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TCT 2011 Research Highlights: A slideshow presentation
 

TCT 2011 Research Highlights: A slideshow presentation

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http://www.theheart.org/editorial-program/1312625.do ...

http://www.theheart.org/editorial-program/1312625.do

"The Transcatheter Cardiovascular Therapeutics (TCT) 2011 took place in San Francisco and the key trials/topics presented at the sessions include:
STACCATO, PARTNER A (QoL and Efficacy), TCT 2011 Keynote Address, BRIDGE, TRIGGER PCI, TCT 2011 Career Achievement Award, RIFLE STEACS, ADVISE (FFR),PARTNER B and TWENTE"

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    TCT 2011 Research Highlights: A slideshow presentation TCT 2011 Research Highlights: A slideshow presentation Presentation Transcript

    • TCT 2011 research highlights:A slideshow presentation
    • TCT 2011 Research Highlights The Transcatheter Cardiovascular Therapeutics (TCT) 2011 took place in San Francisco, CA, from November 7 through November 11, 2011. Key trials/topics presented at the sessions include: STACCATO: A study comparing the transapical approach for transcatheter aortic-valve implantation (TAVI) against conventional aortic-valve replacement surgery was stopped due to an increase in adverse events in the TAVI arm PARTNER A (QoL and Efficacy): A quality-of-life assessment in a trial comparing the transfemoral vs transapical route in high-risk, surgery-eligible patients showed substantial QoL benefits via the transfemoral route TCT 2011 Keynote Address: The future of humankind by Michio Kaku, PhD Longitudinal stent compression: A panel of specialists discussed this issue and concluded that this phenomenon is rare and can be avoided and that stent design should be revisedBRIDGE: Continuous cangrelor may safely wean ACS patients off oral antiplateletsTRIGGER PCI: Platelet function not always a useful guide to antiplatelet therapyTCT 2011 Career Achievement Award: Dr Eric TopolRIFLE STEACS: Lower risk of MACCE with radial-access PCI in STEMI patientsADVISE (FFR): New pressure measurement does not require adenosine and equals FFRTCT 2011 Inspirational Address and TCT 2011 Thomas J Linnemeier Spirit of Interventional Cardiology Young Investigator Award"Third-gen" stents: Two experimental drug-eluting stents, Synergy and Cre8, have shown positive results in early phase trials.PARTNER B: Transcatheter valves at two years continue to support the role of TAVR as the standard of care for symptomatic patients with aorticstenosis who are not surgical candidatesTWENTE: Zotarolimus stent matches everolimus drug-eluting stentTCT 2011 Geoffrey O Hartzler Master Clinical Operator Award: Dr Horst SievertView our complete TCT coverage here.
    • STACCATO A study comparing the transapical approach for transcatheter aortic-valve implantation (TAVI) against conventional aortic-valve replacement surgery Results: The STACCATO trial was designed three years ago and included elderly patients with valvular aortic stenosis who could be treated with surgery or transapical TAVI. Based on data from a surgery registry, they anticipated a surgical-event rate—defined as a composite of 30-day all-cause mortality, major stroke, and/or renal failure—of 13.5% and an estimated event rate in the TAVI arm of 2.5%. The study was stopped due to an increase in adverse events in the TAVI arm after the inclusion of 70 patients."There is no doubt there are patients who cant be operated on, and they should be treated with TAVI," said Dr LeifThuesen. "But the patient who can be operated on—here, we should be very, very cautious. Its the operable patients, thelow-risk patients; they should not have the TAVI procedures, but thats what is happening. We had one patient, for instance,who did not want the conventional operation, so he had the TAVI procedure in Canada. Thats how it is. Indications areslipping."See: STACCATO: Transapical TAVI in surgery-eligible patients stopped due to adverse events
