Pulse of CRF The Newsletter of the Cardiovascular Research Foundation Winter 2013 - Vol 7, TCT Issue

IN THIS ISSUE

Cutting-Edge Clinical Research Presented at TCT 2013 ...... 1

CRF Selects Jack Lewin, MD, to Serve as President and CEO ...... 1

In Memoriam: Andreas Gruentzig, MD, Receives TCT Career Achievement Award ...... 2

TCT Goes Tablet ...... 3 Cutting-Edge Clinical Research Presented at TCT 2013

The annual Transcatheter substantially reducing the need for ongoing and has enrolled nearly Cardiovascular Therapeutics (TCT) printed materials. Highlights from double the number of patients scientific symposium is the world’s the scientific sessions included: included in the current research. preeminent forum for interventional New TAVR Options on Further, the REPRISE II trial tested cardiologists, cardiac surgeons, and the safety of a second-generation vascular medicine specialists. the Horizon: TAVR device internationally. The The pivotal CoreValve Extreme Risk TCT celebrated a milestone 25 years Lotus Valve System was associated trial found that transcatheter aortic at the 2013 meeting held in San with low rates of complications in valve replacement (TAVR) with Francisco, California. Attracting over symptomatic patients with severe the CoreValve device substantially 11,500 attendees, the symposium aortic blockages who were at reduced the incidence of death broke new ground by distributing high risk for surgery. Successful and major stroke at 1 year in US tablet computers to attendees and implantation and positioning of the patients with severe aortic blockages producing an innovative digital valve was achieved in all patients. considered too high risk to undergo Upcoming CRF app, enabling attendees to interact surgery. An expanded study is Educational Events with sessions like never before and (See TCT 2013 page 4)

Conference on Cell Therapy for Cardiovascular Disease January 22-24, 2014 CRF Selects Jack Lewin, MD, to Serve Vivien and Seymour Milstein Family Center as President and CEO New York, NY The Cardiovascular Research He succeeds William A. Foundation has appointed Jack Himmelsbach, MPH, who retired Lewin, MD, as the organization’s in late 2012. CRF board member Complex PCI new president and chief executive Colette Y. Gardner has served February 27-March 1, 2014 officer. Lewin, who will also serve as president and co-chair of the New York Marriott Marquis on CRF’s board of directors, Executive Leadership Council New York, NY comes equipped for his new role in the interim. Jack Lewin, MD after years of experience as a President and Chief Executive practicing physician, leader and Officer of CRF manager. (See Jack Lewin, MD, page 6) In Memoriam: Andreas Gruentzig, MD, Receives TCT Career Achievement Award

