Ischemic Events Registry Research Articles

Statin Therapy in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention (from the Evaluation of Drug Eluting Stents and Ischemic Events Registry)

Secondary prevention trials have demonstrated the efficacy of statins in reducing cardiovascular morbidity and mortality in patients with coronary artery disease and events after percutaneous coronary intervention (PCI). However, there are few data describing the clinical value of statins in patients with coronary artery disease and chronic kidney disease (CKD) undergoing PCI. Of 10,148 patients who entered into Evaluation of Drug Eluting Stents and Ischemic Events, a multicenter registry of unselected patients undergoing PCI from July 2004 to December 2007, we studied 2,306 patients with CKD (estimated glomerular filtration rate ≤60 ml/min based on the Modified Diet in Renal Disease calculation). Patients were stratified into those receiving statins at discharge (n = 1,833, 79%) or not (n = 473, 21%). Patients in the statin group had a greater prevalence of hypertension, recent myocardial infarction (MI), and use of β blockers and angiotensin-converting enzyme inhibitors. Outcomes were assessed from discharge through 1-year follow-up. One-year all-cause mortality was 5.7% in statin group versus 8.7% in the no statin group (adjusted hazard ratio 0.55, 95% confidence interval 0.34 to 0.88). The composite of death, MI, and repeat revascularization was lower in statin group (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.99). In conclusion, among patients with CKD undergoing PCI, the prescription of statins at hospital discharge was associated with a significant improvement in subsequent outcomes including mortality and composite end point of death, MI, and repeat revascularization.

In‐hospital and one year outcomes with drug‐eluting versus bare metal stents in large native coronary arteries: A report from the evaluation of drug‐eluting stents and ischemic events registry

We sought to compare the clinical outcomes after percutaneous coronary revascularization of large coronary arteries using drug-eluting (DES) or bare-metal (BMS) stents. In de novo native coronary lesions with reference diameters of 2.5-3.5 mm, DES reduce target lesion revascularization (TLR) with no increase in death or myocardial infarction (MI). The relative efficacy of DES in larger coronary artery lesions is less certain. From the prospective Evaluation of Drug-Eluting Stents and Ischemic Events registry, we identified patients undergoing stenting of de novo lesions in native coronary arteries 3.5-5.0 mm in diameter (n = 1,485). In-hospital and 1-year clinical outcomes were compared for BMS (n = 282) and DES (n = 1,203) patients, using propensity stratification to adjust for differences in potential confounding factors. Most patient characteristics were similar for the two groups, but BMS patients were more likely to have been treated in the setting of ST elevation MI, whereas DES patients had more bifurcation lesions, smaller vessels, and longer total stent lengths. In risk-adjusted analyses, the composite endpoint of 1-year death, MI or TLR was similar for BMS and DES (standardized rate: 11.9% vs. 8.5%, P = 0.10). DES was associated with a 62% reduction in the risk of TLR, although the absolute difference in event rates was small (standardized rates 4.6% vs. 1.8%, P = 0.016). Among relatively unselected patients undergoing PCI of large native coronary arteries, use of DES was associated with a modest reduction in rates of TLR, with a neutral effect on other ischemic endpoints.

Red cell distribution width is a predictor of mortality in patients undergoing percutaneous coronary intervention

