Effect of prior revascularization on outcome following percutaneous coronary intervention; NHLBI Dynamic Registry.

AIMS: An increasing number of patients undergoing percutaneous coronary intervention (PCI) have experienced previous revascularization procedures. Their outcome after PCI has seldom been compared to that of patients without prior procedures. This study investigates which elements of prior revascularization affect in-hospital and long-term outcome after PCI. METHODS AND RESULTS: Baseline characteristics as well as in-hospital and 1-year outcomes were compared in 4010 consecutive patients undergoing PCI in the NHLBI Dynamic Registry, categorized by type of prior procedure. In-hospital mortality was lowest and procedural success highest among patients with prior PCI only. Patients with prior coronary artery bypass grafting (CABG) had higher rates for the combined endpoint of death and myocardial infarction (MI) at 1 year compared to patients with no prior procedures. However, in multivariate regression analysis adjusting for potential confounders, neither prior PCI nor prior CABG were independent predictors of death or death/MI at 1 year. Patients with prior procedure had higher rates for repeat PCI and patients with prior PCI had higher rates for CABG during the year following the index procedures. These associations persisted after adjustment for potential confounders. Finally, patients with prior procedures had a higher prevalence of angina at 1 year. CONCLUSIONS: Due to adverse baseline characteristics, patients with prior CABG have higher rates for death/MI during the first year after PCI and both groups of patients with prior procedures have higher revascularization rates. However, only the associations with repeat revascularization persist after adjustment for baseline and procedural factors.

Outcomes of patients with chronic renal insufficiency in the bypass angioplasty revascularization investigation.

BACKGROUND: Although severe chronic kidney disease (CKD) is an independent predictor of mortality among patients with coronary artery disease, the impact of mild CKD on morbidity and mortality has not been fully defined. METHODS AND RESULTS: Morbidity and mortality for the 3608 patients with multivessel coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation randomized trial and registry were compared on the basis of the presence and absence of CKD, defined as a preprocedure serum creatinine level of >1.5 mg/dL. Seventy-six patients had CKD. Patients with renal insufficiency were older and more likely to have a history of diabetes, hypertension, and other comorbidities. Among patients undergoing PTCA, patients with CKD had a greater frequency of in-hospital death and cardiogenic shock (P<0.05 and 0.01, respectively). There was a trend toward a larger proportion of patients with CKD experiencing angina at 5 years (P=0.079). Patients with CKD had more cardiac admissions (P=0.003 and <0.0001 for patients undergoing PTCA and CABG, respectively) and a shorter time to subsequent CABG after initial revascularization than patients without CKD (P=0.01). CKD was associated with a higher risk of death at 7 years, both of all causes (relative risk 2.2, P<0.001) and of cardiac causes (relative risk 2.8, P<0.001). CONCLUSIONS: CKD is associated with an increased risk of recurrent hospitalization, subsequent CABG, and mortality. This increased risk of death is independent of and additive to the risk associated with diabetes.

Survival following coronary angioplasty versus coronary artery bypass surgery in anatomic subsets in which coronary artery bypass surgery improves survival compared with medical therapy. Results from the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: We sought to compare survival after coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in high-risk anatomic subsets. BACKGROUND: Compared with medical therapy, CABG decreases mortality in patients with three-vessel disease and two-vessel disease involving the proximal left anterior descending artery (LAD), particularly if left ventricular (LV) dysfunction is present. How survival after PTCA and CABG compares in these high-risk anatomic subsets is unknown. METHODS: In the Bypass Angioplasty Revascularization Investigation (BARI), 1,829 patients with multivessel disease were randomized to an initial strategy of PTCA or CABG between 1988 and 1991. Stents and IIb/IIIa inhibitors were not utilized. Since patients in BARI with diabetes mellitus had greater survival with CABG, separate analyses of patients without diabetes were performed. RESULTS: Seven-year survival among patients with three-vessel disease undergoing PTCA and CABG (n = 754) was 79% versus 84% (p = 0.06), respectively, and 85% versus 87% (p = 0.36) when only non-diabetics (n = 592) were analyzed. In patients with three-vessel disease and reduced LV function (ejection fraction <50%), seven-year survival was 70% versus 74% (p = 0.6) in all PTCA and CABG patients (n = 176), and 82% versus 73% (p = 0.29) among non-diabetic patients (n = 124). Seven-year survival was 87% versus 84% (p = 0.9) in all PTCA and CABG patients (including diabetics) with two-vessel disease involving the proximal LAD (n = 352), and 78% versus 71% (p = 0.7) in patients with two-vessel disease involving the proximal LAD with reduced LV function (n = 72). CONCLUSION: In high-risk anatomic subsets in which survival is prolonged by CABG versus medical therapy, revascularization by PTCA and CABG yielded equivalent survival over seven years.

