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For the first time in its 69-year history, the American College of Cardiology (ACC) had to cancel its annual congress, which was scheduled to take place on 28-30 March 2020 in Chicago, together with the World Congress of Cardiology (WCC). However, these societies rose to the challenge by converting the congress into an entirely virtual and free meeting: ACC.20/WCC Virtual.
At least 38,000 people from 157 countries attended the virtual congress, a number far in excess of the 16,000 people who were expected to attend the congress in person in Chicago.
Patients with peripheral artery disease (PAD) are at particularly high risk of major adverse limb and cardiovascular (CV) events after peripheral revascularization. These events are associated with a poor prognosis and can have a significant impact on a patient's quality of life and ability to function. Furthermore, there is a lack of evidence on optimal antithrombotic therapy in patients with symptomatic PAD undergoing peripheral revascularization. No previous antithrombotic strategy has demonstrated efficacy for reducing major CV and limb events in this setting. The VOYAGER PAD study aimed to address the unmet need for evidence-based antithrombotic therapy in this setting and was one of the highlights of the ACC.20/WCC virtual congress.
Professor Marc Bonaca from Brigham and Women's Hospital, Boston, MA, USA, presented the overall results of the study in a session attended by over 4000 people, which investigated the efficacy and safety of dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily (bid) plus aspirin versus aspirin in patients with symptomatic PAD undergoing peripheral revascularization.
The VOYAGER PAD study met its primary efficacy endpoint (the composite of acute limb ischaemia, major vascular amputation, myocardial infarction, ischaemic stroke or CV death), with no significant increase in the primary safety outcome of Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Specifically, the risk of the primary efficacy endpoint was significantly reduced by 15% compared with aspirin. The number needed to treat (NNT) decreased over time, from 65 at 6 months to 39 at 3 years, which demonstrated that the benefit of DPI versus aspirin accrued over time. In fact, for every 10,000 patients treated for a year, DPI was expected to prevent approximately 181 primary efficacy outcome events at the cost of 29 primary safety outcome events versus aspirin. Although the secondary safety outcome of International Society on Thrombosis and Haemostasis (ISTH) major bleeding was significantly increased, there was no increase in the risk of fatal or intracranial bleeding with DPI versus aspirin.
Professor Marc Bonaca presents the results of the VOYAGER PAD trial
The presentations can be viewed On Demand until the end of June 2020. The slides and video are also available on www.clinicaltrialresults.org. The study results were published simultaneously in the New England Journal of Medicine.
“Corroborates COMPASS trial, good news.”
“This study definitely will change practice among vascular surgeons and vascular specialists.”
“The composite primary outcome is mostly driven by ALI, which is clinically relevant.”
“DAPT does not affect limb outcomes after peripheral intervention. It's the first study that shows better limb outcomes.”
“Very low NNT values in favor of rivaroxaban for the main endpoint with overtime NNT decrease: excellent results.”
Patients with diabetes were shown to be at particularly high risk of ischaemic events in the COMPASS risk stratification analysis. At ACC.20/WCC Virtual, the results of a new subanalysis of the COMPASS trial, which focused on the subgroup of patients with diabetes, were presented by Professor Deepak Bhatt from Brigham and Women's Hospital, Boston, MA, USA, in a session attended by more than 4600 people. The analysis showed that rivaroxaban vascular dose 2.5 mg bid plus aspirin reduced the risk of major adverse cardiovascular events compared with aspirin alone, irrespective of whether patients had a history of diabetes. However, the absolute risk of major adverse cardiovascular events is higher in patients with diabetes versus those without diabetes, which means that the absolute risk reduction with DPI versus aspirin was also larger in patients with diabetes. The safety profile of DPI was consistent in patients with or without diabetes; the risk of modified ISTH major bleeding was increased, but the risk of intracranial or fatal bleeding was consistent between treatment arms. Furthermore, the prespecified net clinical benefit outcome showed a numerically larger net benefit with DPI versus aspirin in patients with diabetes compared with those without diabetes.
“Very good result. Rivaroxaban 2.5 [mg bid plus aspirin] is suitable for patients with/without diabetes. This result is the same with COMPASS main result.”
“VOYAGER+COMPASS+ATLAS-TIMI-51, all positive results, very impressive.”
Patients who have had a venous thromboembolism (VTE) are at risk of recurrence. In these patients, extended anticoagulant treatment can reduce the risk of recurrent VTE in the long term. Since long-term anticoagulation may increase the risk of bleeding, patients with a high risk of recurrent VTE and low-to-moderate risk of bleeding are expected to benefit most from extended anticoagulation for the prevention of recurrent VTE.
Dr Madhan Shanmugasundaram from the University of Arizona, Tuscan, AZ, USA, shared a poster on the results of a meta-analysis of randomized trials assessing extended-duration non-vitamin K antagonist oral anticoagulant (NOAC) treatment for preventing recurrent VTE in patients with unprovoked VTE. The meta-analysis, which included data from the EINSTEIN, EINSTEIN CHOICE and AMPLIFY-EXT studies, showed that extended NOAC therapy in patients with unprovoked VTE significantly reduced the risk of recurrent VTE by 70% compared with placebo. Although the risk of non-major bleeding was significantly increased with NOAC versus placebo, there were no statistically significant differences between treatment arms in the risk of death or major bleeding.
In another study presented as a poster by Dr Ryuki Chatani from Kurashiki Central Hospital, Kurashiki, Japan, the real-world rates of VTE recurrence and major bleeding were investigated in Japanese patients with VTE receiving NOAC therapy. Patients in this single-centre, retrospective observational study were classified according to the type of risk factor for VTE: transient, unprovoked and cancer. The rates of VTE recurrence (5.1%, 3.8% and 3.9%, respectively) and major bleeding (5.1%, 3.8% and 9.5%) were not statistically different between the three groups, and major gastrointestinal bleeding was observed mainly in patients with cancer-associated thrombosis (1.5%, 0.5% and 6.7%, respectively).