Red cell distribution width (RDW), a measure of the variability in size of circulating erythrocytes, is an independent predictor of mortality in patients with cardiovascular disease. We hypothesized that RDW is a prognostic marker of death, myocardial infarction and unplanned revascularization in a broad population undergoing percutaneous coronary intervention (PCI). We investigated the prognostic value of RDW derived from a complete blood count drawn ≤24 h of PCI in 1,689 patients at four centers who underwent PCI between 2004 and 2007 in the evaluation of drug eluting stents and ischemic events registry. Patients who underwent blood transfusions were excluded. Multivariable analyses of death, MI, unplanned revascularization, and the combined occurrence of these events at 1 year were performed using methods from survival analysis. The analysis was adjusted for creatinine ≥1.5 mg/dL, hemoglobin, congestive heart failure, coronary artery bypass grafting history, male sex, BMI, atherosclerosis of ≥2 coronary vessels, and hypertension. In univariate analysis of RDW stratified by quartiles, membership in the highest quartile was a predictor of mortality as compared to the lowest quartile (HR 5.07, CI 2.07-12.40, p < 0.001). In multivariate analysis, RDW was not an independent predictor of unplanned revascularization after PCI; however, RDW remained an independent correlate of 1 year mortality (HR 1.65, CI 1.22-2.23, p = 0.001); with a continuous net reclassification improvement of 46.5% (95% CI 15.1-76.4%) and a relative integrated discrimination improvement of 57.8% (95% CI 22.1-94.9%) after PCI. RDW is a widely available independent correlate of 1-year mortality after PCI that increases the discriminative value of risk prediction in these patients.

Mode of death after contemporary percutaneous coronary intervention: A report from the Evaluation of Drug Eluting Stents and Ischemic Events registry

When selecting clinical trial end points, some investigators prefer cardiovascular death (CVD) while others believe that all-cause mortality is more relevant. However, the relative contribution of CVD to 1-year mortality after contemporary percutaneous coronary intervention (PCI) is not known. We evaluated the mode of death (MOD) in EVENT, a prospective PCI registry at 55 US hospitals. Vital status was assessed at 6 and 12 months as part of the study protocol, and MOD was independently reviewed in blinded fashion. Between 2004 and 2007, EVENT enrolled 10,144 patients of whom 295 (2.9%) died within the first year: 51 (17%) ≤30 days; and 244 (83%) between 31 and 365 days after index PCI. Overall, CVD accounted for 42% of deaths, and no clear cause could be identified in a substantial subgroup (25% of deaths). Among patients who died ≤30 days, the MOD was more likely to be CVD (odds ratio 3.96, 95% CI 2.08-7.55), whereas the incidence of CVD and non-CVD was similar after 30 days. Findings were similar after a series of sensitivity analyses including reassignment of unknown MOD to the CVD category, using multiple imputation modeling, or when evaluating MOD in prespecified subgroups of patients with diabetes, acute coronary syndromes, or left ventricular dysfunction. Among unselected PCI patients, 1-year mortality is approximately 3%, and CVD is confirmed in <50% of all deaths. Regardless of analytic approach, CVD is the primary contributor to overall mortality during the first 30 days after PCI, whereas rates of CVD and non-CVD are remarkably similar after the first month after PCI.

Incidence and clinical outcome of minor surgery in the year after drug-eluting stent implantation: Results from the Evaluation of Drug-Eluting Stents and Ischemic Events Registry

The aim of the study was to describe the incidence and consequences of minor surgery after drug-eluting stent (DES) implantation. The Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Registry prospectively enrolled unselected patients undergoing percutaneous coronary intervention at 47 US centers between July 2004 and December 2007. We examined 8,323 patients who received a DES in EVENT to determine the frequencies of minor surgery and postoperative adverse events. Minor surgery (defined as procedures not requiring a major surgical incision) was performed in 164 (2.0%) of 8,323 patients <1 year after stenting, as follows: pacemaker/defibrillator implantation (46%), eye surgery (17%), orthopedic (9%), dermatologic (8%), endovascular (6%), and gastrointestinal procedures (5%). Compared with patients who did not undergo minor surgery, those who did were older, had more comorbidities, had more extensive coronary disease, and were more likely to have received warfarin after stenting. Only 1 (0.6%, 95% CI 0.0%-3.4%) of 164 patients had an event (stent thrombosis causing myocardial infarction) during the first week after minor surgery; this rate was slightly higher than the background rate of ischemic events in the study population (exact mid P = .01). Clopidogrel use at 12 months was similar between patients who did and those who did not undergo minor surgery (65.2% vs 65.5%, P = .95). In the EVENT Registry, minor surgery was performed in 2% of patients in the first year after DES implantation. The risk of stent thrombosis during the first week after surgery was increased slightly compared with background rates, but the absolute event rate was low (0.6%).

