The interim results of EVAPORATE trial, a study on the effect of Icosapent Ethyl on coronary plaque progression in statin-treated patients with elevated Triglyceride (TG) level (200-499mg/dl), were presented by Dr. Matthew Budoff at the American Heart Association 2019 meeting. Dr. Budoff and his team found that in patients with coronary atherosclerosis treated with statins, the addition of Icosapent Ethyl​ (Vascepa) was not associated with a change in low attenuation plaque volume but was associated with a decrease in total plaque volume. However, these are preliminary findings and the trial is set for completion at 18 months.

Icosapent Ethyl, a high‐purity eicosapentaenoic acid (EPA) derivative, has been approved as an adjunct to diet for the reduction of TG levels in adults with elevated TG levels. Its utility has been associated with an increase in serum EPA levels, a lower serum TG level as well as a decrease in inflammatory markers. A prior trial investigated the effect of long-term eicosapentaenoic acid (1.8 g/d) on more than 18000 statin-treated patients, in Japan, showed a significant reduction (19%) in the relative risk of major coronary events.

In the EVAPORATE trial, statin-treated patients with coronary atherosclerosis (defined by narrowing≥20% in 1 coronary artery by either invasive angiography or multidetector computed tomography angiography (MDCTA)) and elevated serum TG levels (135-499mg/dl) were enrolled. Exclusion criteria included severe heart failure, hypersensitivity to contrast or fish and renal insufficiency. The primary endpoint of the study was progression rates of low attenuation coronary plaques as measured by MDCTA. The secondary endpoints were the quantitative changes in plaque morphology, inflammatory markers and the relationship between plaque vulnerability and these changes.

A total of 80 individuals participated in the study (40 randomized to receive Icosapent Ethyl and 40 to receive the placebo). Participants were evaluated at baseline, 3 and 9 months of the study. At baseline, each participant underwent a cardiac computed tomography angiography (CCTA) to evaluate plaque morphology and volume as well as its composition. At 9 months, compared to placebo, Icosapent Ethyl slowed low attenuation coronary plaque progression by 21% (p=0.469). Although the primary outcome was statistically insignificant, the study continues until 18 months. Secondary outcomes of the study were promising, including a reduction in total non-calcified plaque volume by 19% (p = 0.01) and a 42% (p <0.0004) reduction in total plaque volume.

In an interview with Dr. C. Michael Gibson, Dr. Budoff discussed the primary findings of the trial. He noted that the increase in serum EPA levels significantly increased in those receiving Icosapent Ethyl and this increase was associated with a coronary plaque regression as well as an anti-inflammatory effect.

This study limited by some points. First, the follow-up duration was shorter than prior studies. Second, the primary endpoint was not statistically significant at the interim time point. The ultimate result of this trial may further define the potential clinical benefits of Icosapent Ethyl on atherosclerotic disorders.

Click here to view the study slides.

Click here to listen to Dr. Budoff and Dr. Gibson discuss the findings of the study.

A randomized parallel-group trial comparing intensive LDL-C lowering to modest lowering for prevention of major adverse cardiovascular events (MACE) in patients with recent ischemic stroke in the setting of atherosclerosis has shown that an aggressive LDL-C reduction strategy with a goal of < 70mg/dl is superior to modest reduction approach which targets a range of 90-110 mg/dl.

Results of the Treat Stroke to Target Trial (TST trial) which enrolled 2860 patients (32% females) with a median follow-up of 3.5 years were presented by Dr. Amarenco (Department of Neurology and Stroke Center, Bichat Hospital, France) at AHA 2019 and simultaneously published in The New England Journal of Medicine.

Patients with established atherosclerotic cardiovascular disease (ASCVD) and ischemic stroke within the past 3 months or transient ischemic stroke (TIA) within the past 15 days (modified Rankin score of 0-3) were randomized in 1:1 fashion to statin therapy with either a goal LDL-C of < 70 mg/dl (n =1430) or 90-110 mg/dl (n = 1430).