    • PARTNER A (QoL and cost-efficacy data) A quality-of-life (QoL) assessment in a trial comparing the transfemoral vs transapical route in high-risk, surgery- eligible patients Results: New QoL data show that high-risk, surgery-eligible patients treated via a transfemoral route in PARTNER A reported substantial QoL benefits compared with surgery in the early weeks postprocedure. This was not the case for patients treated via a transapical route."For patients eligible only for the transapical approach, there was no benefit of transcatheter aortic-valve replacement oversurgical aortic-valve replacement at any time point, and in fact, QoL tended to be better with surgical replacement both atone and six months," said Dr David Cohen.See: PARTNER QoL data hint transapical TAVI falls short of aortic-valve surgery
    • TCT 2011 Keynote Address: The future of humankind The renowned theoretical physicist, futurist, and author Dr Michio Kaku presented the keynote address, "The future of humankind," on Wednesday, November 9, 2011, in the main arena of the Moscone Center. His humanistic approach propels audiences into the future with thought-provoking insights about science and society and optimistic but realistic observations about the human condition combined with sage guidance for our own evolution and enlightenment. See: Keynote Speaker: Michio Kaku, PhD
    • Longitudinal stent compression Interventional cardiologists hashed over the emerging issue of longitudinal stent compression, with the bulk of experts concluding that this phenomenon is rare, grabbing undue attention, and in many cases avoidable with meticulous technique. Most agreed, however, that stent design may play a factor in making some stents more vulnerable than others. Presenters included: Dr Paul Williams (Manchester Heart Centre, UK) Dr Simon Walsh (Belfast Health and Social Care Trust, Northern Ireland) Dr John Ormiston (Mercy Angiography, Auckland, New Zealand)Panelists included:Dr Tullio Palmerini (Istituto di Cardiologia, Bologna, Italy)Dr Peter C Smits (Maasstad Ziekenhuis, Rotterdam, the Netherlands)Dr Gregg Stone (Columbia University, New York, NY)Dr Louis Cannon (Northern Michigan Hospital Heart and Vascular Institute, Petoskey, MI)Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA)See: Hype or hazard? Longitudinal stent compression hashed out at TCT
    • BRIDGE Continuous cangrelor may safely wean ACS patients off oral antiplatelets Results: The BRIDGE trial showed that continuous infusion of cangrelor, an investigational P2Y12 platelet inhibitor, allowed patients with acute coronary syndromes or coronary stents to go off oral dual-antiplatelet therapy safely in advance of CABG surgery in a modest-sized placebo-controlled phase 2 study."This is the first time we have a trial assessing, in a prospective, randomized, double-blind fashion, the use of a novel[antiplatelet] agent that has the ideal properties for bridging. And the trial clearly shows that we are able to achieve andsustain adequate levels of P2Y12 inhibition during the preoperative stage, with overall favorable safety signals," said DrDominick Angiolillo.See: BRIDGE to surgery: Cangrelor may safely wean ACS patients off oral antiplatelets
    • TRIGGER-PCI Platelet function not always a useful guide to antiplatelet therapy Results: Investigators who explored platelet-function testing for guiding antiplatelet therapy in a low-risk PCI population, who earlier this year had announced that their trial was prematurely halted due to futility, presented available main data. In the TRIGGER-PCI trial, 423 patients (out of a planned 2150) receiving PCI for stable CAD who had high on-treatment platelet reactivity levels were assigned to therapy with prasugrel or clopidogrel. Clinical events were few, probably because the trials patients were unusually low risk. As anticipated, prasugrel suppressed the high platelet-reactivity levels that are known to persist on clopidogrel. The generally good outcomes in both randomization groups suggest that choosing prasugrel over clopidogrel based on platelet-function testing isnt likely to make much of a clinical difference in such low-risk patients. "High on-clopidogrel platelet reactivity was observed less frequently than expected," acknowledged Dr Dietmar Trenk. See: TRIGGER-PCI enlightens: Platelet function not always useful as guide to antiplatelet therapy