Mortality of men versus women in comparable high-level jobs: 15-year experience in the Federal Women's Study.

The authors investigated exposure to high-level occupations in relation to the well-known survival advantage of women compared with men of the same age. Women in the federal workforce in positions of General Schedule 14 and above in 1979--1993 (n = 4,727) were each matched with three men (n = 14,181) by age, General Schedule level, and supervisory role. Fifteen-year mortality rates were compared between men and women and against expected 15-year mortality from the US general population. Despite similar job demands, women experienced markedly lower 15-year mortality than did men. However, men in these positions had nearly 50% lower mortality compared with age-matched men in the general population; the comparable reduction for women was 38%. The simultaneous substantial, but unequal by gender, improvement in mortality resulted in a reduced male/female mortality ratio, from 1.67 in the general population to 1.40. The reduced male/female mortality ratio was especially prominent for cancer and was not evident for heart disease mortality. Survival was nominally higher in non-White than in White participants. In summary, high-level employment is associated with substantially reduced mortality in both men and women. The relative improvement in survival is greater in men despite a comparable reduction in risk of heart disease mortality by gender.

Risk stratification after successful coronary revascularization: the lack of a role for routine exercise testing.

OBJECTIVE: The objective of this study was to evaluate the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise testing (EXT) after successful coronary revascularization (CR) using the Bypass Angioplasty Revascularization Investigation experience. BACKGROUND: The ACC/AHA guidelines state that EXT within three years of successful CR is not useful. METHODS: The 1,678 patients randomized to CR by either angioplasty or bypass surgery were required to take symptom-limited treadmill tests one, three and five years after revascularization. RESULTS: Patients who took the test at each specified time had a much lower subsequent two-year mortality than those who did not (1.9% vs. 9.4%, 3.5% vs. 12.6% and 3.3% vs. 11.0% at one, three and five years, respectively, after CR [p < 0.0001 for each]). Exercise parameters at the one- and three-year test did not improve a multivariable model of survival after including clinical parameters. Exercising to Bruce stage 3 or generating a Duke score >-6 were independently predictive of two-year survival after the five-year test. ST depression on the one-year test was associated with more revascularizations (relative risk = 1.6; p < 0.001). CONCLUSIONS: Patients with stable multivessel coronary disease who took a protocol-mandated exercise test at one, three and five years after revascularization were at low risk for mortality in the two years subsequent to each test. Exercise parameters did not improve prediction of mortality in the two years after the one- and three-year tests. The ACC/AHA guidelines on exercise testing after CR (no value for routine testing in stable patients for three years after revascularization) are supported by these results.

Immediate and one-year outcome in patients with coronary bifurcation lesions in the modern era (NHLBI dynamic registry).

Balloon angioplasty of bifurcation lesions has been associated with lower success and higher complication rates than most other lesion types. The development of alternative strategies such as debulking and stenting, either alone or in combination, are currently used relatively often. The relative role of these newer approaches in improving acute or long-term outcome, however, remains uncertain. Of the total of 2,436 patients treated between July 1997 to February 1998 in the National Heart, Lung, and Blood Institute Dynamic Registry, there were 321 patients (group 1) with bifurcation lesions and 2,115 patients without any bifurcation lesions attempted (group 2). Treatment strategies in terms of major devices used were significantly different between the 2 groups (group 1 vs 2): balloon angioplasty alone (23.1% vs 26.5%), balloon angioplasty and rotational atherectomy (6.9% vs 4.4%), balloon angioplasty and stent (55.8% vs 59.9%), and balloon angioplasty, rotational atherectomy, and stent (10.3% vs 7%) with p <0.01. There were no significant differences between the groups in terms of age, gender, and frequency of prior myocardial infarction (MI) or coronary artery bypass graft surgery (CABG). Complete angiographic success was achieved in only 86% of bifurcation lesions versus 93.5% of nonbifurcation lesions (p <0.001). In-hospital complication rates were increased in patients with bifurcation lesions compared with the nonbifurcation group: MI, 3.7% versus 2.6%; CABG, 2.2% versus 1.1%; side branch occlusion, 7.3% versus 2.3% (p <0.001); and the composite of death, MI, and any CABG, 7.2% versus 5.0%. At 1-year follow-up, major adverse cardiac events were 25% higher in group 1 than in group 2 (32.1% vs 25.7%, p <0.05). We conclude that despite the widespread use of newer percutaneous devices, treatment of bifurcation lesions remains difficult and is associated with decreased success and increased complication rates compared with nonbifurcation lesions.

