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.

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.

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.

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.

Long-term analysis of conventional coronary balloon angioplasty and an initial "stent-like" result. The NHLBI PTCA Registry.

OBJECTIVES: We examined the influence of an initial "stent-like" result on long-term outcome in patients in the 1985-86 NHLBI PTCA Registry. BACKGROUND: Stent use in selected patients is associated with improved angiographic and short-term clinical outcome; however, due to potential for in-stent restenosis and high costs of stents, there is interest in a strategy of more optimal dilatation to achieve a "stent-like" result without a stent. The long-term outcome of patients with a "stent-like" percutaneous transluminal coronary angioplasty (PTCA) remains unknown. METHODS: Ten-year outcome was compared between 225 successfully treated patients with and 1,764 successfully treated patients without an initial "stent-like" result ( > or = 1 lesion dilated to < or = 10% stenosis). The sample had 75% and 80% power, respectively, to detect an absolute difference of 8% in the 10-year rate of death and myocardial infarction (MI) between the two groups. RESULTS: Ten-year rates of death and MI were similar between the stent-like and non-stent-like groups (22.3% vs. 22.2%, 17.6% vs. 17.9%), however, there was less target lesion revascularization in the stent-like group (30.2% vs. 36.8%). In subgroup analysis of patients with multivessel disease, those with a stent-like result had less follow-up bypass surgery (25.2% vs. 32.7%), yet more repeat PTCA (53.8% vs. 42.7%). These findings were unaffected by adjustment for differences in baseline characteristics between the two patient groups. CONCLUSIONS: Achievement of an initial stent-like result via balloon angioplasty alone may not appreciably reduce the long-term risk of death or MI, nor confer equivalent clinical benefit as achieving a stent-like result with a stent.

Cause of death analysis in the NHLBI PTCA Registry: results and considerations for evaluating long-term survival after coronary interventions.

OBJECTIVES: We examined cause of death in relation to age, length of follow-up and other baseline characteristics in patients in the 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty (NHLBI PTCA) Registry. BACKGROUND: The manner in which cardiac versus noncardiac mortality of patients with coronary revascularization varies in relation to patient and study characteristics has not been well documented. METHODS: Cause of death determined from a review of 5 years of annual follow-up forms and death certificates was analyzed in 2,127 patients who had coronary angioplasty (mean age 57.6 years) without acute myocardial infarction. RESULTS: Within 5 years of the initial procedure, there were 205 deaths (9.6%), with 52.7% attributed to cardiac causes. Patients with a low baseline ejection fraction, history of hypertension, previous bypass surgery, previous myocardial infarction, inoperable or high surgical risk or multivessel disease had significantly higher 5-year cardiac mortality. Patients with a history of diabetes, congestive heart failure or severe concomitant noncardiac disease had higher rates of both cardiac and noncardiac mortality. As length of follow-up increased, older patients died of noncardiac causes more often than cardiac causes. Age > or = 65 years was a strong independent predictor of 5-year noncardiac mortality (p < 0.001), but not cardiac mortality (p = 0.08). CONCLUSIONS: All-cause mortality rates may be high in elderly revascularized patients, yet cardiac mortality may be less than that expected because of a high risk of noncardiac death. Although all-cause mortality is a more reliable end point than cause-specific mortality, both cardiac and all-cause mortality should be considered in coronary intervention studies involving older patients and long-term follow-up.

Treatment of patients admitted to the hospital with congestive heart failure: specialty-related disparities in practice patterns and outcomes.

