A quantitative measure of diabetes risk in community practice impacts clinical decisions: the PREVAIL initiative.

BACKGROUND AND AIMS: While predictive tools are being developed to identify those at highest risk for developing diabetes, little is known whether these assays affect clinical care. METHODS AND RESULTS: Thirty sites who used the PreDx(®) (Tethys BioScience, Emeryville, CA) abstracted clinical information from baseline clinic visits prior to a PreDx test and from the most recent visit at time of abstraction. All visits occurred between May 2008-April 2011 (median follow-up 198 days, IQR 124-334). The primary analysis was the influence of the PreDx test (5-year diabetes prediction) on subsequent care; descriptive statistics were used to summarize baseline and follow-up variables. Overall 913 patients with 2 abstracted visits were included. Relative to baseline, median SBP decreased 1.5 mmHg (p = 0.039), DBP decreased 2 mmHg (p < 0.001), LDL-C decreased 4 mg/dL (p = 0.009), and HDL-C increased 2 mg/dL (p < 0.001) at follow-up. Behavioral or lifestyle counseling was not significantly different from baseline to follow-up (71.2% vs. 68.1% (p = 0.077), but BMI was lower by 0.2 kg/m(2) at follow up (p = 0.013). At follow-up, more patients were prescribed metformin (13.7% vs. 9.7%, p < 0.001). A higher PreDx score was significantly associated with metformin prescription (p = 0.0003), lifestyle counseling (p = 0.0099), and a lower BMI at follow-up (p = 0.007). CONCLUSION: The use of a prognostic test in patients perceived to be high risk for diabetes was associated with a modest but significant increase in the prescription of metformin and lifestyle interventions and a reduction in BMI.

The effect of race on coronary bypass operative mortality.

OBJECTIVES: The study was done to determine whether race is an independent predictor of operative mortality after coronary artery bypass graft (CABG) surgery. BACKGROUND: Blacks are less frequently referred for cardiac catheterization and CABG than are whites. Few reports have investigated the relative fate of patients who undergo CABG as a function of race. METHODS: The Society of Thoracic Surgeons National Database was used to retrospectively review 25,850 black and 555,939 white patients who underwent CABG-alone from 1994 through 1997. A multivariate logistic regression model was developed to determine whether race affected risk-adjusted operative mortality. RESULTS: Operative mortality was 3.83% for blacks versus 3.14% for whites (unadjusted black/white odds ratio [OR] 1.23 [1.15-1.31]). Blacks were younger, more likely female, hypertensive, diabetic and in heart failure. Nonetheless, the influence of these and other preoperative risk factors on procedural mortality was quite similar in black and white patients. After controlling for all risk factors, race remained a significant independent predictor of mortality in the multivariate logistic model (adjusted black/white OR 1.29 [1.21, 1.38]). Proportionately, these differences were greatest among lower-risk patients. The race-by-gender interaction was significant (p<0.05). The unadjusted mortality for black men, 3.30% and white men, 2.64% differed significantly (p<0.05), whereas for women there was no difference (black, 4.49%; white 4.41%). CONCLUSIONS: Black race is an independent predictor of operative mortality after CABG except for very high-risk patients. The difference in mortality is greatest for male patients and, though statistically significant, is small in absolute terms. Therefore, patients should be referred for CABG based on clinical characteristics irrespective of race.

The effects of New York's bypass surgery provider profiling on access to care and patient outcomes in the elderly.

