Field intercomparison studies for evaluation and validation of the AESminiSamplR technique for sampling and analysis of total particulate mercury in the atmosphere.

This paper presents new data and reviews literature results from six field intercomparison studies to further evaluate and validate the AESminiSamplR [Anal. Chem., 70 (1998) 2403] technique for sampling and analysis of total particulate mercury in ambient air. The intercomparison studies were carried out at: two remote sites in the Arctic [Alert, Nunavut, Canada (82 degrees 28'N, 62 degrees 18'W) and Ny-Alesund, Svalbard (78 degrees 54'N, 11 degrees 53'E)], one site in Ann Arbor, MI, and three sites in Europe (one in Italy and two in Sweden). The AESminiSamplR was compared with five other methods using different materials, different flow rates, different sample treatment procedures, and/or different detection techniques. Four of the five methods compared were operated by different laboratories. When the compared methods were operated by different laboratories, a difference

Epidemiology of psychiatric disability in childhood and adolescence.

The goal of the study was to ascertain the factor structure and prevalence of psychiatric disability in children and adolescents in relation to demographic variables and diagnosis. A representative sample of 1,420 children (9-13 years) from 11 countries in North Carolina was followed for up to 6 years. Children and caretakers were interviewed with the Child and Adolescent Psychiatric Assessment, which generates DSM-IV diagnoses and includes a measure of disability secondary to psychological symptoms. Three broad areas of disability were identified (relating to family, school, and peers). School disabilities were more common in boys than girls. while the reverse was true of family disability. Effects of age were complex, and partially gender-differentiated. Children from minority ethnic groups had a higher overall prevalence of school disabilities, and were more prone than Whites to the disabling effects of disruptive behavior disorders. Anxiety disorders were as likely to result in disability as depressive disorders, and oppositional defiant disorders were more strongly associated with disability in some areas than was conduct disorder. The areas where disability is manifested are different depending on race, gender, age, and the type of disorder suffered. The implications of these findings for nosology and prevention are discussed.

Poverty, race/ethnicity, and psychiatric disorder: a study of rural children.

OBJECTIVES: This study examined the effect of poverty on the prevalence of psychiatric disorder in rural Black and White children. METHODS: A representative sample of 541 Black children and 379 White children aged 9 to 17 was drawn from 4 predominantly rural counties. Structured interviews with parents and children collected information on psychiatric disorders, absolute and relative poverty, and risk factors for psychiatric disorder. RESULTS: Three-month prevalence of psychiatric disorder was similar to that found in other community samples (20%). Federal criteria for poverty were met by 18% of the White and 52% of the Black families. Black and White children were exposed to equal numbers of risk factors overall, but the association between poverty and psychopathology was stronger for White children (odds ratio [OR] = 2.1; 95% confidence interval [CI] = 1.1, 4.2) than for Black children (OR = 1.5; 95% CI = 0.9, 2.6). Family history of mental illness, poor parenting, and residential instability mediated this association in both groups. CONCLUSIONS: In this rural sample, poverty was only weakly associated with child psychiatric disorders. Risk factors for both racial/ethnic groups were family mental illness, multiple moves, lack of parental warmth, lax supervision, and harsh punishment.

Impact of atmospheric deposition on the headworks of a wastewater treatment plant--a case study.

Specialized sampling equipment and ultra-clean analytical methodology were employed to quantify the concentrations or fluxes of mercury (Hg), cadmium (Cd) and polychlorinated biphenyl (PCBs) in ambient air, precipitation, runoff, sanitary sewer, and wastewater treatment plant (WWTP) influent. The relationship between the atmospheric deposition and runoff on controlled surfaces were explored for the three pollutants. The impact of the atmospheric deposition and runoff to the headwork loading of the WWTP were investigated. Atmospheric deposition was found to be the primary source of the mass of Cd, Hg, and PCBs in runoff from the controlled surfaces. Neither atmospheric deposition nor the runoff was the main sources of the three pollutants to the Detroit Wastewater Treatment Plant (WWTP). Wet weather flow contributes the main portion of the Cd, Hg, and PCBs loading to the WWTP.

Adults' response to Massachusetts anti-tobacco television advertisements: impact of viewer and advertisement characteristics.

