Amit P. Amin

Association Between Use of Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing Percutaneous Coronary Intervention

CONTEXT Bleeding complications with percutaneous coronary intervention (PCI) are associated with adverse patient outcomes. The association between the use of bleeding avoidance strategies and post-PCI bleeding as a function of a patients preprocedural risk of bleeding is unknown. OBJECTIVE To describe the use of 2 bleeding avoidance strategies, vascular closure devices and bivalirudin, and associated post-PCI bleeding rates in a nationally representative PCI population. DESIGN, SETTING, AND PATIENTS Analysis of data from 1,522,935 patients undergoing PCI procedures performed at 955 US hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry from January 1, 2004, through September 30, 2008. MAIN OUTCOME MEASURE Periprocedural bleeding. RESULTS Bleeding occurred in 30,654 patients (2%). Manual compression, vascular closure devices, bivalirudin, or vascular closure devices plus bivalirudin were used in 35%, 24%, 23%, and 18% of patients, respectively. Bleeding events were reported in 2.8% of patients who received manual compression, compared with 2.1%, 1.6%, and 0.9% of patients receiving vascular closure devices, bivalirudin, and both strategies, respectively (P < .001). Bleeding rates differed by preprocedural risk assessed with the NCDR bleeding risk model (low risk, 0.72%; intermediate risk, 1.73%; high risk, 4.69%). In high-risk patients, use of both strategies was associated with lower bleeding rates (manual compression, 6.1%; vascular closure devices, 4.6%; bivalirudin, 3.8%; vascular closure devices plus bivalirudin, 2.3%; P < .001). This association persisted following adjustment using a propensity-matched and site-controlled model. Use of both strategies was used least often in high-risk patients (14.4% vs 21.0% in low-risk patients, P < .001). CONCLUSIONS In a large national PCI registry, vascular closure devices and bivalirudin were associated with significantly lower bleeding rates, particularly among patients at greatest risk for bleeding. However, these strategies were less often used among higher-risk patients.

Contemporary Incidence, Predictors, and Outcomes of Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Interventions: Insights From the NCDR Cath-PCI Registry

OBJECTIVES This study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions. BACKGROUND Acute kidney injury (AKI) is a serious and potentially preventable complication of percutaneous coronary interventions (PCIs) that is associated with adverse outcomes. The contemporary incidence, predictors, and outcomes of AKI are not well defined, and clarifying these can help identify high-risk patients for proactive prevention. METHODS A total of 985,737 consecutive patients underwent PCIs at 1,253 sites participating in the National Cardiovascular Data Registry Cath-PCI registry from June 2009 through June 2011. AKI was defined on the basis of changes in serum creatinine level in the hospital according to the Acute Kidney Injury Network (AKIN) criteria. Using multivariable regression analyses with generalized estimating equations, we identified patient characteristics associated with AKI. RESULTS Overall, 69,658 (7.1%) patients experienced AKI, with 3,005 (0.3%) requiring new dialysis. On multivariable analyses, the factors most strongly associated with development of AKI included ST-segment elevation myocardial infarction (STEMI) presentation (odds ratio [OR]: 2.60; 95% confidence interval [CI]: 2.53 to 2.67), severe chronic kidney disease (OR: 3.59; 95% CI: 3.47 to 3.71), and cardiogenic shock (OR: 2.92; 95% CI: 2.80 to 3.04). The in-hospital mortality rate was 9.7% for patients with AKI and 34% for those requiring dialysis compared with 0.5% for patients without AKI (p < 0.001). After multivariable adjustment, AKI (OR: 7.8; 95% CI: 7.4 to 8.1, p < 0.001) and dialysis (OR: 21.7; 95% CI: 19.6 to 24.1; p < 0.001) remained independent predictors of in-hospital mortality. CONCLUSIONS Approximately 7% of patients undergoing a PCI experience AKI, which is strongly associated with in-hospital mortality. Defining strategies to minimize the risk of AKI in patients undergoing PCI are needed to improve the safety and outcomes of the procedure.

Trends in the incidence of acute kidney injury in patients hospitalized with acute myocardial infarction.

BACKGROUND Acute kidney injury (AKI) is common in patients with acute myocardial infarction (AMI) and is associated with permanent renal impairment and death. Although guidelines increasingly emphasize AKI prevention, whether increased awareness has translated into reduced AKI rates is unclear. METHODS Among 33,249 consecutive hospitalizations in 31,532 unselected patients with AMI across 56 US centers from Cerner Corporations Health Facts database, we examined the temporal trends in AKI incidence from 2000 to 2008. Acute kidney injury was defined as an absolute increase in creatinine level of at least 0.3 mg/dL or a relative increase of at least 50% during hospitalization. RESULTS From 2000 to 2008, the mean age of patients increased (from 66.5 to 68.6 years), as did the known AKI risk factors, including chronic kidney disease, cardiogenic shock, diabetes mellitus, heart failure, coronary angiography, and percutaneous coronary intervention. Despite this, AKI incidence declined from 26.6% in 2000 to 19.7% in 2008 (P < .001). After multivariate adjustment, the trend of decreasing AKI rates persisted (4.4% decline per year; P < .001). In addition, in-hospital mortality also declined over time among patients developing AKI, from 19.9% in 2000 to 13.8% in 2008 (P = .003). CONCLUSIONS In a large national study, AKI incidence in patients hospitalized with AMI declined significantly from 2000 to 2008 despite the aging population and rising prevalence of AKI risk factors. These findings may reflect increased clinician awareness, better risk stratification, or greater use of AKI prevention efforts during this time period.