Spencer B. King III, MD, of Saint “There was a lot of collegiality Joseph’s Medical Group in Atlanta, at that time,” said King. “People Ga., said Dr. Gruentzig hit upon the who had done 10 procedures idea of a balloon that would expand were experts at the time and they inside the artery. Working in his interacted with people who were kitchen with colleagues, he began to just starting out with it.” experiment with materials, focused on Gruentzig had a drive and the idea that the balloon would have determination to educate and share to be rigid to force open the lesion. his knowledge with the world, but The double lumen catheter with he also was concerned that the a polyvinyl chloride balloon they procedure not be misused. developed was tried first in leg According to Stone, Gruentzig arteries and then kidney arteries, and symbolized the characteristics that was finally miniaturized enough for exemplify current interventional use in coronary arteries. including a thoughtful Early Experiments and evidence-based approach to In 1976, Gruentzig presented procedures that always puts the the results of his animal studies patient’s interests and outcomes first. involving his new device in a poster In January 1980, Gruentzig moved CRF was delighted to have Gruentzig’s family and close associates from the at the American Heart Association to the United States where he joined early years of his career present at TCT to share in this special tribute. (AHA) Scientific Sessions. In the the faculty, including King, at Emory studies, a silk ligature was used as University in Atlanta. During the next a constrictor in the canine coronary The Cardiovascular Research not have benefited from the lesser few years, he worked with others to artery dilation. The balloon was Foundation presented Andreas invasive approach to coronary artery develop the technique. By 1984, trials expanded to break the thread and Gruentzig, MD, the TCT Career disease that is ,” said comparing angioplasty with bypass restore flow. Achievement Award posthumously TCT director Gregg W. Stone, MD. surgery were initiated. Unfortunately, on Tuesday, October 29, in Although Dr. King admitted to being Gruentzig did not live to see the Gruentzig had the “charisma and recognition of his contribution skeptical of the idea, the experiment amazing results of those studies. force of personality to stand up to to the development of the field of caught the eye of other physicians doubters and persist in the face of interventional cardiology. at the meeting, including Richard adversity, promoting a technique Myler, MD, who would eventually If he was alive today, More than 35 years ago, Dr. that he knew in his soul could help invite Gruentzig to perform he would be tremendously Gruentzig, now considered by many so many,” Stone said. angioplasty on one of his sedated proud of this whole to be the father of interventional Birth of a Subspecialty surgical patients in San Francisco. specialty that he started, cardiology, performed the first balloon angioplasty of a coronary Gruentzig earned his medical Not long after in September 1977, which has gone from a artery in , . The degree in Heidelberg, Germany, Dr. Gruentzig performed the kitchen table to a specialty procedure began a revolution in the in 1964 and began training in first coronary angioplasty on an that has grown worldwide.” angiology. Soon after, he took an field of cardiology, offering patients unanesthetized patient in Zurich. - Spencer B. King III, MD an alternative to bypass surgery and interest in techniques pioneered Spreading the Word opening the door to percutaneous by vascular radiologist Charles cardiovascular procedures including Dotter, MD, for opening vessels in In 1977, Gruentzig was invited back transcatheter treatment of valvular the legs using catheters. Gruentzig to the AHA Scientific Sessions to make “Interventional procedures not disease, hypertension and heart learned these techniques from his an oral presentation about his animal only have become the dominant failure, and prevention of stroke. mentor, Eberhard Zeitler, MD, in experiments. Instead, he presented procedures for coronary Nuremberg, Germany. his first four human angioplasty cases interventions, but also are Gruentzig, 46, and his wife Margaret including one very dramatic procedure dramatically outpacing surgery and With his interest piqued, Gruentzig Anne, died in a plane crash in of a left main stenosis. have, more importantly, become began using catheters in practice Georgia in October 1985. CRF was the primary procedure for acute MI but knew that in order to apply the “The reaction from the audience delighted to have his family and and have opened the flood gates to technique to coronary arteries, a new was astonishment,” King said. “He close associates from the early years structural heart interventions and type of device would be required. The received a standing ovation.” of his career present at TCT to share more,” said King. device would have to be small enough in this special tribute. As interest in learning the technique to enter the arteries, but also would increased, Gruentzig began to “Without Dr. Gruentzig’s singular have to be able to enlarge once it was televise courses from Zurich where vision and determination, our placed inside the obstruction. subspecialty would not exist, and he would demonstrate the procedure tens of millions of patients would to colleagues eager to learn.

2 The Newsletter of the Cardiovascular Research Foundation TCT Goes Tablet By distributing tablets to attendees, TCT reinvents the medical conference.

• The TCT app: This app provided Tech Savvy attendees the ability to view and The tablet also allowed attendees to search the TCT program, plan tally the number of CME hours they their schedule, claim CME credits, accrued at the meeting and to have a navigate the Moscone Center, certificate sent verifying the credits. communicate with other attendees, take notes and much more. If attendees arrived at the conference with their own tablet, • TCTMD app: This app provided they could download the apps attendees with mobile access to through iTunes and Google Play. slide presentations from every recent TCT as well as the library TCT provided technical support of content from the TCTMD Web for the tablets on the second floor site, including daily news, journal of the West building, as well as at summaries, conference coverage multiple kiosks located throughout and CME programming. the convention center.

Importantly, TCT and CRF For the first time in its history, Information at fingertips did not collect any data the Transcatheter Cardiovascular from the tablet, and At TCT 2013, instead of a bulky Therapeutics conference went advertisements were conference bag stuffed full of completely paperless and only visible within programs, calendars, abstracts, distributed tablet computers to all the preloaded apps. and agendas, each attendee paid registrants for the full TCT received a Samsung Galaxy Tab® week, a decision that reflects its 3 8 tablet preloaded with all of the 25-year history of forward thinking information needed to successfully and innovation not only in the field navigate the conference. of interventional cardiology but also in education.

