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Objectives: Review the use of drug-eluting stents (DES) to evaluate changes in use. Background: The DES were approved after several small studies in carefully selected patients showed dramatic reduction in in-stent restenosis. The DES were then rapidly adopted into routine practice. In 2006, 3 years after introduction, serious concerns regarding long-term safety were raised. Methods: We queried the American College of Cardiology/National Cardiovascular Data Registry (ACC/NCDR) CathPCI Registry. The percentage of DES used through mid-2009 was reviewed overall and in subgroups of patients categorized by lesion type, clinical factors, insurance, and hospital characteristics. Multivariable logistic models relating these covariates to DES usage were constructed for 3 relevant time intervals. Results: A total of 2,247,647 coronary stent procedures were analyzed. By 2005 over 90% of first stents placed were DES. Safety concerns arising in 2006 reduced DES use to 64% of first stent placed. After publication of salutary outcomes data in 2008, usage increased to 76% by mid-2009. The logistic models demonstrated decreased likelihood of DES usage in patients with: 1) ST-segment elevation myocardial infarctions; and 2) no medical insurance. The DES usage increased for in-stent restenosis. Hospital characteristics were not associated with significant differences in DES usage. Conclusions: There was rapid adoption of DES into U.S. clinical practice. Concern for late stent thrombosis in 2006 significantly altered DES use with reductions seen in subgroups at risk for thrombosis and patients with no insurance. These rapid cyclic changes after DES introduction reinforce the need for continuous, timely reporting of outcomes data after the introduction of new technologies. [ABSTRACT FROM AUTHOR]

Objectives: This study applied risk adjustment methods to evaluate member institutions of the American College of Cardiology–National Cardiovascular Data Registry with respect to in-hospital mortality in percutaneous coronary intervention patients over a 4-year period to assess variability in risk-adjusted performance measures. Background: Cardiac catheterization laboratories, hospital networks, and third-party payers are interested in assessing the outcomes of percutaneous coronary interventions. Evaluation of outcomes without considering case selection may lead to erroneous conclusions about program quality. Methods: The National Cardiovascular Data Registry database was queried for all percutaneous coronary intervention cases performed between January 1, 2001, and September 30, 2004. Random effects logistic regression was used to develop models of in-hospital mortality and compute an expected mortality rate for each program. The observed mortality rate in each program was divided by the program''s predicted rate to obtain the observed/expected (O/E) mortality ratio. Change in the O/E ratio was assessed by a generalized estimating equation approach to repeated measures. An index of variability was calculated by the mean absolute difference between O/E ratios of each pair of years. Results: There were 664,909 interventional procedures performed in 403 National Cardiovascular Data Registry programs from 2001 to 2004. There was no significant systematic change in O/E ratios over the 4-year period, but there was significantly greater variation in O/E ratios associated with lower percutaneous coronary intervention volume programs. Conclusions: Our risk-adjustment models had very good discrimination and were relatively consistent over the study period. There was substantial within-program variation in O/E ratios. This information would provide an indication for a detailed examination of individual programs. [Copyright &y& Elsevier]

Drug-eluting stents (DES) constitute a major breakthrough in restenosis prevention after initial percutaneous coronary intervention (PCI). Target lesion and vessel revascularization rates of <10% at six months follow-up represent a significant medical advance. Many cardiologists consider it reasonable to assume that PCI using DES ought to be considered equivalent, if not superior, to bypass surgery. The argument made is that in previous randomized clinical trials comparing PCI to coronary artery bypass grafting, restenosis was the determining factor favoring surgery, an event that clinical experience suggests is no longer as frequent. In the absence of a definitive clinical trial to support this view, how should the prudent, cutting edge cardiologist evaluate the data and manage their patients? [Copyright &y& Elsevier]

