The European Society of Cardiology (ESC) 2012 Congress took place in Munich, Germany, from August 25 through August 29.
Key trials presented at the sessions include:
• WOEST: Drop aspirin in stent patients on oral anticoagulants
• ALTITUDE: Increase in ischemic stroke played role in decision to stop trial
• FAME II: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) reduces urgent reinterventions but does not change mortality or myocardial infarction (MI)
• TRILOGY ACS: No win for prasugrel over clopidogrel in high-risk patients with acute coronary syndrome (ACS) who are medically managed without revascularization
• ACCESS EU: Encouraging registry data on the MitraClip
• PURE: Healthy lifestyle factors and diet are linked with income
• GARY: Transcatheter aortic valve implantation (TAVI) in-hospital death, stroke rates stay low even as use climbs
• IABP SHOCK II: No survival benefit of balloon pump in acute MI with shock
• PARAMOUNT: Dual-action agent shows promise in preserved ejection fraction (EF) heart failure
• DeFACTO: Results encouraging for "virtual" FFR despite missing target
WOEST
Drop aspirin in stent patients on oral anticoagulants
Patients on oral anticoagulant therapy who are undergoing stenting should be treated with clopidogrel but not aspirin, according to results reported at ESC 2012. Presenting the trial, Dr Willem Dewilde (TweeSteden Hospital, Tilburg, the Netherlands) noted that oral anticoagulants are obligatory in most patients with AF and those with mechanical heart valves. The study showed a large reduction in overall bleeding using the Thrombolysis in Myocardial Infarction (TIMI) criteria in patients receiving dual therapy with oral anticoagulants and clopidogrel compared with those receiving triple therapy including aspirin. 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, Minnesota). "How to treat atrial fibrillation (AF) patients undergoing stenting is a huge clinical problem. These results have incredibly important clinical implications. They are going to change guidelines overnight."
ALTITUDE
Increase in ischemic stroke played role in decision to stop trial
New data shed more light on why the trial of the direct renin inhibitor aliskiren (Tekturna®, Novartis) was halted prematurely. The trial was studying the effects of aliskiren on top of angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker therapy in diabetic patients with renal disease (glomerular filtration rate <60 mL/min per 1.73 m2 or microalbuminuria). It was stopped late last year by the data and safety monitoring board because of 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. As more data have come in, this finding is no longer statistically significant, although it still shows 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 harm here, but it could also be a chance finding," said Parving. He stressed that an increased risk for stroke is converse to what would be expected with a drug that lowers blood pressure and has not been seen in any studies of the drug in hypertension. "It is a very peculiar finding. It is certainly unique to have a blood-pressure-lowering medication that increases stroke risk."
FAME II
FFR-guided PCI reduces urgent reinterventions but does not change mortality or MI
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 trial's 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 urgent revascularization than patients randomized to optimal medical therapy.
Although FAME II did not show any mortality or MI benefit for PCI among patients with stable coronary disease, the difference in the need for urgent revascularizations is an important benefit, insists lead investigator Dr Bernard De Bruyne (OLV Clinic, Aalst, Belgium). All of the urgent revascularizations were performed in patients fulfilling the criteria for acute coronary syndrome, either with acute MI, ECG evidence of ischemia, or clear unstable angina. De Bruyne also pointed out that a landmark analysis showed that PCI patients were more likely to die or have an MI than the medical-therapy-only patients within the first week after randomization, but this trend reversed after 8 days, "suggesting that over time, we might witness the emergence of a significant difference."
TRILOGY ACS
No win for prasugrel over clopidogrel in high-risk patients with ACS who are medically managed without revascularization
In one of the few studies to focus on high-risk patients with ACS who are medically managed without revascularization, the newer antiplatelet agent prasugrel (Effient®, Lilly/Daiichi-Sanyo) 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, Durham, North Carolina). But, he says, there was a surprising twist: The study had a median duration of 17 months -- 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."
ACCESS EU
Encouraging registry data on the MitraClip
Encouraging new results were presented from the largest registry yet using the MitraClip (Abbott, Abbott Park, Illinois) in patients with mitral regurgitation who are unsuitable for surgery. The new data come from the ACCESS-EU registry, which included 567 patients from 4 European countries (Denmark, Switzerland, Italy, and Germany). A high implant success rate (99.6%); a low rate of procedural events; and meaningful improvements in New York Heart Association class, mitral regurgitation (MR) grade, quality of life, and walking distance were reported in this elderly, symptomatic, high-risk population with multiple comorbidities.
