Faculty Bibliography

OBJECTIVES: The purpose of this study was to assess the impact of rosiglitazone on survival in patients with diabetes mellitus (DM) and coronary artery disease (CAD). METHODS: We carried out a drug-exposure analysis in 801 patients with DM and CAD in a cardiac catheterization laboratory registry (490 patients treated with a percutaneous coronary intervention, 224 patients treated with coronary artery bypass grafting, and 87 patients treated with medication alone). RESULTS: A total of 193 patients (24.1%) were exposed to rosiglitazone. The median survival from the date of cardiac catheterization in the rosiglitazone group was 146.7 months versus 109.1 months in the unexposed group (P<0.001). At 5 years, the unadjusted survival was 82% in the rosiglitazone-exposed group versus 69% in the unexposed group (P<0.001). There was no difference in survival between rosiglitazone-exposed and rosiglitazone-unexposed patients in the groups treated with coronary artery bypass grafting or medical therapy (P=0.37 and 0.11, respectively). In a multivariable model, rosiglitazone exposure had no effect on mortality (hazard ratio=0.737; 95% confidence interval: 0.521-1.044, P=0.86). CONCLUSION: We conclude that exposure to rosiglitazone is not associated with increased mortality in diabetics who are treated for CAD. These findings support the notion that insulin sensitization with a thiazolidinedione is safe in carefully selected and treated patients with DM and CAD.

BACKGROUND: Randomized trials using measurement of fractional flow reserve (FFR) to guide percutaneous coronary intervention (PCI) have demonstrated both safety and efficacy with regard to cardiac events. Real-world, long-term outcomes using an FFR-based revascularization strategy are unknown. METHODS: Prospective clinical data were collected on consecutive patients referred for coronary angiography and found to have lesions of intermediate severity where the operators were unable to make a decision regarding revascularization based on angiographic, clinical, and stress testing parameters. FFR was measured on intermediate lesions, and revascularization was deferred on those lesions with a measurement >0.8. Clinical outcomes of interest included death, myocardial infarction, and late revascularization status. RESULTS: A total of 151 patients were included in this study. Fifty-seven patients (37.7%) underwent revascularization based on their FFR measurement. The mean length of follow-up was 6.1 years (range, 5-10 years). Follow-up was completed in 97.0%. At the end of the follow-up period, 107 patients (70.9%) were alive. Late revascularization had been performed in 18 patients (11.9%). Comparing the initial revascularization group with the group in which revascularization was deferred, 64.9% and 74.5% were alive, respectively (P=.29). Of the initial revascularization group, 12.3% had undergone late revascularization of the lesion on which FFR was originally performed, compared with 11.7% in the deferred group (P=.99). CONCLUSIONS: FFR is a useful adjunct to coronary angiography in selecting patients with lesions of intermediate angiographic severity in whom coronary revascularization may be safely deferred.

Background: Studies using measurement of coronary fractional flow reserve (FFR) to guide percutaneous coronary intervention have demonstrated both safety and efficacy with regard to cardiac events. Real-world, long-term outcomes using an FFR-based revascularization strategy are unknown. Methods: The rates of death and target lesion revascularization (TLR) were determined in 151 consecutive patients who had FFR measurements done on coronary lesions of intermediate severity from January 1, 2000 to December 31, 2005. The mean length of follow-up was 5.9 years. Follow-up was complete in 98.0%. Revascularization was deferred on all lesions with FFR > 0.8 and selectively with FFR >75 and < 80. Revascularization of the index lesion was performed in 37.1% of the patients. Results: TLR occurred in 11.9% of the cohort. TLRrates were similar whether revascularization was initially done or deferred (12.5 and 11.6%, respectively). Overall survival was 69.5%. Survival was 64.3% in patients who underwent initial revascularization compared to 72.6% of patients in whom revascularization was deferred. Conclusions: The real world long-term outcomes of an FFR guided strategy to select patients with coronary lesions of intermediate angiographic severity in whom coronary revascularization may be deferred are similar to the short-term outcomes reported in trials, without excess risk of death or TLR for up to ten years

