Science News: Late Breaking Clinical Trials

Scientific Sessions 2017

Scientific Sessions: November 11–15

Resuscitation Science Symposium: November 11–13

Cardiovascular Nursing Clinical Symposium: November 13–14

Anaheim, California

LBCT.01 - Big Trials for Big Questions

Sunday, Nov. 13 | 3:45–5:15 p.m. | Main Event 1
Manesh R. Patel

Effects of Ticagrelor Compared With Clopidogrel in Patients With Peripheral Artery Disease (EUCLID)
Manesh R Patel | Duke Clinical Research Institute, Duke University Medical Center, Durham, NC

RESULTS: PAD patients did not gain more benefit from long-term ticagrelor compared to clopidogrel in preventing cardiovascular death, heart attack, or ischemic stroke. The primary endpoint was not met.

Steven E Nissen

Cardiovascular Outcomes With Celecoxib vs. Ibuprofen or Naproxen: The Precision Trial
Steven E Nissen | Cleveland Clinic, Cleveland, OH

RESULTS: In a non-inferiority cardiovascular safety comparison of the COX-2 selective inhibitor celecoxib to non-selective NSAID’s, similar primary endpoint outcomes were seen in this trial at these doses for these drugs.

Jackie Bosch

The Effect of Blood Pressure and Cholesterol Lowering on Cognition (HOPE-3)
Jackie Bosch | McMaster University, Hamilton, ON, Canada

RESULTS: Cognitive decline was not prevented by long-term (5.6 years) cholesterol or blood pressure lowering in patients at moderate risk for cardiovascular disease.

Milton Packer

Short- and Long-Term Effect of Immediate Vasodilator Therapy in Acutely Decompensated Heart Failure:Results of the TRUE-AHF Trial
Milton Packer, Baylor University Medical Center, Dallas, TX

RESULTS: While immediate vasodilator therapy in acute AF reduced congestion and cardiac wall stress, the long-term risk of cardiovascular death was not reduced.

LBCT.02 - Pioneering the Future of HeART Interventions

Monday, Nov. 14 | 10:45 a.m.–12:00 p.m. | Main Event 1

Randomized Comparison of Single Versus Bilateral Internal Mammary Artery Grafting in 3102 Patients: Effects on Major Cardiovascular Outcomes After Five Years Follow Up (ART)
David P Taggart | University of Oxford, Oxford, United Kingdom

RESULTS: Bilateral mammary artery grafting was not found to be superior to single mammary artery grafting. Cardiovascular outcomes were similar for both approaches at 5 years.

The FUnctional Testing Underlying Coronary REvascularization (FUTURE) Study: A "Real World" Comparison of Fractional Flow Reserve-guided Management versus Conventional Management in Multi Vessel Coronary Artery Disease Patients
Gilles Rioufol | Hospices Civils de Lyon, Lyon, France

RESULTS: In high-risk patients with multivessel coronary disease, the use of FFR to guide management strategy decisions demonstrated significantly more mortality and no clinical benefit compared to angiogram-guided traditional therapy.

An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention PIONEER AF-PCI
C Michael Gibson | Beth Israel Deaconess Medical Center, Boston, MA

RESULTS: Atrial fibrillation patients having PCI with stents had lower rates of significant bleeding with either of two low doses of rivaroxaban compared to the current standard triple therapy.

Patients at Intermediate Surgical Risk Undergoing Isolated Interventional or Surgical Aortic Valve Replacement for Severe Symptomatic Aortic Valve Stenosis One Year Results From the German Aortic Valve Registry
Nicolas Werner | Klinikum Ludwigshafen, Ludwigshafen, Germany

RESULTS: This registry analysis found that 1-year adjusted mortality rates were not significantly different between TAVI and SAVR for patients at intermediate surgical risk. TAVI was found to be used more in older patients with higher risk scores.

LBCT.03 - Insights from New Therapeutic Trials for Lipids

Tuesday, Nov. 15 | 10:45 a.m. - 12:00 p.m. | Main Event 1

Inhibition of PCSK9 Synthesis via RNA Interference: 90 Day Data From Orion-1-a Multi-centre Phase-2 Randomized Controlled Trial
Kausik K Ray | Imperial College of London, London, United Kingdom

RESULTS: At 180 days, inhibiting PCSK9 synthesis using RNA interference safely reduced LDL-C.