“In addition to TCT’s usual focus on the latest research breakthroughs and developments in interventional cardiology, the tablet initiative is part of CRF’s overall long-term digital strategy to innovate and enhance medical education, making it more interactive, dynamic and informative. Our goal was to optimize the educational experience and enhance learning for all meeting participants.” - Gregg W. Stone, MD

Johnnie White, executive director Attendees were welcome to use of the CRF Center for Education their own mobile devices—there highlighted another benefit to are downloadable Android and iOS the new format. “You’re able to versions of the app. Unlike program have access to the most up-to-date and abstract books, which are used content for the TCT program,” for a few days and then typically he said, noting that the app was discarded, the TCT tablet will serve updated frequently to keep pace as year-round educational tool that with events during the conference. not only reduces waste but also enhances learning. Going paperless is not a new idea when it comes to medical In addition to the traditionally conferences. Many physicians preloaded apps like an have likely attended a conference Internet browser with information available online. and e-mail, TCT However, these meetings rely on preloaded two the attendees to have a tablet, applications onto computer, or smartphone to access each tablet for the that information. convenience of attendees:

3 Continued from Page 1 cohort, who were at lower risk TCT 2013 than the overall population, were randomly assigned to either stop DAPT or continue it for up to 18 High Prospects for months. At follow-up, there was Third-Generation DES no difference in complication rates. Safety and effectiveness of new However, those who discontinued stents were tested in two studies. DAPT experienced less bleeding The SORT-OUT VI trial compared a stent with a permanent polymer Two Stents for Bifurcation coating and a stent with a Lesions? Celebrating biodegradable coating that releases Treating coronary blockages that Global Collaboration the drug biolimus in Scandinavian have split into two branches, also patients. Both stents were known as bifurcation lesions, has associated with low rates of major proven difficult and two studies cardiovascular complications 12 examined the outcomes associated With Special Honorees months after angioplasty. with using a two-stent treatment approach compared with traditional The DUTCH PEERS (TWENTE single stenting plus using an II) trial was the first to compare additional stent when necessary. In the safety and effectiveness of NORDIC-BALTIC BIFURCATION third-generation drug-eluting IV, rates of major complications at stents. Both the Resolute Integrity 6 months were comparable between zotarolimus-eluting stent and treatment options. the Promus Element everolimus- Antonio Runlin Patrick W. J. Eduardo Colombo, MD Gao, MD Serruys, MD, PhD Sousa, MD, eluting stent performed well The Tryton Bifurcation study failed PhD with no differences in a study of to show noninferiority of the two- nearly 2,000 patients. The third- stent strategy compared with single- Co-Chairs generation stents release the same stenting plus an additional stent drugs as second-generation DES, when necessary. However, it did find Martin B. Leon, MD but involve novel stent platforms that the new technique was better Gregg W. Stone, MD with more flexible designs. The than provisional stenting at widening trial was simultaneously published the side branch, or the secondary in The Lancet. branch of the lesion, at 9 months. Friday, December 13, 2013 · 6:30 pm Cocktails· Dinner· Dancing Support for Short-Term Angioplasty Best Practices Dual Therapy The CHAMPION PHOENIX trial The Plaza· Grand Ballroom Results of two studies provided explored the relationship between Fifth Avenue at Central Park South · New York, NY further evidence that shorter-term stent thrombosis that occurs dual antiplatelet therapy, or DAPT, For more information, please contact Irma Damhuis at during angioplasty and short-term 646-434-4690 or [email protected]. lasting 3 months after stenting complications. While a small percent may be safe, while prolonged of patients develop stent thrombosis therapy beyond 1 year may be during angioplasty, the study found harmful. OPTIMIZE showed the that it carries serious implications noninferiority of 3-month DAPT for patients, as it is related to longer to standard 12-month therapy after hospital stays. Importantly, use implantation of the Endeavor stent. of the antiplatelet drug cangrelor Importantly, short-term DAPT did was found to help prevent not increase the risk of dangerous intraprocedural stent thrombosis. blood clots that can form inside the Performing angioplasty via an stent, known as stent thrombosis. artery in the wrist (radial) as Results of the OPITMIZE trial were opposed to the groin (femoral) is CRF Physician Participates in also published in the Journal of the reasonable and may be preferable in American Medical Association. NYC Marathon women, according to results from In the ARCTIC-INTERRUPTION the SAFE-PCI for Women study. Congratulations to Philippe trial, no benefit was noted and There was a substantial reduction Généreux, MD, Director, greater risk of bleeding was seen in complications with the radial when DAPT was continued beyond Angiographic Core approach, and it resulted in lower 12 months. The study was the volumes of contrast dye being Laboratory at CRF, who ran second half of the randomized used. In addition, radial access was the NYC Marathon with a ARCTIC trial, which tested preferred by the majority of women. time of 3:50. adjustment of antiplatelet therapy A subgroup analysis from the based on platelet function testing. FREEDOM trial of diabetic patients At 1 year after stenting, roughly assigned to either open-heart half of the original randomized