OBJECTIVE: The aim of this study was to examine the effects of provider profiling on bypass surgery access and outcomes in elderly patients in New York. BACKGROUND: Since 1989, New York (NY) has compiled provider-specific bypass surgery mortality reports. While some have proposed that "provider profiling" has led to lower surgical mortality rates, critics have suggested that such programs lower in-state procedural access (increasing out-of-state transfers) without improving patient outcomes. METHODS: Using national Medicare data, we examined trends in the percentages of NY residents aged 65 years or older receiving out-of-state bypass surgery between 1987 and 1992 (before and after program initiation). We also examined in-state procedure use among elderly myocardial infarction patients during this period. Finally, we compared trends in surgical outcomes in NY Medicare patients with those for the rest of the nation. RESULTS: Between 1987 and 1992, the percentage of NY residents receiving bypass out-of-state actually declined (from 12.5% to 11.3%, p < 0.01 for trend). An elderly patient's likelihood for bypass following myocardial infarction in NY increased significantly since the program's initiation. Between 1987 and 1992, unadjusted 30-day mortality rates following bypass declined by 33% in NY Medicare patients compared with a 19% decline nationwide (p < 0.001). As a result of this improvement, NY had the lowest risk-adjusted bypass mortality rate of any state in 1992. CONCLUSIONS: We found no evidence that NY's provider profiling limited procedure access in NY's elderly or increased out-of-state transfers. Despite an increasing preoperative risk profile, procedural outcomes in NY improved significantly faster than the national average.

Contemporary outcome trends in the elderly undergoing percutaneous coronary interventions: results in 7,472 octogenarians. National Cardiovascular Network Collaboration.

OBJECTIVES: We sought to define the risks facing octogenarians undergoing contemporary percutaneous coronary interventions (PCIs). BACKGROUND: The procedural risks of PCI for octogenarians have not been well established. METHODS: We compared the clinical characteristics and in-hospital outcomes of 7,472 octogenarians (mean age 83 years) with those of 102,236 younger patients (mean age 62 years) who underwent PCI at 22 National Cardiovascular Network (NCN) hospitals from 1994 through 1997. RESULTS: Octogenarians had more comorbidities, more extensive coronary disease and a two- to fourfold increased risk of complications, including death (3.8% vs. 1.1%), Qwave myocardial infarction (1.9% vs. 1.3%), stroke (0.58% vs. 0.23%), renal failure (3.2% vs. 1.0%) and vascular complications (6.7% vs. 3.3%) (p < 0.001 for all comparisons). Independent predictors of procedural mortality in octogenarians included shock (odds ratio [OR] 5.4, 95% confidence interval [CI] 3.3 to 8.8), acute myocardial infarction (OR 3.2, 95% CI 2.3 to 4.4), left ventricular ejection fraction (LVEF) <35% (OR 2.9, 95% CI 2.1 to 3.9), renal insufficiency (OR 2.8, 95% CI 2.0 to 3.8), first PCI (OR 2.3, 95% CI 1.7 to 3.3), age >85 years (OR 2.1, 95% CI 1.5 to 2.7) and diabetes mellitus (OR 1.5, 95% CI 1.1 to 2.0). For elective procedures, octogenarian mortality varied nearly 10-fold, and was strongly influenced by comorbidities (0.79% mortality with no risk factors vs. 7.2% with renal insufficiency or LVEF <35%). Despite similar case-mix, PCI outcomes in octogenarians improved significantly over the four years of observation (OR of 0.61 for death/myocardial infarction/stroke in 1997 vs. 1994; 95% CI 0.45 to 0.85). CONCLUSIONS: Risks to octogenarians undergoing PCI are two- to fourfold higher than those of younger patients, strongly influenced by comorbidities, and have decreased in the stent era.

Challenges in comparing risk-adjusted bypass surgery mortality results: results from the Cooperative Cardiovascular Project.

OBJECTIVES: We sought to evaluate the predictive accuracy of four bypass surgery mortality clinical risk models and to examine the extent to which hospitals' risk-adjusted surgical outcomes vary depending on which risk-adjustment method is applied. BACKGROUND: Cardiovascular "report cards" often compare risk-adjusted surgical outcomes; however, it is unclear to what extent the risk-adjustment process itself may affect these metrics. METHODS: As part of the Cooperative Cardiovascular Project's Pilot Revascularization Study, we compared the predictive accuracy of four bypass clinical risk models among 3,654 Medicare patients undergoing surgery at 28 hospitals in Alabama and Iowa. We also compared the agreement in hospital-level risk-adjusted bypass outcome performance ratings depending on which of the four risk models was applied. RESULTS: Although the four risk models had similar discriminatory abilities (C-index, 0.71 to 0.74), certain models tended to overpredict mortality in higher-risk patients. There was high correlation between a hospital's risk-adjusted mortality rates regardless of which of the four models was used (correlation between risk-adjusted rating, 0.93 to 0.97). In contrast, there was limited agreement in which hospitals were identified as "performance outliers" depending on which risk-adjustment model was used and how outlier status was defined. CONCLUSIONS: A hospital's risk-adjusted bypass surgery mortality rating, relative to its peers, was consistent regardless of the risk-adjustment model applied, supporting their use as a means of provider performance feedback. Designation of performance outliers, however, can vary significantly depending on the benchmark and methods used for this determination.