Effect of Evolocumab on Progression of Coronary Atherosclerosis in Statin-Treated Patients: A Placebo-Controlled Intravascular Ultrasound Trial (GLAGOV)
Steven E Nissen | Cleveland Clinic, Cleveland, OH

RESULTS: In patients being treated with statins for cardiovascular disease, intravascular ultrasound documented that evolocumab, a PCSK9 inhibitor, decreased percent atheroma volume over 76 weeks.

The Safety and Tolerability of CSL112, a Reconstituted, Infusible, Human ApoA-I, After Acute Myocardial Infarction - The ApoA-I Event Reduction in Ischemic Syndromes I (AEGIS-I) Trial
C. Michael Gibson | Beth Israel Deaconess Medical Center, Boston, MA

RESULTS: In AMI patients, CSL112 was well-tolerated; no renal and hepatic function safety concerns were noted.

Ionis-angptl3-lRx, an Antisense Inhibitor to Angiopoietin-like Protein 3 [angptl3] Reduces Plasma Angptl3 and Lipids in Healthy Volunteers With Elevated Triglycerides
Sotirios Tsimikas | Ionis Pharmaceuticals, Carlsbad, CA

RESULTS: Ionis-ANGPTL3-lRx lipid reduction was dose-dependent and was found to be safe, well tolerated, and rapidly absorbed.

Impact of Infusion of an ApoA-IMilano HDL Mimetic on Regression of Coronary Atherosclerosis in Acute Coronary Syndrome patients: the MILANO-PILOT Study
Stephen Nicholls | South Australian Health and Medical Research Institute, Adelaide, Australia

RESULTS: The ApoA-I HDL mimetic did not significantly change the percent atheroma volume for ACS patients in this pilot study.

LBCT.04 - Guiding the Momentum to Effect HF Outcomes- Ironing out the Wrinkles

Wednesday, Nov. 16 | 10:45 a.m. - 12:00 p.m. | Main Event 2
David Kaye

Transcatheter Interatrial Shunt Device Provides Sustained Clinical Benefit at One Year in Patients With Preserved or Mildly Reduced Ejection Fraction: The REDUCE LAP Heart Failure Trial
David Kaye | Alfred Hospital, Melbourne, Australia

RESULTS: At 12-months benefits with the transcatheter interatrial shunt device included safety, shunting with reduction of left atrial pressure during exercise, improved exercise capacity, and improved QOL.

Javed Butler

Aldosterone Targeted NeuroHormonal CombinEd With Natriuresis TherApy in Heart Failure (ATHENA-HF) Trial
Javed Butler | Stony Brook University, Atlanta, GA

RESULTS: High-dose mineral-corticoid receptor antagonists (MRA) added to usual care (including loop diuretics) in acute heart failure patients did not result in a difference in the primary endpoint, change in NTproBNP levels, or in symptoms, urine output, or clinical events.

Gregory D. Lewis

Oral Iron Repletion effects ON Oxygen UpTake in Heart Failure (IRONOUT HF)
Gregory D. Lewis | Massachusetts General Hospital, Boston, MA

RESULTS: High-dose oral iron supplementation did not improve exercise capacity in these heart failure patients and only minimally repleted iron stores.

Dirk J Van Veldhuisen

Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure (EFFECT-HF): A Randomized, Controlled Study
Dirk J Van Veldhuisen | University Medical Center Groningen, Groningen, Netherlands

RESULTS: Peak VO2 improved in patients who received FCM.

Mandeep R Mehra

Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) - Primary Results of the Short Term (6 month) Cohort
Mandeep R Mehra | Brigham and Women's Hospital, Boston, MA

RESULTS: The HeartMate 3 LVAD improved composite clinical outcomes (survival free of a disabling stroke or reoperation for pump malfunction) at 6 months compared to the HeartMate II for advanced HF patients.

John P Boehmer

A Multi-sensor Algorithm Predicts Heart Failure Events in Patients with Implanted Devices: Results from the MultiSENSE Study
John P Boehmer, Pennsylvania State University, Hershey, PA

RESULTS: Indicators of worsening HF were detected using the multi-sensor algorithm with a high sensitivity and a low rate of unexplained alerts.