Faculty Bibliography

OBJECTIVE:To determine patterns and outcomes of drug-eluting stents (DES) use in clinical practice. BACKGROUND:DES are technology associated with superior outcomes. The initial limited availability and high cost of DES had the potential to influence their use. METHODS:Data from the American College of Cardiology-National Cardiovascular Data Registry were examined to describe the patterns of DES use in 408,033 percutaneous coronary intervention (PCI) procedures at 383 sites. Predictors of DES use were determined, and inhospital outcomes were examined. RESULTS:From April 2003 through December 2004, the proportion of procedures using DES increased from 19.7% to 78.2%. DES use increased across all patient groups and hospital types, but adoption was slower among older patients and those without health insurance. DES use varied among hospitals such that use was lower at rural and low-volume hospitals. Multivariable regression demonstrated a progressive decrease in the odds of DES use as age increased. White race, female sex, presence of insurance, diabetes mellitus, PCI of de novo lesion, PCI at a high volume center, and PCI at a suburban hospital were significant predictors of DES use. The availability of a second DES product did not influence the adoption patterns. Inhospital outcomes with DES were excellent. CONCLUSIONS:Access to DES was influenced by demographic, socioeconomic, and hospital characteristics. Further study is needed to determine if the availability of another DES platform or increased overall availability of DES impacts favorably on PCI practice patterns.

BACKGROUND:Prior studies of atheroablation (directional atherectomy, rotational atherectomy and laser angioplasty) have demonstrated either no advantage or worse outcomes relative to conventional balloon angioplasty. Because these techniques are still required in a minority of patients, we hypothesized that the use of drug-eluting stents (DES) would minimize the rate of major adverse cardiac events (MACE) after atheroablation. METHODS:From 2,252 percutaneous coronary intervention procedures, 212 patients were extracted using case control matching and were analyzed to compare the rate of MACE across four groups (DES with atheroablation, bare-metal stent (BMS) with atheroablation, DES without atheroablation, bare-metal stent without atheroablation). A Cox proportional hazards model was constructed to determine predictors of MACE after adjustment for potential confounders. Internal validation was performed with bootstrapping. RESULTS:There were 36 patients, 42 patients, 63 patients and 71 patients in each of the groups, respectively. The incidence of 30-day and 6-month MACE was numerically lowest among patients who received DES after atheroablation, although the differences did not reach statistical significance (30-day MACE: 0% DES with atheroablation, 4.8% BMS with atheroablation, 3.2% DES without atheroablation, 8.5% BMS without atheroablation; 6-month MACE: 2.8% DES with atheroablation, 19.0% BMS with atheroablation, 6.4% DES without atheroablation, 16.9% BMS without atheroablation). After adjustment, the use of atheroablation was not a predictor of MACE. CONCLUSIONS:This study suggests that in situations where directional atherectomy, rotational atherectomy or laser angioplasty is required to optimize stenting, the use of DES can minimize MACE associated with atheroablation.

The increased rate of bleeding during and after cardiac procedures is a concern. The best strategy is prevention of bleeding complications with anticoagulant therapy that provides an adequate anti-thrombotic effect while reducing bleeding. The independent relationship between bleeding and blood transfusion and mortality among patients with coronary artery disease is reviewed. Findings suggest that in the modern era of percutaneous coronary intervention, prevention of bleeding should be a goal of therapy, which can be achieved while preserving the low rate of ischemic complications.

This paper provides a comprehensive up-to-date review of the medical and invasive management of patients with non- ST-segment elevation acute coronary syndromes (NSTE-ACS). The authors have summarized findings from key clinical trials published recent years that contribute to clinicians' understanding of how best to optimize therapy. The goals for the management of NSTE-ACS are rapid and accurate risk stratification, appropriate and institution-specific triage to interventional versus medical strategies and optimal pharmacologic therapy--all of which provide for a smooth and seamless transition of care between the emergency department and the cardiology service. High-risk features or absolute treatment trigger criteria that support more aggressive medical therapy (i.e., addition of small-molecule GP IIb/IIIa inhibitor to a core regimen of aspirin, enoxaparin, and in most cases, clopidogrel) and/or that would direct clinicians toward percutaneous, mechanical/interventional strategies as the preferred modality include, but are not limited to, the presence of one or more of the following: (1) elevated cardiac markers (troponin and/or CK-MB); (2) elevated levels of inflammatory markers (particularly CRP > 3 microg/dl); (3) age > 65 years; (4) presence of ST-T wave changes; (5) TIMI Risk Score greater than or equal to 4; (6) diabetes; and/or (7) clinical instability in the setting of suspected NSTE-ACS.Specific clinical, ECG and/or biochemical trigger points modulate the aggressiveness of both the medical therapy and the propensity to perform early angiography with or without subsequent revascularization in patients with NSTE-ACS. Although additional refinements and changes in ACS management are still to come, evidence-based strategies suggest that prompt mechanical revascularization is associated with the best possible clinical outcomes, particularly for patients with high-risk features and in whom benefits of adjunctive, pharmacoinvasive antithrombotic therapies can be consolidated. Patient transfer for cardiac catheterization/percutaneous coronary intervention (PCI) is strongly recommended in patients who manifest high-risk features and/or aggressive treatment trigger criteria, so that this high-risk subgroup may receive definitive, interventional and/or cardiology-directed specialty care at appropriate sites of care. When available, interventional management is preferred in these patients. The importance of safe and effective anticoagulation in the spectrum of management strategies has been confirmed, and the evidence in support of enoxaparin and other antithrombotic agents has been reviewed. Dosing recommendations for enoxaparin use in the setting of PCI have been issued by the CATH Panel and have been summarized in this consensus report. Similar recommendations have been presented for the use of oral antiplatelet agents and GP IIb/IIIa antagonists. The addition of statins, ACE-inhibitors and beta-blockers is also stressed as part of a comprehensive secondary cardioprotective strategy for patients with coronary heart disease

