Cath Lab Digest - April 2008 - (Page 53)

53 controlled trial of 250 patients at 24 sites in Europe and India comparing the use of the Export Aspiration Catheter with conventional PCI. Reported at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2007, the EXPORT study demonstrated that primary aspiration with the Export Aspiration Catheter followed by stenting improved myocardial reperfusion in AMI patients. ■ Benefits from Thrombus Aspiration cont. resolution of ST-segment elevation compared to the conventional PCI group. Importantly, the study showed a reduction in death and major adverse cardiac events in patients that exhibited angiographic signs of improved blood flow to the heart muscle and resolution of ST-segment elevation. There also was a positive trend in favor of the Export Aspiration Catheter in reducing death. Results from TAPAS are consistent with those from Medtronic’s EXPORT study, a randomized, Three-Year Follow-up Data Suggest Better Outcomes Were Maintained with the Cypher® Sirolimus-Eluting Coronary Stent Compared to Brachytherapy in Patients with In-Stent Restenosis L ong-term, follow-up data presented suggest that patients who received the Cypher ® sirolimus-eluting coronary stent for blockage of a bare metal stent were significantly less likely to need another procedure (target lesion revascularization or TLR) at three years compared to patients who received brachytherapy. In addition, there were no significant differences in safety endpoints, such as the rates of death, myocardial infarction (MI), or stent thrombosis between the two treatment arms of this study. These data were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) Annual Scientific Sessions in Partnership with American College of Cardiology (ACC) i2 Summit during the 57th Annual Scientific Sessions. The SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents) is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States. The original trial was designed for follow-up at nine months. This longer-term, follow-up analysis focused on pre-specified safety endpoints, namely death, MI and stent thrombosis, as well as target lesion revascularization (TLR), an efficacy endpoint, to determine whether any new safety issues emerged and whether the major benefit of the Cypher stent, namely reduction in TLR, was maintained. Cordis Corporation sponsored the trial. “These data continue to favor the Cypher stent compared to radiation therapy in these patients with complex coronary artery disease,” said David R. Holmes Jr., MD, Principal Investigator and Professor of Medicine, The Mayo Clinic College of Medicine, Rochester, Minnesota. “Neither treatment modality in this study was associated with any new safety issues or concerns.” Dr. Holmes also serves as an advisory board member to the company’s eSELECT registry, which is being conducted outside the United States. At three years, 81 percent of patients who received the Cypher stent were free from a TLR compared to 71.6 percent of patients receiving brachytherapy (p=0.018). For target vessel revascularization, the survival free rates were 78.2 percent for the Cypher stent and 68.8 percent for the brachytherapy arm (p=0.022). The stent thrombosis rates, as defined as definite and probable per the Academic Research Consortium (ARC) definitions, were not significantly different (3.7 percent for the Cypher stent vs. 2.6 percent for brachytherapy; p=0.606). Although three year rates of target vessel failure (the Cypher stent, 75.1 percent; brachytherapy, 67.9 percent; p=0.067) and major adverse cardiac events, also known as MACE, were both improved with the Cypher stent, this did not reach statistical significance, likely reflecting progression of coronary artery disease at sites other than the original location of bare metal stent restenosis. Rates of MACE were 75.5 percent for the Cypher stent and 70.5 percent for brachytherapy (p=0.186). The Cypher stent does not have an approved indication for the treatment of in-stent restenosis in the United States. ■ ExoSeal Vascular Plug Gets Good Reviews in ECLIPSE Study A new bioabsorbable plug that seals the arterial puncture site after diagnostic angiography and interventional procedures significantly shortens bleeding time and enables patients to get up and walk around far sooner than when manual compression is applied to the groin. In addition, there were no access site complications at 30 days in the ECLIPSE Trial, a multicenter randomized study that is testing the safety and effectiveness of the investigational ExoSeal vascular closure device. The study was reported in a LateBreaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. “We demonstrated that the ExoSeal device is a great alternative to manual compression following diagnostic and interventional procedures,” said Shing-Chiu Wong, MD, a professor of medicine at Weill Medical College of Cornell University and director of the cardiac catheterization laboratories at New York Presbyterian Hospital/Weill Cornell Medical Center, New York City. “It enables early ambulation and, potentially, early discharge from the hospital following the procedure.” The ExoSeal™ Vascular Closure Device consists of a felt-like plug made of polyglycolic acid. It is anchored in place on top of the puncture in the femoral artery, after the catheter is removed. Because none of the plug is inserted into the artery itself, it does not interfere with blood flow. Over about three months, it completely dissolves. For the study, Dr. Wong and his colleagues recruited 488 patients from 17 medical centers, half of whom were undergoing diagnostic angiography and half, an interventional procedure. Some 90 percent were being examined or treated for coronary disease, the remaining 10 percent for peripheral disease. Patients were randomly assigned to treatment with the ExoSeal or to manual compression. The ExoSeal device was put into place in an average of just one minute and was used successfully in 89.1 percent of patients. There was no difference in procedural success between the ExoSeal and manual compression groups (91.8 percent and 91.0 percent, respectively). However, the average time to cessation of bleeding was significantly shorter in patients treated with the ExoSeal (4.38 minutes vs. 20.05 minutes, p<0.0001). Similarly, patients treated with the vascular closure device were able to get out of bed and walk around far sooner, within 2.54 hours, on average, with the ExoSeal, as compared with 6.24 hours with manual compression (p=0.028). “Further investigation is needed to delineate the device’s applicability in patients with access puncture sites at or below the branchpoint of the femoral and iliac arteries and in patients with mild or moderate peripheral vascular disease,” he said. “Comparative studies of efficacy and patient comfort with the ExoSeal and other vascular closure devices will also be intriguing.” ■

Table of Contents Feed for the Digital Edition of Cath Lab Digest - April 2008

Cath Lab Digest - April 2008 Kaiser San Rafael Medical Center Orbital Atherectomy: A New Treatment for Complex Peripheral Arterial Disease Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Contents Clinical Editor’s Corner CEU Education Center The Missing Link in STEMI Interventions — Thrombus Aspiration during Primary Percutaneous Coronary Intervention Predicting Stent Thrombosis Using A Clinical Risk Score Use of a New Guidewire: The Tigerwire Should I Stay or Should I Go? Weighing Options for New Opportunities Navigating Tortuous Coronary Sinus Anatomy Using a Bipolar Lead The National Society of Radiology Practitioner Assistants (NSRPA) Holds 9th Annual Educational Conference For Medical Imaging Physician Extenders and Mid-Level Healthcare Providers Cath Lab & Beyond: A Meeting Update The Ten-Minute Interview with… Dale Hansen RT, CVT Sometimes, You Just Know Twin Circumflex Arteries: A Rare Coronary Artery Anomaly What Do You Think? Meetings Calendar News from the American College of Cardiology (ACC) Scientific Session and the Society of Cardiovascular Angiography & Interventions (SCAI) Annual Scientific Sessions in Partnership with the ACC i2 Summit Clinical & Industry News Cath Laughs Classifieds Advertisers Index

Cath Lab Digest - April 2008

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