Funds Raised Will Support Heart Disease Research and Educational Initiatives

WHAT:

The Cardiovascular Research Foundation (CRF) will salute renowned cardiologist, Dr. Clyde Yancy for his extraordinary contributions to the field. His vital work in improving access to healthcare and cardiovascular outcomes for underserved populations will be recognized, along with his tireless efforts to promote health equity by mentoring and encouraging young people to pursue careers in medicine.  

WHEN:

6:30 PM

Friday, December 7, 2018

WHERE:

The Plaza

Grand Ballroom

Fifth Avenue at Central Park South, NYC

WHO:

More than 400 luminaries in interventional cardiology, politicians, celebrities, and others with a close connection and desire to improve treatments for those affected by cardiovascular disease will gather to pay tribute to the honoree. The program, led by Gala Chairs Juan F. Granada, MD, Martin B. Leon, MD; Roxana Mehran, MD; and Gregg W. Stone, MD, will feature remarks by Clyde W. Yancy, MD, MSc.

Dr. Clyde Yancy is a widely respected expert in heart failure, clinical guideline generation, outcomes sciences, and healthcare disparities. A former President of the American Heart Association in 2009-2010, he is also a past recipient of the AHA National Physician of the Year and Gold Heart Award. Dr. Yancy currently serves as Chief of Cardiology at Northwestern University, Feinberg School of Medicine, and Associate Director of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital. He holds the Magerstadt Endowed Professor of Medicine Chair and a concurrent Professorship in Medical Social Sciences. He also serves as Vice-Dean of Diversity & Inclusion, Northwestern University, Feinberg School of Medicine.

WHY:

Funds raised from this year’s Gala will benefit CRF’s medical research and educational programs. This support will help CRF to pursue innovative areas of research, train tomorrow’s physician leaders, and educate the medical community and the public about heart health.

ABOUT CRF

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and educated doctors on the latest treatments for heart disease. For more information, please visit www.crf.org.

Results from the Lipid-Rich Plaque (LRP) Study Reported at TCT 2018

SAN DIEGO – September 24, 2018 – Results from the Lipid-Rich Plaque (LRP) study demonstrate the correlation between the presence of non-flow-limiting, non-intervened upon, lipid-rich plaques detected by NIRS-IVUS imaging and the development of a major adverse cardiac event (MACE) from a de novo culprit lesion at both the patient level (vulnerable patients) and segment level (vulnerable plaques) within 24 months post intravascular imaging.

Findings were reported today at the 30th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Coronary lipid-rich plaques may be associated with subsequent cardiovascular events and it has been hypothesized that the outcome post-PCI could be improved by the detection and subsequent treatment of vulnerable patients and lipid-rich vulnerable coronary plaques. Intravascular near-infrared spectroscopy (NIRS) is available as a dual modality catheter with simultaneous, co-registered intravascular ultrasound (IVUS).

From February 2014 to March 2016, a total of 1,563 patients with suspected coronary artery disease who underwent cardiac catheterization with PCI for an index event were enrolled at 44 sites in the United States and Europe. Imaging by NIRS-IVUS was performed in two or more arteries and patient level and plaque level events were detected for two years. All patients with at least one maxLCBI4mm segment greater than or equal to 250 and a randomly selected 50% of patients with all maxLCBI4mm segments less than 250 were followed.

In the vulnerable patient-level analysis, the risk of experiencing non-culprit MACE event within 24 months was 18% higher with each 100 unit increase in maxLCBI4mm. Patients with maxLCBI4mm ≥400 had a MACE rate of 12.6% compared with 6.3% for patients with maxLCBI4mm˂400. In the vulnerable plaque-level analysis, the risk of experiencing an event in a coronary segment within 24 months was 45% higher with each 100 unit increase in maxLCBI4mm. Plaque with maxLCBI4mm ≥400 had a MACE rate of 3.7% compared to 0.8% for plaque with maxLCBI4mm˂400.

“Multi-vessel NIRS can be easily and safely performed to assess and identify vulnerable patients and vulnerable plaques,” said Ron Waksman, MD, associate director of the Division of Cardiology at MedStar Heart Institute in Washington, D.C. “Intravascular NIRS imaging in mildly or non-obstructive coronary arteries can be used as a tool to identify both patients and non-culprit arteries at high risk for future events and should be considered for use in patients undergoing cardiac catheterization with possible PCI.”

The LRP study was funded by Infraredx Nipro Company. Dr. Waksman disclosed that he is on advisory boards for Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips Volcano, Pi-Cardia LTD, and Cardioset; a consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Medtronic, and Philips Volcano; and received grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, and Chiesi. In addition, he is part of the AstraZeneca and Chiesi speaker’s bureaus; and is an equity holder in MedAlliance, DOMed, Pi-Cardia LTD and Cardioset.

Results from the OAC-ALONE Trial Reported at TCT 2018 and Published Simultaneously in Circulation

SAN DIEGO – September 24, 2018 – The first randomized trial of its kind was unable to establish non-inferiority of oral anticoagulation (OAC) alone to combined OAC and a single antiplatelet agent (APT) in patients with atrial fibrillation (AF) and stable coronary artery disease beyond one year after stent implantation.

Findings of the OAC-ALONE study were reported today at the 30th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published simultaneously in Circulation.