OBJECTIVE: To assess adults' receptivity to the Massachusetts television anti-tobacco campaign. Reactions were examined as a function of respondents' demographics, baseline tobacco control attitudes, changes in smoking status during the campaign, and advertisements' affective qualities. DESIGN: A random digit dial telephone survey in 1993 at the start of the media campaign and re-interview in 1996 of respondents to the baseline survey. PARTICIPANTS: Respondents were 1544 adults who completed the baseline and follow up interview. INTERVENTION: By the time the follow up survey was completed, approximately $49 million had been spent on the media campaign. Approximately 66 spots had been aired. MAIN OUTCOME MEASURES: Reported exposure to television advertisements; perceived effectiveness of nine specific advertisements each. RESULTS: 56% of respondents reported seeing anti-tobacco advertisements at least once a week during the preceding three years. The average effectiveness rating for all advertisements recalled on a 0-10 scale was 7.29, and did not differ by smoking status group. Advertisements eliciting strong negative emotions (sadness and fear) were rated most effective by quitters, non-smokers, and by smokers who at baseline were planning to quit soon. Humorous, entertaining advertisements were seen as ineffective by all groups. CONCLUSION: The Massachusetts anti-tobacco campaign achieved high levels of penetration into the population and was well received by both smokers and non-smokers. The results suggest that advertisements depicting suffering as a result of tobacco use may be instrumental in promoting cessation or reinforcing the decision to quit. Further research is needed to lend additional support to the link between perceived effectiveness and smoking behaviour change.

Domestic biomass fuel combustion and chronic bronchitis in two rural Bolivian villages.

BACKGROUND: Chronic bronchitis is an important public health problem worldwide. A study was undertaken to examine the association between exposure to air pollution from domestic biomass fuel combustion and chronic bronchitis in two rural Bolivian highland villages: a village in which cooking is done exclusively indoors and a village in which cooking is done primarily outdoors. Apart from this difference, the villages were virtually identical in terms of socioeconomic status, climate, altitude, access to health care, and other potential confounders. METHODS: Pollution exposure was assessed by combining information on concentrations of particulate matter of <10 microm diameter (PM(10)) in 12 randomly selected households in each village in all potential microenvironments of exposure with time allocation information. The prevalence of chronic bronchitis was assessed using the British Medical Research Council's questionnaire on individuals >20 years of age in both villages (n = 241). RESULTS: Daily pollution exposure was significantly higher in the indoor cooking village (range for adults: 9840-15 120 microg-h/m(3)) than in the outdoor cooking village (range for adults: 5520-6240 microg-h/m(3)) for both seasons and for men and women. The overall prevalence of chronic bronchitis was 22% and 13% for the indoor and outdoor cooking villages, respectively. Logistic regression analysis, which excluded the few smokers present in the population, showed a 60% reduced risk of chronic bronchitis in the outdoor cooking village compared with the indoor cooking village (OR 0.4; 95% CI 0.2 to 0.8; p = 0.0102) after adjusting for age and sex. Individuals aged >40 years were 4.3 times more likely to have chronic bronchitis than the younger age group (OR = 4.3; 95% CI 2.0 to 9.3; p = 0.0002). There was no significant difference in the prevalence of chronic bronchitis in men and women. CONCLUSIONS: The results of this study suggest an association between chronic bronchitis and exposure to domestic biomass fuel combustion, but further large scale studies from other areas of the developing world are needed to confirm the association. Results from this and other studies will assist the development of culturally acceptable and feasible alternatives to the high exposure cooking stoves currently being used by most people worldwide.

Childhood asthma.

Asthma prevalence in children has increased 58% since 1980. Mortality has increased by 78%. The burden of the disease is most acute in urban areas and racial/ethnic minority populations. Hospitalization and morbidity rates for nonwhites are more than twice those for whites. Asthma is characterized by recurrent wheezing, breathlessness, chest tightness, and coughing. Research in the past decade has revealed the importance of inflammation of the airways in asthma and clinical treatment to reduce chronic inflammation. Asthma is associated with production of IgE to common environmental allergens including house dust mite, animal dander, cockroach, fungal spores, and pollens. Some interventions to reduce symptoms through control of dust mite and animal dander have had positive results. Control of symptoms through interventions to reduce exposures to cockroach antigen has not been reported. Studies illustrating causal effects between outdoor air pollution and asthma prevalence are scant. Increases in asthma prevalence have occurred at the same time as general improvements in air quality. However, air quality appears to exacerbate symptoms in the child who already has the disease. Decreased pulmonary function has been associated with exposure to particulates and bronchial hyperresponsiveness to smoke, SO(2) and NO(2). Symptoms have been correlated with increased levels of respirable particulates, ozone, and SO(2). Interventions that reduce the negative outcomes in asthma associated with outdoor environmental factors have not been reported. Control of asthma in children will entail the collaborative efforts of patients, family, clinical professionals, and school personnel, as well as community-wide environmental control measures and conducive national and local policies based on sound research.

