ESC 2012 research highlights: A slideshow presentation


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The European Society of Cardiology (ESC) 2012 Congress took place in Munich, Germany from August 25 through August 29, 2012. Key trials presented at the sessions include: WOEST, ALTITUDE, FAME II, TRILOGY ACS, ACCESS EU,PURE, GARY. IABP SHOCK II, PARAMOUNT and DeFACTO

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ESC 2012 research highlights: A slideshow presentation

  1. 1. ESC 2012 research highlights:A slideshow presentation
  2. 2. ESC 2012 Research Highlights he European Society of Cardiology (ESC) 2012 Congress took place in Munich, Germany from August 25 through August 29, 2012. Key trials presented at the sessions include: WOEST: Drop aspirin in stent patients on oral anticoagulants ALTITUDE: Details on why the trial was stopped, including the role of ischemic stroke FAME II: FFR-guided PCI reduces urgent reinterventions, but does not change mortality, MI TRILOGY ACS: No win for prasugrel in high-risk patients with ACS who are medically managed without revascularization ACCESS EU: Encouraging registry data on the MitraClip PURE: Healthy lifestyle factors and diet linked with income GARY: TAVI in-hospital death, stroke rates stay low even as use climbs IABP SHOCK II: No survival benefit of balloon pump in AMI with shock PARAMOUNT: Dual-action agent shows promise in preserved- EF heart failure DeFACTO: Results encouraging for "virtual" FFR despite missing target
  3. 3. WOEST Drop aspirin in stent patients on oral anticoagulants Results: Patients on oral anticoagulant therapy undergoing stenting should be treated with clopidogrel but not aspirin, according to results reported at the ESC 2012. The study showed a large reduction in overall TIMI bleeding in patients receiving dual therapy with oral anticoagulants and clopidogrel compared with those receiving triple therapy including aspirin. And efficacy did not seem to be compromised. If anything, there appeared to be lower rates of ischemic events and a significant reduction in all-cause mortality. "This is a huge deal," said Dr David Holmes (Mayo Clinic, Rochester, MN). "How to treat AF patients undergoing stenting is a huge clinical problem. These results have incredibly important clinical implications. They are going to change guidelines overnight." See: WOEST: Drop aspirin in stent patients on oral anticoagulants
  4. 4. ALTITUDE Increase in ischemic stroke played role in decision to stop trial Results: New data from the trial with the direct renin inhibitor aliskiren (Tekturna, Novartis) in diabetic patients were released at the ESC 2012, shedding more light on why the trial was halted prematurely. The trial, which was studying the effects of aliskiren on top of ACE-inhibitor or angiotensin-receptor-blocker (ARB) therapy in diabetic patients with renal disease (glomerular filtration rate <60 mL/min per 1.73 m2 or microalbuminuria), was stopped late last year by the data and safety monitoring board. The reason given was no apparent benefit and an increase in adverse events, including nonfatal stroke, renal complications, hyperkalemia, and hypotension. Dr Hans-Henrik Parving (University of Copenhagen, Denmark) said an increase in ischemic stroke was "prominent" in the decision to stop the trial. At the time the decision was made, the increase in stroke was significant in the aliskiren group, but as more data have come in, this finding is no longer statistically significant, although they still show a strong signal."There was a 25% relative increase in stroke risk in the aliskiren group, which is a warning signal that there could be harmhere, but it could also be a chance finding," said Parving. He stressed that an increased risk of stroke is converse to whatwould be expected with a drug that lowers blood pressure and has not been seen in any studies of the drug inhypertension. "It is a very peculiar finding. It is certainly unique to have a blood-pressure–lowering medication thatincreases stroke risk."See: ALTITUDE: New data on why trial halted
  5. 5. FAME II FFR-guided PCI reduces urgent reinterventions, but does not change mortality, MI Results: Stable patients who got a stent to treat a functionally significant coronary lesion were less likely to need an urgent reintervention than those treated with medical therapy alone. However, all the other outcomes, including mortality, were the same with either therapy, so the significance of the trials findings remains controversial. The trial was stopped last winter—over the objections of some outside observers—after an interim analysis clearly showed that patients randomized to PCI were much less likely to need an urgent revascularization than patients randomized to optimal medical therapy.Although FAME II did not show any mortality or MI benefit for PCI among stable coronary disease patients, the differencein the need for urgent revascularizations is an important benefit, insists lead investigator Dr Bernard De Bruyne (OLVClinic, Aalst, Belgium). All of the urgent revascularizations were performed in patients fulfilling the criteria for acutecoronary syndrome, either with acute MI, ECG evidence of ischemia, or clear unstable angina. De Bruyne also pointed outthat a landmark analysis showed that PCI patients were more likely to die or have an MI than the medical-therapy-onlypatients within the first week after randomization, but this trend reversed after eight days, "suggesting that over time, wemight witness the emergence of a significant difference."See: FAME II: FFR-guided PCI reduces urgent reinterventions, but not change mortality, MI
