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ObjectivesThis study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions.BackgroundAcute 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.MethodsA 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.ResultsOverall, 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.ConclusionsApproximately 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.

ObjectivesThis study sought to investigate the long-term effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS).BackgroundImproved recanalization techniques have increased interest in percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). The long-term effectiveness of DES and BMS is not known.MethodsWe used data from 10,261 stable patients age ≥65 years at 889 U.S. hospitals who underwent CTO PCI from January 1, 2005, to December 31, 2008, in the NCDR (National Cardiovascular Data Registry) CathPCI Registry with linked Medicare inpatient claims for follow-up. Patient and procedural characteristics, and 30-month death, myocardial infarction, revascularization, and hospitalization for bleeding were evaluated by stent type. Outcomes following stenting were adjusted and compared using propensity score matching.ResultsDES were used for CTO PCI in 8,218 (80%) and BMS in 2,043 (20%). DES patients were younger (74.0 vs. 75.5 years, p < 0.001), had longer lesions (18.8 vs. 16.5 mm, p < 0.001), received more stents (≥2 stents in 45.7% vs. 37.9%, p < 0.001), and underwent multivessel PCI (18.9% vs. 15.1%, p < 0.001). DES implantation was associated with a lower hazard of mortality (hazard ratio [HR]: = 0.72, 95% confidence interval [CI]: 0.60 to 0.86, p < 0.001), a similar hazard for myocardial infarction (HR: 0.85, 95% CI: 0.61 to 1.19, p = 0.35), and subsequent revascularization (HR: 0.94, 95% CI: 0.79 to 1.12, p = 0.48), including PCI (HR: 0.98, 95% CI: 0.83 to 1.19, p = 0.87) and coronary artery bypass grafting (HR: 0.71, 95% CI: 0.46 to 1.10, p = 0.12). Hospitalization for bleeding was also similar for DES versus BMS (HR: 0.92; 95% CI: 0.61 to 1.39, p = 0.70).ConclusionsCompared with BMS, DES use in stable patients undergoing CTO PCI was associated with lower mortality, as well as similar myocardial infarction and repeat revascularization rates without an increase in subsequent bleeding requiring hospitalization.

ObjectivesThis study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial.BackgroundWomen are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear.MethodsWomen undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population.ResultsThe trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access.ConclusionsIn this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)

ObjectivesThe purpose of this study was to determine whether bleeding risk varies depending on which P2Y12 receptor inhibitor agent is used.BackgroundPrior studies have shown significant bleeding risk among patients treated with triple therapy (i.e., oral anticoagulant, P2Y12 receptor inhibitor, and aspirin).MethodsWe evaluated patients with acute myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) at 233 hospitals in the United States enrolled in the TRANSLATE-ACS (Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study (April 2010 to October 2012). Using inverse probability-weighted propensity modeling, we compared 6-month adjusted risks of Bleeding Academic Research Consortium (BARC) bleeding, stratifying by whether or not bleeding was associated with rehospitalization among patients discharged on aspirin + anticoagulant + clopidogrel (triple-C), aspirin + anticoagulant + prasugrel (triple-P), aspirin + clopidogrel (dual-C), or aspirin + prasugrel (dual-P).ResultsOf 11,756 MI patients, 526 (4.5%) were discharged on triple-C, 91 (0.8%) on triple-P, 7,715 (66%) on dual-C, and 3,424 (29%) on dual-P. Compared with dual-therapy patients, triple-therapy patients had significantly higher any BARC-defined bleeding. Triple-P was associated with a greater risk of any BARC-defined bleeding events compared with triple-C. This finding was driven mostly by an increased risk of bleeding events that were patient-reported only and did not require rehospitalization. There were no significant differences in bleeding requiring rehospitalization between the triple-P and -C groups.ConclusionsAmong MI patients, the addition of an oral anticoagulant was associated with a significantly greater risk of any BARC-defined bleeding relative to dual antiplatelet therapy, regardless of which P2Y12 receptor inhibitor was selected. Among patients on triple therapy, prasugrel use was associated with higher patient-reported–only bleeding, but not bleeding requiring rehospitalization, than clopidogrel-treated patients.