Wolfgang Schillinger (University Medical Center Göttingen, Germany) commented, "It took time to get going, but numbers are now taking off. There is a large group of patients who may benefit from this procedure, and our data are likely to increase demand in the markets where is it available." Dr Simon Ray (Academic Health Science Centre, Manchester, United Kingdom) stressed, however, that the procedure should be done only to improve symptoms. "There is no evidence that it improves 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."
PURE
Healthy lifestyle factors and diet are linked with income
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, Ontario, Canada), the lead researcher of the PURE study, said that the study, which describes an "epidemiological transition," might help shift global food policies so that countries subsidize the production of fruits and vegetables rather than meat and dairy. In addition, the study highlights an insufficient policy approach when it comes to increasing levels of physical activity.
GARY
TAVI in-hospital death, stroke rates stay low even as use climbs
Data collected in 2011 for the German Aortic Valve Registry (GARY) suggest that several forms of TAVI were being used primarily in high-risk patients, just as the guidelines recommend. Although the in-hospital rate of cerebrovascular events was lowest for conventional surgery in absolute terms, it wasn't significantly higher in the TAVI groups and stayed fairly low for those patients -- "in the 3.5% range," said Dr Christian W Hamm (Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany). Nor was the risk significant between the 2 main categories of TAVI based on the catheter approach, transfemoral and transapical.
IABP SHOCK II
No survival benefit of balloon pump in acute MI with shock
Use of an intra-aortic balloon pump (IABP) offered no mortality benefits at 30 days in the 600-patient IABP SHOCK II trial. Although use of the pump may make PCI safer by improving left ventricular unloading, this did not translate into a survival benefit or give a boost to any of the secondary endpoints in the study, investigators observed.
"We were really surprised by the results," said Dr Holger Thiele (University of Leipzig, Germany). "We thought we'd at least find something positive in the secondary endpoints. Our assumption was that the trial would be positive, but we have to live with the results. That's why we need randomized trials."
PARAMOUNT
Dual-action agent shows promise in preserved-EF heart failure
In a randomized comparison -- a phase 2 study of the angiotensin-receptor/neprilysin inhibitor LCZ696 (Novartis) vs the ARB valsartan -- levels of a biomarker of heart failure severity dropped significantly in patients with heart failure and preserved EF 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," said lead investigator Dr Scott D Solomon (Brigham and Women's Hospital, Boston, Massachusetts). The subgroup analysis broke patients out by age, normal vs elevated systolic blood pressure, low vs preserved left ventricular EF, with vs without AF or poor renal function, and with vs without a prior admission for heart failure. "But there was one subgroup in which [LCZ696] was more effective." There was a significant interaction in patients with diabetes, added Solomon. "It appeared to be even more efficacious in that subgroup, even though it was effective in every subgroup."
New European STEMI guidelines emphasize care coordination
Authors of the new ESC guidelines for the management of patients with acute ST-elevation MI (STEMI) hope that 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 2 hours of presentation seems to be impossible, then fibrinolysis should be administered within 30 minutes.
DeFACTO
Results encouraging for "virtual" FFR despite missing target
Noninvasive FFR calculated from CT angiography (FFRCT) did not achieve the prespecified target for diagnostic accuracy in the 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, North Carolina) 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."
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Credits and disclosures
Editor:
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, British Columbia, Canada
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Contributors:
Steven Rourke
Editorial Director
theheart.org
Montreal, Quebec, Canada
Disclosure: Steven Rourke has disclosed no relevant financial relationships.
Maria Turner
Montreal, Quebec, Canada
Disclosure: Maria Turner has disclosed no relevant financial relationships.
Journalists:
Sue Hughes, theheart.org
London, United Kingdom
Disclosure: Sue Hughes has disclosed no relevant financial relationships.
Reed Miller, theheart.org
State College, Pennsylvania
Disclosure: Reed Miller has disclosed no relevant financial relationships.
Lisa Nainggolan, theheart.org
London, United Kingdom
Disclosure: Lisa Nainggolan has disclosed no relevant financial relationships.
Michael O'Riordan, theheart.org
Toronto, Ontario, Canada
Disclosure: Michael O'Riordan has disclosed no relevant financial relationships.
Steve Stiles, theheart.org
Fremont, California
Disclosure: Steve Stiles has disclosed no relevant financial relationships.
