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Top News From AHA 2016: Slideshow

Steve Stiles; Darbe Rotach; Fredy Perojo; Patrice Wendling; Larry Hand; Marlene Busko; Allison Shelley; Megan Brooks  |  November 28, 2016

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Slide 1

Widely anticipated results of the PRECISION study on the relative safety of different nonsteroidal anti-inflammatory drugs in high-CV-risk patients and a host of other key clinical trials greeted attendees here at the American Heart Association (AHA) 2016 Scientific Sessions, held November 12 to 16, in New Orleans, Louisiana.

Slide 2

In addition to the PRECISION trial, key studies presented at this year's sessions include:

  • ART: No gain from bilateral vs single internal mammary artery bypass graft
  • HOPE-3: Statin did not harm, but BP therapy did not help cognition
  • GLAGOV: PCSK9 inhibitor evolocumab shows atheroma reduction on top of statins
  • RE-VERSE AD: Dabigatran antidote idarucizumab fast and effective
  • PIONEER AF-PCI: New strategies for AF patients undergoing PCI cut bleeding
  • EFFECT-HF, IRONOUT: Support for IV but not oral iron supplementation in HF
Slide 3

PRECISION: Celecoxib Similar to Ibuprofen, Naproxen for CV Risk

The long-awaited PRECISION trial suggests the selective cyclooxygenase-2 inhibitor celecoxib has cardiovascular safety similar to naproxen and ibuprofen in arthritis patients at increased CVD risk but is unlikely to be the last word, given questions about interpretation of the data. Celecoxib achieved noninferiority for the primary CV end point—the Antiplatelet Trialists Collaboration (APTC) composite of CV and hemorrhagic deaths, nonfatal MI, or nonfatal stroke—for the intention-to-treat and on-treatment populations. Ibuprofen also just met the noninferiority criteria compared with naproxen. Celecoxib, however, was associated with fewer GI events than either NSAID and fewer renal events than naproxen. "After the withdrawal of rofecoxib [Vioxx, Merck] everybody thought they knew the answer; that COX-2 inhibitors have an unfavorable cardiovascular profile," principal investigator Dr Steven Nissen (Cleveland Clinic, OH) said. "We didn't find that." But some experts have reservations, including Dr Clyde Yancy (Northwestern University, Chicago, IL). He called the noninferiority data "reassuring" but expressed concerns about treatment doses, a 68.8% treatment discontinuation rate, and 27.4% loss of patients to follow-up, which "appears to be even above the threshold that would qualify as an acceptable data set."

Slide 4

ART: No Gain From Bilateral vs Single IMA Bypass Graft

Contrary to conventional wisdom, there was no improvement in 5-year outcomes using bilateral vs single internal mammary artery (IMA) grafts in patients with symptomatic CAD, according to an interim report from the Arterial Revascularization Trial (ART). All-cause mortality was 8.7% with bilateral IMA and 8.4% with single left IMA plus vein grafts (hazard ratio [HR] 1.04; P=0.77). The composite of death, MI, or stroke at 5 years was also similar (12.2% vs 12.7%, HR 0.96; P=0.69), as were rates of repeat revascularization and angina. Principal investigator Dr David Taggart (University of Oxford, UK) said the results are somewhat surprising, but "at this stage, for people who believe in arterial grafts because of the very convincing angiographic data, they're not going to stop doing them."

Slide 5

Statin Didn’t Harm, BP Therapy Didn’t Help Cognition: HOPE-3

In patients age 70 and older with an intermediate risk of cardiovascular disease, 5.6 years of antihypertensive therapy did not improve their cognitive function, but statin treatment did not worsen it, in a new study. Dr Jackie Bosch (McMaster University, Hamilton, ON) reported the findings from a subset of older patients who were part of the Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial. These findings should "put to rest" any concerns that statins may cause memory loss, she said. The US Food and Drug Administration (FDA) had required a boxed warning based on observational postmarketing surveillance data, as did the UK Medicines and Healthcare Products Regulatory Agency (MHRA), "but randomized controlled trials never showed the same issues.... Our study clearly shows that there is no negative effect on cognition," Bosch noted.

Slide 6

GLAGOV: Evolocumab on Top of Statins Shows Atheroma Reduction

Adding the PCSK9 inhibitor evolocumab (Repatha) to statin therapy produced significant atheroma regression and a continuous benefit with LDL-C levels as low as 20 mg/dL in the GLAGOV trial presented here by study chair Dr Steven Nissen (Cleveland Clinic, OH). "While we have to wait for the clinical-outcome studies to know for sure, we think this [intravascular ultrasound] IVUS trial is a signal of the benefit that can be achieved with very low levels of LDL-C," Nissen said. "This is the first time we have looked at what happens in the artery at such low levels of LDL-C, and I think we can say the GLAGOV study provides intriguing evidence that the clinical benefits of lowering LDL can extend to levels as low as 20 mg/dL." Study discussant Dr Raul Santos (InCor University of San Paulo, Brazil) said, "This study confirms the role of LDL-C in atherosclerosis modification and suggests we are at the start of a new era in lipid management."

Slide 7

Dabigatran Antidote Fast, Effective in RE-VERSE AD: Now What?