Outcomes of cardiac surgery in patients > or = 80 years: results from the National Cardiovascular Network.

OBJECTIVES: The purpose of this study was to evaluate characteristics and outcomes of patients age > or =80 undergoing cardiac surgery. BACKGROUND: Prior single-institution series have found high mortality rates in octogenarians after cardiac surgery. However, the major preoperative risk factors in this age group have not been identified. In addition, the additive risks in the elderly of valve replacement surgery at the time of bypass are unknown. METHODS: We report in-hospital morbidity and mortality in 67,764 patients (4,743 octogenarians) undergoing cardiac surgery at 22 centers in the National Cardiovascular Network. We examine the predictors of in-hospital mortality in octogenarians compared with those predictors in younger patients. RESULTS: Octogenarians undergoing cardiac surgery had fewer comorbid illnesses but higher disease severity and surgical urgency than younger patients. Octogenarians had significantly higher in-hospital mortality after cardiac surgery than younger patients: coronary artery bypass grafting (CABG) only (8.1% vs. 3.0%), CABG/aortic valve (10.1% vs. 7.9%), CABG/mitral valve (19.6% vs. 12.2%). In addition, they had twice the incidence of postoperative stroke and renal failure. The preoperative clinical factors predicting CABG mortality in the very elderly were quite similar to those for younger patients with age, emergency surgery and prior CABG being the powerful predictors of outcome in both age categories. Of note, elderly patients without significant comorbidity had in-hospital mortality rates of 4.2% after CABG, 7% after CABG with aortic valve replacement (CABG/AVR), and 18.2% after CABG with mitral valve replacement (CABG/MVR). CONCLUSIONS: Risks for octogenarians undergoing cardiac surgery are less than previously reported, especially for CABG only or CABG/AVR. In selected octogenarians without significant comorbidity, mortality approaches that seen in younger patients.

Provisional stenting strategies: systematic overview and implications for clinical decision-making.

Coronary stents reduce the rates of abrupt closure, emergency coronary artery bypass graft surgery and restenosis, but do not prevent myocardial infarction or death at six months. The financial burden of increased stent use and the difficulty in managing in-stent restenosis have provided the impetus to develop provisional stenting strategies. Patients at low risk for restenosis after balloon angioplasty may not derive additional benefit from stent implantation and may be successfully managed with percutaneous transluminal coronary angioplasty (PTCA) alone. Numerous patient, lesion and procedural predictors of restenosis have been identified. Postprocedural assessment using quantitative coronary angiography, intravascular ultrasound (IVUS), coronary flow velocity reserve (CVR) or fractional flow reserve (FFR) may further enhance the ability to predict adverse outcomes after PTCA. Several studies have been performed to investigate the feasibility of provisional stenting strategies using various modalities to identify low risk patients who could be managed with PTCA alone. An optimal or "stent-like" angiographic result after PTCA is associated with favorable clinical outcomes. Preliminary results of studies using IVUS or CVR to guide provisional stenting appear promising. Angiography alone may be inadequate to identify truly low risk patients and may need to be combined with clinical factors, assessment of recoil, IVUS or physiologic indexes. Strategies that avoid unnecessary stenting in even a small proportion of patients may have large impacts on health care costs. Provisional stenting may potentially reduce costs and rates of in-stent restenosis without compromising the quality of health care delivery.

Impact of early discharge after coronary artery bypass graft surgery on rates of hospital readmission and death. The Ischemic Heart Disease (IHD) Patient Outcomes Research Team (PORT) Investigators.