Adolescent outcomes of childhood disorders: the consequences of severity and impairment.

OBJECTIVE: To examine the adolescent consequences of clinical and threshold-level psychiatric disorders, with and without significant functional impairment; to predict serious emotional disturbance (SED: clinical-level diagnosis with impairment); and to examine sex differences in the consequences of emotional and behavioral disorders. METHOD: 300 children aged 7 through 11 years were recruited from urban and suburban offices of a large health maintenance organization (HMO). Child and parent were interviewed at home using the Diagnostic Interview Schedule for Children (DISC), version 1.3. Five to 7 years later, 278 (93%) of the sample were reinterviewed using the DISC-2.1. RESULTS: There was considerable continuity of psychopathology, particularly in children with functional impairment. Behavioral disorders at every level of severity predicted adolescent SED in both sexes. For emotional disorders, girls but not boys with childhood SED had significantly higher levels of adolescent SED. CONCLUSIONS: Childhood disorders falling below the level of severity required to meet criteria for treatment set by many HMOs or insurance companies nevertheless can carry a significantly increased risk for severe pathology years later. Functional impairment played an important role in the adolescent consequences of childhood psychiatric disorder.

Application of recent advances in aerosol sampling science towards the development of improved sampling devices: the way ahead.

This paper reviews the framework that underpins the development of a new generation of personal samplers capable of operating at much lower flowrates that those of the current generation and so capable of being used for exposure assessment not only for 'traditional' occupational populations (i.e., industrial workers) but also for people exposed to aerosols in the ambient atmosphere (including children). The opportunity for this new generation of samplers stems from the availability of very light and compact low-flowrate pumps. The development and deployment of such instruments presents: (a) physical challenges in terms of how to collect particle size fractions in a manner which is consistent with the new particle size-selective sampling criteria, and (b) analytical challenges in terms of how to quantitate the much smaller amounts of collected material that need to be analysed. The paper lays out the physical and analytical scenarios, and points the way forward to how such challenges can be overcome. Work is already in progress in several countries to develop prototype instruments for applications like those described.

Impact of diabetes mellitus on percutaneous revascularization (CAVEAT-I). CAVEAT-I Investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

We examined the relation between diabetes mellitus and outcomes in patients undergoing percutaneous coronary revascularization in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), a randomized trial comparing treatment with either percutaneous transluminal coronary angioplasty or directional atherectomy for de novo lesions in native coronary arteries. Acute success and complication rates, 6-month angiographic restenosis rates, and 1-year clinical outcomes were compared between diabetic and nondiabetic patients undergoing each procedure. Acute success rates between diabetic (n = 191) and nondiabetic (n = 821) patients were similar for both revascularization techniques. Except for the need for dialysis, complication rates were also similar. Six months after atherectomy, diabetic patients had significantly more angiographic restenosis than nondiabetics (59.7% vs 47.4%) and significantly smaller minimum luminal diameters (1.20 vs 1.40 mm). Diabetics undergoing atherectomy required more frequent bypass surgery (12.8% vs 8.5%) and more repeat percutaneous revascularizations (36.5% vs 28.1%) than nondiabetics undergoing atherectomy. Restenosis rates, minimum luminal diameters and repeat revascularizations between diabetics and nondiabetics undergoing angioplasty were similar. The higher restenosis and repeat revascularization rates and the smaller minimum luminal diameter at follow-up in diabetic patients suggest that atherectomy may provide only modest benefit for these patients. The increased restenosis rate in diabetics undergoing atherectomy (but not angioplasty) requires further evaluation.

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.

Abrupt closure: the CAVEAT I experience. Coronary Angioplasty Versus Excisional Atherectomy Trial.