    • TCT 2011 Career Achievement Award On the morning of Wednesday, November 9, 2011, Dr Martin B Leon presented the TCT 2011 Career Achievement Award to Dr Eric J Topol. The award is presented annually to a pioneer in the field of interventional cardiology medicine. Dr Topol spearheaded the discovery of multiple genes that increase a persons risk of heart attacks and pioneered the development of critical heart-care therapies now used in daily practice—therapies such as clot busters, antiplatelet agents, and angioplasty devices. He has led more than 15 international, multicenter research trials involving 40 countries and more than 200 000 patients. He is also a leader in the movement to modernize medical treatment through wireless digital innovative technologies. Dr Topol is also the editor-in-chief of theheart.org. See: TCT 2011 program (page 102)
    • RIFLE STEACS Results: The RIFLE STEACS study included 1001 patients with STEMI randomized to radial- or femoral-access PCI. The primary composite end point included bleeding and MACCE, a composite known as the net adverse clinical event (NACE) rate. At 30 days, the overall NACE rate was 21.0% in the femoral- access PCI group and 13.6% in the radial-access group, a statistically significant difference (p=0.003). The MACCE rate— a composite of cardiac death, MI, target lesion revascularization, and stroke—was also significantly reduced: 11.4% in the femoral-access group and 7.2% in the radial- access group (p=0.029). The reduction in MACCE was driven by a significant reduction in cardiac death, which was 5.2% in the radial-access group and 9.2% in the femoral—access group (p=0.20)."This is a strong message of the study, an important reduction [in cardiac death]," said Dr Enrico Romagnoli. He addedthat the radial approach was an independent predictor of improved outcomes. Investigators say the findings show that theradial-access approach should no longer be considered a substitute for the femoral approach but instead should becomethe primary recommended access site for STEMI and other acute coronary syndromes.See: RIFLE STEACS: Lower risk of MACCE with radial-access PCI in STEMI patients
    • ADVISE (FFR) Results: In the ADVISE trial, a new technology that analyzes pressure inside the vessel without the use of adenosine provides intracoronary pressure measurements similar to fractional flow reserve (FFR). Investigators say the technology should have increased applicability in more patients, especially those who are unable to tolerate adenosine, and can improve work flow in the catheterization lab."Its exactly the same as FFR, theres no change, except weve managed to stabilize our resistance using a mathematicalalgorithm rather than having to give a drug to do the same thing," said lead investigator Dr Justin Davies. "We know nowfrom clinical trials that we do a lot better if we dont make our judgments based on visual estimations of stenosis butactually make an assessment based on the pressure drop across the whole length of the artery."See: ADVISE: New pressure measurement does not require adenosine, equals FFR
    • TCT 2011 Inspirational Address and TCT 2011 Thomas J. Linnemeier Spirit ofInterventional Cardiology Young Investigator Award On the morning of Thursday, November 10 2011, Dr Shigeru Saito presented the TCT 2011 Inspirational Address: A story of despair, hope, and recovery in Japan. As well, Dr Gregg W Stone presented the TCT 2011 Thomas J Linnemeier Spirit of Interventional Cardiology Young Investigator Award. Finalists included: Masaki Awata MD (Kansai Rosai Hospital, Amagasaki, Japan) Davide Capodanno MD ( Ferrarotto Hospital, Catania, Italy) Thomas T Tsai, MD MSc (Denver VA Medical Center , Denver CO) Robert W Yeh MD MBA (Massachusetts General Hospital, Boston, MA) See: TCT 2011 Program (page 122)
    • Third-generation stents show promise Results: Two experimental drug-eluting stents (DES) seeking to overcome the shortcomings of current market-approved devices have shown positive results in early-phase trials. In the EVOLVE trial, the everolimus-eluting Synergy stent was tested against the market—approved Promus Element. At six months, late loss—the primary angiographic end point for the study—was no different between all stent groups. "The findings support the safety and efficacy of the novel abluminal bioabsorbable polymer Synergy everolimus—eluting stent in these low-risk lesions and pave the way for larger studies," said Dr Ian Meredith.In a second trial, the NEXT trial, a prospective, randomized controlled trial compared the polymer-free Cre8 sirolimus-eluting stent with the paclitaxel-eluting Taxus Liberté stent in patients with simple de novo CAD and showed that the Cre8stent had significantly lower late lumen loss at six months."The NEXT study results support the rationale that high-risk patients should benefit from polymer-free DES implantation,"concluded Dr Didier Carrié (Hôpital de Rangueil, Toulouse, France).See: "Third-generation" Synergy and Cre8 DES show promise