The primary efficacy endpoint of the trial was composite of MACE (nonfatal cerebral infarction or stroke of undetermined origin, nonfatal myocardial infarction, hospitalization for unstable angina followed by urgent coronary-artery revascularization, TIA treated with urgent carotid revascularization, or CV death). The primary outcome occurred in 8.5% of patients assigned to the group with intensive LDL lowering compared to 10.9% of patients in the modest control approach (adjusted hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.04). Mean LDL-C levels at baseline were 135 mg/dl for both groups and at 3.5 years for the intensive vs. modest treatment groups were 65 vs. 96 mg/dl (p < 0.05). Secondary outcomes were occurrence of MI, need for urgent revascularization, all-cause mortality, intracranial hemorrhage, and newly diagnosed diabetes mellitus. Rates of intracranial hemorrhage (1.3% vs. 0.9% [p > 0.05]) and new-onset diabetes mellitus (7.2% vs. 5.7% [p > 0.05]) were numerically higher with more aggressive control, but not statistically significant.

The present study highlights the clinical benefit obtained by a tighter control of plasma LDL levels for secondary prevention of stroke. Previously, the SPARCL trial showed that in patients who have had a stroke within the prior one to six months without coronary artery disease, treatment with 80 mg atorvastatin led to a lower incidence of recurrent MACE including fatal and nonfatal strokes. In the Heart Protection Study (HPS), simvastatin 40mg did not show benefit in secondary stroke protection, but in HPS, patients were enrolled after a mean of 4.3 years of having a cerebrovascular accident, whereas the greatest risk for recurrent strokes resides within the first year of suffering from a cerebrovascular accident.  Though findings from the current TST trial are in line with the SPARCL trial in terms of reduction of recurrent MACE, the SPARCL trial saw an increase in the incidence of hemorrhagic strokes in the treatment arm, while the present TST clinical trial revealed no rise in hemorrhagic stroke rates in patients despite achieving more aggressive reductions in their serum LDL-C levels.

The authors ask the readers to interpret the results of the TST trial while considering the fact that the study was stopped prematurely due to insufficient funding at 3.5 years and did not reach the goal of 385 events, instead, 277 primary events were recorded for the analysis. In addition, secondary endpoints could not be tested due to the failure of hierarchical clustering of endpoints.

An expanded analysis of 231 patients from the GALILEO trial comparing rivaroxaban-aspirin based anti-thrombotic therapy with clopidogrel-aspirin based dual anti-platelet therapy post transcatheter aortic valve replacement (TAVR), has shown that the rivaroxaban based regimen protects from valve leaflet motion abnormalities. The rivaroxaban based strategy led to decreased prosthetic valve leaflet thickening and motion reduction following TAVR performed for severe aortic valve stenosis. Continue reading →

New findings from the COAPT study were just published in Circulation and presented at TCT 2019 by Dr. Suzanne J. Baron. The findings of the study suggest that in patients with symptomatic heart failure and secondary mitral regurgitation, transcatheter mitral valve repair (TMVr) increases life expectancy and quality-adjusted life years (QALY) as compared with guideline-directed medical therapy.

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Findings from the ongoing PARTNER 3 trial were published in the Journal of the American College of Cardiology and presented at TCT 2019 by Dr. Suzanne J. Baron. The findings of this study further support the use of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR).

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Findings of an ongoing REMEDIAL (REnal Insufficiency Following Contrast MEDIA Administration triaL) III trial have been published recently in Catheter Cardiovasc Interventions and were presented by Dr. Carlo Briguori from Naples, Italy at the TCT-2019 in San Francisco. The study showed that urine flow rate (UFR) guided hydration is superior to left ventricular end‐diastolic pressure (LVEDP)-guided hydration for preventing contrast-induced acute kidney injury (CIAKI) and/or acute pulmonary edema.

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The results of a randomized controlled trial led by Dr. Gregg W. Stone presented at TCT 2019 and published in the New England Journal of Medicine showed that in patients with left main coronary artery disease of low or intermediate complexity, there was no significant difference in the composite endpoint of death, stroke, or myocardial infarction at 5 years in patients who received either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

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The results of a substudy of the COMPLETE Trial were presented at TCT 2019 by Dr. David Wood, an interventional cardiologist, and Professor of Medicine at the University of British Columbia, Canada. The analyses revealed that compared with culprit-lesion only PCI, the timing of complete revascularization, whether performed early during the index hospitalization or after discharge have similar benefits on major cardiovascular events.

