Impact of ethnicity and gender differences on angiographic coronary artery disease prevalence and in-hospital mortality in the American College of Cardiology-National Cardiovascular Data Registry.

BACKGROUND: Although populations referred for coronary angiography are increasingly diverse, there is limited information on coronary artery disease (CAD) prevalence and in-hospital mortality other than for predominately white male patients. METHODS AND RESULTS: We examined gender and ethnic differences in CAD prevalence and in-hospital mortality in a prospective cohort of patients referred for angiographic evaluation of stable angina (n=375,886) or acute coronary syndromes (ACS; unstable angina or myocardial infarction, n=450,329) at 388 US hospitals participating in the American College of Cardiology-National Cardiovascular Data Registry, an angiographic registry. Univariable and multivariable (with covariates that included risk factors, symptoms, and comorbidities) logistic regression models were used to estimate significant CAD, defined as > or = 70% stenosis, and in-hospital mortality. Within stable angina and ACS cohorts, 7% of patients were black, 2% were Hispanic, 0.3% were Native American, 1% were Asian, and 90% were white, respectively. In stable angina, the risk-adjusted OR for significant CAD was 0.34 for women compared with men (P<0.0001), with black women having the lowest risk-adjusted odds (P<0.0001) compared with other females. Among ACS patients, the risk-adjusted OR of significant CAD was 0.47 for women compared with men (P<0.0001); similarly, black women had the lowest risk-adjusted odds (P<0.0001) compared with other females. Higher in-hospital mortality was reported for white women presenting with stable angina (P<0.00001). White women had a 1.34-fold (95% CI 1.21 to 1.48) higher risk-adjusted odds ratio for mortality than white men with stable angina (P<0.0001), with higher rates noted for white women who were older or had significant CAD (both P<0.0001). Lower utilization of elective coronary revascularization, aspirin, and glycoprotein IIb/IIIa inhibitors (all P<0.0001) may have contributed to higher in-hospital mortality for white women. In ACS, higher in-hospital mortality was reported for Hispanic (P=0.015) and white (P<0.0001) women; however, neither white (P=0.51) or Hispanic (P=0.13) women had higher in-hospital risk-adjusted mortality. CONCLUSIONS: The likelihood for significant CAD at coronary angiography and for in-hospital mortality varied significantly by ethnicity and gender. Future clinical practice guidelines should be tailored to gender subsets of the population, in particular for black women, to improve the efficient use of angiographic laboratories and to target at-risk populations of women and men.

Comparison of coronary artery calcium scores between electron beam computed tomography and 64-multidetector computed tomographic scanner.

OBJECTIVE: Because almost all data currently available with coronary calcium scanning are from electron beam tomography (EBT), we assessed whether scores obtained with 64-multidetector computed tomography (CT; MDCT) are similar. We evaluated the interscan variation in coronary artery calcium (CAC), Agatston score (AS), and volume score (VS) between EBT and 64-MDCT (VCT; GE, Milwaukee, Wis). MATERIALS AND METHODS: One hundred two patients (mean age, 61.1 years; 27 women) underwent dual CAC scanning with both EBT and 64-MDCT. The AS and VS were measured with the Aquarius workstation (TeraRecon, Inc, San Mateo, Calif). The correlation coefficient, Bland-Altman analysis, interscanner variation, and agreement in AS and VS scores between EBT and 64-MDCT were computed. RESULTS: Interscan agreement for presence of CAC was 99%. Median values were 286 and 268 mm for AS and 243 and 213 mm for VS with EBT and 64-MDCT, respectively (P > 0.05). There was significant linear relationship between scores from the 2 scanners (R = 0.98 in AS and R = 0.99 in VS; P < 0.001). The interscanner variability between EBT and 64-MDCT was 20.9% and 17.6% in AS and VS, respectively (P = NS). Bland-Altman analysis demonstrated a mean difference in scores of 8.3% for AS and 7.8% by VS. When compared with EBT, there were larger and more prevalent motion artifacts (P < 0.001) and larger mean Hounsfield units using 64-MDCT (P < 0.001). CONCLUSIONS: At CAC scanning, 64-MDCT and EBT were comparable in AS and VS. The interscan variability between scanners is similar to interscan variability of 2 calcium scores done on the same equipment. However, heart rate control was achieved for this study for calcium scores. Whether these results are repeatable without heart rate control needs to be further assessed.

