Long-term outcome of human leukocyte antigen mismatching in liver transplantation: results of the National Institute of Diabetes and Digestive and Kidney Diseases Liver Transplantation Database.

UNLABELLED: A perfect or nearly perfect human leukocyte antigen (HLA) match has been associated with better immediate and long-term survival of diseased donor kidney transplants. However, the effect of HLA matching for hepatic allografts remains poorly defined. Using data from the National Institutes of Diabetes and Digestive and Kidney Diseases Liver Transplantation Database, we investigated the association between HLA mismatches and hepatic allograft survival, disease recurrence, and immunosuppression interactions. A, B, and DR loci were used to calculate total mismatch scores of 0 (no mismatches in any loci) to 6 (mismatches in all loci). Seven hundred ninety-nine adults (male, 55%; female, 45%) underwent 883 liver transplants. The 10-year graft survival according to total mismatch score was as follows: 0-2, 60%; 3-4, 54%; and 5-6, 57%. There was a negative effect of mismatching at the A locus on patient survival, with shorter survival for patients with 1 or 2 mismatches compared with 0 mismatches [P = 0.05, hazard ratio (HR) = 1.6]. Patients on tacrolimus with 1 or 2 mismatches at B or DR loci appeared to have increased rates of patient and graft survival compared to patients with 0 mismatches, with the appearance of a protective effect of tacrolimus (HR = 0.67). The effect of HLA mismatching was more pronounced on certain disease recurrences. DR-locus mismatch increased recurrence of autoimmune hepatitis (P = 0.01, HR = 4.2) and primary biliary cirrhosis (P = 0.04, HR = 2). Mismatch in the A locus was associated with more recurrence of hepatitis C virus (P = 0.01, HR = 1.6) and primary sclerosing cholangitis (P = 0.03, HR = 2.9). CONCLUSION: Mismatching at the A locus decreases patient survival in liver transplant recipients, and mismatching at the DR and A loci affects recurrence of autoimmune liver diseases and hepatitis C, respectively.

Effects of heart failure and diabetes mellitus on long-term mortality after coronary revascularization (from the BARI Trial).

This study evaluated the effect of heart failure (HF) and ejection fraction (EF) at baseline on long-term cardiac mortality in patients undergoing coronary revascularization and investigated the effect of diabetes mellitus (DM) on mortality. We evaluated long-term outcomes of patients without HF, HF and a preserved EF, and HF and a decreased EF who underwent revascularization with percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery after enrollment in the Bypass Angioplasty Revascularization Investigation (BARI) trial. Ten years after initial revascularization, cumulative rates of freedom from cardiac death were 90% in patients without HF, 75% in patients with HF and a preserved EF, and 59% in patients with HF and a decreased EF (p <0.001, 3-way comparison). In diabetic patients with HF and a preserved EF, there was a significant increase in cardiac mortality compared with patients without HF (p <0.001); however, this relation was not seen in patients without DM. In conclusion, patients with HF and a preserved EF have increased mortality over 10 years compared with those without HF. Only in patients with DM did HF with preserved EF confer additional risk.

The effect of coronary artery bypass grafting on specific causes of long-term mortality in the Bypass Angioplasty Revascularization Investigation.

OBJECTIVES: We sought to examine the effect of revascularization with coronary artery bypass grafting on specific causes of death in the Bypass Angioplasty Revascularization Investigation cohort. Although the effect of coronary revascularization on long-term mortality has been previously described, there are limited data describing its effect on specific causes of death in patients with coronary artery disease. Evaluation of cause of death might help elucidate disease mechanisms and be useful for developing treatment strategies. METHODS: In the Bypass Angioplasty Revascularization Investigation randomized trial and registry, 3610 patients underwent initial revascularization with coronary artery bypass grafting or balloon angioplasty and were followed for an average of 7.7 years. Causes of all deaths were classified by an independent committee. RESULTS: Among 3610 revascularized patients, 2239 underwent coronary artery bypass grafting as an initial or subsequent procedure. Over 7.7 years of follow-up, 3% of all patients died of sudden cardiac death, 3% died of myocardial infarction-related death, 2% died of congestive heart failure and other cardiac causes, and 9% died of noncardiac causes. Coronary artery bypass grafting (vs no coronary artery bypass grafting) was associated with a significantly lower risk of sudden cardiac death (relative risk, 0.60; P = .01) but was not significantly associated with any other causes of long-term mortality. CONCLUSIONS: In the Bypass Angioplasty Revascularization Investigation coronary artery bypass grafting significantly decreased the risk of sudden cardiac death but not any other cause of long-term mortality. Because major risk factors for sudden cardiac death have historically favored a revascularization strategy of coronary artery bypass grafting over angioplasty, evaluation of the current practice of extending angioplasty as an alternative to coronary artery bypass grafting in similar high-risk subgroups is paramount.

