Dual anti-platelet therapy after coronary stenting

Dual antiplatelet therapy (DAPT) is essential after coronary stenting to reduce the risk of stent thrombosis, myocardial infarction and sudden death. With bare metal stents, DAPT is required for only 4-6 weeks at which time the stent struts are covered by neointimal tissue. Drug-eluting stents (DES), on the other hand, have a delayed healing response,

and therefore require prolonged DAPT.

The ideal duration of DAPT after a DES has been the subject of debate. In 2007, an advisory statement from several US professional societies em-phasized the importance of 12-months DAPT. In contrast, interventionalists in Europe have typically used 6-12 months DAPT after DES implantation.

Since these recommendations, new thinner strut DES platforms have been introduced which have a lower risk of stent thrombosis. Observational studies have also shown an increased risk of bleeding in patients receiving DAPT >12-months. Accordingly, the European Society of Cardiology recently shorted the duration of DAPT to 6-months, and also suggested that 3-months could be sufficient in patients with a higher risk of bleeding.

These recent recommendations have been challenged however following results of the DAPT Study, which compared 12 versus 30-months DAPT after coronary stenting in 9,961 patients. At 12-months patients were ran-domized to continue aspirin alone, or aspirin and thienopyridine treatment. Patients who continued DAPT had a lower risk of stent thrombosis (0.4% vs. 1.4%, P<0.001) and myocardial infarction (2.1% vs. 4.1%, p<0.001), but higher risk of moderate or severe bleeding (2.5% vs. 1.6%, p=0.001). In both groups, there was an elevated risk of stent thrombosis and MI during the 3-months after DAPT discontinuation.

Given these recent data, it is clear that decisions regarding the duration of DAPT are complex and must individualized to the patient, carefully weighing the risks and benefits or prolonged DAPT.

(Reference: Mauri L, et al. Twelve or 30 months dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014;371:2155-66.)

Extraction of pacemaker and implantable defibrillator leads

The body’s response to implantation of pacemaker or implantable defibrillator lead systems is tissue ingrowth and endothelial-ization. As a result, the leads become adherent to the walls of the heart and great vessels. If a device becomes infected, the entire system including leads needs to be removed. Because of tissue ingrowth, the leads cannot be easily withdrawn. To ac-

complish this, a lead extraction system is employed that uses a central pull wire inserted into the stylet lumen of the lead, and an external cutting sheath (either physical, laser or radiofrequency) to shear the tissue off the lead and free it from points of adhesion. While complex lead extraction can routinely be accomplished by an experienced operator without too much difficulty, there is a very small risk of serious complications such as major (including life threatening) hemorrhage. For that reason, these procedures are performed in the hybrid catheterization-surgical suite, and the cardiac surgical team is on standby throughout the procedure. Aside from in-fection, indications for lead extraction include the presence of multiple nonfunctioning leads, lead failure in a young patient, and loss of central vascular access due to subclavian vein occlusion.

Atrial Fibrillation

RESEARCH

Beaumont’s Heart and Vascular Research department is one of the largest in the country with many ongoing leading edge clinical research trials.

Selected Current Trials

BEST–CLI trial: Best Endovascular versus best Surgical Therapy in patients with critical limb ischemia

BEST-CLI is a multicenter randomized clinical trial sponsored by the National Institutes of Health (NIH). Similar to TAVR trials, this study is designed as an integrated collaborative study among cardiologists, vascular surgeons, and vascular medicine specialists. The purpose of the BEST-CLI trial is to determine the best revascularization strategy for patients with critical limb ischemia, defined as Rutherford class 4-6 (ischemic rest pain, ischemic ulcers, or gangrene) due to critical occlusive disease in the infrainguinal circulation (fem-oropopliteal and tibial arteries). All patients in the trial will receive optimal medical therapy, similar to patients in COURAGE and CORAL. Eligible patients will be randomized 1:1 to endovascular reconstruction (using any FDA-approved device at physician discretion, including PTA, stents, ather-ectomy, laser) versus surgical bypass (using venous or pros-thetic conduits), provided they are anatomically suitable for endovascular intervention and surgery. Approximately 2000 patients from 120 centers in the United States and Canada will be enrolled in the study and followed every 3-6 months for 5 years. The primary endpoint of the study is 5-year MALE-free survival (MALE=major adverse limb event, in-cluding repeat revascularization or amputation). Secondary endpoints include clinical (death, MI, stroke, duplex evidence for restenosis), functional (quality of life, objective exercise performance), cost-effectiveness (dollars per quality-adjusted life years), and safety endpoints (MACE at 30 days, including death, MI, stroke, and procedure-related complications).

Principal Investigator: ROBERT SAFIAN, M.D. Coordinator: Dorothy Richardson, 248-898-9161, drichardson@beaumont.edu

COAPT trial

Mitral valve regurgitation is the most common form of heart valve disease. Beaumont is one of a select group of sites par-ticipating in the COAPT trial. In the COAPT trial, high risk patients with 3-4+ functional mitral regurgitation on optimal medical therapy (and cardiac resynchronization therapy if in-dicated) are randomized to the MitraClip® versus medical therapy. Currently less than 10 percent of patients with sig-nificant functional mitral regurgitation are treated with surgery. The objective of the COAPT trial is to determine whether this large population of patients benefit from the MitraClip®, a transfemoral catheter-based procedure for the treatment of mitral regurgitation.

