News from the American College of Cardiology meeting (Atlanta, Georgia, March 17-21, 2002)

Three Clinical Studies Using Cordis CYPHER Sirolimus-eluting Stent Demonstrate Unprecedented Results Results from three separate major clinical studies document continued excellent performance of the investigational CYPHER Sirolimus-eluting Stent in patients with coronary artery disease. New findings further support extensive reductions in late lumen loss and in-stent restenosis. 1. RAVEL: 12-Month Results The landmark RAVEL clinical trial, involving 238 patients at 19 centers across Europe and Latin America, was the first large-scale stent study to document sustained zero restenosis at 6 months post treatment. More than 12 months after the initiation of this study, researchers continue to document exceptional findings: 0% restenosis, 0% percutaneous TLR (target lesion revascularization), no thromboses, and no cardiac deaths, and no deaths. The study population includes patients with single de novo lesions measuring 18 mm in length and 2.5-3.5 mm in diameter. On admission, patients were randomly assigned to one of two treatment arms: the CYPHER Sirolimus-eluting stent cohort (120 patients) or the control cohort (118 patients who received a conventional Bx Stent). In both groups, anti-platelet therapy with ticlopidine or clopidogrel was discontinued after just 2 months. The reduction in neointimal hyperplasia has resulted in an event-free survival rate of 94% at 12 months in the sirolimus-treated cohort. This finding is superior (P2. First-in-Man Feasibility Studies in Patients with de novo lesions: Twenty-four-month follow-up data for the 30 patients enrolled in the original CYPHER Sirolimus-eluting Stent pilot study in Sao Paulo, Brazil, continue to demonstrate the outstanding results reported at 12 months. Of these patients, 29 agreed to have repeat angiography at 24-month follow-up. The average sustained in-stent late loss is essentially zero. One patient had evidence of progression of a lesion immediately adjacent and proximal to the stent, resulting in 51% diameter stenosis. Two other patients had evidence of disease progression in unstented vessels. All three of these patients were treated with additional CYPHER stents. One additional patient was referred for bypass due to progression of disease in a different area of the treated vessel. There were no stent thromboses and no deaths. One patient had a myocardial infarction due to plaque rupture proximal to the stent at 14 months. 3. In-stent Restenosis (ISR) Study: Investigators reported 8-month clinical follow-up data for the 41 patients enrolled in the first-in-man study to evaluate the feasibility of using CYPHER to treat in-stent restenosis. In November 2001, researchers reported outstanding 4-month follow-up data showing extremely low in-stent late lumen loss (0.08 mm minimum lumen diameter); zero restenosis; and no TLR, stent thromboses, or deaths for the 25 ISR patients. Eight-month clinical follow-up data for these patients, indicates no change in their status. GE Medical Systems Showcases Vision for Cardiac Care at ACC GE Medical Systems featured the first-ever cardiology technology pavilion at ACC, allowing visitors to get a look at emerging applications and concept equipment under development. GE Medical Systems Information Technologies introduced Centricity Cardiology, a fully integrated cardiac care clinical information system. Centricity Cardiology software provides clinicians with increased cardiac patient information at one workstation. The system delivers a seamless, paperless flow of patient cardiovascular data on a single interface with a single login. GE Medical Systems Information Technologies showcased its new 12SL GenderSmart electrocardiograph software. Studies have shown that this technology, which accounts for gender-specific heart rhythm differences, improves heart attack detection in women by 14%. Boston Scientific Shares Preliminary, Six-Month Results of TAXUS III Paclitaxel-Eluting Stent Clinical Trial TAXUS III is a single-arm registry examining the feasibility of implanting up to two paclitaxel-eluting stents for the treatment of in-stent restenosis. Enrollment of 30 patients was completed in July 2001. The trial’s main focus is safety, and the primary endpoint is 30-day MACE (Major Adverse Cardiac Events; including death, myocardial infarction and revascularization). The study reported a 7% 30-day MACE rate (one myocardial infarction and one target vessel revascularization unrelated to the stent study), both of which occurred during the stent placement procedure. No early stent thromboses were reported. Systemic paclitaxel levels were undetectable at 30 days, consistent with the data from TAXUS I. Six-month data demonstrated a 17% MACE rate (four target lesion revascularizations, one target vessel revascularization without any deaths or coronary artery bypass grafts). This rate compares favorably with brachytherapy. Analysis of the patterns of restenosis is underway to determine the optimal lesion criteria and implant technique to improve outcomes. Siemens Presents New IT Solution of Soarian Cardiology Soarian Cardiology is an information solution designed to address the specific clinical, financial, and operational workflow challenges of the cardiac care team. In a departmental setting, Soarian Cardiology allows users to build a continuous, comprehensive electronic patient record that includes medications, lab results, images, ECG, physiological waveforms, and documentation. Used departmentally or in conjunction with the enterprise-wide Soarian health information system, it provides a holistic solution to the cardiology professional and seamless, real-time integration with the complete enterprise patient record. Built for the web, Soarian’s user interface (UI) organizes and presents information based on how the cardiology department user thinks and works. The UI was deliberately modeled on syngo® ¾ Siemens’ medical imaging user interface that works across all Siemens modalities. New Treatment Guidelines Recommend Lovenox® The low-molecular-weight heparin Lovenox® (enoxaparin sodium) Injection is preferable to unfractionated heparin as an anticoagulant in certain patients with unstable angina or non-ST-segment elevation MI, unless CABG is planned within 24 hours. This recommendation is contained in updated guidelines issued by the ACC and the American Heart Association. The revised 2002 ACC/ AHA guidelines provide recommendations and supporting data for the continued management of patients with unstable angina (UA) and non-ST-segment elevation myocardial infarction (NSTEMI). The recommendation for enoxaparin is based on the results of two trials with enoxaparin, the ESSENCE and TIMI 11B studies, which showed a moderate benefit over unfractionated heparin. A meta-analysis of the two trials that involved a total of 7,081 patients showed a statistically significant reduction of approximately 20 percent in the rate of death, myocardial infarction, or urgent revascularization at 2, 8, 14 and 43 days and in the rate of death or MI at 8, 14, and 43 days. Data Released at ACC Support the Benefits of ReoPro® Results of numerous studies show that treating patients with ReoPro® following a heart attack reduces patients’ risk of death, recurrent heart attack and the need to re-open clogged arteries. Data presented at the ACC highlight the strength of ReoPro in treating patients with diabetes, visible and non-visible thrombus and complex lesions. In particular, the combination of ReoPro and a stent appeared to significantly limit further damage to the heart muscle compared with a combination of ReoPro and a thrombolytic. Other data suggested that ReoPro improved blood circulation to the heart, as measured by Myocardial Blush Grade (MBG), a sensitive indicator of future heart problems. Diabetic patients experienced a particularly beneficial effect with ReoPro treatment. A separate analysis examining left ventricular (LV) function in 47 patients who underwent angioplasty, revealed that treatment with ReoPro helped to maintain blood flow to the heart muscle and improved heart muscle function at both 30 days and six months. Two additional presentations from the GUSTO V (Global Use of Strategies to Open Occluded Arteries in Acute Myocardial Infarction) trial studied the potential use of ReoPro in combination with a thrombolytic as an alternative treatment option for heart attack patients: 1. Patients treated with the combination of ReoPro and the thrombolytic RETAVASE® (reteplase) were 34 percent less likely to experience a re-current heart attack than patients treated with Retavase alone (2.3% vs. 3.5%, respectively). 2. The ReoPro and RETAVASE combination restored overall blood flow more quickly and improved the stability of the target vessel.

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