Marked improvements in outcomes of contemporary percutaneous coronary intervention in patients with diabetes mellitus.

We sought to determine if advances in percutaneous coronary intervention (PCI) are associated with better outcomes among patients with diabetes mellitus (DM). Patients with DM enrolled in the National Heart, Lung, and Blood Institute (NHLBI) early PTCA Registry (1985-1986) were compared to those in the subsequent contemporary Dynamic Registry (1999-2002) for in-hospital and one-year cardiovascular outcomes. The study population included 945 adults with DM, 325 from the PTCA Registry and 620 from the Dynamic Registry. Multivariable Cox regression models were built to estimate the risk of clinical events. Dynamic Registry patients were older, had more noncardiac comorbidities, and a lower mean ejection fraction (50.5% vs 57.8%, P < or = 0.001) compared to the PTCA Registry patients. The incidence of in-hospital mortality (1.9% vs 4.3%, P < or = 0.05), myocardial infarction (MI) (1.0% vs 7.4%, P

Hypotheses, design, and methods for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial.

The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) is a National Institutes of Health (NIH)-sponsored randomized clinical trial that evaluates treatment efficacy for patients with type 2 diabetes mellitus and angiographically documented stable coronary artery disease. Using a 2 x 2 factorial design, BARI 2D compares revascularization combined with aggressive medical treatment versus aggressive medical treatment alone; simultaneously, BARI 2D compares 2 glycemic control strategies, insulin sensitization versus insulin provision. All patients have goals of glycosylated hemoglobin values <7.0% and uniform control of hypertension, dyslipidemia, and obesity following recommended medical guidelines. The primary end point of BARI 2D is all-cause 5-year mortality analyzed by intention to treat, and the principal secondary end point is the combination of death, myocardial infarction, and stroke. A total of 2,368 patients have been enrolled at 49 clinical centers throughout North America, South America, and Europe. The study enrollment period was January 2001 through March 2005, and the patient treatment and follow-up phase is expected to extend at least through May 2007. Participants are treated at the local BARI 2D clinical sites on a monthly basis for the first 6 months and then every 3 months until the end of the study. Within BARI 2D, central management centers oversee the control of glycemia, plasma lipid levels, hypertension, and obesity. The randomized clinical trial collects data on patient symptoms, clinical measurements, medications, and clinical events as well as data from centralized evaluations of angiograms, electrocardiograms, nuclear stress tests, blood and urine specimens, and relative economic costs.

The impact of ejection fraction on outcomes after percutaneous coronary intervention in patients with congestive heart failure: an analysis of the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry and Dynamic Registry.

BACKGROUND: Patients with congestive heart failure (CHF) have higher rates of adverse outcomes after percutaneous coronary intervention (PCI). A comprehensive analysis of outcomes in patients with CHF in the current era has not been done. We studied the outcomes of patients with CHF who underwent PCI in the National Heart, Lung, and Blood Institute-sponsored Percutaneous Transluminal Coronary Angioplasty (PTCA) and Dynamic registries. METHODS: We evaluated demographic and angiographic characteristics and the clinical outcomes of patients with CHF in the Dynamic Registry and the PTCA Registry, excluding patients with acute myocardial infarction. In the Dynamic Registry, patients with CHF (n = 503) were compared with patients without CHF (n = 4194), and patients with CHF with a preserved ejection fraction (EF) (n = 134) were compared with patients with CHF who have a reduced EF (n = 199). The patients with CHF in the 1997 through 2001 Dynamic Registry (n = 236) were then similarly compared with patients with CHF in the earlier PTCA Registry (n = 117). RESULTS: In the Dynamic Registry, compared with patients without CHF, patients with CHF had a higher-risk clinical and angiographic profile, and a higher mortality rate both inhospital (2.6% vs 0.4%, P < or = .001) and at 1 year (13.1% vs 3.0%, P < .001). Patients with reduced EF had higher inhospital mortality rates and a trend toward higher mortality at 1 year. The patients with CHF in the Dynamic Registry compared with those in the PTCA Registry had a higher risk profile yet had significantly higher procedural success rates and improved clinical outcomes. CONCLUSIONS: Although CHF remains a strong predictor of adverse outcomes after PCI, significant improvement seen in the past decade is likely related to improved procedural techniques and improved medical therapy.