The prognostic importance of worsening renal function during an acute myocardial infarction on long-term mortality

BACKGROUND Although an acute worsening in renal function (WRF) commonly occurs among patients hospitalized for acute myocardial infarction (AMI), its long-term prognostic significance is unknown. We examined predictors of WRF and its association with 4-year mortality. METHODS Acute myocardial infarction patients from the multicenter PREMIER study (N=2,098) who survived to hospital discharge were followed for at least 4 years. Worsening in renal function was defined as an increase in creatinine during hospitalization of ≥0.3 mg/dL above the admission value. Correlates of WRF were determined with multivariable logistic regression models and used, along with other important clinical covariates, in Cox proportional hazards models to define the independent association between WRF and mortality. RESULTS Worsening in renal function was observed in 393 (18.7%) of AMI survivors. Diabetes, left ventricular systolic dysfunction, and a history of chronic kidney disease (documented history of renal failure with baseline creatinine>2.5 mg/dL) were independently associated with WRF. During 4-year follow-up, 386 (18.6%) patients died. Mortality was significantly higher in the WRF group (36.6% vs 14.4% in those without WRF, P<.001). After adjusting for other factors associated with WRF and long-term mortality, including baseline creatinine, WRF was independently associated with a higher risk of death (hazard ratio=1.64, 95% CI 1.23-2.19). CONCLUSIONS Worsening in renal function occurs in approximately 1 of 6 AMI survivors and is independently associated with an adverse long-term prognosis. Further studies on interventions to minimize WRF or to more aggressively treat patients developing WRF should be tested.

Validated Contemporary Risk Model of Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Interventions: Insights From the National Cardiovascular Data Registry Cath‐PCI Registry

Background We developed risk models for predicting acute kidney injury (AKI) and AKI requiring dialysis (AKI‐D) after percutaneous coronary intervention (PCI) to support quality assessment and the use of preventative strategies. Methods and Results AKI was defined as an absolute increase of ≥0.3 mg/dL or a relative increase of 50% in serum creatinine (AKIN Stage 1 or greater) and AKI‐D was a new requirement for dialysis following PCI. Data from 947 012 consecutive PCI patients and 1253 sites participating in the NCDR Cath/PCI registry between 6/09 and 7/11 were used to develop the model, with 70% randomly assigned to a derivation cohort and 30% for validation. AKI occurred in 7.33% of the derivation and validation cohorts. Eleven variables were associated with AKI: older age, baseline renal impairment (categorized as mild, moderate, and severe), prior cerebrovascular disease, prior heart failure, prior PCI, presentation (non‐ACS versus NSTEMI versus STEMI), diabetes, chronic lung disease, hypertension, cardiac arrest, anemia, heart failure on presentation, balloon pump use, and cardiogenic shock. STEMI presentation, cardiogenic shock, and severe baseline CKD were the strongest predictors for AKI. The full model showed good discrimination in the derivation and validation cohorts (c‐statistic of 0.72 and 0.71, respectively) and identical calibration (slope of calibration line=1.01). The AKI‐D model had even better discrimination (c‐statistic=0.89) and good calibration (slope of calibration line=0.99). Conclusion The NCDR AKI prediction models can successfully risk‐stratify patients undergoing PCI. The potential for this tool to aid clinicians in counseling patients regarding the risk of PCI, identify patients for preventative strategies, and support local quality improvement efforts should be prospectively tested.

Clinical and Economic Outcomes of Liberal Versus Selective Drug-Eluting Stent Use Insights From Temporal Analysis of the Multicenter Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) Registry

Background— Although the benefits of drug-eluting stents (DES) for reducing restenosis after percutaneous coronary intervention are well established, the impact of alternative rates of DES use on population-level outcomes is unknown. Methods and Results— We used data from the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry to examine the clinical impact and cost-effectiveness of varying DES use rates in routine care. Between 2004 and 2007, 10 144 patients undergoing percutaneous coronary intervention were enrolled in the EVENT registry at 55 US centers. Clinical outcomes and cardiovascular-specific costs were assessed prospectively over 1 year of follow-up. Use of DES decreased from 92 in 2004 to 2006 (liberal use era; n=7587) to 68 in 2007 (selective use era; n=2557; P<0.001). One-year rates of death or myocardial infarction were similar in both eras. Over this time period, the incidence of target lesion revascularization increased from 4.1 to 5.1, an absolute increase of 1.0 (95 confidence interval, 0.1 to 1.9; P=0.03), whereas total cardiovascular costs per patient decreased by

Clinical and Economic Outcomes of Liberal Versus Selective Drug-Eluting Stent Use

401 (95 confidence interval, 131 to 671; P=0.004). The risk-adjusted incremental cost-effectiveness ratio for the liberal versus selective DES era was

THE SYNERGISTIC RELATIONSHIP BETWEEN ESTIMATED GFR AND MICROALBUMINURIA IN PREDICTING LONG-TERM PROGRESSION TO ESRD OR DEATH IN PATIENTS WITH DIABETES: RESULTS FROM THE KIDNEY EARLY EVALUATION PROGRAM (KEEP)

16 000 per target lesion revascularization event avoided,

Cost-Effectiveness of Targeting Patients Undergoing Percutaneous Coronary Intervention for Therapy With Bivalirudin Versus Heparin Monotherapy According to Predicted Risk of Bleeding

27 000 per repeat revascularization avoided, and

Relation Between Red Blood Cell Omega-3 Fatty Acid Index and Bleeding During Acute Myocardial Infarction

433 000 per quality-adjusted life-year gained. Conclusions— In this prospective registry, a temporal reduction in DES use was associated with a small increase in target lesion revascularization and a modest reduction in total cardiovascular costs. These findings suggest that although clinical outcomes are marginally better with unrestricted DES use, this approach represents a relatively inefficient use of healthcare resources relative to several common benchmarks for cost-effective care.