  6. 6. TRILOGY ACS No win for prasugrel (over clopidogrel) in high-risk patients with ACS who are medically managed without revascularization Results: In one of the few studies to focus on high-risk patients with acute coronary syndrome (ACS) who are medically managed without revascularization, the newer antiplatelet agent prasugrel (Effient, Lilly/Daiichi-Sanyo) has failed to show a reduction in major cardiovascular events compared with clopidogrel. "This trial does not suggest a priori that prasugrel should be used for medically managed patients, because the results are neutral," said senior author Dr Magnus Ohman (Duke Clinical Research Institute). But, he says, there was a surprising twist. The study was a median of 17 months in length, longer than most previous trials in ACS, he noted, and "the most striking thing is that there appears to be a time-dependent treatment effect." See: No win for prasugrel in TRILOGY ACS
  7. 7. ACCESS EU Encouraging registry data on MitraClip Results: Encouraging new results with the MitraClip (Abbott, Abbott Park, IL) in patients with mitral regurgitation who are unsuitable for surgery have been presented from the largest registry yet with the product. The new data come from the ACCESS-EU registry, which included 567 patients from four European countries (Denmark, Switzerland, Italy, and Germany). There was a high implant success rate (99.6%), low rate of procedural events, and meaningful improvements in NYHA class, MR grade, quality of life, and walking distance reported in this elderly, symptomatic, high-risk population with multiple comorbidities."In expert hands, MitraClip is feasible and has an acceptable procedural risk in patients with comorbidities, but the wordexpert needs to be reiterated," said designated discussant of the study Dr Simon Ray (Academic Health Science Centre,Manchester, UK). He stressed that the procedure should be done only to improve symptoms. "There is no evidence that itimproves mortality, and there is no point improving MR grade if there is no symptomatic improvement. And as 25% to 35%of patients derive little or no symptomatic benefit, patient selection is a key issue."See: ACCESS EU: Encouraging registry data on MitraClip
  8. 8. PURE Healthy lifestyle factors and diet linked with income Results: In this newest analysis, energy from total fat, saturated fats, and protein increased almost linearly with increasing incomes. Carbohydrate intake, on the other hand, made up approximately 65% of energy from diets in poor nations, with the percentage declining in wealthier nations. The consumption of fruits and vegetables increased among nations with a higher gross domestic product (GDP) and wealth index, but this was offset by an increase in the amount of energy obtained from total and saturated fats, as well as from protein. In terms of physical activity, the researchers observed that the amount of recreational physical activity increased with increasing GDP and wealth, but this increase was offset by a reduction in the amount of obligatory physical activity, such as activity required for physical labor. Overall, the net result was a reduction of approximately 2000 METS/minute/week, or 2.7 hours of brisk walking every day, among countries with higher incomes.Dr Salim Yusuf (McMaster University, Hamilton, ON), the lead researcher of the PURE study, said the study, whichdescribes an "epidemiological transition," might help shift global food policies so that countries subsidize the production offruits and vegetables rather than meat and dairy. In addition, the study highlights an insufficient policy approach when itcomes to increasing physical-activity levels.See: Healthy lifestyle factors and diet linked with income: PURE
  9. 9. GARYTAVI in-hospital death, stroke rates stay low even as use climbsResults: Data collected in 2011 for the German Aortic Valve Registry (GARY) suggest that several forms oftranscatheter aortic-valve implantation (TAVI) were being used primarily in high-risk patients, just as the guidelinesrecommend, researchers concluded at ESC 2012.Although the in-hospital rate of cerebrovascular events was lowest for conventional surgery in absolute terms, it wasntsignificantly higher in the TAVI groups and stayed fairly low for those patients, "in the 3.5% range," said Dr Christian WHamm (Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany). Nor was the risk significant between the two maincategories of TAVI based on the catheter approach, transfemoral and transapical.See: GARY: TAVI in-hospital death, stroke rates stay low even as use climbs