Temporal variation in inhospital mortality with percutaneous coronary intervention: a report from the National Heart, Lung and Blood Institute Dynamic Registry.

BACKGROUND: Cardiovascular morbidity and mortality display a distinct time dependence also known as circadian variation. Whether such time dependence extends to the risk of procedural-related mortality after percutaneous coronary intervention (PCI) is presently unknown. METHODS: Inhospital mortality was analyzed in 6,347 patients with PCI start times from 8:00 am to 6:59 pm ("usual" workday). The sample was divided into 3 evenly populated groups (morning start 8:00-10:59 AM, midday start 11:00 AM-1:59 PM, afternoon start 2:00-6:59 PM). The association between procedural start time and mortality was assessed using multivariable analysis including a propensity score accounting for factors associated with procedural start time. RESULTS: There was a significant, nonlinear relationship between procedural-related mortality and start time (P = .03). Afternoon start patients were at higher adjusted risk of mortality compared with midday start patients (OR 2.03, 95% CI 1.07-3.83, P = .03 ). Morning start patients were also at higher risk compared with midday start patients although the association was not statistically significant (OR 1.73, 95% CI 0.89-3.39, P = .11). CONCLUSIONS: There is a significant time-dependent variation in the risk of inhospital PCI-related mortality during usual working hours. The highest risk period, taking into account numerous factors that confound this association, is the latter part of the workday. A second period of apparent greater risk occurs during the early part of the workday and is consistent with our present understanding of circadian variation in cardiovascular disease processes.

Post-transplantation growth among pediatric recipients of liver transplantation.

Improving a patient's quality-of-life (QOL) post-liver transplantation is of great importance. An aspect of improved QOL is the restoration of normal growth patterns in pediatric patients. To describe the post-transplantation growth patterns of 72 children included in the National Institute of Diabetes and Digestive and Kidney Diseases - Liver Transplantation Database (NIDDK-LTD), multilevel models were used, according to which children who waited more than a year for transplantation were smaller, compared with age and sex matched peers, at transplantation than children who waited less than a year while children who were growth retarded at transplantation experienced a larger yearly comparison height increase than children who were not growth retarded. The analysis also showed that boys older than 2 yr and younger than 13 yr at transplantation and girls older than 2 yr and younger than 11 yr at transplantation were significantly less growth retarded at transplantation than boys and girls under the age of 2 yr at transplantation.

Importance of the postdischarge interval in assessing major adverse clinical event rates following percutaneous coronary intervention.

In-hospital major adverse clinical event (MACE) rates after percutaneous coronary intervention serve as benchmarks of performance. However, accelerated clinical pathways, decreased lengths of stay, and potential delayed effects of percutaneous coronary intervention may result in an underestimation of this traditional measurement of outcome. Records from patients in the first 3 waves of the National Heart, Lung, and Blood Institute's Dynamic Registry (n = 6,676) were reviewed for rates of composite in-hospital MACEs (death, myocardial infarction, and any repeat target vessel revascularization) and postdischarge MACEs (death, myocardial infarction, repeat hospitalization, and repeat target vessel revascularization) through 30 days. Rates for each composite MACE were compared across waves to assess changes over time. Predictors of each MACE category were identified using multivariate analysis. In-hospital MACE decreased significantly (5.4% of wave 1, 4.9% of wave 2, 3.1% of wave 3, p <0.001), whereas stent implantation increased significantly (67.5% of wave 1, 79.1% of wave 2, 86.2% of wave 3, p <0.001). Postdischarge MACE through 30 days remained unchanged (5.1% of wave 1, 5.1% of wave 2, 4.8% of wave 3, p = 0.6). Mean length of stay decreased (2.7 days for wave 1, 2.2 days for wave 3, p <0.001). Disparate clinical, procedural, and angiographic factors were associated with each MACE. Postdischarge MACE rates through 30 days comprise a significant and unchanging fraction of overall procedurally related MACE rates despite improving in-hospital outcomes. Most postdischarge events derive from pathology related to the controlled vessel. A 30-day MACE rate may serve as a more comprehensive measurement of procedural outcome.

