TCT 2012 research highlights: A slideshow presentation

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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 POST

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TCT 2012 research highlights: A slideshow presentation

  1. 1. TCT 2012 research highlights:A slideshow presentation
  2. 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 worldDESSOLVE I and II: Positive results with bioabsorbable polymer-based SESPARTNER B: Comorbidities influence three-year survival with Sapien TAVIISAR DESIRE 3: Drug-eluting balloon is best option for restenosis of limus-eluting stentsMASTER: Mesh-covered stent results in more complete ST-segment resolution in STEMICareer Achievement Award: The TCT 2012 award recipient was: Dr Renu VirmaniADAPT-DES: Low response to clopidogrel does not increase mortality riskSTEMI-RADIAL: Radial- tops femoral-access PCI in treatment of STEMI patientsPOST: Ischemic conditioning after PCI shows no benefit in STEMI patients
  3. 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) ormedical therapy. Results indicated that closing the PFO failed to reduce the primary end point of death from any cause, nonfatalstroke, transient ischemic attack, and peripheral embolism. There was an 80% reduction in the risk of stroke, but this reduction did notreach statistical significance."We conclude from these data and other data that in carefully selected patients with a history of cryptogenic stroke and PFO that thisprovides evidence of a benefit in stroke risk reduction from closure with this particular device over medical management alone," saidDr John Carroll (University of Colorado, Denver). "The primary analysis, which was the intention to treat, was borderline and formallynot 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. 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 toPCI, 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 urgentrevascularization and improving quality of life," said Dr William Fearon (Stanford University, CA).See: FAME II: FFR-guided PCI is cost-effective
  5. 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 devices 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. Were preventing complications, and this affects long-term survival ina positive way," said Dr Axel Linke (University of Leipzig Heart Center, Germany). "There is more room to grow withadjustment of devices. The next generations will address paravalvular leaks, and weve seen that paravalvular leaks affectmortality. I hope that when were as good as conventional surgery at 30 days [and reduce paravalvular leaks], well be asgood as conventional surgery at one year."See: ADVANCE: TAVI mortality with CoreValve still falling
  6. 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 showthat 15% of patients had moderate to severe aortic regurgitation (grade >2) following successful TAVR. The presence ofaortic regurgitation was associated with a twofold increase in the risk of death at one year. At one year, the rate of deathamong patients with aortic regurgitation grade >2 was 25% compared with 10% among patients with mild or no aorticregurgitation."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 anonfemoral-artery approach is used. For balloon- and self-expandable devices, the benefit of the nonfemoral arteryapproach on the rate of aortic regurgitation suggests that a good axial control of the device at the time of the delivery iskey to reduce the rates of aortic regurgitation."See: TAVR experiences identifying risks for stroke, LBBB, and perivalvular leak
  7. 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 were sure they have active coronary diseasedriving their event," said Dr Stephen Wiviott (Brigham and Womens Hospital, Boston, MA). "In order to get into the trial, ifyou had angiography, you had to demonstrate that you had significant coronary lesions. There are many people who comeinto the hospital who have ST-segment changes or positive troponin, and when we take them to the cath lab they donthave significant coronary lesions. I think the angiography creates a purer coronary-based population."See: Prasugrel bests clopidogrel in TRILOGY-ACS angiography cohort
  8. 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. 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) datain 25 patients from DESSOLVE I was also presented. Compared with eight-month data previously presented, long-termfollow-up showed that late lumen loss and neointimal obstruction as measured by IVUS were unchanged, suggestingstability 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," saidDr David Kandzari (Piedmont Heart Institute, Atlanta, GA). He added that these types of stents, with a biodegradablepolymer 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. 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 ofillnesses after TAVI, because when we stratified mortality according to STS score, we were quite surprised that the higherSTS 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. 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 dont know the optimaltreatment 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 verypromising therapy, particularly in patients with bare-metal-stent restenosis. It has the advantage of avoiding additionalstent layers, and if we can achieve good results with drug-eluting therapy comparable to that of DES without requiringadditional 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. 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 its not a stable lesion," said Dr Sigmund Silber (Heart Center, Munich, Germany). "Its highly thrombotic, so if you push aballoon through this thrombus you have a risk of dislocating the thrombus to the peripheral vessels. Theres nothing you can doabout it. Once you dislodge a thrombus and the thrombus goes downstream, theres no intervention to heal this. So you have toprevent it."See: MASTER: Mesh-covered stent results in more complete ST-segment resolution in STEMI
  13. 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 Virmanis biography http://www.cvpath.org/about/virmani/
  14. 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. 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. 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. 17. For more information Complete TCT 2012 coverage on theheart.org TCT 2012 Conference TCT 2012 Final Program
  18. 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 ORiordan, heartwire Katherin Vasilopoulos Hamilton, ON Montreal, QC Disclosure: Michael ORiordan 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. 19. More slideshows ESC 2012 research highlights HRS 2012 research highlights EuroPCR 2012 research highlights ACC 2012 research highlights
  20. 20. 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/theheartorgtheheart.org is the leading online source of independent cardiology news.We are the top provider of news and opinions for over 100 000 physicians.

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