“In patients with concomitant atrial fibrillation and stable coronary artery disease beyond one year after coronary stent implantation, the ESC guidelines have consistently recommended oral anticoagulation without antiplatelet therapy,” said Yukiko Nakano, MD, with the Kyoto University Graduate School of Medicine in Kyoto, Japan. “In clinical practice, however, antiplatelet therapy is often used on top of oral anticoagulation beyond one year after coronary stenting. Importantly, no randomized controlled trials have evaluated OAC monotherapy in this patient subset.”

From November 2013 to December 2016, a total of 696 patients were enrolled in the study from 111 participating centers. The trial was designed to enroll 2,000 patients for 12 months. However, enrollment was prematurely terminated after enrolling 696 patients in 38 months.

Patients were randomized 1:1 to OAC alone (n=344) or combined OAC and APT (n=346). The mean age was 75.0±7.6 years, and 85.2% were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients. The baseline clinical characteristics were similar in both groups.

The primary endpoint was a composite of all-cause death, myocardial infarction (MI), stroke, or systemic embolism, while the major secondary endpoint was a composite of the primary endpoint or major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) classification.

During a median follow-up interval of 2.5 years, the primary endpoint occurred in 54 patients (15.7%) in the OAC alone group and in 47 patients (13.6%) in the combined OAC and APT group (HR, 1.16; 95% confidence interval [CI], 0.79-1.72; P=0.20 for non-inferiority; P=0.45 for superiority). The major secondary endpoint occurred in 67 patients (19.5%) in the OAC alone group and in 67 patients (19.4%) in the combined OAC and APT group (HR, 0.99; 95% CI, 0.71-1.39; P=0.016 for non-inferiority; P=0.96 for superiority). MI occurred in 8 (2.3%) and 4 (1.2%) patients, while stroke or systemic embolism occurred in 13 (3.8%) and 19 (5.5%) patients, respectively. Major bleeding occurred in 27 (7.8%) and 36 (10.4%) patients, respectively.

“Because the patient enrollment was prematurely terminated, the study was underpowered and inconclusive,” added Dr. Nakano. “Larger adequately powered randomized trials are required to establish the optimal antithrombotic regimen in this population.”

The OAC-ALONE trial was funded by Daiichi Sankyo. Dr. Nakano has no conflicts of interest.

Results from the ULTIMATE Trial Reported at TCT 2018 and Published Simultaneously in JACC

SAN DIEGO – September 24, 2018 – The first study designed to determine the benefits of intravascular ultrasound (IVUS) guidance over angiography guidance during drug-eluting stent (DES) implantation in all-comer patients found that IVUS improved clinical outcomes by lowering the rate of target vessel failure at one year.

Findings from the ULTIMATE trial were reported today at the 30th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published simultaneously in the Journal of the American College of Cardiology (JACC).

IVUS is an intravascular imaging modality that provides detailed anatomic information about reference vessel dimensions and lesion characteristics, including severity of diameter stenosis, lesion length, and morphology (vulnerable plaque), which is less well-detected by coronary angiography. Whether the routine use of IVUS is associated with improved outcomes in all-comer patients is not known.

From August 2014 to May 2017, a total of 1,448 all-comer patients from eight centers in China who were undergoing DES implantation were randomly assigned (1:1) to either IVUS guidance (n=724) or angiography guidance (n=724). Multi-vessel disease was seen in 54.9% of patients. Mean lesion length was 34.5 mm, and 66.9% of lesions were classified as Type B2/C lesions. IVUS-guided procedures were longer in duration, and on a per-lesion basis used slightly greater stent diameters and stent lengths.

The primary endpoint was target vessel failure (TVF) at 12 months, defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target vessel revascularization (TVR). At 30-day follow up, primary and secondary endpoints were comparable between the two groups.

One year after PCI, a total of 60 (4.2%) TVFs occurred, with 21 (2.9%) in the IVUS group and 39 (5.4%) in the angiography group (HR 0.530; 95% CI: 0.312-0.901; p=0.019). In lesion-level analyses, the IVUS group had a lower rate of target lesion revascularization (TLR) compared with the angiography group (0.9% vs. 2.3%, p=0.02). Despite the use of IVUS, 53% of patients met prespecified optimal criteria for stent implantation; in this group, TVF was 1.6%, compared with 4.4% in patients who failed to achieve all optimal IVUS criteria (HR 0.349; 95% CI: 0.135-0.898; p=0.029).

“The study demonstrated that IVUS-guided stent implantation significantly improved clinical outcomes in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared to angiography guidance,” said Junjie Zhang, MD, Vice Director of the Cardiovascular Department at Nanjing First Hospital in Nanjing Medical University (Nanjing, China). “While previous studies and this trial have demonstrated the overall favorable effect of IVUS guidance for patients with particular lesion subsets, this study further reports that achievement of IVUS-defined optimal PCI improves clinical outcomes for all-comers.”

The ULTIMATE trial was funded by the National Natural Science Foundation of China and was jointly supported by Six Talent Peaks Project in Jiangsu Province, Nanjing Health and Family Planning Commission, Nanjing Health Youth Talent Training project, and Nanjing Municipal Commission of Science & Technology. Dr. Zhang has no conflicts of interest.

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