Clinical progression of incidental, asymptomatic lesions discovered during culprit vessel coronary intervention.

BACKGROUND: With the reduction in restenosis rates by drug-eluting stents, there is new controversy concerning the optimal management of incidental, nontarget lesions identified during percutaneous coronary intervention (PCI). Such lesions have been treated conservatively because of risk of restenosis but now are being considered for PCI to prevent plaque instability. However, the impact of incidental stenoses on future cardiac events remains unknown. METHODS AND RESULTS: We performed a retrospective cohort study to determine the rate and features of clinical plaque progression using the National Heart, Lung, and Blood Institute Dynamic Registry of consecutive patients undergoing PCI at multiple centers in 1997 to 1998 and 1999. Of 3747 PCI patients, 216 (5.8%) required additional nontarget lesion PCI for clinical plaque progression at 1 year. Fifty-nine percent presented with new unstable angina, and 9.3% presented with nonfatal myocardial infarction. Patients with multivessel coronary artery disease during original PCI were more likely to require nontarget lesion PCI during follow-up (adjusted odds ratio, 1.72 [95% CI, 1.18 to 2.52] for 2 vessels; adjusted odds ratio, 3.37 [95% CI, 2.32 to 4.89] for 3 vessels). Angiographic review showed that the majority (86.9%) of lesions requiring subsequent PCI were < or =60% in severity during original PCI, with the mean lesion stenosis 41.8+/-20.8% at the time of the initial PCI and 83.9+/-13.9% during the recurrent event. CONCLUSIONS: Approximately 6% of PCI patients will have clinical plaque progression requiring nontarget lesion PCI by 1 year. Greater coronary artery disease burden confers a significantly higher risk for clinical plaque progression.

Impact of age on procedural and 1-year outcome in percutaneous transluminal coronary angioplasty: a report from the NHLBI Dynamic Registry.

BACKGROUND: Older age has been associated with adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). As PCI technology evolves and the US population becomes proportionally older, assessment of PCI in older age groups is essential. METHODS: From the National Heart, Lung, and Blood Institute Dynamic Registry, 4620 PCI-treated patients (1997 to 1999) were studied. Differences in clinical presentation, treatment strategy, and inhospital and 1-year outcomes were compared between patient age groups: younger (<65 years, n = 2537); older (65 to 79 years, n = 1776); and elderly (> or =80 years, n = 307). RESULTS: Older and elderly patients had more cardiac and comorbid noncardiac conditions and more extensive and complex arteriosclerosis, including stenoses in bypass grafts. Stent use was similar as age increased (72% vs 73% vs 73%), as was the use of IIb/IIIa receptor antagonists (29% vs 26% vs 28%). Rates of successful treatment of all attempted lesions were 93%, 92%, and 89%, respectively. Adjusted relative risks of inhospital death (1.0 vs 2.91 vs 3.64) and myocardial infarction (1.0 vs 1.35 vs 2.57) increased by age group, as did 1-year mortality rates (1.0 vs 1.87 vs 3.02). However, the relative magnitude of excess mortality rates at 1 year was comparable to that observed by age in the US general population. Age was not associated with 1-year risk of myocardial infarction or coronary artery bypass grafting. CONCLUSIONS: Although new technologies may allow for treatment of complex disease in older and elderly patients with comorbid disease, the increased procedural risk remains substantial in these patients. After PCI, the long-term relative risk of death is similar to that expected among persons of similar ages in the general population.

Comparison of in-hospital and one-year outcomes in patients with left ventricular ejection fractions or=50% having percutaneous coronary revascularization.