OBJECTIVES: This study examined the impact of early hospital discharge on short-term clinical outcomes of elderly patients treated with coronary artery bypass graft surgery (CABG) in the United States in 1992. BACKGROUND: Protocols that encourage earlier discharge of patients who have had CABG have been implemented across the country. Although delivery of efficient care benefits both patients and providers, premature discharge can adversely affect clinical outcomes, resulting in increased hospital readmissions and higher long-term costs. METHODS: We examined the prevalence of early discharge (postoperative length of stay < or = 5 days) among 83,347 non-health maintenance organization (HMO) Medicare patients who underwent CABG in the United States in 1992. Using logistic regression models, we identified patient characteristics associated with early discharge and obtained risk-adjusted rates of death and readmission or death for postoperative lengths of stay between 4 and 14 days. RESULTS: In 1992, 6% of Medicare patients undergoing CABG were discharged within 5 days of the operation. The prevalence of early discharge varied considerably among states, ranging from 1% to 21%. Patients discharged early tended to be younger and male and have fewer comorbid illnesses. Risk-adjusted rates of death and death or cardiovascular readmission were lowest among patients discharged early. CONCLUSIONS: As of 1992, early discharge of elderly patients treated with CABG in non-HMO settings was not associated with higher 60-day rates of death or readmission. This suggests that physicians were able to identify low risk candidates for early discharge. Variation across the nation in early discharge rates, along with the percentage of patients without major risk factors for adverse outcomes, suggests that higher rates of early discharge might be safely achieved.

Potential impact of evidence-based medicine in acute coronary syndromes: insights from GUSTO-IIb. Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes trial.

OBJECTIVES: The purpose of this study to determine whether use of cardiac medications reflects evidence-based recommendations for patients with non-ST elevation acute coronary syndromes. BACKGROUND: Agency for Health Care Policy and Research practice guidelines for unstable angina recommend the use of cardiac medications based on evidence from randomized trials. It is unknown whether practitioners in the U.S., Canada and Europe follow these recommendations in patients with non-ST elevation acute coronary syndromes. METHODS: We studied 7,743 patients with non-ST elevation acute coronary syndromes enrolled in the international Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes trial. The use of aspirin, beta-adrenergic blocking agents, angiotensin-converting enzyme inhibitors and calcium channel blocking agents was determined at discharge for all patients and "ideal" patients (those with indications and no contraindications). Using published estimates of relative mortality reductions with these drugs, we calculated the lives that could have been saved at 1 year if discharge medication use had better matched guideline recommendations. RESULTS: Overall, guideline adherence at discharge in "ideal" patients was 85.6% for aspirin, 59.1% for beta-blockers and 51.7% for angiotensin-converting enzyme inhibitors. Calcium channel blockers were given to 26.7% of patients with a contraindication to these drugs. These rates were similar across locations of enrollment. Women and older patients less often received aspirin when "ideal," and younger patients more often received calcium channel blockers when they were contraindicated. If medication use had been more evidence-based, 1-year mortality might have been reduced by a relative 22%. CONCLUSIONS: There is significant room for improvement in the use of recommended drugs in patients with non-ST elevation acute coronary syndromes. Medication use that more closely follows recommendations could reduce mortality in this population.

Acute and long-term cost implications of coronary stenting.

OBJECTIVES: We compared the acute and one year medical costs and outcomes of coronary stenting with those for balloon angioplasty (percutaneous transluminal coronary angioplasty) in contemporary clinical practice. BACKGROUND: While coronary stent implantation reduces the need for repeat revascularization, it has been associated with significantly higher acute costs compared with coronary angioplasty. METHODS: We studied patients treated at Duke University between September 1995 and June 1996 who received either coronary stent (n = 384) or coronary angioplasty (n = 159) and met eligibility criteria. Detailed cost data were collected initially and up to one year following the procedure. Our primary analyses compared six and 12 month cumulative costs for coronary angioplasty- and stent-treated cohorts. We also compared treatment costs after excluding nontarget vessel interventions; after limiting analysis to those without prior revascularization; and after risk-adjusting cumulative cost estimates. RESULTS: Baseline clinical characteristics were generally similar between the two treatment groups. The mean in-hospital cost for stent patients was $3,268 higher than for those receiving coronary angioplasty ($14,802 vs. $11,534, p < 0.001). However, stent patients were less likely to be rehospitalized (22% vs. 34%, p = 0.002) or to undergo repeat revascularization (9% vs. 26%, p = 0.001) than coronary angioplasty patients within six months of the procedure. As such, mean cumulative costs at 6 months ($19,598 vs. $19,820, p = 0.18) and one year ($22,140 vs. $22,571, p = 0.26) were similar for the two treatments. Adjusting for baseline predictors of cost and selectively examining target vessel revascularization, or those without prior coronary intervention yielded similar conclusions. CONCLUSIONS: In contemporary practice, coronary stenting provides equivalent or better one-year patient outcomes without increasing cumulative health care costs.