OBJECTIVES: This study sought to define specialty-related differences in the care and outcome of patients admitted to the hospital with congestive heart failure (CHF). BACKGROUND: Congestive heart failure is the leading diagnosis-related group (DRG) discharge diagnosis in the United States and accounts for an estimated annual hospital cost in excess of $7 billion. The clinical impact of aggressive CHF management and the importance of the subspecialist in guiding this care have not been evaluated. METHODS: To define differences in physician practice patterns, we performed a chart review of consecutive patients admitted to a university teaching hospital with a primary DRG discharge diagnosis of CHF. We compared treatment and outcome of patients cared for by a generalist (n = 160) and those whose care was guided by a cardiologist (n = 138) during their index hospital period with CHF and over the next 6 months. RESULTS: At our institution, > 50% of patients admitted to the hospital with CHF cared for by generalists alone had minimal (New York Heart Association functional class I or II) symptoms, compared with < 15% of those cared for by a cardiologist (p < 0.01). Although generalists' patients underwent significantly fewer in-hospital diagnostic tests and had shorter lengths of stay, they had a 1.7-fold increased risk of readmission for CHF within 6 months (p < 0.05). Six-month cardiac and all-cause mortality were not significantly different between the groups. The type of physician caring for the patient and a history of diabetes, previous CHF or myocardial infarction were independent predictors of readmission for CHF. CONCLUSIONS: Involvement of a cardiologist in the care of patients admitted to the hospital with CHF is associated with increased use of diagnostic testing, longer hospital stays and improved clinical outcome. These results substantiate practice guidelines that suggest a role for cardiologists in the care of symptomatic patients with CHF.

Contemporary practice of coronary revascularization in U.S. hospitals and hospitals participating in the bypass angioplasty revascularization investigation (BARI).

OBJECTIVES: To assess generalizability of the Bypass Angioplasty Revascularization Investigation (BARI), we conducted a separate study comparing revascularization in U.S. and BARI hospitals. BACKGROUND: The BARI trial is a multicenter investigation comparing initial revascularization with percutaneous transluminal coronary angioplasty and coronary bypass graft surgery in patients with symptomatic multivessel coronary disease. METHODS: All revascularization procedures during 5 consecutive workdays were surveyed at 75 U.S. hospitals offering coronary angioplasty and bypass surgery and at all BARI hospitals. Data collected were demographics, extent of disease and type of current and previous revascularization. RESULTS: At both U.S. and BARI hospitals, 57% of all revascularization procedures were coronary angioplasty and 43% were bypass surgery. The U.S. hospitals had more patients with single-vessel disease, acute myocardial infarction and primary procedures. Other characteristics were similar. The majority of revascularization procedures were angioplasty for single-vessel disease (U.S. 32% vs. BARI 25%) and bypass surgery for triple-vessel disease (U.S. 31% vs. BARI 31%). Overall, the choice between bypass surgery and angioplasty was similar in BARI and U.S. hospitals (adjusted odds ratio [OR] 1.0, p = 0.914). However, older patients were more likely and younger patients less likely to undergo bypass surgery in BARI versus U.S. hospitals (older patients: adjusted OR 1.6, p = 0.031; younger patients: adjusted OR 0.6, p = 0.028). The BARI protocol would have excluded 65% of all candidates for revascularization, for whom indications already exist for angioplasty or bypass surgery, and another 23%, for whom angioplasty would be contraindicated for individual lesions. CONCLUSIONS: Patients undergoing coronary revascularization in BARI and U.S. hospitals were generally similar, as was the choice between types of revascularization. Results from the BARI trial apply to approximately 300 (12%) candidates for coronary revascularization/workday.

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.

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.

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.

Balloon angioplasty versus new device intervention: clinical outcomes. A comparison of the NHLBI PTCA and NACI registries.