    • PARTNER B (2 years) Results: Two-year outcomes in the PARTNER B trial, testing transcatheter aortic-valve replacement (TAVR) using the Sapien device against best medical care, show that survival curves are continuing to separate and the number needed to treat to save one life dropped from five at one year to four patients at two. The FDA approved the Sapien valve for the US market, based on PARTNER B results."Two-year data continue to support the role of TAVR as the standard of care for symptomatic patients with aortic stenosis whoare not surgical candidates," said Dr Raj R Makkar (Cedars-Sinai Medical Center, Los Angeles, CA). "There was half thenumber of repeat hospitalizations in the TAVR group as in the standard-therapy group, despite the fact that there were manymore patients alive in the TAVR group at one year."See: Transcatheter valves at two years: PARTNER B
    • TWENTE Results: Another randomized controlled "real-world" trial has demonstrated noninferiority of the Resolute zotarolimus- eluting stent against the market-leading Xience everolimus- eluting stent at one year. TWENTE was designed with no limit to the number of lesions or vessels treated and no limit to lesion length or vessel size, in a cohort of patients with stable angina or non-ST-elevation ACS. In all, 1391 patients were randomized to receive the Xience V stent or the Resolute stent. At one year, rates of the primary end point of target vessel failure—a composite of cardiac death, target vessel-related MI, and clinically driven target vessel revascularization (TVR)—were nearly identical in the two groups. Rates of each end point within the composite were also very similar. Stent-thrombosis rates, both definite/probable and definite, were very low, and there was no difference between groups."Zotarolimus-eluting Resolute stents were noninferior to everolimus [Xience V stents] in terms of safety and efficacy fortreating real-world patients with a vast majority of complex lesions and off-label indications for [drug-eluting stents] DES," saidDr Clemens von Birgelen.See: Zotarolimus stent matches everolimus DES in TWENTE
    • TCT 2001 Geoffrey O Hartzler Master Clinical Operator Award On Friday, November 11, 2011, Dr Martin B Leon and Dr Gregg W Stone presented the TCT 2001 Geoffrey O Hartzler Master Clinical Operator Award to Dr Horst Sievert (CardioVascular Center Frankfurt, Sankt Katharinen Frankfurt, Germany). Dr Sievert is known for his expertise in highly specialized noncoronary interventions for patients with congenital heart disease, carotid disease, or a high risk of stroke. Dr Sievert was the first to close the left atrial appendage percutaneously and has the greatest experience worldwide in catheter closure of heart defects in adults. Over the course of his career, Dr Sievert has personally performed more than 25 000 percutaneous coronary interventions and 12 000 peripheral angioplasties as well as more than 5000 structural and valvular interventions. In addition to serving as the principal investigator of a number of clinical trials, Dr Sievert is the author of more than 200 manuscripts and 600 abstracts in peer-reviewed journals, as well as 100 books and book contributions. He has also delivered more than 1000 invited lectures around the world. See: TCT 2001 Program (page 140)
    • For more information Complete TCT 2011 coverage on theheart.org TCT 2011 Cardiovascular Research Foundation
    • Credits and disclosures Editor: Shelley Wood Managing Editor, heartwire theheart.org Kelowna, BC Disclosure: Shelley Wood has disclosed no relevant financial relationships. Contributors: Steven Rourke Manager, Editorial programming 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. Journalists: Michael ORiordan, theheart.org Toronto, ON Disclosure: Michael ORiordan has disclosed no relevant financial relationships. Steve Stiles, theheart.org Fremont, CA Disclosure: Steve Stiles has disclosed no relevant financial relationships.
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