Outcome studies of percutaneous coronary intervention (PCI) with conventional balloon angioplasty have established increased in-hospital and 1-year mortality in patients with left ventricular (LV) dysfunction compared with others. It is unclear whether recent PCI practice innovations, including stents and adjunctive pharmacotherapy, have made PCI safer and more effective in patients with LV dysfunction. We evaluated the influence of LV ejection fraction (EF) indexes on in-hospital and 1-year outcomes in 1,458 patients within the National Heart, Lung, and Blood Institute-sponsored Dynamic Registry. Patients (n = 300) with acute myocardial infarction were excluded. The remaining 1,158 patients were subdivided into 3 categories: group 1, EF or=50% (n = 866). We determined the frequency of individual and composite adverse events (death/myocardial infarction [MI]/coronary artery bypass grafting) at discharge and 1 year. In the Dynamic Registry patients, mean EF in the 3 groups was 32%, 45%, and 62% and in-hospital mortality was 3.0%, 1.6%, and 0.1%, respectively (p <0.001). The composite end point of death/MI was also significant, but other in-hospital adverse events did not differ between groups. The respective mortality rates were 11.0%, 4.5%, and 1.9% (p <0.001) after 1 year. The composite end points of death/MI and death/MI/coronary artery bypass grafting also occurred more frequently in group 1 patients. Thus, significant LV dysfunction was still associated with increased in-hospital and 1-year mortality in patients having contemporary PCI.

Modeling and risk prediction in the current era of interventional cardiology: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

BACKGROUND: Validation of in-hospital mortality models after percutaneous coronary interventions using multicenter data remains limited. METHODS AND RESULTS: This study evaluated whether multivariable mortality models developed during the pre-stent era by New York State, American College of Cardiology (ACC)-National Cardiovascular Data Registry, Northern New England Cooperative Group, Cleveland Clinic Foundation, and the University of Michigan are relevant in patients undergoing percutaneous coronary intervention in the 1997 to 1999 National Heart, Lung, and Blood Institute Dynamic Registry. Of 4448 Dynamic Registry patients, 73% received > or =1 stent and 28% received a IIB/IIIA receptor inhibitor. In-hospital mortality occurred in 64 patients (1.4%). The New York state model predicted mortality in 69 patients (1.5%; 95% confidence bounds [CI], 0.89% to 1.70%); Northern New England predicted mortality in 60 patients (1.3%; 95% CI, 1.0% to 1.7%); and Cleveland Clinic predicted mortality in 76 patients (1.7%; 95% CI, 1.3% to 2.1%). Among high-risk subgroups, with these 3 models, observed and predicted in-hospital mortality rates in general were not different. The other 2 models yielded different results. The University of Michigan predicted fewer deaths (n=47; 1.1%; 95% CI, 0.7% to 1.3%), and the ACC Registry model predicted 603 deaths (13.5%; 95% CI, 12.6% to 14.4%). Using the ACC Registry model, predicted mortality was higher than observed in each subgroup. CONCLUSIONS: Application of 5 mortality risk models developed from different data sets to patients undergoing percutaneous coronary intervention in the Dynamic Registry predicted, in 3 models, mortality rates that were not significantly different than those observed. In both high and low risk subgroups, the University of Michigan slightly underpredicted mortality, and the ACC Registry predicted significantly higher mortality than that observed.

Burgeoning dilemmas in the management of diabetes and cardiovascular disease: rationale for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial.

A paradoxical increase in mortality attributable to diabetes has occurred, particularly during the last decade, despite the overall decrease in mortality attributable to coronary artery disease in patients without diabetes. Insulin resistance with or without frank type 2 diabetes has emerged as a major determinant of accelerated coronary artery disease and its sequelae. The advent of insulin sensitizers enables clinicians to target treatment of insulin resistance, as well as hyperglycemia and dyslipidemia. The prevalence of diabetes in the United States is enormous and is increasing rapidly. Patients with diabetes respond less favorably to percutaneous coronary interventions and surgery compared with nondiabetic patients. These considerations led to the initiation of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. It is designed to determine whether treatment targeted to attenuate insulin resistance can arrest or retard progression of coronary artery disease compared with treatment targeted to the same level of glycemic control with an insulin-providing approach. It is designed also to determine whether early revascularization reduces mortality and morbidity in patients with type 2 diabetes whose cardiac symptoms are mild and stable. Despite challenges in study design and enrollment, intensive follow-up, and the long duration of follow-up planned, the questions being addressed are compelling and seem to merit the effort.

Angina 1 year after percutaneous coronary intervention: a report from the NHLBI Dynamic Registry.

