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2016 Biomedtracker / Datamonitor Healthcare Post-ESC Report

September 26, 2016

The European Society of Cardiology Congress was held in Rome, Italy from 27–31 August 2016. Data were largely incremental, though there were some interesting results supporting usage of PCSK9 inhibitors and novel oral anticoagulants (NOACs) in certain settings, as well as pivotal data for AndexXa (PTLA). New European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) dyslipidemia guidelines were also released at the meeting, and there were interesting discussions about Entresto (NVS) for heart failure.

Dyslipidemia
  • ODYSSEY ESCAPE found that Praluent (SNY, REGN) can reduce or even eliminate the need for high-cost lipoprotein apheresis treatment in patients with heterozygous familial hypercholesterolemia. However, there are questions about the magnitude of the reduction in actual practice, due to differences in criteria for skipping apheresis.
    • Soon after the conference, Repatha's (AMGN, Astellas) GLAGOV atherosclerosis imaging (using intravascular ultrasound) study was reported to be positive, bolstering confidence that the PCSK9 inhibitor’s cardiovascular outcome trials will be successful. Details from GLAGOV are to be presented at the American Heart Association Scientific Sessions in November.
  • New ESC/EAS dyslipidemia guidelines, released during the conference, recommend an absolute low-density lipoprotein- cholesterol (LDL- C) target, but also call for at least a 50% reduction if baseline LDL-C is within certain levels closer to the targets.
NOACs and Antidotes
  • Data from AndexXa's single-arm study (ANNEXA-4) in patients with clinical bleeding from factor Xa inhibitors appeared encouraging, supporting approval of the drug, though the actual clinical benefit is difficult to fully assess without a control group.
    • A rebound of anti-factor Xa activity after the end of the infusion could raise some questions about the dosing, but Portola Pharmaceuticals believes anti-factor Xa activity just needs to be suppressed long enough for a definitive hemostatic plug to be formed.
      • The ongoing study will include an amendment, requested by the US Food and Drug Administration (FDA), to allow physicians to readminister a second dose.
    • There were concerns that the rate of thrombosis was somewhat high; this will need to be followed as the study accrues more patients.
    • Company officials expect the recent complete response letter, much of which was due to manufacturing issues, to delay approval about a year, though they still need to meet with the FDA for more details on what is needed.
  • Savaysa’s (Daiichi) ENSURE-AF trial results indicated that the drug was at least as safe and effective as vitamin K antagonist-based anticoagulation in conjunction with cardioversion, helping to further bolster the case for preferential use of NOACs.
    • While such trials cannot feasibly be large enough for statistical testing, Savaysa, like Xarelto (JNJ, BAYRY) in X-VeRT, showed a numerical benefit on the primary efficacy endpoint and major bleeding.
Acute Coronary Syndrome (ACS)
  • ANTARCTIC was yet another in a series of negative trials evaluating platelet function monitoring to adjust antiplatelet therapy. In this study, Accriva's VerifyNow was used to monitor treatment with Effient (LLY, Daiichi).
    • The trial reinforces the notion that routine platelet function monitoring is not warranted. However, critics noted that not many patients in the trial had to be uptitrated due to platelet function testing, and it is not clear if the 5mg dose used initially in the elderly study population really has a substantial advantage over clopidogrel, the drug used when platelet testing suggested de-escalation.
      • Platelet function testing may still have a role in niche situations.
Heart Failure
  • Panelists at had a number of interesting comments on how physicians may approach the use of Entresto (NVO), in the context of the recent ESC heart failure guidelines.
  • Heart failure with mid-range ejection fraction is a new classification in the ESC heart failure guidelines that warrants further study.
  • ARRY-797 (ARRY) demonstrated some interesting signals of efficacy in a study of an orphan cardiomyopathy indication, but caution is warranted as the study was quite small and without a control—and some of the data were more mixed.
    • The company is not disclosing what the FDA has said about a path forward and is considering a range of options.
  • Data for stem cell therapies Stemedyne-MSC (Stemedica, Phase IIa trial) and C-Cure (Celyad, Phase III trial) were mixed, with only signals for efficacy in some endpoints or subgroup analyses.
    • Stemedica indicated it planned to further study its cells, which have the advantage of being delivered intravenously rather than injected into the heart muscle, but Celyad said it was looking for a partner for the US trial of its candidate.
    • The studies just add to the mixed picture for stem cells in cardiovascular (CV) indications, with much frustration over the lack of a large definitive study.
This report covers a number of other drug and device studies as well, including preclinical results for anti-arrhythmic AP14145 (Acesion), NORSTENT (newer generation bare-metal stents versus drug-eluting stents), DANISH (implantable cardioverter-defibrillators for non- ischemic heart failure), REM-HF and MORE-CARE (remote monitoring for heart failure), and SAVE (continuous positive airway pressure for CV disease). Like our report? Have any questions or feedback? Please let us know at askanalyst@sagientresearch.com.

For our disclosures, please read the Biomedtracker Research Standards.
Indications Covered: Acute Coronary Syndrome (ACS)
Atrial Fibrillation/Flutter
Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF)
Dyslipidemia / Hypercholesterolemia
Percutaneous Coronary Interventions (PCIs) for Stable Angina
Stroke Prevention in Atrial Fibrillation (SPAF)
Venous Thromboembolism (VTE)