Stent Technology Takes Two Steps Forward
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Inside This Issue Heart and Vascular Update Hybrid operating room, provides information to PRESORTED HEART and VASCULAR healthcare providers on the latest FIRST CLASS MAIL a regional first in cardiovascular medicine and surgery U.S. POSTAGE at The Christ Hospital. PAID Stent technology takes CINCINNATI, OH Heart and Vascular Update PERMIT #5489 two steps forward Editorial Board 2139 Auburn Avenue | Cincinnati, Ohio 45219 Stent technology Dean J. Kereiakes, MD, FDA advisory panel: Medical Director SPRING 2013 The Christ Hospital Heart and Vascular Center Update MitraClip could serve as takes two steps forward Carl and Edyth Lindner Research Center an alternative treatment Ian Sarembock, MD, Executive Medical Director for reducing mitral Resorbable Absorb scaffold and flexible Absorb takes bioabsorbability to next level The Christ Hospital Heart and Vascular Service Line regurgitation For the past two decades, incremental improvements in stent Mike Keating Synergy stent expected to improve technology have improved outcomes for hundreds of thousands of President and CEO outcomes in coronary artery disease people with coronary artery blockages. These devices have evolved Michael W. Schwebler from short, bare-metal mesh tubes that could be deployed only The Carl and Eydth Lindner Research Center at The Christ Hospital is Executive Director in the largest coronary vessels to a variety of thinner, longer stents The Christ Hospital Heart and Vascular Service Line leading two major clinical trials that will significantly advance stent coated with medications to reduce the risk of new blockages. technology for people with blocked coronary arteries. Heather Adkins While stents have dramatically reduced the need for open-chest Chief Strategy and Mission Officer National principal investigator in the multinational EVOLVE II clinical coronary bypass operations, the devices have had one limiting factor trial, Dean Kereiakes, MD, Medical Director, The Christ Hospital Heart Patty Thelen from the beginning: their use has required leaving a foreign metal Director of PR & Marketing and Vascular Center, leads _ number of sites in the evaluation of the object permanently implanted along the coronary arteries. Soon, that novel Synergy stent made by Boston Scientific, as well as _ number Emily Owens may change. of sites in the national ABSORB III trial to evaluate the Absorb BVS Manager, PR & Marketing stent made by Abbott. Both devices are approved in Europe but are The Lindner Research Center at The Christ Hospital is testing a Brian Riesenberg pending approval in the United States from the U.S. Food and Drug breakthrough stent, called Absorb, that represents the first fully Senior Consultant, PR & Marketing Administration (FDA). bioresorbable drug-eluting stent in the world. Two years after insertion, nothing remains of the stent except two tiny platinum dots Synergy offers more flexibility, used to track the original location of the device. bioabsorbable polymer The Absorb stent, made by Abbott, already is approved for sale in FDA advisory panel continued on back cover The first procedures to implant the novel Synergy bioabsorbable Europe and parts of Asia and South America. The ABSORB III clinical polymer drug-eluting stent as part of the EVOLVE II trial were trial will enroll about 2,250 patients, mostly in the United States, to • The EVEREST II study was the first to compare a catheter- (CRT). The study confirmed that mitral regurgitation can cause recently performed by Thomas Broderick, MD, and Joseph Choo, gather data required for U.S. FDA approval. Dr. Kereiakes is principal delivered mitral valve repair device against conventional a poor response to CRT and it showed that treatment with the MD, interventional cardiologists at The Christ Hospital. investigator for this nationwide study. surgical therapy. Of the 279 patients enrolled, 184 received the MitraClip is safe, leads to substantial symptom improvement The Synergy stent, like many other stents, emits the drug The Absorb stent’s tubular scaffold is composed of polylactide, MitraClip and 95 had conventional surgery. After 30 days, 48 and can reverse ventricular remodeling. everolimus to prevent restenosis. The new stent stands out for a biocompatible material commonly used in dissolvable sutures percent of the surgical patients experienced a major adverse two reasons: It features an ultra-thin metal scaffold and a fully and other medical implants. The drug eluted by the stent is fully event compared to 15 percent in the MitraClip group. A year Lindner Research Center Joins COAPT Trial bioabsorbable polymer coating that reduces the risks of irritation absorbed in about 90 days. The scaffold maintains its structural after surgery, 