BACKGROUND: As percutaneous coronary intervention (PCI) is most commonly performed for relief of angina, it is important to identify factors associated with recurrence of anginal symptoms. METHODS: We examined symptoms at 1-year follow-up in 1755 consecutive NHLBI Dynamic Registry patients who underwent PCI in the setting of symptoms or acute infarction. RESULTS: At 1-year follow-up, 26% of patients reported angina in the previous 6 weeks. Younger patients and females reported more symptoms. History of coronary artery bypass graft (CABG) or PCI, prior myocardial infarction (MI), diabetes, graft disease, and extensive coronary artery disease (CAD) (>4 significant lesions) were also associated with follow-up angina. Patients receiving stents reported less angina (24% vs 29%, P <.05). Completely revascularized patients and those with residual single-vessel disease had comparable 1-year angina rates (23% both subgroups), while 32% of patients with residual multivessel CAD reported symptoms. Patients undergoing repeat PCI during follow-up reported more 1-year angina than others (34% vs 24%, P <.001), whereas those undergoing CABG after post-PCI hospitalization had less symptoms (15% vs 26%, P <.05). After adjustment for baseline symptom status and outcome of index PCI, residual CAD, and reintervention during follow-up, patient characteristics significantly predictive of angina included female sex, age <62 years, and prior MI. CONCLUSIONS: While approximately three quarters of patients receiving PCI are angina-free at 1 year, females continue to have more symptoms, as do other subgroups including patients with history of MI or previous intervention. As these symptoms are associated with self-reported activity and quality of life limitation, evaluations of PCI should include angina as a key follow-up outcome.

Coronary bypass graft patency in patients with diabetes in the Bypass Angioplasty Revascularization Investigation (BARI).

BACKGROUND: Few studies have compared long-term status of bypass grafts between patients with and without diabetes, and uncertainty exists as to whether diabetes independently predicts poor clinical outcome after CABG. METHODS AND RESULTS: Among 1526 patients in BARI who underwent CABG as initial revascularization, 99 of 292 (34%) with treated diabetes mellitus (TDM) (those on insulin or oral hypoglycemic agents) and 469 of 1234 (38%) without TDM had follow-up angiography. Angiograms with the longest interval from initial surgery and before any percutaneous graft intervention (mean 3.9 years) were reviewed. An average of 3.0 grafts were placed at initial CABG for patients with TDM (n=297; internal mammary artery [IMA], 33%) and 2.9 grafts for patients without TDM (n=1347; IMA, 34%). Patients with TDM were more likely than those without to have small (<1.5 mm) grafted distal vessels (29% versus 22%) and vessels of poor quality (9% versus 6%). On follow-up angiography, 89% of IMA grafts were free of stenoses > or =50% among patients with TDM versus 85% among patients without TDM (P=0.23). For vein grafts, the corresponding percentages were 71% versus 75% (P=0.40). After statistical adjustment, TDM was unrelated to having a graft stenosis > or =50% (adjusted odds ratio, 0.87; 95% CI, 0.58 to 1.32). CONCLUSIONS: Despite diabetic patients' having smaller distal vessels and vessels judged to be of poorer quality, diabetes does not appear to adversely affect patency of IMA or vein grafts over an average of 4-year follow-up. Previously observed differences in survival between CABG-treated patients with and without diabetes may be largely a result of differential risk of mortality from noncardiac causes.

Contemporary percutaneous coronary intervention versus balloon angioplasty for multivessel coronary artery disease: a comparison of the National Heart, Lung and Blood Institute Dynamic Registry and the Bypass Angioplasty Revascularization Investigation (BARI) study.

BACKGROUND: This investigation compares the results of contemporary percutaneous coronary intervention (PCI) with standard balloon angioplasty among patients with multivessel coronary disease. Patients having balloon angioplasty in the Bypass Angioplasty Revascularization Investigation (BARI) and those within the Dynamic Registry meeting BARI eligibility criteria were studied. METHODS AND RESULTS: Clinical features and in-hospital and 1-year outcomes of 857 BARI-eligible patients in the Dynamic Registry (contemporary PCI) were compared with the 904 randomized patients who underwent percutaneous transluminal coronary angioplasty in BARI. Compared with BARI patients, Registry patients had fewer lesions attempted (1.53 versus 2.56, P=0.001), more frequent single-vessel PCI (76% versus 33%, P<0.001), greater use of intracoronary stents (76% versus 1%, P<0.001), and GP IIb/IIIa receptor antagonist (24% versus 0%, P<0.001). Angiographic success was achieved more often among Registry patients (91% versus 72%, P<0.001), whereas abrupt closure (1.5% versus 9.5%, P<0.001) and in-hospital coronary artery bypass graft (CABG) (1.9% versus 10.2%, P<0.001) and myocardial infarction (0.8% versus 2.1%, P=0.025) were less common. No differences were observed in either in-hospital or 1-year death, but 1-year death/myocardial infarction was lower in the Registry. Registry patients had lower 1-year rates of subsequent CABG (8.6% versus 22.7%, P<0.001) and PCI (12.4% versus 22.5%, P<0.001). By multivariate analysis, contemporary PCI was independently associated with reduced risk for in-hospital CABG, 1-year CABG, and 1-year PCI. CONCLUSIONS: Among patients with multivessel disease, contemporary PCI resulted in safer and more durable revascularization. These results support the role of PCI for selected patients with multivessel coronary artery disease.