Risk-adjusted mortality analysis of percutaneous coronary interventions by American College of Cardiology/American Heart Association guidelines recommendations.

An American College of Cardiology (ACC)/American Heart Association (AHA) task force on practice guidelines in 2001 published evidence-based recommendations for performing percutaneous coronary interventions (PCIs). These guidelines grouped the indications for PCI into 4 classes (I, IIa, IIb, and III) based on analyses of risks and benefits. In a previous study, we found that clinical success and in-hospital adverse events varied by indications class. However, no adjustment for risk was used in those comparisons. The ACC/National Cardiovascular Data Registry (ACC-NCDR) previously developed a risk-adjustment model for the adverse event of in-hospital PCI mortality. We investigated how the 14 individual risk factors in the ACC-NCDR PCI mortality model might differ across the 4 indications classes and whether estimated mortality for each class approximated the observed mortality for that class. We analyzed the ACC-NCDR PCI database for January 1, 2001 to December 31, 2004. We excluded procedures performed for treatment of acute ST-segment elevation myocardial infarction; all others were included, yielding 559,273 procedures for analysis. An algorithm derived from the 2001 guidelines was used to assign procedures to an indications class. Increasing frequencies of risk components were observed across classes I, IIa, IIb, and III. Expected mortalities for each class calculated by the risk-adjustment model were close to observed values (expected 0.52%, 0.59%, 1.72%, and 1.96%, respectively; observed 0.49%, 0.63%, 1.88%, and 1.60%, respectively). In conclusion, the ACC-NCDR risk-adjusted mortality model can be linked to the ACC/AHA PCI guidelines, and together these produce mortality risk estimates by indications classes that are close to actual observed values. With further refinement, these methods should be able to be used as powerful analytic tools for quality assurance and appropriateness purposes.

Cardiac CT angiography (CTA) and nuclear myocardial perfusion imaging (MPI)-a comparison in detecting significant coronary artery disease.

RATIONALE AND OBJECTIVES: Endowed with sufficient diagnostic accuracy, electron beam computed tomography angiography (CTA) is being increasingly used to evaluate coronary arteries. However, data on direct comparisons with nuclear myocardial perfusion studies are limited. In this study, we sought to compare the accuracies of CTA and myocardial perfusion imaging (MPI) for identifying symptomatic patients with hemodynamically significant obstructive coronary artery disease (CAD). MATERIALS AND METHODS: In a single-center study, symptomatic outpatients who were scheduled for cardiac catheterization were prospectively enrolled. Only patients with exertional angina or dyspnea were included. After fulfilling the inclusion criteria, 30 patients were enrolled in the study (mean age 54 +/- 9 years and 70% males). Patients underwent MPI, CTA including coronary artery calcification (CAC) measure, and invasive coronary angiography for evaluation of obstructive coronary artery disease. Significant CAD was defined as >50% left main artery stenosis or >70% stenosis of any other epicardial vessel by invasive angiography. The sensitivities, specificities and predictive values of MPI, CAC, and CTA were analyzed per patient RESULTS: CTA demonstrated significant higher sensitivity than MPI (95% vs. 81%, P < .05). CTA demonstrated significantly higher specificity than both MPI (89% versus 78%, P = .04) and CAC (56%, P = .002). CTA also performed better in a per-vessel analysis (sensitivity 94%, specificity 96%) than both nuclear and CAC. There were no significant differences between the sensitivities and specificities of MPI and CAC. CONCLUSION: CTA accurately detects obstructive CAD in symptomatic patients and may be more accurate than MPI or CAC assessment. Larger studies in a more diverse population are needed.

Safety and efficacy of extended-release ranolazine in patients aged 70 years or older with chronic stable angina pectoris.

