PARTNER 3: TAVR Associated with Better Health Status At 12 Months As Compared to SAVR in Patients with Severe Aortic Stenosis and Low Surgical Risk

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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REMEDIAL III: Urine Flow Rate Guided Hydration Is Superior to Left Ventricular End‐Diastolic Pressure Guided Hydration for Preventing Renal And/Or Pulmonary Edema in Interventional Cardiology Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design.

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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EXCEL Trial: Five-Year Data Suggests PCI Non-Inferior to CABG in Patients with Left Main Coronary Artery Disease

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 COMPLETE Timing Substudy: A Randomized Trial of Complete Staged Revascularization Vs. Infarct Artery PCI Alone in Patients With Acute Myocardial Infarction and Multivessel Disease – Importance of Revascularization Timing

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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AUGUSTUS Trial: Dual Therapy with P2Y12 Inhibitor and Apixaban Safer Than Triple Therapy or Dual Therapy with Warfarin in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

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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New 1,500 Patient Study Demonstrates Favorable 1-Year Mortality Rate in Mitral Valve-In-Valve Implantation in Patients With Failed Mitral Valve Surgery

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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SCOPE I: ACURATE Neo (Self-Expanding TAVR System) Struggles to Have An Edge On SAPIEN 3 (Balloon-Expandable TAVR System)

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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Novel Subcutaneously Administered GpIIb/IIIa Inhibitor (RUC-4) Exhibits Promising Potential As The First Point-of-Contact Therapy of STEMI First human use of a novel subcutaneous platelet GPIIb/IIIa inhibitor (RUC-4) for STEMI point of care treatment

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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Dual Anti-thrombotic Therapy Safe For Patients with Atrial Fibrillation and Recent PCI:ENTRUST-AF PCI Results of the ENTRUST-AF PCI trial presented at the ESC Congress 2019

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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STOPDAPT-2 Explores Safety and Efficacy of 1-month DAPT Followed by Clopidogrel Monotherapy vs Standard 12-month DAPT After Drug-Eluting Stent Implantation

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

Dapagliflozin and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Prior MI ACC 2019: A Sub-analysis From DECLARE TIMI-58 Trial

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

TAVR Using Balloon Expandable Valve Superior To Surgical Aortic Valve Replacement In Low Risk Patients With Severe Aortic Valve Stenosis 1-year trial results presented at the ACC 2019 annual scientific session, New Orleans

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

TREAT Trial Addresses the Safety and Efficacy of Ticagrelor Use for STEMI Management in the Setting of Fibrinolytic Therapy ACC 2019: Ticagrelor versus Clopidogrel in Patients with STEMI Treated with Fibrinolytic Therapy

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

Total Event Analysis from REDUCE-IT Showcases a Substantial Reduction in the Burden of Ischemic Events, Experts Debate Possible Mechanisms of Action of Icosapent Ethyl Presented at ACC 2019, New Orleans, Los Angeles

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

AUGUSTUS: Less Bleeding and Fewer Hospitalizations Without Significant Differences in Ischemic Events With Apixaban and No Aspirin in Patients With AFib and ACS ACC 2019: Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation

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

HeartMate3 Found to be More Superior Than Other LVADs on Endpoints of Stroke, Pump Thrombosis and Bleeding Complications ACC 2019: A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

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

COAPT Analysis Affirms Quality of Life Advantage of MitraClip for Secondary MR ACC 2019: Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secondary Mitral Regurgitation

NEW ORLEANS — Transcatheter repair of functional mitral regurgitation (or secondary MR) with MitraClip improved quality of life and hemodynamics better than optimal medical therapy alone, COAPT trial analyses showed. Indeed, the COAPT QOL study showed that among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. Continue reading

HEARTLINE: A 180,000 Patient-Strong, Pragmatic, Real World Randomized Trial Assesses the Prowess of Apple Technology in Afib Diagnosis and Improvement of Hard Outcomes Presented at the ACC 2019, New Orleans, LA.

The design of the HEARTLINE randomized trial of up to 180,000 pts for assessing the efficacy of the Apple Watch & educational initiatives to reduce a composite outcome of death, MI and stroke was presented by Dr. C. Michael Gibson, PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston, Massachusetts, at ACC 2019, in New Orleans,  LA earlier today. The HEARTLINE Study brings together Johnson & Johnson’s health and behavioral science expertise and long heritage in treating cardiovascular disease with Apple’s technology expertise. Emerging technology holds great potential to help identify people at risk for future disease and develop interventions to prevent disease before it occurs. Leveraging a new heart health app from Johnson & Johnson in combination with Apple Watch’s irregular rhythm notifications and ECG app, the HEARTLINE Study will seek to investigate whether this technology can accelerate the diagnosis of AFib and improve outcomes including the prevention of stroke, as well as assess the impact of a medication adherence program. The study will be conducted in the U.S. only and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older. Continue reading

Findings From a Randomized Controlled Trial May Usher the Adoption of Angiotensin–Neprilysin Inhibition to the Heart-Failure Armamentarium Presented At the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA.

The results of a trial presented by Dr. Adam DeVore at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, reflected that among patients with heart failure with reduced ejection fraction who were hospitalized for acute decompensated heart failure, the initiation of sacubitril–valsartan therapy led to a greater reduction in the NT-proBNP concentration as compared with enalapril therapy. In addition to this, the rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema did not differ significantly between the two arms. Continue reading

ALERTS: Use of an Implanted Electrocardiographic Monitoring Device in High-Risk Patients Aids in the Early Detection of ACS Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction

According to a randomized controlled trial led by Dr. Michael Gibson, PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston, Massachusetts, the implantable cardiac system was found to detect early ST-segment deviation and alert patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, the report published in the Journal of the American College of Cardiology provided evidence that the device was beneficial among high-risk subjects in the identification of asymptomatic events. Continue reading