Journal of Vascular and Interventional Radiology
SIR Reporting Standards for the Treatment of Acute Limb Ischemia with Use of Transluminal Removal of Arterial Thrombus
Section snippets
PATIENT SELECTION
Demographic data are important to assess any differences between study groups, and they also allow a clinician to determine whether the study is relevant to his or her patient population. Useful demographic data includes age, sex, and race.
Thrombus can cause occlusion of native arterial segment(s) or surgical bypass graft(s). For a given occlusion, a clear determination of embolic versus in situ thrombotic etiology may not be possible. Nevertheless, an attempt should be made to distinguish
Clinical Evaluation
Clinical evaluation of revascularization procedures, particularly those that compare different treatment methods, may be difficult to interpret unless differences in factors that can affect outcome are identified and characterized. The history and physical examination will help define risk factors, comorbidities, previous interventions and operations, and the severity and duration of ischemia. Tobacco use, hypertension, diabetes, hyperlipidemia, and hypercoagulable states (protein C, protein S,
Transuminal Removal of Thrombus
Currently, there are three TRT methods used to treat acute limb ischemia: thrombolytic therapy, PAT, and PMT. Thrombolytic therapy refers to the use of a thrombolytic drug to dissolve thrombus in the vascular system. The infusion of a thrombolytic drug (streptokinase, urokinase, tissue plasminogen activator) upregulates the conversion of endogenous plasminogen to plasmin. As a result, plasminmediated biochemical cleavage of fibrinogen is promoted. Thrombolytic therapy may be accomplished by
POSTTREATMENT EVALUATION
There are multiple single-center reports of the shortand long-term results on the revascularization of the acutely ischemic limb. Unfortunately, these studies are difficult to compare and apply directly to patient management. This problem is attributable to differences in study populations, differences in reporting methods, and lack of relevant outcome data. The evaluation of therapeutic effectiveness requires patient outcome measures rather than hemodynamic measures alone (1).
Immediate success
COMPLICATIONS
Complications may be hemorrhagic or nonhemorrhagic. The bleeding can be local or remote and should be divided into major and minor. Major bleeding is defined as an intracranial bleed, bleeding resulting in death, or bleeding requiring transfusion, surgery, or cessation of TRT. Minor bleeding is defined as less severe bleeding managed by local compression, increases in vascular sheath size, or decreases in dose of the lytic, anticoagulant, or antiplatelet drug. Nonbleeding complications include
COSTS
Thrombolytic therapy has been criticized because of high costs associated with the thrombolytic drug. The cost of thrombolytic therapy has been evaluated in only a few studies (54, 55). Van Breda et al (56) examined the cost of two thrombolytic drugs, urokinase and streptokinase, in the treatment of peripheral arterial occlusive disease. Despite the greater cost of urokinase, the total cost of care was greater with streptokinase because urokinase therapy had greater success with fewer
COMPARISON BETWEEN TREATMENT GROUPS
There are two general types of studies that can be used in clinical trials to evaluate TRT (5, 68). The first is a randomized clinical trial, which involves the random assignment of treatment to each subject (69). The double-blind randomized clinical trial is the “gold standard” of clinical research. However, it is often not feasible to conduct such studies because of cost, patient recruitment issues, and/or ethical considerations. If a clinical trial is either not possible or not feasible,
CONCLUSION
Published studies on thrombolytic therapy for the treatment of acute limb ischemia have been limited by inconsistencies in study design, and published studies on mechanical thrombectomy are currently lacking. It is the purpose of these reporting standards to bring greater uniformity to research on TRT for the treatment of acute limb ischemia. A summary of the recommendations and requirements for reporting are provided in Table 10.
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This article first appeared in J Vasc Interv Radiol 2001; 12:559–570.
Members of the Technology Assessment Committee are: Curtis W. Bakal, MD, MPH; Gary J. Becker, MD; Dana R. Burke, MD; Patricia E. Cole, PhD, MD; William B. Crenshaw, MD; Michael D. Dake, MD; Alain Drooz, MD; Scott C. Goodwin, MD; Margaret E. Hansen, MD; Ziv Haskal, MD; Thomas B. Kinney, MD; Lindsay Machan, MD; David L. Marinelli, MD; Louis G. Martin, MD; Reed Ali Omary, MD; Douglas C.B. Redd, MD; John H. Rundback, MD; Richard Shlansky-Goldberg, MD; James E. Silberzweig, MD; Kenneth S. Rholl, MD; and Robert L. Vogelzang, MD.