Despite significant advancements in the treatment of heart failure over the past 2 decades, this patient population is still subject to considerably high morbidity and mortality rates. In recent years, the field of device therapy as adjunctive treatment to the medical management of congestive heart failure has grown in the wake of the large number of randomized trials that have demonstrated the safety and efficacy of these devices. The implantable defibrillator currently represents the standard of care in certain segments of the heart failure population, even in those without a prior arrhythmic event. Biventricular pacing systems appear to have a role in heart failure patients with prolongation of their QRS duration in improving ventricular performance and symptoms, if not mortality. Last, the shortage of organs available for orthotopic transplant has heightened interest in using ventricular-assist devices as destination therapy, and although there is evidence for the feasibility for this approach at the current time, there is a next generation of devices that appear even more promising.

BACKGROUND:Previous studies suggest that patients hospitalized with acute myocardial infarction (MI) in December have poor outcomes, and some studies have hypothesized that the cause may be the infrequent use of evidence-based therapies during the December holiday season. OBJECTIVE:To compare the care and outcomes of patients with acute MI hospitalized in December and patients hospitalized during other months. DESIGN/METHODS:Retrospective analysis of data from the Cooperative Cardiovascular Project. SETTING/METHODS:Nonfederal, acute care hospitals in the United States. PATIENTS/METHODS:127 959 Medicare beneficiaries hospitalized between January 1994 and February 1996 with confirmed acute MI. MEASUREMENTS/METHODS:Use of aspirin, beta-blockers, and reperfusion therapy (thrombolytic therapy or percutaneous coronary intervention), and 30-day mortality. RESULTS:When the authors controlled for patient, hospital, and physician characteristics, the use of evidence-based therapies was not significantly lower but 30-day mortality was higher (21.7% vs. 20.1%; adjusted odds ratio, 1.07 [95% CI, 1.02 to 1.12]) among patients hospitalized in December. LIMITATIONS/CONCLUSIONS:This was a nonrandomized, observational study. Unmeasured characteristics may have contributed to outcome differences. CONCLUSIONS:Thirty-day mortality rates were higher for Medicare patients hospitalized with acute MI in December than in other months, although the use of evidence-based therapies was not significantly lower.

OBJECTIVES/OBJECTIVE:In a large contemporary population of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS), we sought to describe blood transfusion rates (overall and in patients who did not undergo coronary artery bypass grafting [CABG]), patient characteristics and practices associated with transfusion, variation among hospitals, and in-hospital outcomes in patients receiving transfusions. BACKGROUND:The use of antithrombotic agents and invasive procedures reduces ischemic complications but increases risks for bleeding and need for blood transfusion in patients with NSTE ACS. METHODS:We evaluated patient characteristics and transfusion rates in the overall population (n = 85,111) and determined outcomes and factors associated with need for transfusion in a subpopulation of patients who did not undergo CABG (n = 74,271) from 478 U.S. hospitals between January 1, 2001, and March 31, 2004. RESULTS:A total of 14.9% of the overall and 10.3% of the non-CABG population underwent transfusion during their hospitalization. Renal insufficiency and advanced age were strongly associated with the likelihood of transfusion. Interhospital transfusion rates varied significantly. Non-CABG patients who received transfusions had a greater risk of death (11.5% vs. 3.8%) and death or reinfarction (13.4% vs. 5.8%) than patients who did not undergo transfusion. CONCLUSIONS:Transfusion is common in the setting of NSTE ACS, and patients who undergo transfusion are sicker at baseline and experience a higher risk of adverse outcomes than their nontransfused counterparts. Given the wide variation in transfusion practice, further efforts to understand patient and process factors that result in bleeding and need for transfusion in NSTE ACS are needed.