OBJECTIVES: This study sought to assess the incidence and consequences of abrupt closure in a series of patients undergoing directional coronary atherectomy versus percutaneous coronary angioplasty. BACKGROUND: Abrupt closure with coronary angioplasty has been associated with adverse outcome. The results from the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) I, a randomized trial of coronary angioplasty versus directional coronary atherectomy, were analyzed. METHOD: This multicenter trial enrolled 1,012 patients from 1991 to 1992. All records from patients with abrupt closure, which was coded as a discrete complication, were reviewed. RESULTS: Abrupt closure occurred in 60 patients (5.9%) and was associated with a significantly longer hospital stay (median 8 vs. 3 days). Severe proximal target vessel tortuosity was more common in patients with abrupt closure (20.3% vs. 11.6%, p = 0.046), as was preexistent coronary artery thrombus (30.5% vs. 18.3%, p = 0.02). Abrupt closure was associated with a marked increase in subsequent complications (myocardial infarction 46.7% vs. 2.1%, emergency bypass surgery 38.3% vs. 0.32%, death 33% vs. 0%) and occurred more frequently in the directional coronary atherectomy group (8.0% vs. 3.8%, p = 0.005). In the coronary angioplasty group, the occlusion usually occurred at the target lesion (91%), presumably related to the effects of barotrauma. In the directional coronary atherectomy group, the site of the occlusion was the target lesion in only 58% (p = 0.045). The remaining occlusions related to problems with the technique (guide catheter or nose cone trauma), reflecting the fact that directional coronary atherectomy is a more complex procedure. CONCLUSIONS: Abrupt closure remains the principal determinant of adverse outcome after percutaneous procedures for the treatment of coronary artery disease. Although abrupt closure is more common with directional atherectomy than angioplasty, the sequelae are similar.

Balloon aortic valvuloplasty in adults: failure of procedure to improve long-term survival.

OBJECTIVES: This study sought to determine the long-term outcome of adult patients undergoing percutaneous balloon aortic valvuloplasty. BACKGROUND: Percutaneous balloon aortic valvuloplasty has been offered as an alternative to aortic valve replacement for selected patients with valvular aortic stenosis. Although balloon aortic valvuloplasty produces an immediate reduction in the transvalvular aortic gradient, a high incidence of restenosis frequently leads to recurrent symptoms. Therefore, it is unclear whether balloon aortic valvuloplasty impacts on the long-term outcome of these patients. METHODS: Clinical, hemodynamic and echocardiographic data were collected at baseline in 165 patients undergoing balloon aortic valvuloplasty and examined for their ability to predict long-term outcome. RESULTS: The median duration follow-up was 3.9 years (range 1 to 6). Ninety-nine percent follow-up was achieved. During this 6-year period, 152 patients (93%) died or underwent aortic valve replacement, and 99 (60%) died of cardiac-related causes. The probability of event-free survival (freedom from death, aortic valve replacement or repeat balloon aortic valvuloplasty) 1, 2 and 3 years after valvuloplasty was 40%, 19% and 6%, respectively. In contrast, the probability of survival 3 years after balloon aortic valvuloplasty in a subset of 42 patients who underwent subsequent aortic valve replacement was 84%. Survival after aortic valvuloplasty was poor regardless of the presenting symptom, but patients with New York Heart Association functional class IV congestive heart failure had events earliest. Univariable predictors of decreased event-free survival were younger age, advanced congestive heart failure symptoms, lower ejection fraction, elevated left ventricular end-diastolic pressure, presence of coronary artery disease and increased left ventricular internal diastolic diameter. Stepwise multivariable logistic regression analysis found that only younger age and a lower left ventricular ejection fraction contributed independent adverse prognostic information (chi-square 14.89, p = 0.0006). CONCLUSIONS: Long-term event-free and actuarial survival after balloon aortic valvuloplasty is dismal and resembles the natural history of untreated aortic stenosis. Aortic valve replacement may be performed in selected subjects with good results. However, the prognosis for the remainder of patients who are not candidates for aortic valve replacement is particularly poor.

Assessment of outcome of bifurcation lesions and non-bifurcation lesions treated in the CAVEAT trial. CAVEAT investigator group.

Registry data suggests that bifurcation lesions are associated with reduced success during percutaneous revascularization. We studied 1012 CAVEAT patients to compare procedural outcomes in patients with and without bifurcation lesions whose target vessel was treated with either atherectomy or angioplasty. Bifurcation lesions have increased angiographic complexity and interventions on them are associated with lower acute procedural success rates compared to non-bifurcation lesions. Subgroup analysis suggests that atherectomy treatment of bifurcation lesions improves acute procedural success rates and lowers restenosis rates compared to angioplasty treatment of bifurcation lesions but atherectomy of bifurcation lesions is associated with higher acute complication rates than angioplasty of bifurcation lesions.

Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I).

OBJECTIVES: In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. BACKGROUND: The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy. METHODS: At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma > 4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. RESULTS: Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. CONCLUSIONS: Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.

Predictors and sequelae of distal embolization during saphenous vein graft intervention from the CAVEAT-II trial. Coronary Angioplasty Versus Excisional Atherectomy Trial.

BACKGROUND: The purpose of this study was to identify the predictors and sequelae of distal embolization from a multicenter, randomized trial of saphenous vein graft intervention. The CAVEAT-II trial demonstrated that saphenous vein graft directional coronary atherectomy (DCA) was associated with greater angiographic success and less need for repeat intervention compared with percutaneous transluminal coronary angioplasty (PTCA) but at the cost of more acute complications--notably distal embolization. METHODS AND RESULTS: In CAVEAT-II, 305 patients were randomly assigned to DCA (149 patients) or PTCA (156 patients) for lesions with > 60% diameter stenosis in vein grafts > or = 3 mm in diameter. Distal embolization occurred in 20 patients (13.4%) assigned to DCA and 8 patients (5.1%) assigned to PTCA (P = .011). Independent predictors of distal embolization were use of DCA (71% in distal embolization patients versus 47% in patients without distal embolization, P = .011) and presence of thrombus (39% in distal embolization patients versus 14% in patients without distal embolization, P < .00). In-hospital adverse events were more frequent after distal embolization; 71% versus 20%, odds ratio plus (95% confidence intervals) 9.87 (4.65, 20.94). At 12-month follow-up, adverse event rates were also higher in patients with distal embolization (odds ratio, 3.05 [1.95, 4.76]). CONCLUSIONS: In this first prospective multicenter trial of saphenous vein graft intervention, distal embolization was more common after DCA than PTCA and in lesions containing thrombus. It also was associated with worse in-hospital and 12-month outcomes. The risk and sequelae of distal embolization should be considered when choosing a treatment strategy for vein graft disease.

Characteristics and consequences of myocardial infarction after percutaneous coronary intervention: insights from the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT).

OBJECTIVES: We examined the results of the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) to determine the characteristics and consequences of creatine kinase (CK) and creatine kinase, MB myocardial isoenzyme fraction (CK-MB) elevations after percutaneous coronary intervention. BACKGROUND: Enzyme elevations after interventional procedures have usually been thought to be without long-term clinical consequences. However, recent preliminary reports have suggested that there are important long-term clinical sequelae in patients with even mild enzyme elevations after coronary procedures. METHODS: Patients with new native lesions undergoing coronary intervention at 35 clinical sites were randomized to undergo percutaneous coronary angioplasty (n = 500) or directional coronary atherectomy (n = 512). Cardiac enzyme levels were measured 12 and 24 h after the interventional procedure and when clinically indicated for recurrent myocardial ischemia. Enzyme profiles were analyzed using a ratio that compared the peak enzyme level and the local laboratory upper limit of normal. Standard 12-lead electrocardiograms (ECGs) recorded before and after the procedure were interpreted by two independent readers who had no knowledge of the randomization data. Postprocedural myocardial infarction was defined as the appearance of new Q waves on the ECG, CK-MB levels three or more times the upper limit of normal or a total CK concentration two or more times the upper limit of normal when CK-MB levels were unavailable. Regression models were used to evaluate the predictive significance of a postintervention myocardial infarction with respect to clinical outcomes at 30 days and 1 year. RESULTS: There were 78 myocardial infarctions in the atherectomy group and 34 in the angioplasty group (15.2% vs. 6.8%, p = 0.001). Patients with a myocardial infarction more often had a repeat intervention or emergency coronary artery bypass surgery. Hospital length of stay was increased among patients with an infarction, as were mean hospital costs ($17,340.65 vs. $11,308.47, p = 0.0003). Postprocedural myocardial infarction was highly predictive of mortality, bypass surgery or repeat intervention within 30 days (p < 0.0001). CONCLUSIONS: Myocardial infarction occurred commonly after coronary intervention in CAVEAT and was associated with a worse clinical outcome. Although the incidence of myocardial infarction was higher with atherectomy than with angioplasty, the baseline characteristics and consequences of the infarctions were similar between the treatments with regard to 30-day outcome. Myocardial enzyme elevations after an otherwise successful interventional procedure may identify a population at risk for a future cardiac event.