Background: Elevated periprocedural blood glucose is associated with increased mortality in percutaneous coronary intervention (PCI) patients regardless of diabetic status (Am Heart J 2003;146:351-358; Am J Cardiol 2005;96:543-546) and predicts renal and myocardial injury as well as target vessel revascularization in patients with diabetes mellitus (DM) undergoing PCI (Am J Cardiol 2004;94:1027-1029; JACC 2004;43:8-14). Strategies to safely achieve periprocedural glycemic control in the cardiac catheterization laboratory have not been systematically evaluated. Therefore, we performed an IRB approved pilot trial comparing the strategies of continuing versus holding prescribed long-acting hypoglycemic medications in patients with DM undergoing coronary angiography and possible PCI. Methods: Patients were randomly assigned to continue (n = 17) or hold (n = 18) their prescribed long-acting hypoglycemic medications. Patients scheduled for an afternoon procedure were encouraged to have a light morning snack. Blood glucose was assessed at the time of vascular access in the cardiac catheterization laboratory by nurses trained to use a glucometer. Hypoglycemia was defined as blood glucose <50 mg/ dL without symptoms or blood glucose <75 mg/dL with symptoms relieved by glucose supplementation. Data are expressed as mean + SD and significance assessed by t test. Results: Glucose was 137.8 + 57.4 in the continue medication group and 160.1 + 69.6 in the hold medication group (p = 0.3). There was 1 asymptomatic hypoglycemic event in the continue medication group (glucose = 43) that was corrected with intravenous glucose supplementation and no hypoglycemic events in the hold hypoglycemic medication group. Conclusions: In a setting where blood glucose levels are closely monitored, a strategy of routinely continuing long-acting hypoglycemic medications prior to coronary angiography may help achieve euglycemia during coronary angiography and PCI and appears safe. A larger trial with clinically significant endpoints is warranted

Chronic kidney disease (CKD) is a risk factor for poor outcomes in patients with coronary artery disease (CAD), but it is unknown whether CKD influences the efficacy of alternative CAD treatment strategies. Thus, we compared outcomes in stable CAD patients with and without CKD randomized to percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) or OMT alone in a post hoc analysis of the 2,287 patient COURAGE study. At baseline, 320 patients (14%) had CKD defined as a glomerular filtration rate of <60 mL/min/1.73 m(2), as estimated by the abbreviated 4-variable Modification of Diet in Renal Disease equation. The patients with CKD were older (68 +/- 9 vs 61 +/- 10 years; p <0.001) and more often had diabetes mellitus (42% vs 33%; p = 0.002), hypertension (81% vs 65%; p <0.03), heart failure (13% vs 3.4%; p <001), and three-vessel CAD (37% vs 29%, p = 0.01). After adjustment for these differences, CKD remained an independent predictor of death or nonfatal myocardial infarction (hazard ratio 1.48, 95% confidence interval 1.15 to 1.90). PCI had no effect on these outcomes. Furthermore, at 36 months, a similar percentage of patients with CKD treated with OMT (70%) and PCI plus OMT (76%) were angina free compared to patients without CKD. In conclusion, CKD is an important determinant of clinical outcomes in patients with stable CAD, regardless of the treatment strategy. Although PCI did not reduce the risk of death or myocardial infarction when added to OMT for patients with CKD, it also was not associated with worse outcomes in this high-risk group

OBJECTIVES: We evaluated the effect of metabolic syndrome (a risk factor for the development of coronary artery disease) on survival in patients with established coronary artery disease. METHODS: Survival was determined for 2886 patients with coronary artery disease diagnosed by cardiac catheterization performed between 1990 and 2005 at a Department of Veterans Affairs hospital. Variables obtained from the computerized medical record were evaluated in multivariate analysis by Cox regression. The analysis was performed for the entire population; separate analyses were performed for patient cohorts treated with percutaneous coronary intervention and medication (n=1274), coronary artery bypass grafting and medication (n=1096), or medication alone (n=516). RESULTS: Although age (odds ratio 0.948; P<0.000), left ventricular function (odds ratio 0.701; P<0.000), serum creatinine (odds ratio 0.841; P<0.000), and smoking (odds ratio 0.873; P=0.019) were all strong predictors of mortality. Metabolic syndrome had no independent effect irrespective of diabetic status. CONCLUSION: Metabolic syndrome does not impact survival patients with coronary artery disease treated by revascularization and/or medical therapy

Percutaneous intervention with balloon expandable stents has proven to be an effective measure to enhance renal blood flow and control blood pressure in subjects with severe ostial renal artery lesions. A small cohort of these subjects have an ostial bifurcation, which complicates the approach to revascularization. In these cases there is a concern of creating a total side-branch occlusion during balloon expansion. We report two cases of an ostial lesion at a renal artery bifurcation revascularized by employing a sequential dilatation double guidewire technique. Using a single 7F sheath in each case, both renal artery branches were wired, and each branch was predilated and stented in a sequential fashion. Excellent angiographic results were obtained in both cases

Strict glycemic control improves outcomes in critically ill patients. We evaluated the hypothesis that strict glycemic control might be similarly beneficial after percutaneous coronary intervention. This study reports the correlation of periprocedural blood glucose with long-term survival in 1,746 patients who underwent percutaneous coronary intervention from 1990 to 2003 in a Department of Veterans Affairs hospital