Changes in the practice of percutaneous coronary intervention: a comparison of enrollment waves in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry.

The National Heart, Lung, and Blood Institute Dynamic Registry includes 15 clinical sites in wave 1, and 16 sites in wave 2 as well as a data-coordinating center. The first wave of enrollment began in July 1997 and was completed in February 1998. The second wave began in February 1999 and ended in June 1999. There were a total of 2,526 patients in wave 1 and 2,109 patients in wave 2. Comprehensive pre-, intra-, and postprocedure (in-hospital) data were analyzed for changes between recruitment waves. Patients in wave 2 were more frequently nonwhite (p < or = 0.001), hypertensive by history (p < or = 0.001), had more significant noncardiac comorbidity (p < or = 0.01), and had more frequently undergone prior percutaneous coronary intervention (p < 0.05). Patients in wave 2 underwent percutaneous coronary intervention in a setting of acute coronary syndromes more frequently than wave 1 patients (p < or = 0.001). However, most interventions in both waves were performed on 1 vessel, irrespective of the extent of disease. Attempted lesions in wave 2 were longer (p < or = 0.001), less frequently totally occluded (p < or = 0.001), and more frequently in vessels with a prior stent (p < or = 0.01). Using the American Heart Association/American College of Cardiology lesion classification scheme, attempted lesions in wave 2 were less complex than those in wave 1 (p < or = 0.001). Stent use increased significantly from wave 1 (67%) to wave 2 (79%, p < or = 0.001) as did the use of platelet glycoprotein IIb/IIIa antagonists (wave 1, 24%; wave 2, 32%: p < 0.001). Procedural outcomes (angiographic success without major in-hospital adverse events) were excellent in both waves 1 (94.6%) and 2 (95.6%) and were not significantly different. However, the frequency of significant procedural coronary dissection and in- and out-of-laboratory abrupt closure were significantly less in wave 2 (p < or = 0.001) Discharge medications were more likely to include angiotensin-converting enzyme inhibitors, beta-adrenergic blocking agents, and hypolipidemic treatment in wave 2 than in wave 1 (p < or = 0.001). These data indicate a continuing aggressive approach to patient care over the time interval analyzed. Although overall procedural outcomes are excellent, procedural safety has been further enhanced. There is also a growing awareness of the importance of secondary prevention among interventional cardiologists.

Comparison of immediate and one-year outcome after coronary angioplasty of narrowing < 3 mm with those > or =3 mm ( the National Heart, Lung, and Blood Institute Dynamic Registry).

Balloon angioplasty of small coronary artery lesions has been associated with lower success and higher complication rates than large coronary artery lesions. This study evaluates the in-hospital and 1-year outcome of the treatment of small coronary artery lesions in the modern era of interventional cardiology and compares it with the outcome of treating large coronary artery lesions. Of 1,658 patients with a single lesion treated from July 1997 to February 1998 in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry, there were 587 patients with small coronary artery lesions (<3 mm) and 1,071 patients with large coronary artery lesions (> or =3 mm). Success, in-hospital, and 1-year outcomes between both groups were compared. Patients with lesions in small coronary arteries were more often women, insulin-treated diabetics, and had undergone more prior coronary bypass graft surgery. Conventional angioplasty alone was performed more often and angioplasty with stents was performed less often in the small coronary artery than in the large coronary artery group. Angiographic success was slightly lower in the small coronary artery group (94.2% vs 96.9%, p <0.05). Periprocedural and in-hospital complication rates were similar in both groups. Likewise, at 1-year follow-up, major adverse cardiac events including death, myocardial infarction, and coronary artery bypass graft surgery were relatively low and comparable between the 2 groups, although patients with small coronary arteries were more likely to undergo repeat revascularization (17.4% vs 13.6%, p <0.05). Treatment of lesions in small coronary arteries in the modern era is associated with high success and low complication rates, comparable to the treatment of large coronary artery lesions, although the incidence of repeat revascularization was significantly greater at follow-up even if stents were used.