Bleeding is a complication of current therapies for acute coronary syndrome (ACS). No studies have examined the effect of bleeding events on clinical outcomes. We analyzed pooled data from 4 multicenter, randomized clinical trials of patients who had ACS (n = 26,452) to determine an association between bleeding severity as measured by the GUSTO scale and 30-day and 6-month mortality rates using Cox proportional hazards modeling that incorporated bleeding as a time-dependent covariate. The analysis was repeated to examine procedure- and non-procedure-related bleeding and after censoring at the time of coronary artery bypass grafting. Of all the patients included, 27.6% had > or =1 bleeding episode. Patients who bled were older and sicker at presentation than were those who did not bleed. Unadjusted rates of 30-day and 6-month mortality increased as bleeding severity increased. There were stepwise increases in the adjusted hazards of 30-day mortality (mild bleeding, hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.3 to 1.9; moderate bleeding, HR 2.7, 95% CI l 2.3 to 3.4; severe bleeding, HR 10.6, 95% CI 8.3 to 13.6) and 6-month mortality (mild bleeding, HR 1.4, 95% CI 1.2 to 1.6; moderate bleeding, HR 2.1, 95% CI 1.8 to 2.4; severe bleeding, HR 7.5, 95% CI 6.1 to 9.3) as bleeding severity increased. Results were consistent after censoring for coronary artery bypass grafting and for procedure- and non-procedure-related bleeds. In conclusion, the GUSTO bleeding classification identifies patients who are at risk for short- and long-term adverse events. Therapies that minimize bleeding risk and maintain an anticoagulant effect may improve outcomes among patients who have ACS.

BACKGROUND:Although the Medicare entitlement provides universal hospital care coverage for elderly Americans, disparities in care processes after acute myocardial infarction still exist. Whether these disparities account for increased mortality among elderly poor patients is not known. METHODS:To determine the association between socioeconomic status and acute myocardial infarction treatment, procedure use, and 30-day and 1-year mortality, we analyzed data from 132 130 elderly Medicare beneficiaries hospitalized for acute myocardial infarction between January 1994 and February 1996. Patients were categorized into 10 groups of increasing income using the median income of the ZIP code of residence. RESULTS:The highest-income beneficiaries received higher rates of evidence-based medical therapy and had lower adjusted 30-day and 1-year mortality rates compared with the middle-income beneficiaries (30-day relative risk, 0.89 [95% confidence interval, 0.85-0.94]; and 1-year relative risk, 0.92 [95% confidence interval, 0.88-0.97]). Conversely, the lowest-income beneficiaries received lower rates of evidence-based medical treatment and had higher adjusted 30-day and 1-year mortality rates relative to the middle-income beneficiaries (30-day relative risk, 1.09 [95% confidence interval, 1.04-1.13]; and 1-year relative risk, 1.05 [95% confidence interval, 1.00-1.10]). Coronary revascularization rates were similar among income groups. CONCLUSIONS:Despite the Medicare entitlement, there remain significant socioeconomic disparities in medical treatment and mortality among elderly patients following acute myocardial infarction. Income was independently associated with short- and long-term mortality. More research is required to determine the mechanisms contributing to adverse outcomes among poor elderly patients and to determine whether expansion of Medicare coverage will alleviate these disparities.

OBJECTIVES/OBJECTIVE:The purpose of this study was to determine whether state-mandated continuing medical education (CME) requirements affect the use of evidence-based therapies and outcomes in patients with acute myocardial infarction (AMI). BACKGROUND:The Institute of Medicine recommends that educational programs demonstrate their effect through process and outcome measures. METHODS:We analyzed 134,609 patients according to whether or not CME was mandated in the state of physician practice. A hierarchical multivariable model was developed that controlled for state, hospital, physician, and patient level characteristics to determine the association between state CME requirements and the use of evidence-based therapies. Primary outcome measures were admission aspirin use and reperfusion therapy, and discharge aspirin and beta-blocker prescription. Thirty-day and one-year mortality were secondary outcome measures. RESULTS:States with and without CME requirements had similar rates of aspirin use at admission and discharge (79.9% vs. 79.4% and 72.5% vs. 72.5%, respectively) and beta-blocker prescription at discharge (53.6% vs. 55.3%). The rate of reperfusion therapy at admission was significantly higher in states requiring CME (53.1%) compared with states without CME (47.9%) (p < 0.0001). After adjustment, patients admitted in CME-requiring states were significantly more likely to receive reperfusion therapy, mainly owing to "patented" thrombolytic therapy (odds ratio 1.15; p = 0.016). There was no association between CME requirements and one-year mortality. CONCLUSIONS:State-mandated CME had little association with AMI care or outcome, other than an increased use of patented thrombolytic therapy. Further research is needed to maximize the measurable effect of CME on the use of proven therapies irrespective of whether patented or generic medications are involved.