A comparison of U.S. and Canadian cardiac catheterization practices in detecting severe coronary artery disease after myocardial infarction: efficiency, yield and long-term implications.

OBJECTIVES: We sought to compare U.S. and Canada's post-myocardial infarction (MI) cardiac catheterization practices in the detection of severe coronary artery disease (CAD). BACKGROUND: Little is known about the efficiency with which the aggressive post-MI catheterization strategy observed in the U.S. detects severe CAD compared with the more conservative strategy observed in Canada. METHODS: From the U.S. and Canadian patients who had participated in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries trial (n = 22,280, 11.5% Canadian), we examined the frequency of in-hospital cardiac catheterization, the prevalence of severe CAD observed at catheterization (diagnostic efficiency) and the total number of MI patients with severe CAD identified (diagnostic yield). RESULTS: The rate of catheterization in the U.S. was more than 2.5 times that in Canada (71% vs. 27%, respectively, p < 0.001). With identical prevalences of severe CAD at catheterization (17%) in the two countries, the higher frequency of catheterization in the U.S. resulted in the identification of more than two and a half times as many cases of severe CAD compared with Canada (12 severe CAD cases identified per 100 post-MI patients in the U.S., vs. 4.6 per 100 in Canada). If considered in isolation, we estimated that these differences in severe disease detection might effect a small long-term survival advantage in favor of the U.S. strategy (estimated 5.0 lives saved per 1,000 MI patients). CONCLUSIONS: Canada's more restrictive post-MI cardiac catheterization strategy is no more efficient in identifying severe CAD than the aggressive U.S. strategy, and may fail to identify a substantial number of post-MI patients with high risk coronary anatomy. The long-term impact of these differences in practice patterns requires further evaluation.

Value of exercise treadmill testing in women.

OBJECTIVES: We sought to determine the ability of a treadmill score to provide accurate diagnostic and prognostic risk estimates in women. BACKGROUND: Treadmill testing has been reported to have a lower accuracy for diagnosis of chest pain in women. The diagnostic and prognostic value of the Duke Treadmill Score (DTS) in women is unknown. METHODS: We determined the diagnostic and prognostic value of the DTS in 976 women and 2,249 men who underwent both treadmill testing and cardiac catheterization in a single institution from 1984 to 1994. RESULTS: Women and men differed significantly in DTS (1.6 vs. -0.3, p < 0.0001), disease prevalence (32% vs. 72% significant coronary artery disease [CAD], p < 0.001), and 2-year mortality (1.9% vs. 4.9%, p < 0.0001). The DTS provided information beyond clinical predictors of both coronary disease and survival in women and men. Although overall women had better survival, the DTS performed equally well in stratifying both genders into prognostic categories. The DTS actually performed better in women than in men for excluding disease, with fewer low risk women having any significant coronary disease (> or = 1 vessel with > or =75% stenosis) (20% vs. 47%, p < 0.001), or severe disease (3-vessel disease or > or =75% left main stenosis) (3.5% vs. 11.4%, p < 0.001). CONCLUSIONS: By combining several aspects of treadmill testing, the DTS effectively stratifies women into diagnostic and prognostic risk categories.

Identification of variables needed to risk adjust outcomes of coronary interventions: evidence-based guidelines for efficient data collection.