This analysis examined the safety and efficacy of extended-release ranolazine among patients aged 70 years or older (n=363) compared with patients younger than 70 years (n=1024) enrolled in 2 large multinational prospective clinical trials. The primary end points were exercise capacity and number of weekly angina episodes. Beneficial effects of ranolazine, relative to placebo, were generally similar for each of these outcomes among older and younger participants. For example, at a ranolazine dose of 1000 mg bid, mean exercise duration increased by 19.8+/-13.1 seconds (mean +/- SE) relative to placebo in patients younger than 70 years and by 32.4+/-19.7 seconds relative to placebo in patients 70 years or older. Adverse effects were more common in older than in younger patients, but the incidence of serious adverse effects attributable to ranolazine did not differ significantly between age groups. Outcomes were also similar at dosages of either 750 mg or 1000 mg bid. In conclusion, pooled data from 2 large randomized trials indicate that the efficacy of ranolazine is similar in older and younger patients but that adverse effects are more common in the elderly.

Relationship between procedure indications and outcomes of percutaneous coronary interventions by American College of Cardiology/American Heart Association Task Force Guidelines.

BACKGROUND: An American College of Cardiology/American Heart Association (ACC/AHA) Task Force periodically revises and publishes guidelines with evidence-based recommendations for appropriate use of percutaneous coronary intervention (PCI). Some studies have suggested that closer adherence to guidelines can reduce variations in care, can improve quality, and may ultimately result in better outcomes, but this finding is incompletely understood. Guidelines themselves must change to be responsive to continuously evolving clinical practice. Our goal here was to investigate whether any relationship existed between the most recent ACC/AHA recommended indications for PCI and short term in-hospital outcomes. METHODS AND RESULTS: We analyzed the ACC National Cardiovascular Data Registry for the period of January 1, 2001, through March 31, 2004. We excluded PCI procedures performed for acute myocardial infarction (ST-segment elevation myocardial infarction); all others were grouped by their indications according to the standard ACC/AHA scheme: Class I, evidence and/or agreement that PCI is useful and effective; Class IIa, conflicting evidence and/or divergent opinions, weight is in favor; Class IIb, usefulness/efficacy is less well established; and Class III, evidence and/or agreement that PCI is not useful or effective and may be harmful. Clinical success was defined as angiographic success (<20% residual stenosis) at all lesions attempted without the adverse events of myocardial infarction, same-admission bypass surgery, or death. There were 412 617 PCI procedures included in the analysis. Frequency of indications was as follows: Class I, 64%; Class IIa, 21%; Class IIb, 7%; and Class III, 8%. Clinical success declined across the indications classes (92.8%, 91.7%, 89%, and 85.5%, respectively; P<0.001), whereas adverse events increased. CONCLUSIONS: In this large survey of contemporary PCI practice, most procedures were performed for Class I indications. A significant relationship between evidence-based indications recommended by the ACC/AHA Task Force and in-hospital outcomes was noted.

Assessment of coronary plaque morphology by contrast-enhanced computed tomographic angiography: comparison with intravascular ultrasound.

BACKGROUND: Computed tomographic (CT) angiography provides accurate noninvasive assessment for coronary artery stenosis. The ability of CT angiography to determine plaque morphology remains unclear. METHODS: Twelve patients undergoing intravascular ultrasound for clinical indications underwent CT angiography for the evaluation of plaque morphology. Plaque morphology was classified as (1) soft, (2) fibrous, (3) fibrocalcific or (4) calcific. CT angiography data sets were evaluated for the presence and morphology of plaque in the coronary artery segments. The results were blindly compared with intravascular ultrasound results on a segment by segment basis using angiographic landmarks. RESULTS: Fifty-nine coronary segments were analyzed; 10 segments were normal and 49 contained plaque. Plaque morphology by intravascular ultrasound was soft in 12 segments, fibrous in four, fibrocalcific in 29 and calcific in four. To determine coronary segments with any plaque, CT angiography had a sensitivity of 100% (49 of 49) and specificity of 90% (9 of 10). To determine plaque morphology as calcified (fibrocalcific and calcific) versus noncalcified (soft and fibrous), CT angiography had a sensitivity of 100% (33 of 33) and a specificity of 94% (15 of 16). Overall accuracy for CT angiography to determine plaque morphology was 92% (54 of 59). CT angiography density values (Hounsfield units, mean+/-standard deviation) were significantly different for each plaque morphology: soft 23+/-71, fibrous 108+/-79, fibrocalcific 299+/-112 and calcific 404+/-264 (P<0.0001). CONCLUSIONS: CT angiography accurately characterized plaque morphology and may be a useful tool in noninvasive evaluation of plaque morphology during drug therapy trials.

