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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                  Contributors:
                                                          Steven Rourke
                 Journalists:                             Editorial Director
                 Reed Miller, heartwire                   theheart.org
                 State College, PA                        Montreal, QC
                 Disclosure: Reed Miller has disclosed    Disclosure: Steven Rourke has disclosed
                 no relevant financial relationships.     no relevant financial relationships.
                 Michael O'Riordan, heartwire
                                                          Katherin Vasilopoulos
                 Hamilton, ON
                                                          Montreal, QC
                 Disclosure: Michael O'Riordan has
                                                          Disclosure: Katherin Vasilopoulos has
                 disclosed no relevant financial
                 relationships.
                                                          disclosed no relevant financial
                                                          relationships.
                 Managing editor:
                 Shelley Wood
                 Managing Editor, heartwire
                 Kelowna, BC
                 Disclosure: Shelley Wood has disclosed
                 no relevant financial relationships.
More slideshows
                  ESC 2012 research highlights

                  HRS 2012 research highlights

                  EuroPCR 2012 research highlights

                  ACC 2012 research highlights
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TCT 2012 research highlights: A slideshow presentation

  • 1. TCT 2012 research highlights: A slideshow presentation
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
  • 7. 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
  • 8. 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.
  • 9. 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
  • 10. 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
  • 11. 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
  • 12. 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
  • 13. 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/
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. For more information Complete TCT 2012 coverage on theheart.org TCT 2012 Conference TCT 2012 Final Program
  • 18. Credits and disclosures Credits and disclosures Contributors: Steven Rourke Journalists: Editorial Director Reed Miller, heartwire theheart.org State College, PA Montreal, QC Disclosure: Reed Miller has disclosed Disclosure: Steven Rourke has disclosed no relevant financial relationships. no relevant financial relationships. Michael O'Riordan, heartwire Katherin Vasilopoulos Hamilton, ON Montreal, QC Disclosure: Michael O'Riordan has Disclosure: Katherin Vasilopoulos has disclosed no relevant financial relationships. disclosed no relevant financial relationships. Managing editor: Shelley Wood Managing Editor, heartwire Kelowna, BC Disclosure: Shelley Wood has disclosed no relevant financial relationships.
  • 19. More slideshows ESC 2012 research highlights HRS 2012 research highlights EuroPCR 2012 research highlights ACC 2012 research highlights
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