Cath Lab Digest - December 2007 - (Page 41) DECEMBER 2007 CLINICAL AND INDUSTRY NEWS 41 Clinical Study Shows 50% Reduction in Median Time-to-Hemostasis for Vascular Solutions’ D-Stat Dry Hemostatic Bandage V ascular Solutions, Inc. announced the published results of a 376-patient, five-center, prospective randomized U.S. clinical study regarding its thrombin-based DStat Dry hemostatic bandage used for the control of surface bleeding from vascular access sites following percutaneous procedures. The study showed that when used as an adjunct to hemostasis, D-Stat Dry reduces time to hemostasis following diagnostic femoral catheterizations using 4F-6F introducer sheaths, compared with standard manual compression alone. A 50-percent reduction in median time-to-hemostasis (6 minutes with DStat Dry vs. 12 minutes with manual compression alone) was observed. The randomized 1:1 D-Stat Dry to manual compression study also demonstrated a lower rate of adverse events (0.5% with D-Stat Dry vs. 1.1% with manual compression alone). The results of the study, “The Use of the D-Stat Dry Bandage for the Control of Vascular Access Site Bleeding: A Multicenter Experience in 376 Patients,” were published in the July/August 2007 issue of Cardiovascular & Interventional Radiology. Five sites participated in the study: Charleston Area Medical Center, Charleston, WV; Abbott Northwestern, Minneapolis, MN; Tri-Health (Good Samaritan/Bethesda), Cincinnati, OH; Mount Sinai Medical Center, Miami, FL; and Terrebonne General Medical Center, Houma, LA. ■ Certain Infusion Therapy After STEMI Does Not Appear to Be Beneficial, May Cause Harm I nfusion of a combination therapy consisting of glucose, insulin, and potassium, which was thought could be a beneficial treatment immediately following a heart attack, may increase the risk of heart failure and death in the first 3 days for patients with ST-segment elevation myocardial infarction (STEMI), according to a study in the Journal of the American Medical Association. Small studies have supported the use of glucoseinsulin-potassium (GIK) infusion in the treatment of STEMI, while a larger study indicated a neutral effect of GIK infusion on the risk of death at 30 days after a heart attack. Rafael Díaz, MD, of the Etudios Cardiologica Latin America, Rosario, Argentina, and Abhinav Goyal, MD, MHS, from the Emory School of Medicine, Atlanta, and colleagues conducted a study to determine the association between GIK infusion therapy and 30-day and 6-month outcomes in patients with STEMI, and whether GIK infusion may cause harm in the early post-infusion period. The study included analysis of the outcomes of the OASIS-6 GIK randomized controlled trial of 2,748 patients with acute STEMI, and the prespecified analyses of the combined trial data from the OASIS6 GIK and CREATE-ECLA GIK trial populations of 22,943 patients with acute STEMI. The researchers found that in the OASIS-6 trial, there were no differences between the GIK infusion and control groups in the 30-day outcomes of death, heart failure, or the composite of death or heart failure. There also were no differences in six-month clinical event rates. In the combined OASIS-6 and CREATE-ECLA GIK trial results, there were no differences between the GIK infusion and control groups in the 30-day rate of death, heart failure, or the composite of death or heart failure. In the analyses from days 0 to 3, the risks of death and the composite of death or heart failure were higher in the GIK group compared with the control group, with 712 deaths (6.2 percent) in the GIK group and 632 deaths (5.5 percent) in the control group; and 1,509 death or heart failure events in GIK group (15.8 percent) and 1,388 events in the control group (14.5 percent). The difference in the death rate disappeared by 30 days, with 1,108 deaths (9.7 percent) in the GIK group and 1,068 (9.3 percent) in the control group. “GIK therapy increased levels of glucose, potassium, and net fluid gain post-infusion, all three of which predicted death after adjusting for multiple confounders. Adjusting for glucose, potassium, and net fluid gain eliminated the apparent increase in mortality at 3 days observed with GIK infusion, suggesting a direct association with these factors. Administration of GIK infusion within 4 hours of symptom onset yielded no benefit compared with later initiation,” the authors write. “The combined OASIS-6 and CREATE-ECLA trial analysis of almost 23,000 patients with STEMI (the largest global experience with GIK therapy) demonstrates that GIK infusion has no effect on any important clinical end point through 30 days following STEMI. However, contrary to our prespecified hypothesis, we observed a higher rate of death and the composite of death or heart failure at 3 days in patients allocated to GIK therapy compared with control.” ■ Source: JAMA 2007;298(20):2399–2405. COURAGE Sub-study: PCI Outperforms Drugs-Only P atients with ischemia benefit significantly from percutaneous coronary intervention (PCI) when compared with optimal medical therapy, according to a nuclear substudy of the COURAGE trial presented at the American Heart Association (AHA) in Orlando. This sub-study is especially significant given that the COURAGE trial had previously called into question the relative effectiveness of PCI compared to medications alone in the prevention of death and heart attack in patients with stable heart disease. The Society for Cardiovascular Angiography and Interventions (SCAI) questioned those findings from the beginning. SCAI noted that the COURAGE study excluded all but the most stable patients, including only those who were able to adhere to very strict medication and lifestyle-change requirements. COURAGE also enrolled patients only after their anatomy was determined, another significant study design limitation. Furthermore, the existing data had never suggested that angioplasty or stenting reduced the risk of death or heart attack in this population of stable patients. “This new analysis confirms what interventional cardiologists have said all along — when compared to using only drugs, PCI improves overall heart health and reduces debilitating chest pain by opening up blocked arteries,” said Dr. Bonnie Weiner, President of The Society for Cardiovascular Angiography and Interventions. Continued on next page
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