Percutaneous coronary intervention in the current era compared with 1985-1986: the National Heart, Lung, and Blood Institute Registries.

BACKGROUND: Although refinements have occurred in coronary angioplasty over the past decade, little is known about whether these changes have affected outcomes. METHODS AND RESULTS: Baseline features and in-hospital and 1-year outcomes of 1559 consecutive patients in the 1997-1998 Dynamic Registry who were having first coronary intervention were compared with 2431 patients in the 1985-1986 National Heart, Lung, and Blood Institute Registry. Compared with patients in the 1985-1986 Registry, Dynamic Registry patients were older (mean age, 62 versus 58 years; P:<0.001) and more often female (32.1% versus 25.5%; P:<0.001). In the Dynamic Registry, procedures were more often performed for acute myocardial infarction (22.9% versus 9.9%; P:<0.001) and treated lesions were more severe (84.5% versus 82.5% diameter reduction; P:<0.001), thrombotic (22.1% versus 11.3%; P:<0.001) or calcified (29.5% versus 10.8%; P:<0.001). Stents were used in 70.5% of Dynamic Registry patients, whereas 1985-1986 patients received balloon angioplasty alone. Procedural success was higher in the Dynamic Registry (92.0% versus 81.8%; P:<0.001) and the rate of in-hospital death, myocardial infarction, and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%; P:=0.001) than in the 1985-1986 Registry. The 1-year rate for CABG was lower in the Dynamic Registry (6.9% versus 12.6%; P:<0.001). CONCLUSIONS: Although Dynamic Registry patients had more unstable and complex coronary disease than those in the 1985-1986 Registry, their rate of procedural success was higher whereas rates of complications and subsequent CABG were lower. Results of percutaneous coronary intervention have improved substantially over the past decade.

Quality of life after coronary revascularization in the United States and Canada.

Cardiac procedures are performed less frequently in Canada than in the United States (US), yet rates of cardiac death and myocardial infarction are similar. We therefore sought to compare long-term symptoms and quality of life in Canadian and American patients undergoing initial coronary revascularization. The 161 patients enrolled in the Bypass Angioplasty Revascularization Investigation at the Montreal Heart Institute were compared with 934 patients enrolled at 7 US sites. Patients' outcomes were documented for 5 years after random assignment to percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery. Functional status was assessed using the Duke Activity Status Index. Canadian patients were significantly younger and had more angina at study entry. Death and nonfatal myocardial infarction were not significantly different between Canadian and US patients after adjustment for baseline risk. Canadian patients had significantly greater improvements in functional status at 1-year follow-up (Duke Activity Status Index score + 13.5 vs. + 6.0, p = 0.002), but this difference progressively narrowed over 5 years. Angina was equally prevalent in Canadian and US patients at 1 year (16% vs. 19%), but significantly more prevalent in Canadian patients at 5 years (36% vs. 16%, p = 0.001). Repeat revascularization procedures were performed less often over 5 years among Canadian patients (26% vs. 34%, p = 0.08), especially coronary artery bypass graft surgery after initial percutaneous transluminal coronary angioplasty (18% vs. 32%, p = 0.03). These results suggest more anginal symptoms are required in Canada before coronary revascularization, but as a result Canadians receive greater improvements in quality of life after the procedure.

Association between new electrocardiographic abnormalities after coronary revascularization and five-year cardiac mortality in BARI randomized and registry patients.