OBJECTIVES: Our objectives were to identify and define a minimum set of variables for interventional cardiology that carried the most statistical weight for predicting adverse outcomes. Though "gaming" cannot be completely avoided, variables were to be as objective as possible and reproducible and had to be predictive of outcome in current databases. BACKGROUND: Outcomes of percutaneous coronary interventions depend on patient risk characteristics and disease severity and acuity. Comparing results of interventions has been difficult because definitions of similar variables differ in databases, and variables are not uniformly tracked. Identifying the best predictor variables and standardizing their definitions are a first step in developing a universal stratification instrument. METHODS: A list of empirically derived variables was first tested in eight cardiac databases (158,273 cases). Three end points (in-hospital death, in-hospital coronary artery bypass graft surgery, Q wave myocardial infarction) were chosen for analysis. Univariate and multivariate regression models were used to quantify the predictive value of the variable in each database. The variables were then defined by consensus by a panel of experts. RESULTS: In all databases patient demographics were similar, but disease severity varied greatly. The most powerful predictors of adverse outcome were measures of hemodynamic instability, disease severity, demographics and comorbid conditions in both univariate and multivariate analyses. CONCLUSIONS: Our analysis identified 29 variables that have the strongest statistical association with adverse outcomes after coronary interventions. These variables were also objectively defined. Incorporation of these variables into every cardiac dataset will provide uniform standards for data collected. Comparisons of outcomes among physicians, institutions and databases will therefore be more meaningful.

The impact of statistical adjustment on economic profiles of interventional cardiologists.

OBJECTIVES: The objective of this study was to identify preprocedure patient factors associated with percutaneous intervention costs and to examine the impact of these patient factors on economic profiles of interventional cardiologists. BACKGROUND: There is increasing demand for information about comparative resource use patterns of interventional cardiologists. Economic provider profiles, however, often fail to account for patient characteristics. METHODS: Data were obtained from Duke Medical Center cost and clinical information systems for 1,949 procedures performed by 13 providers between July 1, 1997, and December 31, 1998. Patient factors that influenced cost were identified using multiple regression analysis. After assessing interprovider variation in unadjusted cost, mixed linear models were used to examine how much cost variability was associated with the provider when patient characteristics were taken into account. RESULTS: Total hospital costs averaged $15,643 (median, $13,809), $6,515 of which represented catheterization laboratory costs. Disease severity, acuity, comorbid illness and lesion type influenced total costs (R(2) = 38%), whereas catheterization costs were affected by lesion type and acuity (R(2) = 32%). Patient characteristics varied significantly among providers. Unadjusted total costs were weakly associated with provider, and this association disappeared after accounting for patient factors. The provider influence on catheterization costs persisted after adjusting for patient characteristics. Furthermore, the pattern of variation changed: the adjusted analysis identified three new outliers, and two providers lost their outlier status. Only one provider was consistently identified as an outlier in the unadjusted and adjusted analyses. CONCLUSIONS: Economic profiles of interventional cardiologists may be misleading if they do not adequately adjust for patient characteristics before procedure.

Prediction of operative mortality after valve replacement surgery.

OBJECTIVES: We sought to develop national benchmarks for valve replacement surgery by developing statistical risk models of operative mortality. BACKGROUND: National risk models for coronary artery bypass graft surgery (CABG) have gained widespread acceptance, but there are no similar models for valve replacement surgery. METHODS: The Society of Thoracic Surgeons National Cardiac Surgery Database was used to identify risk factors associated with valve surgery from 1994 through 1997. The population was drawn from 49,073 patients undergoing isolated aortic valve replacement (AVR) or mitral valve replacement (MVR) and from 43,463 patients undergoing CABG combined with AVR or MVR. Two multivariable risk models were developed: one for isolated AVR or MVR and one for CABG plus AVR or CABG plus MVR. RESULTS: Operative mortality rates for AVR, MVR, combined CABG/AVR and combined CABG/ MVR were 4.00%, 6.04%, 6.80% and 13.29%, respectively. The strongest independent risk factors were emergency/salvage procedures, recent infarction, reoperations and renal failure. The c-indexes were 0.77 and 0.74 for the isolated valve replacement and combined CABG/valve replacement models, respectively. These models retained their predictive accuracy when applied to a prospective patient population undergoing operation from 1998 to 1999. The Hosmer-Lemeshow goodness-of-fit statistic was 10.6 (p = 0.225) for the isolated valve replacement model and 12.2 (p = 0.141) for the CABG/valve replacement model. CONCLUSIONS: Statistical models have been developed to accurately predict operative mortality after valve replacement surgery. These models can be used to enhance quality by providing a national benchmark for valve replacement surgery.