Objectives: The purpose of this study was to characterize long-term outcomes of percutaneous coronary intervention (PCI) in elderly diabetic patients in routine practice. Background: Although drug-eluting stent (DES) implantation in diabetic patients is common practice, pivotal randomized trials enrolled <2,500 diabetic patients, most of whom were <65 years of age. Methods: Data from 405,679 patients ≥65 years old (33% had diabetes mellitus, of whom 9.8% had insulin-treated diabetes mellitus [ITDM], and 23.3% had noninsulin-treated diabetes mellitus [NITDM]) undergoing PCI from 2004 to 2008 at 946 U.S. hospitals were linked with Medicare inpatient claims data. Results: Over 18.4 months median follow-up (25th to 75th percentile: 8.0 to 30.8 months), ITDM/NITDM were associated with significantly increased adjusted hazards of death (hazard ratio [HR]: 1.91 [95% confidence interval (CI): 1.86 to 1.96], p < 0.001/HR: 1.32 [95% CI: 1.29 to 1.35], p < 0.001) and myocardial infarction (HR: 1.87 [95% CI: 1.79 to 1.95], p < 0.001/HR: 1.29 [95% CI: 1.25 to 1.34], p < 0.001) compared with nondiabetic patients. The adjusted hazard of undergoing additional revascularization procedures (HR: 1.14 [95% CI: 1.10 to 1.18, p < 0.001/HR: 1.08 [95% CI: 1.05 to 1.10], p < 0.001) and subsequent hospitalization for bleeding (HR: 1.40 [95% CI: 1.31 to 1.50], p < 0.001/HR: 1.18 [95% CI: 1.13 to 1.24], p < 0.001) were also significantly increased. Compared with nondiabetic patients, there were similar excess risks associated with ITDM/NITDM in patients selected for DES and BMS use; selection for use of DES was associated with reductions in death in ITDM/NITDM and myocardial infarction in ITDM, but not NITDM. There were no significant interactions between diabetes status and stent type for revascularization or bleeding. Conclusions: One-third of older patients undergoing PCI have diabetes. After adjustment for other comorbidities, diabetes, particularly ITDM, remains independently and strongly associated with increased long-term adverse events after both DES and BMS implantation. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non–ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). Background: The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown. Methods: Using the CathPCI Registry, we examined temporal trends in post-PCI bleeding from 2005 to 2009 among patients with elective PCI (n = 599,524), UA/NSTEMI (n = 836,103), and STEMI (n = 267,632). We quantified the linear time trend in bleeding using 3 sequential logistic regression models: 1) clinical factors; 2) clinical + vascular access strategies (femoral vs. radial, use of closure devices); and 3) clinical, vascular strategies + antithrombotic treatments (anticoagulant ± glycoprotein IIb/IIIa inhibitor [GPI]). Changes in the odds ratio for time trend in bleeding were compared using bootstrapping and converted to risk ratio. Results: An approximate 20% reduction in post-PCI bleeding was seen (elective PCI: 1.4% to 1.1%; UA/NSTEMI: 2.3% to 1.8; STEMI: 4.9% to 4.5%). Radial approach remained low (<3%), and closure device use increased marginally from 44% to 49%. Bivalirudin use increased (17% to 30%), whereas any heparin + GPI decreased (41% to 28%). There was a significant 6% to 8% per year reduction in annual bleeding risk in UA/NSTEMI and elective PCI, but not in STEMI. Antithrombotic strategies were associated with roughly half of the reduction in annual bleeding risk: change in risk ratio from 7.5% to 4% for elective PCI, and 5.7% to 2.8% for UA/NSTEMI (both p <0.001). Conclusions: The nearly 20% reduction in post-PCI bleeding over time was largely due to temporal changes in antithrombotic strategies. Further reductions in bleeding complications may be possible as bleeding avoidance strategies evolve, especially in STEMI. [ABSTRACT FROM AUTHOR]

Objectives: We sought to create contemporary models for predicting mortality risk following percutaneous coronary intervention (PCI). Background: There is a need to identify PCI risk factors and accurately quantify procedural risks to facilitate comparative effectiveness research, provider comparisons, and informed patient decision making. Methods: Data from 181,775 procedures performed from January 2004 to March 2006 were used to develop risk models based on pre-procedural and/or angiographic factors using logistic regression. These models were independently evaluated in 2 validation cohorts: contemporary (n = 121,183, January 2004 to March 2006) and prospective (n = 285,440, March 2006 to March 2007). Results: Overall, PCI in-hospital mortality was 1.27%, ranging from 0.65% in elective PCI to 4.81% in ST-segment elevation myocardial infarction patients. Multiple pre-procedural clinical factors were significantly associated with in-hospital mortality. Angiographic variables provided only modest incremental information to pre-procedural risk assessments. The overall National Cardiovascular Data Registry (NCDR) model, as well as a simplified NCDR risk score (based on 8 key pre-procedure factors), had excellent discrimination (c-index: 0.93 and 0.91, respectively). Discrimination and calibration of both risk tools were retained among specific patient subgroups, in the validation samples, and when used to estimate 30-day mortality rates among Medicare patients. Conclusions: Risks for early mortality following PCI can be accurately predicted in contemporary practice. Incorporation of such risk tools should facilitate research, clinical decisions, and policy applications. [Copyright &y& Elsevier]