4 The Newsletter of the Cardiovascular Research Foundation surgery or angioplasty with a first- cooling prior to restoring blood generation drug-eluting stent found flow is safe and feasible. Patients higher rates of major complications were randomly assigned to standard at 5 years among those treated with of care or hypothermia induced insulin. However, the differences in by cold saline and endovascular clinical outcomes between surgery cooling. Cooling did not reduce and angioplasty were maintained infarct size in relation to heart regardless of the presence or tissue at risk in the allotted time. absence of insulin treatment. Stroke No patient died, but the incidence rates were higher among patients of clinical heart failure was lower in assigned to surgery regardless of the hypothermia group. insulin use. Administering the antithrombin The SMART-CASE randomized agent bivalirudin to STEMI patients trial found that in patients with during transport to the hospital intermediate coronary blockages, reduces the risk of short-term a conservative approach to There were over 11,500 attendees at TCT 2013. This year, 1,750 abstracts were death and major bleeding better determining appropriateness of submitted from 56 countries and 39 U.S. states. Reviewers narrowed that than heparin plus optional use of angioplasty is safe and equivalent to number down to 851—a 49% acceptance rate. a glycoprotein IIb/IIIa inhibitor, an aggressive approach. At 1-year or GPI, according to results follow-up, both strategies exhibited from the EUROMAX trial. No comparable rates of adverse events blood flow compared with a method the legs. Six-month findings from difference was seen between the called fractional flow reserve, or the LEVANT 2 trial comparing an two strategies for all-cause or Revascularization FFR. For HeartFlowNXT, FFR investigational paclitaxel-coated heart-related death, although the Techniques Scrutinized derived from computed CT scans balloon with standard balloon trial was underpowered for these The first randomized pilot study of (FFRCT) was compared with angioplasty at 55 global sites endpoints. Findings of the trial were a new revascularization technique coronary CT angiography and showed advantages to the drug- also published in the New England that combines minimally invasive invasive FFR alone. Per-patient coated balloon. Safety outcomes Journal ofvcine bypass surgery with angioplasty is diagnostic performance was better were similar between the two safe and feasible in select patients with FFRCT compared with treatment groups. Inconsistent Results with with multivessel heart disease, the other two methods without Platelet Function Testing Similarly, the multicenter, according to results from the sacrificing specificity. TRANSLATE-POPS showed that prospective, randomized RIBS V trial HYBRID trial. The vast majority routine blood platelet function ADVISE II was a global study compared the use of DES and drug- of patients who underwent the that compared traditional FFR testing with the VerifyNow P2Y12 hybrid procedure received complete test had only a modest impact revascularization, with a small on the amount of adjustment to percentage requiring conversion to antiplatelet therapy of patients open surgery. Complications at 1 TCT 2013 featured nine late breaking trials and 12 with STEMI and non-STEMI year did not differ between study first report investigations. A cornerstone of every heart attacks. Incidence of therapy groups, and there was no incidence adjustment before hospital of stroke in either group. Future TCT, these trials are typically the initial worldwide discharge in the patients who analyses plan to address quality presentation of clinical trials, impactful single-center received routine platelet function of life and cost-effectiveness of the or multicenter registries, or important follow-up testing was higher than in those not undergoing such testing. The hybrid procedure. data from major randomized trials and first-in-man majority of adjustments manifested In TATORT-NSTEMI, aspiration experiences with novel devices or drugs. as drug switches, rather than thrombectomy, or using a device adjustments in dose, and primarily to “suck out” coronary blockages, involved switching from the failed to reduce the extent of standard blood-thinner clopidogrel microvascular obstruction or to the newer agent prasugrel. improve outcomes compared with with instantaneous wave-free coated balloons in treating vessel standard coronary angioplasty alone ratio (iFR), which does not re-narrowing after stenting. Patients But in the GIANT trial, platelet in less severe heart attack patients. require the administration of the with bare metal stents received either function testing was helpful for This lack of benefit was consistent drug adenosine. In the study, iFR the Xience Prime everolimus-eluting optimizing antiplatelet therapy across subgroups and blockage performed well with regard to the stent or SeQuent Please paclitaxel- for individual patients tested size and blood flow level. At 6 percentage of coronary blockages coated balloon. At 1 year follow-up, within 48 hours of an acute heart months, patients showed similar properly classified by hemodynamic the stent was slightly more effective, attack and treated with a first-time complication rates regardless of severity. A hybrid iFR/FFR approach but both techniques yielded similarly angioplasty with stenting. Among whether they did or did not receive also appropriately classified the vast positive outcomes. slow responders to clopidogrel who majority of blockages. thrombectomy with angioplasty. Treatment Additions for were adjusted to optimal therapy based on platelet function testing, the Encouraging Results for STEMI Patients Explored occurrence of death, heart attack, and Diagnostic Tools Improve Drug-Coated Balloons Results from CHILL-MI indicate stent thrombosis at 1 year was similar Upon FFR Two trials showed encouraging that in patients who have suffered to normal or high responders. Two studies explored novel strategies results for drug-coated balloons in the most serious form of a heart of accurately assessing inadequate patients with diseased arteries in attack known as STEMI, rapid

