AUGUSTUS data rolled out to global medical community

Dear colleagues,

The year could not have started better – with very compelling and positive results from the Alliance-sponsored AUGUSTUS trial.

Speaking to a packed auditorium at the AUGUSTUS late-breaker presentation at ACC in New Orleans, Principal Investigator Renato Lopes shared the data with an excited global audience.

AUGUSTUS, a safety study without a primary efficacy endpoint, showed that in patients with NVAF and a recent ACS and/or undergoing PCI treated with a P2Y₁₂ inhibitor with or without aspirin, at six months, the rate of bleeding was 31% lower with an apixaban-based regimen compared with a VKA-based regimen at the apixaban dose approved for the reduction of stroke risk.^* Furthermore, the rate of all-cause death and all-cause hospitalisation was 17% lower with the apixaban regimen compared with the VKA regimen. These findings reinforce the safety profile of apixaban in the largest study to date in this population of patients who are at high risk of bleeding.

^*5 mg BID, or 2.5 mg BID if patients met 2 or more of the following dose-reduction criteria: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 μmol/L)

Professor Renato Lopes, Durham, NC, USA presenting the AUGUSTUS data

Importantly for the medical community, AUGUSTUS also showed that the addition of aspirin to anticoagulation and P2Y₁₂ inhibitor was associated with an almost two-fold increase in bleeding risk. Professor Lopes summarised the data: In patients with atrial fibrillation and a recent ACS and/or PCI treated with a P2Y₁₂ inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in fewer occurrences of major or CRNM bleeding; treatment with apixaban was superior to VKA for occurrence of the composite of all-cause death or all-cause hospitalisation, although it failed to show superiority for occurrence of the composite of all-cause death or ischaemic events.

Apixaban vs VKA based regimen infographic

		OUR DATA IN THE SPOTLIGHT
		AUGUSTUS really hit the headlines: the ACC session was highlighted in the official meeting coverage and daily round-ups, including in a video interview of Professor Lopes; the story was also picked up by high-visibility websites such as Medscape and STAT news and by delegates on Twitter. The global ‘splash’ around AUGUSTUS was greatly amplified by the simultaneous online publication of the primary paper in the *New England Journal of Medicine* (Lopes RD, et al. NEJM 2019; doi: 10.1056/NEJMoa1817083) and through press releases by the Alliance, ACC and Duke Clinical Research Institute.

BMS and Pfizer channels drove interest on Twitter with a series of social media posts, leading to widespread engagement with the AUGUSTUS presentation and study results. Notable tweets included those from the NEJM, ACC, FiercePharma reporter Carly Felhand, Duke Medical School, Cardiology Today and from the cardiologist Dr Geoff Barnes; since the ACC presentation, tweets about the presentation and study results have exceeded 500 unique tweets and thousands of retweets.

Overall, the data were well received by the clinical community; indeed, in an interview with Professor Lopes, Professor Peter Block, Atlanta, CA, USA, called AUGUSTUS ‘a game changer for the way we take care of patients’.

		GLOBAL MEDICAL EDUCATION FOR RAPID RESULTS SHARING
		Just after the primary results presentation in New Orleans, the Alliance also held a sponsored lunchtime Medical Education symposium at the concurrent EHRA congress in Lisbon, Portugal. Using a remote setup, Professor Lopes delivered his AUGUSTUS late-breaker presentation for a second time via a video link to a packed auditorium in Lisbon – from a meeting room in New Orleans.

BUILDING ON OUR STRONG START TO 2019

We can be very proud of the positive impact the AUGUSTUS data will undoubtedly have on patients’ lives worldwide through informing decisions made by clinicians.

This study is an outstanding example of our scientific leadership in the field – and we will continue to work to help optimise care and address unmet medical needs in as many patients with NVAF and VTE as possible.

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