Multivessel drug‐eluting stenting and impact of diabetes mellitus—A report from the EVENT registry

To compare clinical outcomes in patients with and without diabetes after multivessel percutaneous coronary intervention (PCI). Diabetes is associated with significantly worse outcomes after multivessel PCI and coronary bypass surgery is recommended as the preferred option for these patients. The Evaluation of Drug Eluting Stents and Ischemic Events registry is a multicenter evaluation of acute and 1 year outcomes in unselected patients undergoing PCI since approval of drug-eluting stents (DES). Major adverse cardiac events (MACE) were defined as all cause mortality, myocardial infarction, or repeat revascularization and rate was estimated by Kaplan-Meier method and compared using log-rank. The independent correlates of MACE were determined using Cox proportional hazards regression. Of 4,819 nonemergency native coronary DES procedures, 1,595 (33.1%) were in patients with diabetes and 722 (11.7%) involved >1 vessel. Of patients undergoing multivessel procedures, diabetes was present in 256 (35.5%). One year after multivessel PCI, MACE was similar for patients with or without diabetes (22.3% versus 21.2%, log-rank test P = 0.85). The independent correlates of 1 year MACE were female sex (Hazard ratio [HR], 1.58, 95% CI 1.14-2.20), ejection fraction (HR 0.74 per group [<25%, 26-35%, 36-50%, and >50%], 95%CI 0.59-0.94) and number of stents (HR 1.20 per stent, 95%CI 1.04-1.38) but not diabetes (HR 1.00, 95% CI 0.71-1.39). Multivessel DES is performed commonly in patients with diabetes with outcomes at 1 year similar to patients without diabetes. Longer follow-up is required to more fully evaluate the safety and effectiveness of this strategy.

Biomarker Release After Percutaneous Coronary Intervention

Cardiac biomarkers of necrosis provide clinicians with important “messages” from the heart. They are released into the interstitium of the myocardium after loss of the integrity of cardiac myocyte membranes. The pattern of the rise and fall of an individual biomarker (ie, its release kinetics) depends on its intracellular location in the myocyte, molecular weight, and clearance from the interstitium of the myocardium and ultimately the circulation.1 Cardiac biomarkers play an integral role in the clinical diagnosis of myocardial infarction (MI). Referring to the spontaneous occurrence of MI in patients, the World Health Organization required that at least 2 of the following be present to fulfill the criteria for MI: a history of ischemia-type chest discomfort, evolutionary changes on serially obtained ECG tracings, and a rise and fall in serum cardiac markers.2 Article see p 10 See Editorial Circulation . 2008;118:609–611 See Article Circulation . 2008;118:632–638 Several dramatic advances have occurred in the biomarker component of the diagnosis of MI. Analytes with greater specificity for the myocardium were introduced into clinical medicine, with creatine kinase-MB replacing total creatine kinase and subsequently cardiac-specific troponins replacing creatine kinase-MB as the biomarker of choice for diagnosing MI.3 Assay technology improved as clinical chemists moved from enzymatic activity assays for CK to highly specific immunoassays that can detect progressively smaller concentrations of cardiac troponins in the peripheral circulation.4 Although ST-elevation MI (STEMI) is easily identified on the 12-lead ECG, we now recognize that many patients previously diagnosed with unstable angina are more properly diagnosed as having non–ST-elevation MI (NSTEMI) on the basis of the detection of elevated levels of cardiac troponins in their blood.5 Cardiac biomarkers are used as a rough guide to the extent of myocardial necrosis. The higher the peak biomarker level after STEMI, the larger the …