Achieving optimal results with standard balloon angioplasty: can baseline and angiographic variables predict stent-like outcomes?

OBJECTIVES: To predict which patients might not require stent implantation, we identified clinical and angiographic characteristics associated with repeat revascularization after standard balloon angioplasty. BACKGROUND: Stents reduce the risk of repeat revascularization but are costly and may lead to in-stent restenosis, which remains difficult to treat. Identification of patients at low risk for repeat revascularization may allow clinicians to reserve stents for patients most likely to benefit. METHODS: Data from five interventional trials (5,146 patients) were pooled for analysis. We identified patients with optimal angiographic results (final diameter stenosis < or =30% and no dissection) after balloon angioplasty and determined the multivariable predictors of repeat revascularization. RESULTS: Optimal angiographic results were achieved in 18% of patients after angioplasty. The repeat revascularization rate at six months was lower for patients with optimal results (20% vs. 26%, p < 0.001) but still higher than observed in stent trials. Independent predictors of repeat revascularization were female gender (odds ratio [OR] 1.67, p = 0.01), lesion length > or =10 mm (OR 1.62, p = 0.03) and proximal left anterior descending coronary artery lesions (OR 1.62, p = 0.03). For the 8% of patients with optimal angiographic results and none of these risk factors, the repeat revascularization and target vessel revascularization rates were 14% and 8% respectively, similar to rates after stent implantation. Cost analysis estimated that $78 million per year might be saved in the U.S. with a provisional stenting strategy using these criteria compared with elective stenting. CONCLUSIONS: A combination of baseline characteristics and angiographic results can be used to identify a small group of patients at very low risk for repeat revascularization after balloon angioplasty. Provisional stenting for these low risk patients could substantially reduce costs without compromising clinical outcomes.

Prognostic significance of precordial ST segment depression during inferior myocardial infarction in the thrombolytic era: results in 16,521 patients.

OBJECTIVES: We examined the prognostic significance of precordial ST segment depression among patients with an acute inferior myocardial infarction. BACKGROUND: Although precordial ST segment depression has been associated with a poor prognosis, this correlation has not been adequately quantified, partly because of small sample sizes and methodologic limitations in previous studies. METHODS: We examined the clinical and angiographic outcomes of 16,521 patients with an acute inferior myocardial infarction who underwent thrombolysis in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO-I) study. Patients were classified into those without precordial ST segment depression (n = 6,422 [38.9%]), those with ST segment depression in leads V1 to V3 only (n = 5,850 [35.4%]), those with ST segment depression in leads V4 to V6 only (n = 876 [5.3%]) and those with ST segment depression in both leads V1 to V3 and leads V4 to V6 (n = 3,373 [20.4%]) on initial electrocardiography. Outcome measures included postinfarction complications (second- or third-degree heart block, congestive heart failure or shock) and 30-day and 1-year mortality. RESULTS: Patients with precordial ST segment depression had larger infarctions, more postinfarction complications and a higher mortality rate than those without precordial ST segment depression (4.7% vs. 3.2% at 30 days; 5.0% vs. 3.4% at 1 year; both p < 0.001), regardless of whether ST segment depression was noted in leads V1 to V6 or in leads V4 to V6. The magnitude of precordial ST segment depression (sum of leads V1 to V6) added significant independent prognostic information after adjustment for clinical risk factors; the risk of 30-day mortality increased by 36% for every 0.5 mV of precordial ST segment depression. CONCLUSIONS: Assessment of the magnitude of precordial ST segment depression is useful for acute risk stratification in patients with an inferior myocardial infarction.

Relation between estrogen replacement therapy and restenosis after percutaneous coronary interventions.