Principal Investigator: GEORGE HANZEL, M.D. Coordinator: Ann McHugh, 248-898-4267, amchugh@beaumont.edu

JANUARY 2015, ISSUE XI | TRENDING NEWS IN HEART & VASCULAR DISEASE AND SERVICES

Visit: heart.beaumont.edu for other Beaumont Health System heart and vascular information.

Impact of sodium consumption and worldwide cardiovascular deaths

Excessive dietary sodium can cause high blood pressure, which is a major risk factor for heart attack and stroke. Using a sophisticated mathe-matical model, researchers recently evaluated data from surveys on sodium intake in persons from 66 countries, representing nearly 75 percent of adults throughout the world. The average worldwide sodium intake in 2010 was

3.95 grams per day – nearly twice the upper limit (2.0 grams per day) recom-mended by the World Health Organization (WHO). Even more sobering was the fact that 1.65 million deaths from cardiovascular causes were attributable to sodium consumption above the WHO recommendation, corresponding to nearly 1 in 10 cardiovascular deaths globally each year. These findings highlight the substantial cardiovascular burden of high sodium intake and support ag-gressive population-based initiatives to reduce dietary sodium.

Because nearly 90 percent of one’s sodium consumption is already added to the processed foods one eats, patients will benefit from counseling on ways to lower their dietary sodium. For more information, see the New England Journal of Medicine (August 2014) and JAMA Internal Medicine (January 2014).

New center treats cardiomyopathy and advanced heart failure patients

Congestive heart failure (CHF) is at epidemic levels afflicting approximately 6 million Americans (2.8 percent of the adult United States population). The mortality is 50 percent at five years and CHF is the number one reason for hospitalization for people greater than 65 years of age.

The Beaumont Cardiomyopathy and Advanced Heart Failure Center (CM-HF Center) is dedicated to providing consultative ex-pertise in the evaluation and management of complex and advanced disorders of the myocardium and pericardium. The multi-faceted team of experts assesses and treat your patients suffering from dilated cardiomyopathy of un-certain etiology, hypertrophic cardiomyopathy, restrictive cardiomyopathy, complex pericardial disease, acute myocarditis, complex hemodynamic problems, and acute and end-stage CHF requiring advanced therapies.

A fundamental purpose of the CM-HF Center is to provide expertise in advanced diagnostics and therapeutics including: advanced non-invasive imaging, exercise hemodynamics, endomyocardial biopsy, genetic testing and counseling, and advanced therapies such as inotropic infusion, implantable ventricular assist devices and cardiac transplantation.

The Beaumont CM-HF Center provides both outpatient and inpatient consul-tation. For more information, please call 248-898-6168, or page James Goldstein, M.D. directly at 248-992-1631.

D ID YOU KN OW ?

First in Michigan for diagnostic imaging

Beaumont has been designated as Michigan’s first Diagnostic Imaging Center of Excellence by the American College of Radiology. This Center of Excellence designation represents the pinnacle of medical imaging care and is an achievement that goes beyond accreditation to recognize best-quality imaging practices and diagnostic care. Patients at all three Beaumont hospitals have access to the newest, safest and fastest CT scanner, known as the Flash CT Imaging Scanner. Beaumont was the first hospital in the state to offer the technology. Patient scheduling is available by calling the Beaumont Appointment Center at 800-328-8542.

3601 West 13 Mile Rd. | Royal Oak, MI 48073-6769heart.beaumont.edu

MARK YOU R CALEN DAR

U PCO M IN G CO N FEREN CES/EVENTS

12th Annual Vascular Innovations ConferenceFeb. 6-7, 2015TROY MARRIOTT, TROY, MI

24th Annual Cardiovascular ConferenceFeb. 22 – 25, 2015PARK HYATT BEAVER CREEK, BEAVER CREEK, CO

7th Annual Advances in Heart Disease Prevention and RehabilitationMarch 28, 2015TROY MARRIOTT, TROY, MI

Alcohol Septal Ablation Live Proctoring Course 2015April 26 - 28, 2015TYNER CENTER FOR CARDIOVASCULAR INTERVENTIONS, BEAUMONT HOSPITAL, ROYAL OAK

To receive the Beaumont Heart & Vascular Update for Physicians e-newsletter, opt-in at heart.beaumont.edu.

Visit: heart.beaumont.edu for other Beaumont Health System heart and vascular information.

NON-PROFIT ORGU.S. POSTAGE

PAIDPERMIT NO. 404ROYAL OAK, MI

TRENDING NEWS IN HEART & VASCULAR DISEASE AND SERVICES

BEAUMONT HEART & VASCULAR UPDATE FOR PHYSICIANS

EDITORS:

Steven Almany, M.D. Simon Dixon, MBChB, FACC

CONTRIBUTORS:

Barry Franklin, Ph.DJames Goldstein, M.D.David Haines, M.D. George Hanzel, M.D.Robert Safian, M.D.

For more information visit: heart.beaumont.edu or to talk to a Beaumont heart and vascular specialist, call 888-877-8766.

For more information or to register for any of the above conferences, visit: http://meded.beaumont.edu/cardiology-conferences

For more information about Heart and Vascular

Continuing Medical Education, contact

Shannon Herrington, CMP, Heart and Vascular Education

at 800-732-6368 or email

heartandvascularconferences@beaumont.edu.