tct 2012 research highlights: a slideshow presentation
DESCRIPTION
TCT 2012 took place in Miami, FL, on October 22-26. Key trials and presentations at the sessions included: PFO Closure, RESPECT, PC Trial, FAME II, ADVANCE, TAVR, TRILOGY-ACS, Live cases, DESSOLVE I and II, SES PARTNER B, MASTER, Career Achievement Award, ADAPT-DES, STEMI-RADIAL and POSTTRANSCRIPT
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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