BWH cardiologists and researchers are presenting at the annual American College of Cardiology March 10 to 12 in Orlando, Fla. This year, BWH highlights include new analyses from CANTOS – a clinical trial of more than 10,000 heart attack survivors that further illuminates the importance of inflammation in cardiovascular disease – and the long-term results of MOMENTUM 3 – a clinical trial of a novel left-ventricle assist device (LVAD) for heart-failure patients. BWH investigators have also played a key role in some of the most highly anticipated news announcements for this year’s conference, including results from ODYSSEY, a clinical trial of the PCSK9 inhibitor alirocumab. BWH Clinical & Research News will continue to share news from the meeting, so check back for updates.
Here are the results of major trials presented by BWHers:
MOMENTUM 3: Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 – Long Term Outcomes, presented by Mandeep Mehra, MD: Mehra reported results from the MOMENTUM 3 trial’s analysis at 24 months, sharing new findings that provide long-term information about survival, stroke rates and durability of a novel centrifugal-flow pump compared with a commercial axial flow pump for heart-failure patients. Patients who received the centrifugal-flow pump had significantly lower rates of stroke and pump-related blood clots. Researchers report that 151 of 190 patients on the centrifugal flow pump did not experience a disabling stroke or need a re-operation (79.5 percent) compared to 106 of 176 of the patients (60.2 percent) on the axial pump. Only three people who received the centrifugal-flow pump needed a re-operation compared to 30 who received the axial pump. No re-operations occurred due to blood clots in the centrifugal-flow pump. Deaths or disabling strokes were similar between the two groups, but overall, stroke rates were less frequent in the centrifugal-flow pump group. Bleeding and infection rates were no different between the two groups.
Cardiovascular Efficacy of Canakinumab Among Patients with Chronic Kidney Disease: Analyses from the CANTOS Trial presented by Brendan Everett, MD: Everett and colleagues assessed whether the anti-inflammatory therapy canakinumab reduced rates of major adverse cardiovascular events and co-morbidities among high-risk atherosclerotic patients with pre-diabetes or diagnosed type 2 diabetes. The team found that canakinumab was equally effective at reducing rates of cardiovascular events among patients with and without diabetes enrolled in the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS). The drug reduced HbA1C levels – a key indicator of glucose tolerance – in patients with diabetes or pre-diabetes for the first six to nine months of the trial, but this effect was not sustained.
COMPASS: High Mortality after Major Adverse Limb Events in Peripheral Artery Disease: Results from the COMPASS trial: Deepak L. Bhatt, MD, MPH, FACC, executive director of BWH’s Interventional Cardiovascular Program, serves as the US co-national lead investigator for the COMPASS trial, which evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone at preventing adverse cardiovascular events. Results from COMPASS were reported in late 2017 and the cardiology community is waiting to see if the FDA will approve very low dose rivaroxaban in combination with aspirin for secondary cardiovascular prevention. “COMPASS has the potential to be practice-changing in a large proportion of patients with stable coronary or peripheral artery disease,” Bhatt recently told ACC’s Cardiology: Interventions.
ODYSSEY Outcomes: Cardiovascular Outcomes with Alirocumab After Acute Coronary Syndrome: Results of the ODYSSEY Outcomes Trial. Bhatt serves on the Executive Committee of ODYSSEY Outcomes. ODYSSEY Outcomes has examined whether the PCSK9 inhibitor alirocumab can prevent adverse cardiovascular events in high-risk patients when added to statin therapy. The international study, which included more than 18,000 patients, found a survival advantage for patients who received alirocumab after an acute coronary syndrome (ACS). Alirocumab resulted in a 15 percent relative reduction of all-cause death. Bhatt recently told ACC’s Cardiology: Interventions, “The ODYSSEY Outcomes trial will define the role of PCSK9 inhibition in cardiovascular medicine.”
Anti-Inflammatory Therapy with Canakinumab and Incident Type 2 Diabetes: A Pre-Specified Key Secondary Endpoint of the CANTOS Trial, presented by Paul Ridker, MD: In a new analysis led by Ridker, investigators found that canakinumab reduced major adverse cardiovascular event rates among high-risk atherosclerosis patients with moderate to severe chronic kidney disease, with the largest benefits accrued among those who had the most robust anti-inflammatory response. Canakinumab, an IL-1b inhibitor, represents a new class of therapy for atherosclerotic disease that lowers high sensitivity C-reactive protein (hsCRP), an important measure of inflammation, and IL-6 with no effect on lipid levels.
Residual Inflammatory and Cholesterol Risk in the FOURIER Trial presented by Erin Bohula, MD, DPHIL: On behalf of the TIMI Study group, Bohula presented results as part of a “Highlighted Original Research” session on Monday March 12. Researchers investigated whether the PCSK9 inhibitor evolocumab, which targets LDL cholesterol, consistently prevented adverse cardiovascular events irrespective of patients’ baseline hsCRP. They found that the relative benefit of evolocumab was consistent irrespective of baseline hsCRP. However, as patients with higher hsCRP levels suffered from higher rates of adverse cardiovascular events, they also tended to experience greater absolute benefit with evolocumab. Overall, the team found that rates of adverse cardiovascular events were lowest in patients with the lowest hsCRP and LDL-C. Their work, coupled with findings from CANTOS, suggests the importance of targeting both cholesterol and inflammation.