Economic effects of prolonged clopidogrel therapy after percutaneous coronary intervention

ObjectivesThis study examined the incremental cost-effectiveness of extending clopidogrel therapy from one month to one year after percutaneous coronary intervention (PCI) in an unselected, heterogeneous patient population.BackgroundClinical trials suggest that prolonging clopidogrel therapy for up to one year after PCI reduces downstream cardiac events. However, clopidogrel therapy is costly and may increase bleeding risk.MethodsUsing decision analysis, we compared the outcomes and cost of prolonging clopidogrel treatment from one month to one year after PCI with the alternative strategy of discontinuing therapy one month after the procedure. Event rates were based on 3,976 PCI patients who were treated between January 1999 and December 2001 at the Duke Medical Center and received no more than one month of clopidogrel after the procedure. Baseline characteristics and event rates were obtained from Duke clinical information systems. The effect of prolonged clopidogrel therapy on event rates was based on the Clopidogrel for the Reduction of Events During Observation (CREDO) trial per-protocol data. Unit costs and the effect of myocardial infarction (MI) on life expectancy were based on published sources.ResultsExtending clopidogrel therapy from one month to one year after PCI cost $879 per patient and reduced the risk of MI by 2.6$15,696 per year of life saved. Economic attractiveness of therapy varied with baseline risk, the effect of prolonged therapy on MI risk, and the price of clopidogrel.ConclusionsProlonging clopidogrel therapy for one year after PCI is economically attractive, particularly in high-risk patients

738–2 The Evolution of Therapy for Single Vessel Disease: A Treatment Comparison of Medicine, Angioplasty and Left Internal Mammary Artery Graft for Proximal Left Anterior Descending Disease

Saphenous vein bypass grafting for single vessel disease offers no survival or symptom relief advantage compared to medical therapy. Recent evidence suggests the use of the internal mammary artery or PTCA may be more beneficial than medicine. To examine the outcome of these treatment strategies, a retrospective analysis of prospectively collected data on 23,018 consecutive patients undergoing cardiac catheterization between April 1986 and February 1994 was performed. Of the 6,432 patients with single vessel disease, 1,222 had a proximal left anterior descending (LAD) stenosis>74% and no prior PTCA or CABG. A total of 289 were managed medically, 760 underwent PTCA, and 172 received a left internal mammary artery (LIMA) graft.Baseline demographic data and risk factor profiles were similar except for a higher incidence of diabetes (19 vs 15 vs 11%), history of MI (72 vs 58 vs 48%) CHF (18 vs 7 vs 8%), and total occlusions (44 vs 17 vs 7%) and lower incidence of unstable angina (40 vs 61 vs 64%) in the medical group as compared to PTCA and LIMA graft, respectively.Kaplan-Meier 6-year estimates:EventsMedicinePTCALIMAP-value–unadjusted survival (%)7885910.001–adjusted survival (%)8486900.24–event-free survival (%)5443720.0001ConclusionThere is a trend towards improved long-term survival in proximal LAD disease with a strategy of revascularization, particularly the LIMA graft. Furthermore, event-free survival is significantly improved with the LIMA graft as compared to medical therapy or PTCA

The impact of statistical adjustment on economic profiles of interventional cardiologists

AbstractOBJECTIVESThe objective of this study was to identify preprocedure patient factors associated with percutaneous intervention costs and to examine the impact of these patient factors on economic profiles of interventional cardiologists.BACKGROUNDThere is increasing demand for information about comparative resource use patterns of interventional cardiologists. Economic provider profiles, however, often fail to account for patient characteristics.METHODSData were obtained from Duke Medical Center cost and clinical information systems for 1,949 procedures performed by 13 providers between July 1, 1997, and December 31, 1998. Patient factors that influenced cost were identified using multiple regression analysis. After assessing interprovider variation in unadjusted cost, mixed linear models were used to examine how much cost variability was associated with the provider when patient characteristics were taken into account.RESULTSTotal hospital costs averaged $15,643 (median,$13,809), $6,515 of which represented catheterization laboratory costs. Disease severity, acuity, comorbid illness and lesion type influenced total costs (R2= 38%), whereas catheterization costs were affected by lesion type and acuity (R2= 32%). Patient characteristics varied significantly among providers. Unadjusted total costs were weakly associated with provider, and this association disappeared after accounting for patient factors. The provider influence on catheterization costs persisted after adjusting for patient characteristics. Furthermore, the pattern of variation changed: the adjusted analysis identified three new outliers, and two providers lost their outlier status. Only one provider was consistently identified as an outlier in the unadjusted and adjusted analyses.CONCLUSIONSEconomic profiles of interventional cardiologists may be misleading if they do not adequately adjust for patient characteristics before procedure

Diagnostic and prognostic significance of exercise-induced premature ventricular complexes in men and women: A four year follow-up

Two hundred eighty patients (197 men and 83 women) with normal rest electrocardiograms and no history of prior myocardial infarction were referred for evaluation of chest pain. It was found that exercise-induced premature ventricular complexes had a lower sensitivity, specificity, positive predictive value and negative predictive value in predicting significant coronary artery disease than exercise-induced ST segment depression greater than or equal to 1 mm. The incidence of exercise-induced premature ventricular complexes was not significantly different in patients with no significant coronary artery disease, single vessel disease or multivessel disease. The site of origin of exercise-induced premature ventricular complexes was not helpful in predicting the presence or severity of coronary artery disease. At a mean follow-up period of 47.1 months, exercise-induced premature ventricular complexes did not predict coronary events (cardiac death or nonfatal myocardial infarction) in men or women

