Baseline info for PREVENT III trial (thanks to Yahoo poster ThurstonHowellTheThird):
>>Underutilization Of Medical Therapy In Advanced Atherosclerosis: Observations From the PREVENT III Multi-Center Trial Of Edifoligide In Limb Salvage Surgery
Michael S Conte1, Dennis F Bandyk2, Alexander W Clowes3, Gregory L Moneta4, Lynn Seely5
1Brigham and Women's Hospital, Boston, MA;2University of South Florida, Tampa, FL;3University of Washington, Seattle, WA;4Oregon Health and Science University, Portland, OR;5Corgentech, Inc., South San Francisco, CA
Objective(s): The PREVENT III (PIII) study is a prospective, randomized, blinded, multicenter (>80 North American sites), Phase 3 trial of a novel molecular therapy (edifoligide; E2F decoy) for the prevention of vein graft failure in patients undergoing infrainguinal revascularization for critical limb ischemia (CLI). Prior reports describing this patient population have been largely derived from single center tertiary hospitals, and may not reflect broad community practice. We examined the baseline characteristics and pre-randomization medical therapies of the PIII cohort.
Methods: Blinded baseline data, including demographic, medical/surgical history, mode of presentation for the index limb, procedural details, and concomitant medications were reviewed for the first 1200 (of 1405) patients enrolled in PIII from Nov 2001- Sept 2003.
Results: Demographics, comorbidities, mode of presentation, and procedural details are summarized in the Tables below, and reflect a population with CLI and diffuse atherosclerosis. Review of medications taken prior to surgery revealed that 34% of patients were not on antiplatelet therapy , including 25% not receiving antithrombotics of any type. On subgroup analysis, 15% of patients with a history of severe CAD (MI/CABG/PCI), 18% of those with a history of CVD (prior TIA/stroke), and 19% of those with prior leg bypass respectively were not receiving antithrombotic therapy at entry. In addition, 57% of patients overall were not receiving lipid-lowering therapy, including 29% of patients carrying a prior diagnosis of hyperlipidemia, 44% with CAD, 52% with CVD, and 49% with prior leg bypass. In 17% of these CLI patients, neither antithrombotic nor lipid-lowering medications were being utilized.
Conclusions: The PIII cohort represents a broad cross-section of the population undergoing surgery for CLI in current practice. Significant medical undertreatment of this population is evidenced by failure to employ therapies with proven benefit in reducing cardiovascular death and complications. <<
Cheers, Tuck |
