If I hadnt blacked out

Methods

PPAR was a randomized, multicenter, double-blind, two-arm pilot study comparing the effects of rosiglitazone maleate (4 mg BID orally) before and after PCI in patients with obesity and hypertension, dyslipidemia, or glucose intolerance when compared to placebo. Between January 2002 and August 2003, a total of 200 patients from 10 centers were randomized from the population of patients undergoing diagnostic angiography followed by PCI and in those in whom coronary anatomy was known and PCI was planned. Written informed consent was obtained from all patients, and the protocol was approved by the institutional review board at each participating institution.

The primary end point was progression rate in Doppler ultrasound-determined CIMT during the 12 month follow-up. The secondary end points included the net change in CIMT from baseline to 6 and 12 months; the composite of all-cause mortality, MI, stroke, or any coronary vessel revascularization at 12-month follow-up; the composite of all cause mortality, MI, stroke, any coronary vessel revascularization, or rehospitalization for recurrent ischemia; the composite of death, MI, or stroke; net change in angina class and New York Heart Association failure class from baseline to 30 days, 6 months, and 12 months; incidence of symptomatic hypoglycemia (plasma glucose <65 mg/dL); high-sensitivity C-reactive protein (hs-CRP), plasminogen activator inhibitor-1 (PAI-1) activity, PAI-1 antigen, and lipid profile (percent change in low-density lipoprotein [LDL] and high-density lipoprotein [HDL] cholesterol and triglycerides); and glucose levels, insulin levels, hemoglobin A1c (HbA1c), and the homeostasis model assessment (HOMA) of insulin resistance.

The inclusion criteria were as follows: patients 21 to 85 years of age undergoing elective or urgent PCI with angiographic evidence of coronary artery disease who were obese (defined by a body mass index >27 kg/m2 or waist circumference >102 cm [40 in.] in men and >88 cm [35 in.] in women) were enrolled if they had at least one of the following clinical characteristics:Diagnosed or medically treated hypertension determined by patient history or documented blood pressure of ≥130/85 mm Hg but not exceeding 220/120 mm Hg at time of randomization

Dyslipidemia with triglycerides ≥150 mg/dL, HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or LDL cholesterol >100 mg/dL within the last 12 months

Treated hyperlipidemia

HbA1c >6.0% or fasting glucose ≥110 mg/dL

These entry criteria are slightly different than the criteria used by the World Health Organization or the National Cholesterol Education Panel/Adult Treatment Panel III and are a hybrid between these criteria, with the minimal entry criteria for the current study being obesity. In addition, the use of HbA1c and elevated LDL are not typically parameters in the diagnosis of metabolic syndrome.

Exclusion criteria included diabetes requiring pharmacologic treatment within 3 months before randomization; PCI within 14 days before randomization; primary PCI done for acute revascularization of an MI; clinical cardiac failure as defined by New York Heart Association class II, III, or IV or by current treatment with diuretics or angiotensin-converting enzyme inhibitor for the purpose of prior diagnosis of heart failure; anemia defined as hemoglobin level <11 mg/dL in men or <10 mg/dL in women; current treatment with, or known intolerance to, thiazolidinediones; contraindication or sensitivity to aspirin, clopidogrel, heparin, or intravenous glycoprotein IIb/IIIa inhibitors; and renal insufficiency defined by serum creatinine >2.5 mg/dL or hepatic disease defined by alanine aminotransferase >2.5 times the upper limit of normal.Carotid Intima-medial Thickness

Measurements were recorded on the left and right carotid bulb, common and internal carotid artery segments. Intimamedial thickness maximums and means were collected. Measurements were performed in a blinded fashion. No assumptions were made regarding the statistical power of the sample size to detect a difference in CIMT.Laboratory Analyses

All samples were collected using EDTA-plasma vaccutainers, processed and frozen at -80°F until analyzed. Lipoprotein profiles and glucose and insulin levels were performed on a Hitachi autoanalyzer (Roche Diagnostics, Indianapolis, IN). High-sensitivity C-reactive protein levels were performed by nephelometry (Dade Behring, Inc, Deerfield, IL). Plasma myeloperoxidase levels were determined by the recently Food and Drug Administration-approved CardioMPO test (PrognostiX Inc, Cleveland, OH). Plasma PAI-1 concentration was determined by enzyme-linked immunosorbent assay according to manufacturer instructions (Research Diagnostics, Inc, Concord, MA). PAI-1 activity was determined using the SPECTROLYSE pL PAI-1 activity assay (Trinity Biotech, Bray Co, Wicklow, Ireland).Statistical Analysis

All analyses were performed used the SAS system version 8.0 (SAS Institute, Cary, NC). X2 Tests were performed to assess differences between categorical variables. Wilcoxon rank sum tests were used to test median values in continuous variables. Differences in the percent change of the laboratory values were also assessed in multivariate models adjusting for site and baseline measurement. Kaplan-Meier methods were used in the time-to-event analyses of the clinical end points.

Linear random coefficient models (SAS Proc Mixed), with adjustment for center, were used to summarize the progression rate of CIMT in the placebo and rosiglitazone groups. Progression rate was defined as the slope of the CIMT observations in the linear random coefficient model. To test for treatment effect, an interaction term between treatment and timepoint was used in the model. Statistical significance was defined as P < .05 for all analyses.  Printer- Friendly Email This

Am Heart J.  2007;154(1):137-143.  ©2007 Mosby, Inc.
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