3-Year Follow-Up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) Trial

ObjectivesThe aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS).BackgroundTreatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.MethodsWe evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.ResultsTarget vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).ConclusionsAt 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions

918-7 Limitations of Percutaneous Interventions in the Treatment of Bifurcation Lesions Involving the Left Anterior Descending Coronary Artery

Serious complications may occur when intervention is unsuccessful in bifurcation lesions involving the left anterior descending (LAD) and first major diagonal (D), because of the large amount of involved myocardium. To determine this complication rate, we reviewed 82 consecutive cases, over a 3 year period, in which these lesions were attempted. Sixty-six percent of the subjects were male, and 37% had unstable angina. The mean age was 59 and the mean ejection fraction was 56%. Digital calipers were used to measure vessel minimum lumen (MLD) and reference diameters. For the LAD the final MLD was 1.81mm and for the 0 1.32mm. The final percent mean diameter stenoses for the LAD and D were 41% and 45%, respectively. There were no significant differences in the rates of success or complication between groups treated with angioplasty only (N=68) or directional atherectomy (N=14). The in-hospital event-free success rate was 55%. The in-hospital complication rates were:Recurrent Ischemia16%Ventricular Tachycardia2%Myocardial Infarction14%Stroke2%Bypass Surgery12%Death1%Repeat Procedure4%Composite34%ConclusionLAD bifurcation lesion intervention is associated with a high in-hospital complication rate. Since these lesions are not amenable to stent placement or atherectomy with simultaneous protection of both vessels, these cases should be carefully evaluated before intervention, and bypass surgery should be considered as a treatment option

Fine mapping of a linkage peak with integration of lipid traits identifies novel coronary artery disease genes on chromosome 5

Coronary artery disease (CAD), and one of its intermediate risk factors, dyslipidemia, possess a demonstrable genetic component, although the genetic architecture is incompletely defined. We previously reported a linkage peak on chromosome 5q31-33 for early-onset CAD where the strength of evidence for linkage was increased in families with higher mean low density lipoprotein-cholesterol (LDL-C). Therefore, we sought to fine-map the peak using association mapping of LDL-C as an intermediate disease-related trait to further define the etiology of this linkage peak. The study populations consisted of 1908 individuals from the CATHGEN biorepository of patients undergoing cardiac catheterization; 254 families (N = 827 individuals) from the GENECARD familial study of early-onset CAD; and 162 aorta samples harvested from deceased donors. Linkage disequilibrium-tagged SNPs were selected with an average of one SNP per 20 kb for 126.6-160.2 MB (region of highest linkage) and less dense spacing (one SNP per 50 kb) for the flanking regions (117.7-126.6 and 160.2-167.5 MB) and genotyped on all samples using a custom Illumina array. Association analysis of each SNP with LDL-C was performed using multivariable linear regression (CATHGEN) and the quantitative trait transmission disequilibrium test (QTDT; GENECARD). SNPs associated with the intermediate quantitative trait, LDL-C, were then assessed for association with CAD (i.e., a qualitative phenotype) using linkage and association in the presence of linkage (APL; GENECARD) and logistic regression (CATHGEN and aortas)

Gene Expression Patterns in Peripheral Blood Correlate with the Extent of Coronary Artery Disease

Systemic and local inflammation plays a prominent role in the pathogenesis of atherosclerotic coronary artery disease, but the relationship of whole blood gene expression changes with coronary disease remains unclear. We have investigated whether gene expression patterns in peripheral blood correlate with the severity of coronary disease and whether these patterns correlate with the extent of atherosclerosis in the vascular wall

Prevention of acute kidney injury and protection of renal function in the intensive care unit

Acute renal failure on the intensive care unit is associated with significant mortality and morbidity. To determine recommendations for the prevention of acute kidney injury (AKI), focusing on the role of potential preventative maneuvers including volume expansion, diuretics, use of inotropes, vasopressors/vasodilators, hormonal interventions, nutrition, and extracorporeal techniques. A systematic search of the literature was performed for studies using these potential protective agents in adult patients at risk for acute renal failure/kidney injury between 1966 and 2009. The following clinical conditions were considered: major surgery, critical illness, sepsis, shock, and use of potentially nephrotoxic drugs and radiocontrast media. Where possible the following endpoints were extracted: creatinine clearance, glomerular filtration rate, increase in serum creatinine, urine output, and markers of tubular injury. Clinical endpoints included the need for renal replacement therapy, length of stay, and mortality. Studies are graded according to the international Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) group system Several measures are recommended, though none carries grade 1A. We recommend prompt resuscitation of the circulation with special attention to providing adequate hydration whilst avoiding high-molecular-weight hydroxy-ethyl starch (HES) preparations, maintaining adequate blood pressure using vasopressors in vasodilatory shock. We suggest using vasopressors in vasodilatory hypotension, specific vasodilators under strict hemodynamic control, sodium bicarbonate for emergency procedures administering contrast media, and periprocedural hemofiltration in severe chronic renal insufficiency undergoing coronary intervention