OBJECTIVES: We sought to compare outcomes of patients treated in the National Heart, Lung, and Blood Institute (NHLBI) Percutaneous Transluminal Coronary Angioplasty (PTCA) and New Approaches to Coronary Intervention (NACI) registries. BACKGROUND: Coronary angioplasty has numerous shortcomings. New devices for performing coronary interventions have been introduced in an effort to improve clinical outcomes. METHODS: Under the sponsorship of the NHLBI, a registry of consecutive patients treated with PTCA during 1985 to 1986 was established. In 1990, the NHLBI funded a second registry, the NACI. The two registries used the same data coordinating center to collect detailed baseline and follow-up information. RESULTS: Patients enrolled in the NACI registry were older, had undergone more previous bypass surgery procedures and had more stenoses located in bypass grafts than patients in the NHLBI PTCA registry. Procedural success was achieved in 72.1% and 82.6% of patients in the PTCA and NACI registries, respectively; however, in-hospital and 1-year mortality rates were 1.0% versus 1.8% and 3.1% versus 5.9% for the PTCA versus NACI registries, respectively. After risk adjustment, there was no difference in 1-year mortality. Rates of target lesion revascularization (TLR) were 21.5% for the PTCA registry and 24.2% for the NACI registry. NACI registry patients had a higher risk for TLR and the composite end point of death, myocardial infarction or revascularization (relative risk 1.28 and 1.23, respectively). However, the NACI registry patients who received stents tended to have a lower adjusted TLR rate. CONCLUSIONS: This comparative study found no overall superiority of these newer devices in terms of patient survival or freedom from TLR after adjustment for baseline risk profiles. Although technologic improvements (especially improved stenting) continue, these observations highlight the importance of careful assessment of clinical results in the broad population of patients in whom interventions are used.

Bailout and corrective use of Gianturco-Roubin flex stents after percutaneous transluminal coronary angioplasty: operator reports and angiographic core laboratory verification from the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry.

OBJECTIVES: We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device. BACKGROUND: Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry. METHODS: Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included. RESULTS: The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients. CONCLUSIONS: Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.

Is a strategy of intended incomplete percutaneous transluminal coronary angioplasty revascularization acceptable in nondiabetic patients who are candidates for coronary artery bypass graft surgery? The Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: Our objective was to determine whether a strategy of intended incomplete percutaneous transluminal coronary angioplasty revascularization (IR) compromises long-term patient outcome. BACKGROUND: Complete angioplasty revascularization (CR) is often not planned nor attempted in patients with multivessel coronary disease, and the extent to which this influences outcome is unclear. METHODS: Before randomization, in the Bypass Angioplasty Revascularization Investigation, all angiograms were assessed for intended CR or IR via angioplasty. Outcomes were compared among patients with IR intended if assigned to angioplasty, randomized to coronary artery bypass graft surgery (CABG) versus angioplasty; and within angioplasty patients only, among patients with IR versus CR intended. RESULTS: At 5 years, there was a trend for higher overall (88.6% vs. 84.0%) and cardiac survival (94.5% vs. 92.1%) in CABG versus angioplasty patients with IR intended. The excess mortality in angioplasty patients occurred solely in diabetic subjects; overall and cardiac survival were similar among nondiabetic CABG and angioplasty patients. Freedom from myocardial infarction (MI) at 5 years was higher in nondiabetic CABG versus angioplasty patients (92.4% vs. 85.2%, p = 0.02), vet was similar to the rate observed (85%) in nondiabetic CABG and angioplasty patients with CR intended. Five-year rates of death, cardiac death, repeat revascularization and angina were similar in all angioplasty patients with IR versus CR intended. However, a trend for greater freedom from subsequent CABG was seen in CR patients (70.3% vs. 64.0%, p = 0.08). CONCLUSIONS: Intended incomplete angioplasty revascularization in nondiabetic patients with multivessel disease who are candidates for both angioplasty and CABG does not compromise long-term survival; however, subsequent need for CABG may be increased with this strategy. Whether the risk of long-term MI is also increased remains uncertain.

Chronic liver allograft rejection: a National Institute of Diabetes and Digestive and Kidney Diseases interinstitutional study analyzing the reliability of current criteria and proposal of an expanded definition. National Institute of Diabetes and Digestive and Kidney Diseases Liver Transplantation Database.