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The results of a randomized controlled trial led by Dr. Renato Lopes presented at TCT 2019 and published in the New England Journal of Medicine showed that in patients with atrial fibrillation and a recent acute coronary syndrome or percutaneous coronary intervention who are treated with a P2Y12 inhibitor, an antithrombotic regimen that consists of apixaban without aspirin led to lower rates of bleeding and fewer hospitalizations without a significant difference in ischemic events as compared to a regimen that consists of two antiplatelet agents or a vitamin K inhibitor or both.

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The results of a combined analysis of the STS/ACC/TVT Registry and the Centers for Medicare and Medicare Services (CMS) were presented by Dr. Mayra Guerrero, an interventional cardiologist and Professor of Medicine at Mayo Clinic Hospital, at TCT 2019. The analysis suggests that a transcatheter mitral valve-in-valve implantation may be preferable to repeat mitral surgery and should be the standard of care in patients with favorable anatomy.

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Results of a randomized trial presented at TCT 2019 and simultaneously published in The Lancet, showed that TAVR with the self-expanding ACURATE neo (Boston Scientific) did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 (Edwards Lifesciences) in terms of early safety and clinical efficacy outcomes.

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Results of a new ongoing phase 1 study, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2019 San Francisco, showed that as a first point-of-contact therapy for ST-elevation myocardial infarction (STEMI), a novel subcutaneous (SC) GpIIb/IIIa inhibitor, RUC-4, can achieve 80% of platelet inhibition within 15 minutes of the administration.

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Results from a phase-IIIb, open-label, multi-center, randomized clinical trial comparing the safety of dual anti-thrombotic therapy (DAT) with triple anti-thrombotic therapy (TAT) for patients with atrial fibrillation who have undergone recent (4 hours – 5 days) percutaneous coronary intervention (PCI), have shown that the DAT regimen (Edoxaban plus a P2Y12 inhibitor) is non-inferior to Vitamin K antagonist(VKA) plus a P2Y12 inhibitor and aspirin or TAT regimen.

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The results of the STOP-DAPT 2 randomized controlled trial were presented by Dr. Hirotoshi Watanabe at the American College of Cardiology Annual Scientific Session (ACC 2019), at New Orleans, LA. According to the findings, 1-month DAPT was superior to 12-month DAPT in the prevention of net adverse ischemic events. Continue reading →

According to a presentation by Dr. Marc P. Bonaca at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA on March 18, 2019, patients with type 2 diabetes mellitus (T2DM) and prior MI are at high risk of major adverse cardiovascular events (MACE) and cardiovascular (CV) death/HHF. Dapagliflozin appears to robustly reduce the risk of both composite outcomes in these patients. These results were published online in Circulation. Continue reading →

A randomized multi-center trial which enrolled 1000 patients from 71 centers around the world has shown that in patients with severe aortic stenosis who are at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year is significantly lower with transcatheter aortic valve replacement (TAVR) than with surgery. Continue reading →

According to the results of the TREAT trial, among patients aged under 75 years with STEMI, administration of ticagrelor after fibrinolytic therapy did not significantly reduce the frequency of cardiovascular events in comparison with clopidogrel. The results of the 12-month analysis were recently published in the Journal of the American College of Cardiology. Continue reading →

The total event analysis from the REDUCE-IT trial, presented at ACC 2019 showed that among statin-treated patients with elevated triglycerides and cardiovascular disease or diabetes, icosapent ethyl substantially reduced the burden of first, subsequent, and total ischemic events. The results are exciting as this is one of the first non-LDL targeted trials to demonstrate a cardiovascular benefit, and is likely to be featured in future guidelines. Continue reading →

ACC 2019: In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without signifi­cant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both, according to results of the AUGUSTUS trial presented at ACC.19 in New Orleans. The results were also published simultaneously in the New England Journal of Medicine. Continue reading →

The largest LVAD trial ever to be performed, led by Dr. Mandeep Mehra published the final analysis of a fully magnetically levitated left ventricular assist device in the New England Journal of Medicine. According to this, among patients with advanced heart failure, a fully magnetically levitated centrifugal- flow pump has been found to be superior to a mechanical-bearing axial-flow pump in advanced heart failure patients in terms of survival free of disabling stroke or reoperation for removal in case of device malfunction. Continue reading →