  10. 10. IABP SHOCK II No survival benefit of balloon pump in AMI with shock Results: Use of an intra-aortic balloon pump (IABP) offered no mortality benefits at 30 days in the 600-patient IABP SHOCK II trial, according the trial results presented in a hot-line session at ESC 2012. While use of the pump may make PCI safer by improving left ventricular unloading, this did not translate into any survival benefit or give a boost to any of the secondary end points in the study, investigators observed. "We were really surprised by the results," said Dr Holger Thiele (University of Leipzig, Germany). "We thought wed at least find something positive in the secondary end points. Our assumption was that the trial would be positive, but we have to live with the results. Thats why we need randomized trials." See: IABP SHOCK II: No survival benefit of balloon pump in AMI with shock
  11. 11. PARAMOUNT Dual-action agent shows promise in preserved-EF heart failure Results: In a randomized comparison, in a phase 2 study of the angiotensin-receptor/neprilysin inhibitor (ARNI) LCZ696 (Novartis) vs the angiotensin-receptor blocker (ARB) valsartan, levels of a heart-failure severity biomarker dropped significantly in patients with heart failure and preserved ejection fraction (HF-PEF) who received the newer agent for 12 weeks, compared with those who received the ARB. Systolic blood pressure fell significantly more in patients receiving LCZ696. And the drug was associated with significant improvements in left atrial size and volume and in NYHA functional class at 36 weeks."LCZ696 was effective for the primary [natriuretic-peptide] end point in every single one of the subgroups tested," saidlead investigator, Dr Scott D Solomon (Brigham and Womens Hospital, Boston, MA). The subgroup analysis brokepatients out by age, normal vs elevated systolic blood pressure, low vs preserved left ventricular ejection fraction, with vswithout atrial fibrillation or poor renal function, and with vs without a prior HF admission. "But there was one subgroup inwhich [LCZ696] was more effective." There was a significant interaction in patients with diabetes, added Solomon. "Itappeared to be even more efficacious in that subgroup, even though it was effective in every subgroup."See: PARAMOUNT phase 2 study: Dual-action agent shows promise in preserved-EF heart failure
  12. 12. New European STEMI guidelines emphasizecare coordination Summary: Authors of the new European Society of Cardiology (ESC) guidelines for the management of patients with acute ST-elevation MI (STEMI) hope their recommendations spur efforts to improve the speed and efficiency of STEMI care in Europe. The new guidelines are "much more demanding [than the 2008 guidelines] in terms of delays," said Dr Gabriel Steg, chair of the task force that wrote the new recommendations. The new standard for time from medical contact to ECG is 10 minutes, and "the fact that you use primary PCI should not lead to complacency about the delays. You should target 60 minutes." Two hours is the limit of acceptable delay for a patient transferred from a non-PCI center to a PCI center, but the target should be 90 minutes, Steg said. If PCI within two hours of presentation appears to be impossible, then fibrinolysis should be administered within 30 minutes. See: New European STEMI guidelines emphasize care coordination
  13. 13. DeFACTO Results encouraging for "virtual" FFR despite missing target Results: Noninvasive fractional flow reserve calculated from computed tomography angiography (FFRCT) did not achieve the prespecified target for diagnostic accuracy in the Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (DeFACTO) trial. Nevertheless, investigators are optimistic that FFRCT can become an important tool for efficiently identifying high-grade stenoses and determining the hemodynamic significance of lesions. In an editorial on the study, Dr Manesh Patel (Duke University, Durham, NC) writes that FFRCT "represents a novel and important innovation, with the possibility not only to diagnose but also to help direct invasive treatment." Because FFRCT demonstrated only "modest" specificity in DeFACTO, "at first glance, readers of the study may consider FFRCT technology to be limited based on the results presented," Patel acknowledges. "However, this would be a naive conclusion, likely based on the published diagnostic performance of noninvasive tests compared only with invasive angiography." See: DeFACTO results encouraging for "virtual" FFR despite missing target
  14. 14. For more information Complete ESC 2012 coverage on ESC Congress 2012 European Society of Cardiology
  15. 15. Credits and disclosures Editor: Journalists: Shelley Wood Sue Hughes, Managing Editor, heartwire London, UK Disclosure: Sue Hughes has disclosed no Kelowna, BC relevant financial relationships. Disclosure: Shelley Wood has disclosed no relevant financial relationships. Reed Miller, State College, PA Contributors: Disclosure: Reed Miller has disclosed no Steven Rourke relevant financial relationships. Editorial Director Montreal, QC Lisa Nainggolan, Disclosure: Steven Rourke has London, UK disclosed no relevant financial Disclosure: Lisa Nainggolan has disclosed relationships. no relevant financial relationships. Maria Turner Michael ORiordan, Montreal, QC Toronto, ON Disclosure: Maria Turner has disclosed Disclosure: Michael ORiordan has no relevant financial relationships. disclosed no relevant financial relationships. Steve Stiles, Fremont, CA Disclosure: Steve Stiles has disclosed no relevant financial relationships.
  16. 16. More slideshows EuroPCR 2012 research highlights HRS 2012 research highlights ACC 2012 research highlights
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