A study was conducted to assess the inter and intrarater agreement for the histopathologic features and diagnosis of chronic rejection (CR) and several other important causes of late liver allograft dysfunction. On two occasions, five pathologists, experienced with liver transplantation, reviewed a set of 49 slides representing a range of diagnoses, without knowledge of the clinical history or liver injury test results. The readings were correlated with the original histopathologic diagnosis, liver injury tests, and clinicopathologic follow-up. Assessment of biopsy adequacy (kappa = 0.69) and portal tract counts (kappa = 0.79) showed good to excellent intrarater agreement, whereas interrater agreement for these variables was moderate to good, respectively (kappa = 0.44 and 0.65). Likewise, the intrarater agreement for the diagnosis of CR (kappa = 0.68), hepatitis (kappa = 0.77), and obstructive cholangiopathy (kappa = 0.55) showed good to excellent agreement, whereas the interrater agreement for these same diagnoses ranged from fair to good (kappa = 0.58, 0.46, and 0.25, respectively). In 18 specimens, there was a near unanimous diagnosis of CR across both readings. These biopsies were obtained at a median of 7.1 months (range, 42 days to 4.9 years) after transplantation, and the average number of portal tracts was 8.4 (range, 4-15). Interestingly, only 13 of these 18 specimens showed bile duct loss in >50% of the portal triads; the remaining cases showed atrophy/pyknosis of the biliary epithelium in a majority of small bile ducts. Clinicopathologic correlation showed that these 18 biopsies were obtained from 16 grafts from 15 patients, 14 of whom ultimately required retransplantation or died of or with CR, whereas two of the grafts/patients recovered. A high rate of sensitivity (92%) and a somewhat lower, but acceptable, rate of specificity (71% to 80%) was found for the diagnosis of CR. Chronic rejection and other causes of late liver allograft dysfunction can be diagnosed reliably by a group of pathologists experienced with liver transplantation, and the diagnosis of CR correlates with clinical course and liver function abnormalities. Expanded criteria for the diagnosis of CR are presented, and potential problem areas for practicing pathologists are discussed.

Increased waiting time for liver transplantation results in higher mortality.

BACKGROUND: Waiting time to liver transplantation (LTx) has dramatically lengthened, but the proportion of candidates who die awaiting transplantation has not increased. We evaluated whether longer waiting time for LTx candidates increases mortality. METHODS: A cohort of candidates listed for LTx between 1990 and 1993 by three large transplantation programs was followed for 2 years. The exposure measure was ABO blood type, which is not inherently related to outcome, but is a major determinant of waiting time. The main outcome measure was 2-year mortality, as evaluated by logistic regression analysis that controlled for differences in clinical status at the time of evaluation for LTx. RESULTS: The 308 candidates with type O blood waited longer for LTx (median 109 days) than the 399 candidates with other blood types (median 58 days) (P=0.001). Candidates listed for LTx with type O blood had better clinical status at evaluation, but then had higher pretransplantation mortality (13.3%) than other candidates (7.0%) (P=0.005). Blood group O candidates had higher 2-year mortality (26.6%) than other candidates (22.1%), which on multivariate analysis resulted in a mortality odds ratio at 2 years of 1.52 (95% confidence interval=1.04-2.23). With the difference in median waiting time between blood groups increasing from 44 days in the first year to 108 days in the third year, the 2-year mortality odds ratio also rose from 0.94 to 1.97. CONCLUSIONS: When compared with LTx candidates with other blood types, blood type O candidates have longer waiting times and higher pretransplantation mortality, which results in higher 2-year mortality.

Strategy of complete revascularization in patients with multivessel coronary artery disease (a report from the 1985-1986 NHLBI PTCA Registry).

Percutaneous transluminal coronary angioplasty (PTCA) is increasingly performed in patients with multivessel coronary artery disease (CAD) despite reports showing relatively low rates of complete revascularization and poorer long-term prognosis for patients with significant residual narrowings. Reasons for incomplete revascularization were assessed in 618 patients with multivessel CAD in the 1985-1986 National Heart, Lung, and Blood Institute (NHLBI) PTCA Registry. The PTCA operator was asked to describe the treatment plan and outcome for each of the 1,942 significant lesions (greater than or equal to 50% luminal diameter stenosis) in the Registry patients. Although all significant narrowings were considered amenable to balloon angioplasty in 77% of patients, complete correction was intended only for 34% of them. It was attempted in 28% and successful in 19%. Only 63% of total occlusions were considered amenable to PTCA and only 54% of those attempted were successfully dilated. PTCA was intended for 38% with 50 to 69% stenoses versus 80% with 70 to 89% stenoses and for greater than 85% with narrowings greater than or equal to 90%. Dilatation in narrowings of the left circumflex and left anterior descending artery systems was intended less frequently than in lesions of the right coronary artery. Finally, there was wide variability in operator strategy among the different Registry sites.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute coronary events associated with percutaneous transluminal coronary angioplasty.