Intravascular ultrasound in the coronary arteries.

With technical improvements in catheter designs, intravascular ultrasound (IVUS) imaging of coronary arteries has become a routine procedure in most cardiac catheterization laboratories. In clinical practice, IVUS imaging of the coronary arteries is commonly performed to answer specific clinical questions such as the evaluation of an indeterminate narrowing of the left main coronary artery. In recent years, IVUS is also being performed as an endpoint for drug treatment trials in the assessment of atherosclerosis progression and/or regression. In this review we will focus on how validation studies of coronary IVUS systems have advanced our ability to use this powerful imaging tool and understand IVUS images, how acoustic and geometric factors affect proposed image processing tools and illustrate some current clinical uses of coronary IVUS.

The National Cardiovascular Data Registry Voluntary Public Reporting Program: An Interim Report From the NCDR Public Reporting Advisory Group.

Public reporting of health care data continues to proliferate as consumers and other stakeholders seek information on the quality and outcomes of care. Medicare's Hospital Compare website, the U.S. News & World Report hospital rankings, and several state-level programs are well known. Many rely heavily on administrative data as a surrogate to reflect clinical reality. Clinical data are traditionally more difficult and costly to collect, but more accurately reflect patients' clinical status, thus enhancing the validity of quality metrics. We describe the public reporting effort being launched by the American College of Cardiology and partnering professional organizations using clinical data from the National Cardiovascular Data Registry (NCDR) programs. This hospital-level voluntary effort will initially report process of care measures from the percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries of the NCDR. Over time, additional process, outcomes, and composite performance metrics will be reported.

Percutaneous coronary interventions in octogenarians in the American College of Cardiology-National Cardiovascular Data Registry: development of a nomogram predictive of in-hospital mortality.

OBJECTIVES: We sought to evaluate the results of percutaneous coronary intervention (PCI) in elderly patients in contemporary practice. BACKGROUND: Prior studies of PCI in the elderly population demonstrate increased in-hospital mortality, but these studies are limited by small population size. METHODS: Using the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) of 100,253 patients, the in-hospital outcomes in all 8,828 PCI procedures performed on octogenarians were evaluated. Patients underwent PCI between 1998 and 2000 at over 145 participating centers. RESULTS: The mean age was 83.72 +/- 3.02 years, with female preponderance (53%). The PCI was considered angiographically successful in 93%, stents were placed in 75%, and the post-PCI length of stay was 3.3 +/- 5.1 days. Overall in-hospital mortality was 3.77% but was only 1.35% in PCI without recent myocardial infarction (MI) within one week (p < 0.0001). Patients having PCI within 6 h of the onset of their MI had an increase in mortality tenfold (13.79%) compared with patients without a recent MI (p < 0.0001). All groups that were defined based on time of PCI after MI onset up to seven days had increased mortality (all p < 0.0001). Older age (odds ratio [OR] of 1.03 per incremental year), depressed ejection fraction (EF) (OR 0.69 per 10 points for EF <60%), and time of PCI after MI onset (<6 h, OR 6.87; 6 to 24 h, OR 5.66; 24 h to one week, OR 2.93) were most strongly predictive of outcome by multivariate analysis. The predicted mortality from the multivariate model correlated well with the observed in-hospital mortality up to 20% mortality. A 254-point nomogram was constructed employing the logistic model using a weighted point system. CONCLUSIONS: In patients > or = 80 years old, PCI has good success and acceptable mortality. The presence of an acute or recent MI substantially increases the risk of in-hospital death.

A contemporary overview of percutaneous coronary interventions. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR).