5 Continued from Page 1 whatever else we learn, CRF’s work Jack Lewin, MD is going to be important for the nation’s economic future.”

Shaping the future of Bringing proven leadership interventional cardiology and expertise on board According to Lewin, as soon as According to Gregg W. Stone, co- he was approached about the new director of the Medical Research and role, he was eager to hear more. Education Division of CRF, Lewin will “There’s not a cardiologist in the be a good fit. “Jack Lewin is a true interventional space worldwide who visionary with exceptional experience Cell Therapy doesn’t know what TCT is or hasn’t in health care delivery, and in leading looked at the TCTMD Web site,” Nineth International cardiology systems in new and exciting he said. “CRF itself is a fantastic directions,” Stone commented. institution that runs not only Prior to joining the ACC, Lewin Conference on Cell Therapy conferences but also pursues clinical was CEO of the California Medical for Cardiovascular Disease and preclinical research. Putting Association and director of health that all together to advance science of Hawaii. As a commissioned and translate those findings to officer in the U.S. Public Health clinical practice is really exciting.” Service, he founded and directed January 22-24, 2013 During his time as CEO of the the Navajo Nation Department American College of Cardiology of Health, serving the needs of Vivian and Seymour Milstein Family Heart Center (ACC) between 2006 and 2012, America’s largest American Indian New York, NY the ACC and CRF began discussing tribe. Lewin received his BA ways to collaborate. In 2008, CRF in Biological Sciences from the began to help select interventional University of California, Irvine, content for the Innovations in and his MD from the University Interventions (i2) Summit at ACC’s of Southern California. He and his Annual Scientific Session, and in wife Sandra have three children. 2011 ACC became an official co- sponsor of TCT. One of the most pressing concerns Pulse of CRF Register Now: in the United States, Lewin noted, is how to curb costs while providing WWW.CELLTHERAPY.CRF.ORG the best possible care for patients. President and Chief “There is an enormous amount Executive Officer of change going on in terms of Jack Lewin, MD economics that will radically influence where research, External Relations education, and clinical practice Irma J. Damhuis go,” he explained. “The American health care system, for all of its Managing Editor fantastic achievements, is not Jason Kahn always fantastic at the point of Associate Editors care. There’s a lot of unevenness in Caitlin E. Cox, Kim Dalton, quality. But the key issue is that it’s Yael L. Maxwell, unaffordable and unsustainable, L.A. McKeown, and there are many people not included in coverage today.” Program Manager Judy Romero CRF, Lewin predicted, could be the chief advocate in the Project Manager cardiovascular space. “I look Juan Iturriza CTO/LM forward to bringing information Designer back to CRF about where health Diana Sanchez Chronic Total Occlusion and care is going, and I would like to Left Main Summit 2014: bring our experience here back A Live Case Demonstration Course to the national discussion,” he said. “Cardiovascular medicine constitutes almost 40% of the 111 East 59th Street February 27-March 1, 2014 • New York, NY Medicare budget, so to the extent New York, NY 10022 that we can figure out better Tel. 646-434-4500 Visit us online to register: CRF.ORG/CTOLM ways to make people healthier using technology and lifestyle and WWW.CRF.ORG

6 The Newsletter of the Cardiovascular Research Foundation