There are few data comparing the relative frequency of new electrocardiographic (ECG) abnormalities after coronary artery bypass grafting (CABG) compared with percutaneous transluminal coronary angioplasty (PTCA) and their association with long-term cardiac mortality. The study population consisted of 3,373 patients who were either randomized or eligible to be randomized to CABG or PTCA in the BARI trial. The frequency of new postprocedural ECG abnormalities was significantly greater after a CABG procedure than after PTCA. The incidence of new postprocedural major Q waves, ST-segment elevation, and T-wave abnormalities were significantly more frequent after CABG. After PTCA (n = 1,869), the 5-year cardiac mortality rates associated with the new development of major Q waves, ST-segment elevation, ST-segment depression, T-wave abnormalities, or no abnormality was 18.1%, 8.5%, 8.9%, 6.0%, and 5.4%, respectively. After CABG (n = 1,427), 5-year cardiac mortality rates were 8.0%, 4.2%, 3.8%, 2.8%, and 3.7%, respectively. The adjusted relative risk of 5-year cardiac mortality for new Q-wave abnormalities was 2.6 after CABG (p <0.04) and 4.6 after PTCA (p <0.01). Thus, patients who undergo CABG have more postinitial procedural ECG abnormalities than patients who undergo PTCA. Cardiac mortality is significantly increased by the new development of postprocedural Minnesota code Q-wave abnormalities regardless of whether patients undergo CABG or PTCA.

Long-term clinical outcome in the Bypass Angioplasty Revascularization Investigation Registry: comparison with the randomized trial. BARI Investigators.

BACKGROUND: The Bypass Angioplasty Revascularization Investigation (BARI) included 4039 patients with multivessel coronary artery disease; 1829 consented to randomization, and 2010 did not but were followed up in a registry. Thus, we can evaluate the outcome of physician-guided versus random assignment of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the baseline features and outcomes for PTCA and CABG in the overall registry and its predesignated subgroups. We assessed the impact of treatment by choice versus random assignment by comparing the results in the registry with those of the randomized trial. Statistical adjustments for differences in baseline characteristics were made. Within the registry, nearly twice as many patients were selected for PTCA (1189) as CABG (625); mortality at 7 years was similar for PTCA (13.9%) and CABG (14.2%) (P=0.66) before and after adjustment for baseline differences between patients selected for PTCA versus CABG (adjusted RR, 1.02; P=0.86). In contrast to the randomized trial, the 7-year mortality rate of treated diabetics in the registry was equally high (26%) with PTCA or CABG. Seven-year mortality was higher for patients undergoing PTCA in the randomized trial than in the registry (19.1% versus 13.9%, P<0.01) but not for those undergoing CABG (15.6% versus 14.2%, P=0.57). The adjusted relative mortality risk for PTCA in the randomized versus registry population was 1.17 (P=0.16). CONCLUSIONS: BARI physicians were able to select PTCA rather than CABG for 65% of registry patients who underwent revascularization without compromising long-term survival either in the overall population or in treated diabetics.

Race, baseline characteristics, and clinical outcomes after coronary intervention: The New Approaches in Coronary Interventions (NACI) registry.

BACKGROUND: The impact of race and sex on clinical outcomes after percutaneous coronary interventions remains incompletely understood. Specific data on patient demographics, lesion characteristics, and outcomes of black versus white patients are poorly described. To further evaluate these issues, we analyzed the New Approaches in Coronary Interventions (NACI) registry. METHODS: Patients (200 black, 4279 white) undergoing coronary interventions in the NACI trial were compared. A Cox proportional hazards model was used to determine which baseline demographics were independent risk factors for the combined end point of death, Q-wave myocardial infarction, and coronary artery bypass grafting at 1 year. RESULTS: Black patients were significantly younger (age 59 +/- 11 vs 63 +/- 11 years; P <.001), more often obese (29.6 +/- 6 vs 27.5 +/- 4.8 kg/m(2); P <.001), female (50% vs 34%; P <.001), diabetic (34% vs 21%; P <.001), and hypertensive (71% vs 52%; P <.001). Black patients were significantly more likely to have single-vessel disease (48% vs 40%; P <.05) and less likely to have undergone coronary artery bypass grafting (26% vs 34%; P <.05). Blacks were significantly more likely to have a discrete lesion (85% vs 62%; P <. 001) with less thrombus (7% vs 12%; P <.05), tortuosity (17% vs 25%; P <.05), and an ulcerated appearance (5% vs 10%; P <.05). Despite these significant baseline differences, no significant difference was seen in the procedural success (80% vs 82%) or major adverse events (death, Q-wave myocardial infarction, any revascularization) at 1 year (39% vs 34%). Predictors of adverse events for white patients included diabetes (relative risk [RR] = 1.24; confidence intervals [CI], 1.0-1.5) and high-risk status (RR = 1.58; CI, 1.26-1. 91). Predictive characteristics of adverse events for black patients included only sex (RR = 3.45; CI, 1.27-9.35; P =.02). CONCLUSIONS: There are significant differences in baseline characteristics of black patients compared with white patients. Despite these differences in traditional risk factors, they do not affect procedural success or 1-year outcome. In black patients, only sex predicted adverse events. Additional investigation is required to understand the mechanisms for this difference.

