

seldom."

See:

Ischemic conditioning after PCI shows no benefit in STEMI

patients

For more information

Complete TCT 2012 coverage on

theheart.org

TCT 2012 Conference

TCT 2012 Final Program

Credits and disclosures

Credits and disclosures

Journalists:

Reed Miller, heartwire

State College, PA

Disclosure: Reed Miller has disclosed

no relevant financial relationships.

Michael O'Riordan, heartwire

Hamilton, ON

Disclosure: Michael O'Riordan has

disclosed no relevant financial

relationships.

Managing editor:

Shelley Wood

Managing Editor, heartwire

Kelowna, BC

Disclosure: Shelley Wood has disclosed

no relevant financial relationships.

Contributors:

Steven Rourke

Editorial Director

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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