Directional atherectomy versus balloon angioplasty for coronary ostial and nonostial left anterior descending coronary artery lesions: results from a randomized multicenter trial. The CAVEAT-I investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

OBJECTIVES: We hypothesized that atherectomy would be superior to balloon angioplasty for ostial and nonostial left anterior descending coronary artery lesions. BACKGROUND: Balloon angioplasty of ostial coronary artery lesions has been associated with a lower procedural success rate and a higher rate of complications and of restenosis than angioplasty of nonostial stenoses. Directional coronary atherectomy has been proposed as an alternative therapy for ostial lesions. METHODS: In the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), 1,012 patients were randomized to undergo either procedure; 563 patients had proximal left anterior descending coronary artery lesions, of which 74 were ostial. We compared balloon angioplasty with directional atherectomy for early and 6-month results for ostial as well as nonostial proximal left anterior descending coronary artery lesions. RESULTS: Directional atherectomy led to an initially higher gain in minimal lumen diameter for ostial lesions (1.13 vs. 0.56 mm, respectively, p < 0.001) but a higher rate of adjudicated non-Q wave myocardial infarction (24% vs. 13%, respectively, p < 0.001) than balloon angioplasty and no improvement in restenosis rates (48% vs. 46%, respectively). In the nonostial proximal left anterior descending coronary artery lesions, angiographic restenosis was reduced (51% vs. 66%, p = 0.012), but this was also associated with a higher rate of periprocedural myocardial infarction (8% vs. 2%, p = 0.008 by site and 24% vs. 8%, p < 0.001 by adjudication) and no difference in the need for subsequent coronary artery bypass surgery (7.3% vs. 8.4%, respectively) or repeat percutaneous coronary intervention (24% vs. 26%, respectively). CONCLUSIONS: For ostial left anterior descending coronary artery stenoses, both procedures yielded similar rates of initial success and restenosis, but atherectomy was associated with more non-Q wave myocardial infarction. In this trial the predominant angiographic benefit (increased early gain and less angiographic restenosis) of atherectomy for the left anterior descending coronary artery was in proximal nonostial lesions. However, the tradeoffs for this angiographic advantage were more in-hospital myocardial infarctions and no decrease in clinical restenosis.

One-year follow-up in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT I)

BACKGROUND: Directional atherectomy is a frequently used percutaneous revascularization strategy, but its long-term outcomes have not previously been compared with those of balloon angioplasty in a prospective trial. METHODS AND RESULTS: The 1012 patients enrolled in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT I) were followed for at least 1 year after randomization. Analyses of predetermined end points were performed, including a detailed analysis of the 14 patients who died. At 1 year, 11 patients had died in the atherectomy group compared with 3 in the angioplasty group (2.2% versus 0.6%, P = .035), with an excess of out-of-hospital deaths (2.2% versus 0.2%, P = .01) and late cardiac deaths (1.6% versus 0%, P = .01). Univariate predictors of death included age, abrupt closure, periprocedural enzyme elevation, and peripheral vascular complications. There was no evidence that the excess of deaths after atherectomy was linked to perforation, ectasia, or deep resection. Cumulative rates of myocardial infarction were higher in those who had been randomized to atherectomy than in those randomized to angioplasty (8.9% versus 4.4%, P = .005) with a trend toward excess Q-wave and non-Q-wave infarctions. By multivariate analysis, atherectomy was the only variable predictive of the combined end point of death or myocardial infarction. No clinical or angiographic characteristics added to this index. Rates of repeat percutaneous intervention at the target site (24.4% after atherectomy versus 25.9% after angioplasty), coronary artery bypass surgery (9.3% versus 9.1%), hospitalization (50% versus 47.1%), and stroke (1% in both groups) were not significantly different. CONCLUSIONS: Long-term follow-up of the 1012 patients randomized to atherectomy or angioplasty has revealed a statistically significant excess of deaths after directional atherectomy that was not evident at 6 months. This difference could be due to the chance occurrence of a low mortality rate in those randomized to angioplasty. The excess of myocardial infarctions after atherectomy remains statistically significant at 1 year. Further investigation is warranted to improve the safety of atherectomy.