The effect of previous coronary-artery bypass surgery on the prognosis of patients with diabetes who have acute myocardial infarction. Bypass Angioplasty Revascularization Investigation Investigators.

BACKGROUND: Acute myocardial infarction in patients with diabetes is associated with high mortality. We studied whether previous revascularization by coronary-artery bypass grafting (CABG), as compared with percutaneous transluminal coronary angioplasty (PTCA), influences the prognosis in such patients. METHODS: We classified all patients eligible for the Bypass Angioplasty Revascularization Investigation who underwent coronary revascularization within three months after entry into the study according to whether they had diabetes and whether they had undergone CABG, either initially or after PTCA. The protective effect of CABG with regard to mortality in the presence and in the absence of subsequent spontaneous Q-wave myocardial infarction was estimated with the use of Cox regression models. RESULTS: Among the 641 patients with diabetes and the 2962 without diabetes, the cumulative five-year rates of death were 20 percent and 8 percent, respectively (P<0.001), and the five-year rates of spontaneous Q-wave myocardial infarction were 8 percent and 4 percent (P<0.001). CABG greatly reduced the risk of death after spontaneous Q-wave myocardial infarction in the patients with diabetes (relative risk, 0.09; 95 percent confidence interval, 0.03 to 0.29). Among patients with diabetes who had undergone CABG but did not have spontaneous Q-wave myocardial infarctions, the corresponding relative risk of death was 0.65 (95 percent confidence interval, 0.45 to 0.94). Among the patients without diabetes, no protective effect of CABG was evident. CONCLUSIONS: Among patients with diabetes, previous coronary bypass surgery, as compared with coronary angioplasty, has a highly favorable influence on prognosis after acute myocardial infarction and a smaller beneficial effect among patients who do not have infarction. These findings should influence the type of coronary revascularization procedure selected for patients with diabetes who have multivessel coronary artery disease.

Clinical trials of revascularization therapy in diabetics.

Diabetic patients are a high-risk group for cardiovascular morbidity and mortality, with poorer long-term outcomes, with or without revascularization, than non-diabetic patients. Results from the Bypass Angioplasty Revascularization Investigation (BARI) trial, the largest randomized study of coronary revascularization strategies, showed that diabetic patients with multivessel coronary disease who were undergoing an initial revascularization procedure had a significant long-term survival advantage with coronary artery bypass graft surgery (CABG) compared with percutaneous transluminal coronary angioplasty (PTCA). The 8-year follow-up data from the Emory Angioplasty Versus Surgery Trial (EAST) study, the other major US trial of CABG versus PTCA, and results of other clinical trials that enrolled similar patients are consistent with an advantage for CABG in diabetic patients but not for nondiabetic patients. This benefit is entirely a result of improved cardiac mortality. It is limited to patients receiving an internal mammary artery (IMA) graft and is apparent earlier in insulin-treated patients. The benefit of CABG in diabetic patients may be significantly related to a protective effect on mortality after myocardial infarction, because CABG greatly reduced the risk of death after spontaneous Q-wave myocardial infarction in BARI-eligible diabetic patients (relative risk 0.09, P<0.001), an effect not seen in non-diabetic patients.

Analysis of the reversibility of chronic liver allograft rejection implications for a staging schema.