OBJECTIVES: We attempted to determine the relation between estrogen replacement therapy and the rate of restenosis after coronary angioplasty and atherectomy. BACKGROUND: Although estrogen replacement therapy in women has been associated with a reduction in cardiovascular events and improvement in endothelial function, no study has examined whether estrogen reduces restenosis rates after percutaneous coronary interventions. METHODS: A total of 204 women enrolled in the Coronary Angioplasty Versus Excisional Atherectomy Trial with angiographic follow-up were contacted, and their menopausal and estrogen replacement status was determined. Late loss in minimal lumen diameter, late loss index, minimal lumen diameter, rate of restenosis > 50% and actual percent of stenosis were compared in estrogen users and nonusers by quantitative coronary angiography at 6-month follow-up. RESULTS: Late loss in minimal lumen diameter was significantly less in women using estrogen than in nonusers (-0.13 vs. -0.46 mm, p = 0.01). A regression analysis of the determinants of late loss in minimal lumen diameter revealed that estrogen use was the single most important predictor of subsequent late loss (F = 13.38, p = 0.0006). Formal testing revealed a highly significant interaction between the use of estrogen and intervention (angioplasty or atherectomy). Women undergoing atherectomy who received estrogen had a significantly lower late loss index (0.06 vs. -0.63, p = 0.002), less late loss (0.06 vs. -0.61 mm, p = 0.0006), larger minimal lumen diameter (p = 0.044) and lower restenosis rates (p = 0.038 for > 50% stenosis) than those not using estrogen. In contrast, estrogen had minimal effects on restenosis end points after angioplasty. CONCLUSIONS: This study demonstrates the potential for estrogen replacement therapy to reduce angiographic measures of restenosis in postmenopausal women after coronary intervention, particularly in those undergoing atherectomy.

Initiation of hormone replacement therapy after acute myocardial infarction is associated with more cardiac events during follow-up.

OBJECTIVES: This study explored the association between the initiation of hormone replacement therapy (HRT) and early cardiac events (<1 year) in women with a recent myocardial infarction (MI). BACKGROUND: Observational studies have linked postmenopausal hormone use with a reduced risk of death from heart disease. However, a recent randomized trial of HRT found no long-term benefit, primarily due to an increase in cardiac events in the first year. METHODS: The Coumadin Aspirin Reinfarction Study (CARS) database contains information on HRT use and menopausal status for women with a recent MI. We classified the 1,857 postmenopausal women in CARS as prior/current HRT users if they took HRT before enrollment, new users if they began HRT during the study period or never users. We assessed the incidence of cardiac events (death, MI, unstable angina [UA]) during follow-up. RESULTS: In our cohort, 28% (n = 524) used HRT at some point. Of these, 21% (n = 111) began HRT after their MI. New users had a higher incidence of death/MI/UA (41% vs. 28%, p = 0.001) during follow-up than never users, largely due to a higher incidence of UA (39% vs. 20%, p = 0.001). After adjustment, new users still had a significantly higher risk of death/MI/UA than never users during follow-up (relative risk [RR] = 1.44 [1.05-1.99]). Prior/current users had no excess risk of the composite end point after adjustment. Users of estrogen/progestin had a lower incidence of death/MI/UA during follow-up than users of estrogen only (RR = 0.56 [0.37-0.85]). CONCLUSIONS: Postmenopausal women who initiated HRT after a recent MI had an increased risk of cardiac events largely due to excess UA during follow-up.

Acute febrile cerebrovasculitis. A non-spotted fever group rickettsial disease.

In December 1985, a patient was seen with an illness that was clinically compatible with the recently described clinical syndrome of acute febrile cerebrovasculitis, including fever, headache, altered mentation, multifocal neurologic signs, and cerebrospinal fluid pleocytosis. An extensive medical evaluation failed to reveal a cause, until, retrospectively, she was shown to have antibodies to Rickettsia typhi. Detailed serologic analysis with enzyme immunoassays and protein immunoblots indicated that she was infected with a non-spotted fever group Rickettsia, most likely either R typhi or Rickettsia canada. Serum samples from a mouse trapped at her home contained antibody only to R canada. Evaluation of patients with acute febrile cerebrovasculitis in the future should include rickettsial blood cultures to attempt specific identification of the species involved.