Differential influence of diabetes mellitus on increased jeopardized myocardium after initial angioplasty or bypass surgery: bypass angioplasty revascularization investigation.

BACKGROUND: Data are absent that compare midterm angiographic outcome between patients with and without diabetes after initial percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft surgery (CABG). Importantly, diabetes mellitus may differentially influence long-term survival after PTCA or CABG. METHODS AND RESULTS: Patients with multivessel coronary disease who were previously enrolled in the Bypass Angiopathy Revascularization Investigation to compare initial PTCA versus CABG (n=1829) and who had a reduction in jeopardized myocardium after initial revascularization and at least 1 angiogram during 5-year follow-up were analyzed (n=897). This included 369 CABG-treated patients (16% with diabetes) and 528 PTCA-treated patients (18% with diabetes). The influence of diabetes on angiographic increase in percentage of jeopardized myocardium after initial revascularization with either PTCA or CABG was investigated. Among PTCA patients, the mean percentage increase in total jeopardized myocardium was significantly greater in those with diabetes than in those without at 1-year protocol-directed angiography (42% versus 24%, P=0.05) and on the first clinically performed (unscheduled) angiogram within 30 months (63% versus 50%, P=0.01) but not at 5-year protocol-directed angiography (34% versus 26%, P=0.33). This excess midterm risk associated with diabetes persisted after statistical adjustment. In contrast, among CABG patients, diabetes was not associated with percentage increase in jeopardized myocardium at any angiographic follow-up interval. CONCLUSIONS: Presence of diabetes differentially influences worsening of jeopardized myocardium after initial PTCA compared with CABG. This differential effect occurs irrespective of whether follow-up angiography is undertaken for clinical or nonclinical purposes.

Improved outcomes for women undergoing contemporary percutaneous coronary intervention: a report from the National Heart, Lung, and Blood Institute Dynamic registry.

OBJECTIVES: The goal of this study was to determine whether women undergoing contemporary percutaneous coronary intervention (PCI) remain at increased risk in comparison with men and whether the outcomes in women have improved. BACKGROUND: Previous studies have shown that women treated with coronary angioplasty have a higher incidence of procedural morbidity and mortality than men. METHODS: Gender differences in wave 1 of the National Heart, Lung and Blood Institute (NHLBI) Dynamic registry were evaluated. Baseline characteristics and outcomes in women in the Dynamic registry were compared with those in women in the 1985-1986 and 1993-1994 NHLBI Percutaneous Transluminal Coronary Angioplasty (PTCA) registries. RESULTS: Women were older with a higher prevalence of diabetes mellitus, hypertension, congestive heart failure, unstable angina and single vessel disease in comparison with men. Although procedural success and in-hospital death (2.2% vs. 1.3%), myocardial infarction (MI) (2.3% vs. 3.0%) and coronary artery bypass graft surgery (CABG) (1.3% vs. 1.4%) were similar in women and men, respectively, one-year mortality (6.5% vs. 4.3%, p = 0.02) and combined end point of death/MI/CABG (18.3% vs. 14.4%, p = 0.03) were higher in women than in men. After controlling for other factors, gender was not a significant predictor of death or death plus MI at one year. Despite a higher risk profile in women in the Dynamic registry in comparison with women in the 1985-1986 NHLBI PTCA registry, in-hospital death/MI/CABG was lower (6.0% vs. 11.6%, p < 0.001). CONCLUSIONS: Despite persistent high-risk characteristics in women, gender differences in outcomes in patients undergoing contemporary PCI have decreased, and outcomes in women have improved.