In contrast to all other vascularized organ allografts, chronic rejection (CR) of the liver is potentially reversible. We therefore studied demographic, perioperative, biochemical, and histologic features associated with reversibility or progression to graft failure. Using very stringent clinical and histological criteria, we identified a subgroup of 23 of 916 patients receiving primary liver allografts with CR from the Liver Transplantation Database. Of these, 13 experienced graft failure as a result of CR, and 10 patients recovered to normal histology or liver injury test results. Male-to-female sex mismatch (p = 0.07), younger recipient age (p = 0.09), younger donor age (p = 0.06), white-to-white race match (p = 0.09), primary diagnosis of biliary atresia (p = 0.02), and cold ischemia time of more than 12 hours (p = 0.02) were associated with graft failure. Patients who eventually recovered from CR were more likely to have acute rejection within the first 2 weeks (70% vs 23%; p = 0.04), had a higher number of acute rejection episodes (p = 0.08), and were more likely to have been treated with OKT3 (90% vs 46%, p = 0.07). Although overlap existed in the histopathologic findings between the patients whose grafts failed and those who recovered, those patients who developed bile duct loss in more than 50% of the portal tracts (p < 0.01), severe (bridging) perivenular fibrosis (p = 0.05), and the presence of foam cell clusters (p = 0.06) were more likely to require retransplantation. In contrast to other solid organ allografts, CR of the liver is not an irreversible process. These findings can be used to understand the evolution of CR and to design a biologically correct and clinically relevant staging system.

Influence of pre-PTCA strategy and initial PTCA result in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI).

BACKGROUND: In PTCA patients with multivessel coronary artery disease, incomplete revascularization (IR) is the result of both pre-PTCA strategy and initial lesion outcome. The unique contribution of these components on long-term patient outcome is uncertain. METHODS AND RESULTS: From the Bypass Angioplasty Revascularization Investigation (BARI), 2047 patients who underwent first-time PTCA were evaluated. Before enrollment, all significant lesions were assessed by the PTCA operator for clinical importance and intention to dilate. Complete revascularization (CR) was defined as successful dilatation of all clinically relevant lesions. Planned CR was indicated in 65% of all patients. More lesions were intended for PTCA in these patients compared with those with planned IR (2.8 versus 2.1). Successful dilatation of all intended lesions occurred in 45% of patients with planned CR versus 56% with planned IR (P<0. 001). In multivariable analysis, planned IR (versus planned CR), initial lesions attempted (not all versus all intended lesions attempted), and initial lesion outcome (not all versus all attempted lesions successful) were unrelated to 5-year risk of cardiac death or death/myocardial infarction but were all independently related to risk of CABG. CONCLUSIONS: Overall, a pre-PTCA strategy of IR in BARI-like patients appears comparable to a strategy of CR except for a higher need for CABG. Whether the use of new devices may attenuate the elevated risk of CABG in patients with multivessel disease and planned IR remains to be determined.

Trends in coronary revascularization 1989 to 1997: the Bypass Angioplasty Revascularization Investigation (BARI) survey of procedures.

Use of catheter-based and surgical coronary revascularization has steadily increased in North America. Introduction of catheter-based "new devices," including intracoronary stents, has expanded the range of patients who can be treated with percutaneous approaches. We sought to address trends in the practice of catheter-based and surgical coronary revascularization during 1989 to 1997. The 17 North American institutions participating in the NHLBI Bypass Angioplasty Revascularization Investigation (BARI) periodically completed a 5-working day survey of all surgical and catheter-based coronary revascularizations. Data collected included patient demographics, vessel disease, prior interventions, and use of new devices or minimally invasive surgical techniques. The proportion of all procedures that were catheter based (vs surgical) increased from 52.1% in 1989/1990 to 62.0% in 1997 (p <0.001). Among surgically treated patients, prevalence of prior bypass surgery decreased from 13.4% in 1989/1990 to 7.5% in 1997 (p <0.001). In 1997, 3% of surgical procedures used minimal incisions or were performed without cardiopulmonary bypass. Among patients undergoing catheter-based intervention, prevalence of left main disease increased from 2.2% to 5.7% (p <0.001), myocardial infarction within 24 hours increased from 2.4% to 9.7% (p <0.001), and prior bypass surgery increased from 16.2% to 20.8% (p = 0.056). Use of new devices increased from 11.6% of catheter-based procedures in 1990 to 67.0% in 1997 (p <0.001). Compared with the early 1990s, catheter-based revascularization is currently more commonly used for patients with acute myocardial infarction, prior bypass surgery, or severe left main narrowing. These trends are likely due to the proliferation of new devices, especially intracoronary stents, since the mid 1990s.

