Cath Lab Digest - April 2008 - (Page 55)

55 hospitals that participated in trials had significantly lower mortality than patients treated at non-participating hospitals.” “In conclusion, patients treated at hospitals that participate in clinical trials seem to receive better quality of care and seem to have significantly better outcomes than patients treated at hospitals that do not participate in trials-at least in the setting of acute coronary syndrome,” the authors conclude. “For policy makers and physicians, our findings should assuage some of the concerns related to the possible opportunity costs and potential downsides of participating in the clinical research enterprise.” Source: Arch Intern Med 2008; 168[6]:657-662. ■ Clinical Trial Participation cont. 123 hospitals having a midpoint of 4.9 percent enrollment. The overall (composite) median (midpoint) guideline adherence scores increased with increasing levels of trial participation, from 76.9 percent among hospitals with no trial enrollment, 78.3 percent for hospitals with low trial enrollment and 81.1 percent among hospitals with high trial enrollment. “In-hospital mortality decreased with increasing trial participation: 5.9 percent vs. 4.4 percent vs. 3.5 percent,” the authors write. “Patients treated at Results from World’s First Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary Stent Shows No Thrombosis, Low MACE Rates Out to One Year in Preliminary Clinical Study of Thirty Patients D ata published in the March 13th issue of The Lancet from ABSORB, a clinical trial of a fully bioabsorbable drug-eluting stent (DES) for the treatment of coronary artery disease, demonstrated no stent thrombosis, no clinically driven target lesion revascularizations, and a low (3.3 percent) rate of major adverse cardiac events (MACE) in 30 patients out to one year. These one year results for Abbott’s bioabsorbable everolimus-eluting stent were consistent with performance demonstrated by the system at 6 months, as previously reported in October 2007. Abbott’s prospective, non-randomized, ABSORB clinical trial is designed to evaluate the overall safety and performance of a fully bioabsorbable everolimus-eluting stent out to 5 years. “Abbott’s bioabsorbable everolimuseluting stent has demonstrated excellent clinical safety out to one year in patients with coronary artery disease,” said Patrick W. Serruys, MD, PhD, Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. “The positive results from this clinical trial form a strong basis for the development of additional bioabsorbable stent platforms with the potential to eliminate some of the restrictions posed by metallic stents in areas such as vessel imaging and vessel remodeling.” At 6 months, the overall MACE rate in the ABSORB trial was 3.3 percent (one patient, n=30) and late loss, a measure of reduction in vessel lumen diameter after stenting, was 0.44 mm. At one year, the overall MACE rate in the ABSORB trial was consistent with results at 6 months (one patient, 3.3 percent, n=30; 3.4 percent adjusted for one patient who withdrew from follow up, known to be event free at 1 year, n=29). MACE is a composite measure of cardiac death, heart attack and ischemiadriven target lesion revascularization in the ABSORB trial. Abbott's bioabsorbable everolimus-eluting stent also demonstrated 100 percent procedural success and 94 percent device success in the ABSORB trial. “Patients and physicians like the idea of a stent that does its job and is then absorbed away,” said John A. Ormiston, MB, ChB, cardiologist at Auckland City Hospital, in Auckland, New Zealand and principal investigator in the ABSORB trial. “Abbott’s bioabsorbable stent has the potential to hold an artery open long enough for healing to occur, and we would expect an artery that is healed to function as it did before it became diseased.” Abbott’s bioabsorbable everolimuseluting coronary stent is made of polylactic acid, a proven biocompat- ible material that is commonly used in medical implants such as dissolvable sutures. About the ABSORB Clinical Trial. The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. Key endpoints of the study include assessments of safety — MACE and stent thrombosis rates — at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable DES. Other key endpoints of the study include successful deployment of the bioabsorbable DES, follow-up measurements assessed by angiography, intravascular ultrasound and state-of-the-art imaging modalities at 180 days and two years. ■ Vascular Solutions Launches Pronto .035” Extraction Catheter ® V ascular Solutions, Inc. recently launched the Pronto® .035” extraction catheter as the largest addition to its Pronto product line. The Pronto .035” catheter is for the removal of thrombus from large vessels (veins and arteries greater than 4mm). It is in addition to the Pronto V3 catheter, the recently introduced Pronto LP (low-profile) catheter and the specialty Pronto-Short catheter. The Pronto .035” catheter offers over-thewire delivery and is compatible with standard 0.035” guidewires and 10F sheaths. The 120degree angled distal 4cm of the Pronto .035” provides enhanced steerability and vessel selection, while its braid-reinforced shaft increases tip control and resists kinking. The Pronto .035” is currently available in the United States. ■

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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