An agent that reverses the anticoagulation effect of dabigatran (Pradaxa) worked almost right away after infusion, with an effect lasting 2 days, in a new study. The analysis included almost 500 patients who were on the oral direct thrombin inhibitor when they developed severe bleeding or needed urgent surgery. The patients in the cohort, said to be a broad reflection of "real-world" clinical practice, achieved hemostasis within about 4 hours after administration of the reversal agent, idarucizumab (Praxbind), with normalization of coagulation metrics in virtually every case. And most patients went back on oral anticoagulation within days, usually with dabigatran. "When you give idarucizumab, literally within seconds you see reversal. It's almost instantaneous," said Dr Charles V Pollack (Thomas Jefferson University, Philadelphia, PA), principal investigator of the Reversal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD) study.

Slide 8

New Strategies for AF Patients Undergoing PCI Cut Bleeding

A new study may provide more options for anticoagulation and antiplatelet therapy in patients with atrial fibrillation (AF) undergoing PCI with stenting. The PIONEER AF-PCI trial compared standard anticoagulation with a vitamin K antagonist plus dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor plus aspirin for 1, 6, or 12 months with either low-dose rivaroxaban (Xarelto) plus a P2Y12 inhibitor for 12 months or very-low-dose rivaroxaban plus DAPT for 1, 6, or 12 months. Both approaches were associated with a lower rate of bleeding vs standard therapy, and the three groups had similar efficacy rates, although the observed broad confidence intervals diminish the surety of any conclusions regarding efficacy, the researchers said. "The bottom line is you would only have to treat about 11 or 12 people with one of these strategies to prevent a bleeding event, and you'd only have to treat 10 to 15 people to prevent one rehospitalization effectively," concluded lead author Dr C Michael Gibson (Beth Israel Deaconess Medical Center, Boston, MA).

Slide 9

Iron Supplementation in HF: Trials Support IV but Not Oral

The issue of iron supplementation in patients with chronic heart failure remains unsettled after two new studies testing oral and intravenous iron yielded conflicting results. Peak oxygen uptake significantly improved when compared with standard of care after three IV injections of ferric carboxymaltose in HF patients with and without anemia in EFFECT-HF, while functional capacity and other outcomes failed to improve with a considerably cheaper oral iron supplement in the IRONOUT study. Iron deficiency is present in about half of patients with chronic HF and is an independent predictor of mortality. Invited discussant and EFFECT-HF investigator Dr Stefan Anker (University Medicine Göttingen, Germany) said IRONOUT was an excellent trial done by expert teams, but the simple conclusion is that oral iron does not work in heart failure.

Slide 10

MILANO PILOT Clouds Promise of Infusible ApoA-1 for CAD

Final data from the MILANO PILOT clinical trial crushed initial enthusiasm for recombinant apolipoprotein A-1 (apoA-1) Milano, while data from the AEGIS-1 study righted hopes for the reconstituted human apoA-1 CSL112 (CSL Behring) after a rocky start with an earlier formulation. The MILANO-PILOT study was unable to confirm a 2003 study showing weekly infusions of apoA-1 Milano, an HDL mimetic, produced significant regression of coronary atherosclerosis assessed by intravascular ultrasound (IVUS) in ACS patients. The median change in the primary end point of percent atheroma volume was -0.5% after five infusions of MDCO-216 (the Medicines Company), as the agent is known, and -0.8% with placebo (P=0.10), reported study cochair Dr Stephen Nicholls (University of South Wales, Sydney, Australia). The phase 2b dose-ranging AEGIS-1 trial met its primary end point (safety) for CSL112. By enhancing cholesterol-efflux capacity, it is thought CSL112 may stabilize additional lesions at risk of rupture, thereby reducing the rate of recurrent events after an MI, said study cochair Dr C Michael Gibson (Beth Israel Deaconess Medical Center, Boston, MA).

Slide 11

TRUE-AHF Shakes Up Beliefs About Acute Heart-Failure Therapy

Early IV treatment with a synthetic natriuretic peptide decongested patients with acute decompensated heart failure and made them feel better in the first 48 hours but did nothing to improve long-term survival in the large randomized TRUE-AHF trial. Nor did the drug, ularitide (Cardiorentis), an analogue of native urodilatin, seem to protect the myocardium from damage as measured by troponin levels, which was an important prospective end point in the trial. "There is a hypothesis that somehow if you intervene early in patients with heart failure using something magical for 48 hours, that somehow just giving a drug for 48 hours changes the course of the disease for months and years afterward," said executive committee chair Dr Milton Packer (Baylor University Medical Center, Dallas TX). "That's true of acute coronary syndromes, but it's not true of acute heart failure."

Slide 12

Interatrial Shunt Promising for Heart Failure With Preserved Ejection Fraction

For patients with heart failure with preserved ejection fraction, implantation of an interatrial shunt device appeared to be safe and was associated with clinical and hemodynamic improvements sustained for 1 year, according to results of the REDUCE LAP HF study. In his presentation, Dr David Kaye (Alfred Hospital, Melbourne, Australia) concluded: "Taken together, this study provides the longest experience with an interatrial shunt device specifically developed for the management of heart failure with preserved ejection fraction and provides additional longitudinal support for the safety and efficacy of this approach." Study discussant Dr Nancy Sweitzer (Sarver Heart Center, University of Arizona, Tucson) said the 12-month results were reassuring on safety and the efficacy looked promising but needs confirmation in a randomized trial.

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