The American College of Cardiology (ACC) established the National Cardiovascular Data Registry (ACC-NCDR) to provide a uniform and comprehensive database for analysis of cardiovascular procedures across the country. The initial focus has been the high-volume, high-profile procedures of diagnostic cardiac catheterization and percutaneous coronary intervention (PCI). Several large-scale multicenter efforts have evaluated diagnostic catheterization and PCI, but these have been limited by lack of standard definitions and relatively nonuniform data collection and reporting methods. Both clinical and procedural data, and adverse events occurring up to hospital discharge, were collected and reported according to uniform guidelines using a standard set of 143 data elements. Datasets were transmitted quarterly to a central facility for quality-control screening, storage and analysis. This report is based on PCI data collected from January 1, 1998, through September 30, 2000.A total of 139 hospitals submitted data on 146,907 PCI procedures. Of these, 32% (46,615 procedures) were excluded because data did not pass quality-control screening. The remaining 100,292 procedures (68%) were included in the analysis set. Average age was 64 +/- 12 years; 34% were women, 26% had diabetes mellitus, 29% had histories of prior myocardial infarction (MI), 32% had prior PCI and 19% had prior coronary bypass surgery. In 10% the indication for PCI was acute MI < or =6 h from onset, while in 52% it was class II to IV or unstable angina. Only 5% of procedures did not have a class I indication by ACC criteria, but this varied by hospital from a low of 0 to a high of 38%. A coronary stent was placed in 77% of procedures, but this varied by hospital from a low of 0 to a high of 97%. The frequencies of in-hospital Q-wave MI, coronary artery bypass graft surgery and death were 0.4%, 1.9% and 1.4%, respectively. Mortality varied by hospital from a low of 0 to a high of 4.2%. This report presents the first data collected and analyzed by the ACC-NCDR. It portrays a contemporary overview of coronary interventional practices and outcomes, using uniform data collection and reporting standards. These data reconfirm overall acceptable results that are consistent with other reported data, but also confirm large variations between individual institutions.

Development of a risk adjustment mortality model using the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) experience: 1998-2000.

OBJECTIVES: We sought to develop and evaluate a risk adjustment model for in-hospital mortality following percutaneous coronary intervention (PCI) procedures using data from a large, multi-center registry. BACKGROUND: The 1998-2000 American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) dataset was used to overcome limitations of prior risk-adjustment analyses. METHODS: Data on 100,253 PCI procedures collected at the ACC-NCDR between January 1, 1998, and September 30, 2000, were analyzed. A training set/test set approach was used. Separate models were developed for presentation with and without acute myocardial infarction (MI) within 24 h. RESULTS: Factors associated with increased risk of PCI mortality (with odds ratios in parentheses) included cardiogenic shock (8.49), increasing age (2.61 to 11.25), salvage (13.38) urgent (1.78) or emergent PCI (5.75), pre-procedure intra-aortic balloon pump insertion (1.68), decreasing left ventricular ejection fraction (0.87 to 3.93), presentation with acute MI (1.31), diabetes (1.41), renal failure (3.04), chronic lung disease (1.33); treatment approaches including thrombolytic therapy (1.39) and non-stent devices (1.64); and lesion characteristics including left main (2.04), proximal left anterior descending disease (1.97) and Society for Cardiac Angiography and Interventions lesion classification (1.64 to 2.11). Overall, excellent discrimination was achieved (C-index = 0.89) and application of the model to high-risk patient groups demonstrated C-indexes exceeding 0.80. Patient factors were more predictive in the MI model, while lesion and procedural factors were more predictive in the analysis of non-MI patients. CONCLUSIONS: A risk adjustment model for in-hospital mortality after PCI was successfully developed using a contemporary multi-center registry. This model is an important tool for valid comparison of in-hospital mortality after PCI.

Mortality after emergent percutaneous coronary intervention in cardiogenic shock secondary to acute myocardial infarction and usefulness of a mortality prediction model.