Incidence and predictors of target vessel revascularization following percutaneous transluminal coronary angioplasty: a report from the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry.

We sought to determine the rate of target vessel revascularization (TVR) after percutaneous transluminal coronary angioplasty (PTCA) and to determine factors that predispose to its occurrence. The 10-year outcome of 2,262 patients in the National Heart, Lung, and Blood institute PTCA Registry was analyzed to determine the incidence and characterize predictors of TVR. TVR was performed in 30.4% of patients. Male gender (relative risk [RR] 1.26; p <0.05), diabetes (RR 1.57; p <0.001), multiple discrete lesions (RR 1.38, p <0.01), diffuse lesions (RR 1.27; p <0.05), and calcium at the lesion site (RR 1.25; p <0.05) were predictors for TVR. TVR was performed early (< or = 1 year) in 18.3% and late (> 1 year) in 12.2%. Age > or = 65 years (RR 1.24; p <0.05), congestive heart failure (RR 1.70; p <0.05), acute coronary insufficiency (RR 1.28; p <0.05), and left anterior descending lesion location (RR 1.34, p <0.01) were significant predictors of early versus late TVR by multivariate analysis. Coronary artery bypass grafting (CABG) rather than PTCA was the TVR procedure in 21% of patients undergoing early TVR and 58% of those undergoing late TVR. Significant independent predictors of CABG as the TVR procedure were multivessel disease (RR 1.97; p <0.001), presence of collateral vessels (RR 1.81; p <0.05), diffuse (RR 1.89; p <0.01), or occluded (RR 1.82; p <0.05) target lesions, and a greater residual stenosis after the initial PTCA (RR 1.19; p <0.001). Age > or = 65 years (RR 0.65; p <0.05) conferred a lower risk for CABG.

Coronary flow velocity response to adenosine characterizes coronary microvascular function in women with chest pain and no obstructive coronary disease. Results from the pilot phase of the Women's Ischemia Syndrome Evaluation (WISE) study.

OBJECTIVES: We sought to develop and validate a definition of coronary microvascular dysfunction in women with chest pain and no significant epicardial obstruction based on adenosine-induced changes in coronary flow velocity (i.e., coronary velocity reserve). BACKGROUND: Chest pain is frequently not caused by fixed obstructive coronary artery disease (CAD) of large vessels in women. Coronary microvascular dysfunction is an alternative mechanism of chest pain that is more prevalent in women and is associated with attenuated coronary volumetric flow augmentation in response to hyperemic stimuli (i.e., abnormal coronary flow reserve). However, traditional assessment of coronary volumetric flow reserve is time-consuming and not uniformly available. METHODS: As part of the Women's Ischemia Syndrome Evaluation (WISE) study, 48 women with chest pain and normal coronary arteries or minimal coronary luminal irregularities (mean stenosis = 7%) underwent assessment of coronary blood flow reserve and coronary flow velocity reserve. Blood flow responses to intracoronary adenosine were measured using intracoronary Doppler ultrasonography and quantitative angiography. RESULTS: Coronary volumetric flow reserve correlated with coronary velocity reserve (Pearson correlation = 0.87, p < 0.001). In 29 (60%) women with abnormal coronary microcirculation (mean coronary flow reserve = 1.84), adenosine increased coronary velocity by 89% (p < 0.001) but did not change coronary cross-sectional area. In 19 (40%) women with normal microcirculation (mean flow reserve = 3.24), adenosine increased coronary velocity and area by 179% (p < 0.001) and 17% (p < 0.001), respectively. A coronary velocity reserve threshold of 2.24 provided the best balance between sensitivity and specificity (90% and 89%, respectively) for the diagnosis of microvascular dysfunction. In addition, failure of the epicardial coronary to dilate at least 9% was found to be a sensitive (79%) and specific (79%) surrogate marker of microvascular dysfunction. CONCLUSIONS: Coronary flow velocity response to intracoronary adenosine characterizes coronary microvascular function in women with chest pain in the absence of obstructive CAD. Attenuated epicardial coronary dilation response to adenosine may be a surrogate marker of microvascular dysfunction in women with chest pain and no obstructive CAD.