Acute coronary events reported in patients enrolled in the NHLBI PTCA Registry were analyzed. Data were collected on 3,079 patients from 105 contributing centers. Coronary vascular events (dissection, occlusion, spasm, embolism, perforation or rupture) or ischemic events (MI or prolonged angina) occurred in 418 patients (13.6%). Major complications (MI), emergency surgery or death) occurred in 280 patients (67%) with acute coronary events. The most frequent events were prolonged angina, which occurred in 211 (6.8%), and MI, in 170 (5.5%). Coronary dissection, occlusion and spasm each occurred in approximately 5% of patients. Coronary embolism, perforation and rupture were rare (less than 0.2% for each). Dissection and occlusion each had a high frequency (greater than 80%) of associated major complications. A substantially lower incidence of major complications occurred in patients with isolated coronary spasm (18%) or prolonged angina (35%). Clinical and angiographic predictors for overall and specific events were identified. Coronary events occurred more frequently in women and patients with unstable angina. Eccentric lesions were associated with a higher rate of coronary events, and event rates were lower with single discrete lesions than with other types of lesions. The frequency of any coronary event, MI, prolonged angina and coronary spasm each decreased with increasing experience with PTCA. The frequency of dissection and occlusion did not change with experience.

Five-year effect of medical and surgical therapy on resting left ventricular function in stable angina: Veterans Administration Cooperative Study.

The effect of coronary artery bypass grafting (CABG) and medical therapy on 5-year resting left ventricular (LV) function was studied in 194 randomized patients with stable angina in the Veterans Administration Study of Coronary Artery Bypass Surgery. LV ejection fraction (EF) was determined in a central laboratory. The 92 medical and 102 surgical patients were comparable at entry with respect to historic, angiographic and electrocardiographic prognostic indicators. Twenty-eight percent of the medical and 30% of the surgical patients had a baseline EF of less than 50%. There was no significant change in mean EF between baseline and 5-year values in either treatment group. The baseline and 5-year values were 56 and 58% in each treatment group. Intervening myocardial infarction (MI) had an adverse effect in medically treated patients (59 to 46%, p less than 0.01) and in surgically treated patients with late MI (58 to 47%, difference not significant). Perioperative MI was not associated with a decrease in EF (56 to 58%, difference not significant). These findings extend the similar results of previous short-term studies of the effect of coronary bypass surgery on resting LV function to 5 years, and provide data in a comparable medical control group.

Emergency coronary bypass surgery after coronary angioplasty: the National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry experience.

The frequency and outcome of emergency CABG for complications of PTCA in the NHLBI PTCA Registry were analyzed. Emergency surgery was performed in 202 patients (6.6%). The most frequent indications for emergency operation were coronary dissection in 46%, coronary occlusion in 20%, prolonged angina in 14% and coronary spasm in 11%. Emergency surgery was most often necessary in patients in whom lesions could not be reached or traversed, but more than 25% of patients who required emergency surgery had initially successful dilatation followed by abrupt reclosure of the vessel. The mortality rate with emergency CABG was 6.4%, and nonfatal MI occurred in 41% of patients, with Q waves developing in approximately 60% of patients with MI. However, 53% of patients managed with emergency CABG for severe ischemic events with PTCA did not have evidence of MI or die and had an uncomplicated postoperative course. No baseline clinical predictors of emergency surgery were identified. Lesion eccentricity was associated with a significant increase in frequency of emergency operation, and the incidence of emergency surgery declined with increasing experience with PTCA.