ABSTRACT
BACKGROUND: Unfractionated heparin (UFH) is the traditional agent utilized during percutaneous peripheral interventions (PPIs) despite its well-known limitations. Bivalirudin, a thrombin-specific anticoagulant, overcomes many of the limitations of UFH and has consistently demonstrated comparable efficacy with significantly fewer bleeding complications. The purpose of this study was to compare procedural success in patients undergoing bare-metal stent implantation for atherosclerotic blockage of the renal, iliac, and femoral arteries and receiving either bivalirudin (0.75 mg/kg bolus/1.75 mg/kg/hr infusion) or UFH (50-70 U/kg/hr bolus) as the primary anticoagulant. METHODS: This study was an open-label, nonrandomized retrospective registry with the primary endpoint of procedural success. Secondary endpoints included incidence of: death, myocardial infarction (MI), urgent revascularization, amputation, and major and minor bleeding. RESULTS: One hundred and five consecutive patients were enrolled (bivalirudin = 53; heparin = 52). Baseline demographics were comparable between groups. Patients were pretreated with clopidogrel (approx. 71%) and aspirin (approx. 79%). Procedural success was achieved in 97% and 96% of patients in the bivalirudin- and heparin-treated groups, respectively. Event rates were low and similar between groups. CONCLUSION: Bivalirudin maintained an equal rate of procedural success in this cohort without sacrificing patient safety. Results of this study add to the growing body of evidence supporting the safety and efficacy of bivalirudin as a possible substitute for UFH in anticoagulation during peripheral vascular bare-metal stent implantation.
Subject(s)
Angioplasty, Balloon/adverse effects , Anticoagulants/therapeutic use , Atherosclerosis/therapy , Heparin/therapeutic use , Metals , Peptide Fragments/therapeutic use , Stents , Thrombosis/prevention & control , Aged , Amputation, Surgical , Anticoagulants/adverse effects , Atherosclerosis/drug therapy , Atherosclerosis/mortality , Female , Femoral Artery , Hemorrhage/chemically induced , Heparin/adverse effects , Hirudins/adverse effects , Humans , Iliac Artery , Male , Middle Aged , Myocardial Infarction/etiology , Peptide Fragments/adverse effects , Prosthesis Design , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Renal Artery , Research Design , Retrospective Studies , Thrombosis/etiology , Treatment OutcomeABSTRACT
Multiple topical hemostats have been approved for control of surface bleeding from vascular access sites. The majority of these devices, however, have few clinical data supporting their use. This study was conducted to assess the efficacy and safety of the new commercially available D-Stat Dry hemostatic bandage compared to standard care manual compression. A prospective, randomized, multicenter trial was conducted in patients undergoing diagnostic cardiac catheterization or peripheral angiography utilizing femoral artery access. Subjects were randomized to either the D-Stat Dry bandage as an adjunct to manual compression or manual compression alone. Primary end points were time-to-hemostasis (TTH) and major complications. Secondary end points included minor complications, patient satisfaction, time-to-ambulation (TTA), and time-to-discharge (TTD). Three hundred seventy-six subjects (189 control, 187 investigational) with similar baseline characteristics participated in the study. The mean age was 61.5 years, with a male predominance of 58%. TTH was significantly lower in the investigational group (7.8 vs. 13.0 min; p = 0.001). No difference in major complication rates was observed between the groups. The mean TTA (investigational, 392 min, vs. control, 415 min; p = 0.023) and patient satisfaction significantly favored the investigational group (p = 0.025). No difference in TTD or the rate of minor complications was observed. This study demonstrates that in the aforementioned population, the D-Stat Dry bandage is safe and effective in reducing both TTH and TTA and results in improved patient satisfaction.
Subject(s)
Angiography/methods , Bandages , Cardiac Catheterization/methods , Femoral Artery/surgery , Hemostasis, Surgical/methods , Hemostatics/administration & dosage , Adult , Aged , Aged, 80 and over , Early Ambulation , Female , Humans , Male , Middle Aged , Patient Satisfaction , Pressure , Prospective Studies , PuncturesABSTRACT
BACKGROUND: The aim was to investigate the association between elevated left ventricular end diastolic pressure (LVEDP) and subendocardial ischemia. METHODS: A retrospective chart review was performed of 1846 consecutive patients admitted between January and September 2002 who had chest pain, stress testing and coronary angiography. RESULTS: 1592 patients were excluded due to a positive coronary angiogram for coronary artery disease (CAD), 254 patients had an angiogram compatible with non-significant CAD and an ejection fraction > 45%; of whom 210 (82.7%) had a positive stress test (study group) and the others 44 (17.3%) had a negative stress test (control group). The mean LVEDP value for the study group (11.8 +/- 6.1 mmHg) was significantly higher than the mean LVEDP value for the control group (7.8 +/- 4.6 mmHg) (p < 0.001). In addition, there were more people with abnormal LVEDP (>or= 12 mmHg) in the study group (n = 103, 49.05%) compared with the control group (n = 10, 22.73%) (p < 0.001). Furthermore, the results of logistic regression revealed that patients with abnormal LVEDP values were 11 times more likely to have had a positive stress test. CONCLUSIONS: There appears to be a positive association between elevated LVEDP and subendocardial ischemia that manifests as a positive stress test in patients without evidence of significant CAD.