73 percent of the surgical group had achieved Despite a large volume of data from other clinical trials, more and inflammation. It also features a more flexible, fracture-resistant integrity for about six months while it helps prevent arterial recoil desirable reductions in regurgitation compared to 55 percent information about the MitraClip among high-risk surgical design that reduces the risk of rare, late-stage failures that can be and remodeling. The stent completely dissolves in 18 to 24 months, of the MitraClip group. After comparing symptoms, adverse patients is needed. The Lindner Clinical Research Center and the caused by the constant flexing of arteries as the heart beats. leaving behind a normally functioning blood vessel no longer events, quality of life, hospital length of stay and whether Heart and Vascular Center at The Christ Hospital Health Network “The Synergy stent has the smallest polymer load of any drug- irritated by the presence of a foreign object. patients needed nursing home or rehabilitation care, the study have joined 75 medical centers participating in the COAPT trial eluting stent. It also uses less metal and thinner struts, which Dr. Kereiakes and interventional cardiologists Charles Abbottsmith, concluded that the MitraClip was not as effective as traditional (Clinical Outcomes Assessment of the MitraClip Percutaneous enhance its flexibility and conformability,” Dr. Kereiakes says. “This MD, and Thomas Broderick, MD, implanted the first Absorb scaffolds surgery at fully stopping regurgitation, but the clip was superior Therapy for High Surgical Risk Patients). in safety, cost and quality of life measures. stent has the potential to become the dominant metal-platform in the U.S. clinical trial at The Christ Hospital. Worldwide, more than The study seeks patients with significant mitral regurgitation who stent in the U.S.” 3,000 people have received Absorb stents. • Another 133 high-risk patients have been enrolled in the have been adequately managed with heart failure medications, The Synergy stent received CE mark approval in October 2012. The “The Absorb scaffold represents a quantum step in the evolution REALISM clinical trial. So far for these patients, the MitraClip but are considered too high-risk for surgery. Participants will be EVOLVE II clinical trial is expected to enroll 2,000 patients at 160 sites of coronary angioplasty and stenting,” Dr. Kereiakes says. “The has demonstrated superior safety, durable reduction in mitral randomized in a 1:1 ratio to groups receiving the MitraClip device in 21 countries. Patients will be randomly assigned to receive either opportunity for the blood vessels to return to a more natural state is regurgitation, significant reduction in hospitalization for heart or continuing with medical therapy. The study will track mortality, the Promus Element Plus, also made by Boston Scientific, or the one of the unique features of Absorb. This may reduce risk for some failure and reduced mortality compared with predicted risk. stroke, kidney function, the need for heart transplantation or Synergy stent and will then be followed for 5 years. patients, particularly those who may require future interventions.” However, this study is not complete and data has not been permanent ventricular assist devices and other factors. Patients formally published. will be followed for up to 5 years. “The next major step beyond Synergy may be to eliminate the • Disclosures: Kereiakes is a principal investigator of the EVOLVE II trial and co-principal metal skeleton completely with an entirely bioabsorbable stent,” investigator of the ABSORB and DAPT trials, and is an executive steering committee • Meanwhile, the PERMIT-CARE study reports that the MitraClip For more information about the COAPT, Dr. Kereiakes says. member for the Tryton side branch stent system (Tryton Medical); he is a consultant may also help reduce poor results that some heart failure for Abbott Vascular, Boston Scientific, Medtronic and REVA Medical. patients experience after cardiac resynchronization therapy or other clinical trials call 513.585.1777. 5 From the Medical Director Hybrid operating room FDA advisory panel: MitraClip could serve as an alternative treatment a regional first Dean Kereiakes MD Ian J Sarembock, Joseph K Choo, MD for reducing mitral regurgitation MB, ChB, MD $5 million project combines open-heart surgery and cardiac catheterization capabilities Dear Colleague, Introducing the latest advances in cardiac repair procedures to residents of Greater This issue of Heart and Vascular Update features some Cincinnati also requires a state-of-the-art operating room that allows cardiac surgeons of the latest advances in percutaneous catheter-based and interventional cardiologists to work shoulder-to-shoulder. cardiovascular interventions,