Although percutaneous coronary intervention (PCI) in the setting of cardiogenic shock has a high in-hospital mortality rate, it has been shown to decrease the mortality rate in certain subgroups. The identity and relative importance of variables that are predictive of in-hospital mortality rate after PCI for cardiogenic shock are uncertain. Accordingly, we examined data of >300,000 patients in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) that were collected from 1998 to 2002 and evaluated the outcomes in 483 consecutive patients who underwent emergency PCI for cardiogenic shock. Patients' mean age was 65 +/- 13 years, with men predominating (61%). All underwent emergency/salvage PCI in the setting of cardiogenic shock after acute myocardial infarction. Mean left ventricular ejection fraction was 30 +/- 16%. Stents were placed in 64% of patients, and thrombolytic agents were administered in 26%. Although PCI was angiographically successful in 79% of patients, the in-hospital mortality rate was 59.4%. Length of stay after PCI was 7.2 +/- 8 days. Logistic regression using all available variables identified 6 multivariate predictors of death: age (odds ratio [OR] 2.34, 95% confidence interval [CI] 1.68 to 3.28, p <0.001) for each 10-year increment, female gender (OR 1.55, 95% CI 1.00 to 2.41, p <0.001), baseline renal insufficiency (creatinine >2.0 mg/dl; OR 4.69, 95% CI 1.96 to 11.23, p <0.001), total occlusion in the left anterior descending artery (OR 1.99, 95% confidence interval 1.28 to 3.09, p <0.01), no stent used (OR 2.55, 95% CI 1.63 to 3.96, p <0.01), and no glycoprotein IIb/IIIa inhibitor used during PCI (OR 1.96, 95% CI 1.30 to 2.98, p <0.01). In a second analysis using only variables known to the clinician at the time of initial presentation, gender, age, renal insufficiency, and total occlusion of the left anterior descending coronary artery were significant. In conclusion, analysis of patients from the ACC-NCDR who underwent emergency PCI for acute myocardial infarction in the presence of cardiogenic shock shows an in-hospital mortality rate of approximately 60% when PCI is attempted.

Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current "stent era" of coronary interventions (from the ACC-National Cardiovascular Data Registry).

In 1988 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Coronary Angioplasty proposed a lesion classification system to stratify lesions by difficulty and risk to better understand the outcomes of coronary interventions. It was a 3-level (A, B, and C) classification based on 11 lesion characteristics. A modification, dividing the intermediate B category into B1 and B2, is also in common use. Recently, a simplification of this classification was evaluated using the large Society for Cardiac Angiography and Interventions (SCAI) Registry (SCAI I = non-C/patent; SCAI II = C/patent; SCAI III = non-C/occluded; SCAI IV = C/occluded). The lesion classification systems were evaluated in 61,926 patients from the ACC National Cardiovascular Data Registry who underwent single-vessel percutaneous coronary intervention between January 1998 and September 2000. Stents were placed in 74.5% of patients. Logistic models for lesion success and complications were constructed and compared. The c statistic for success using the ACC/AHA original classification system was 0.69, 0.71 for the modified ACC/AHA system, and 0.75 for the SCAI classification. The range of complication and success rates was greater using the SCAI models, and the logistic models for success and complication were more robust for the SCAI system. Thus, in the large ACC-National Cardiovascular Data Registry, with a high percentage of stent usage, the simpler SCAI lesion classification provided better discrimination for success and complications than the more complex ACC/AHA lesion classification system-original or modified.

Updated risk adjustment mortality model using the complete 1.1 dataset from the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR).

OBJECTIVES: To revise and update a risk adjustment model for in-hospital mortality following percutaneous coronary intervention (PCI) procedures using all data from the 1.1 version of the American College of Cardiology National Cardiovascular Data Registry (ACC-NCR). BACKGROUND: A model based on data received at the ACC-NCDR from 1998-2000 was previously reported. The revision of this mortality model reflects all of the data submitted using 1.1 data specifications and collected through the second quarter of 2001. The model was applied to selected high-risk subgroups from a sample of data collected during the year 2001 from version 2.0 of the NCDR. METHODS: Data on 173,743 PCI procedures collected at the ACC-NCDR between January 1, 1998 and March 31, 2001 were analyzed. A mortality model was generated as well as separate models for presentation with and without acute myocardial infarction within 24 hours. The model was used to generate predicted mortalities that were compared to observed mortalities in more current high-risk patient subgroups in the NCDR. RESULTS: The same factors that were previously found to be associated with increased risk of PCI mortality were re-verified in the current analysis. Inclusion of the complete 1.1 dataset produced some changes in the regression weights and the constant value. Excellent discrimination was achieved in the revised model (C-Index = 0.89). The model was applied to high-risk patient groups from data collected on 76,249 during the calendar year 2001 using the 2.0 NCDR data elements and definitions. These analyses showed a high level of agreement between observed mortality of each subgroup and the predicted mortality rates generated from the revised 1.1 PCI mortality model. CONCLUSIONS: Risk adjustment models for in-hospital mortality following PCI for all patients and for those with and without recent MI were regenerated using all data collected from the 1.1 data specifications of the ACC-NCDR and validated on high-risk groups from data collected during 2001 under data version 2.0 of the NCDR. These models reflect the most up-to-date analysis of mortality prediction from this large, multi-center national database.

Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer.

CONTEXT: Researchers conducted extensive investigations of hallucinogens in the 1950s and 1960s. By the early 1970s, however, political and cultural pressures forced the cessation of all projects. This investigation reexamines a potentially promising clinical application of hallucinogens in the treatment of anxiety reactive to advanced-stage cancer. OBJECTIVE: To explore the safety and efficacy of psilocybin in patients with advanced-stage cancer and reactive anxiety. DESIGN: A double-blind, placebo-controlled study of patients with advanced-stage cancer and anxiety, with subjects acting as their own control, using a moderate dose (0.2 mg/kg) of psilocybin. SETTING: A clinical research unit within a large public sector academic medical center. PARTICIPANTS: Twelve adults with advanced-stage cancer and anxiety. MAIN OUTCOME MEASURES: In addition to monitoring safety and subjective experience before and during experimental treatment sessions, follow-up data including results from the Beck Depression Inventory, Profile of Mood States, and State-Trait Anxiety Inventory were collected unblinded for 6 months after treatment. RESULTS: Safe physiological and psychological responses were documented during treatment sessions. There were no clinically significant adverse events with psilocybin. The State-Trait Anxiety Inventory trait anxiety subscale demonstrated a significant reduction in anxiety at 1 and 3 months after treatment. The Beck Depression Inventory revealed an improvement of mood that reached significance at 6 months; the Profile of Mood States identified mood improvement after treatment with psilocybin that approached but did not reach significance. CONCLUSIONS: This study established the feasibility and safety of administering moderate doses of psilocybin to patients with advanced-stage cancer and anxiety. Some of the data revealed a positive trend toward improved mood and anxiety. These results support the need for more research in this long-neglected field. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00302744.

Cost-effectiveness of multidetector computed tomography compared with myocardial perfusion imaging as gatekeeper to invasive coronary angiography in asymptomatic firefighters with positive treadmill tests.

BACKGROUND: In a prospective evaluation of 3950 Los Angeles County firefighters who underwent wellness/fitness examinations, 495 firefighters had abnormal treadmill tests and were referred for cardiology evaluation. Cost of the traditional myocardial perfusion imaging (MPI) followed by invasive coronary angiography (ICA) was compared with a method incorporating 64-slice multidetector computed tomography (MDCT) with coronary calcium score (CCS) followed by computed tomographic angiography (CTA) and ICA as indicated. OBJECTIVE: We compared the costs of 2 methods of predicting coronary artery disease (CAD) by ICA among asymptomatic patients with positive treadmill tests. METHODS: A decision-analytic framework was used to compare the net direct costs of CAD diagnosis associated with MDCT versus MPI. In the MDCT arm, all received CCS followed by CTA for those with calcium scores>10 and ICA for those with > or =50% stenosis on CTA. For the MPI arm, results were estimated from prior years' experience, in which firefighters with abnormal treadmill results were referred to ICA. RESULTS: Of 495 firefighters, 131 (26.9%) had abnormal CCS and went to CTA; 40 (8.1%) had > or =50% stenosis on CTA and went to ICA. According to prior years' experience with MPI, 146 (29.5%) would have shown abnormalities requiring ICA. Average cost was $1376/person for MPI versus $503/person for CCS with or without CTA as gatekeeper. All sensitivity analyses showed lower costs for the MDCT pathway compared with MPI. CONCLUSION: In this firefighter population, the cost of ICA-confirmed diagnosis of CAD is substantially lower with MDCT as gatekeeper than with MPI.