Effect of clinical trials on survival after heart transplantation.

UNLABELLED: The application of clinical trials (CTs) to daily practice is based on the assumption that the patients included in these trials are similar to those seen on a daily basis. We performed a retrospective study to evaluate patient survival depending on whether they were included in a CT. We studied 217 patients who underwent heart transplantation (HT) between January 2000 and September 2006. We excluded patients who received combination transplants, those who underwent repeat HT, and pediatric patients who underwent HT. In total, 54 patients were included in a CT and 163 were not (NCT). The statistical tests included the t test, the chi(2) test and the Kaplan-Meier method. RESULTS: Patients in the NCT group were in worse condition at HT, with a greater percentage of inotropic treatments pre-HT (36% vs 17%; P = .005), emergency transplants procedures (30% vs 13%; P = .01), and worse functional status pre-HT (P = .03). The NCT group exhibited lower survival (80.37% vs 87.04%; P = 0.13, log-rank test). There were no significant differences in the other analyzed variables. CONCLUSIONS: Patients included in CTs tend to have better long-term survival rates, for several reasons: patients in the CT group were more stable at HT (selection bias), and the close follow-up of patients in CTs makes it more likely that any complication will be detected and treated early (follow-up bias).

Effect of circulatory assistance on premature death and long-term prognosis.

BACKGROUND: Patients undergoing urgent heart transplantation (HT) have a poorer prognosis and more long-term complications. The objective of this study was to compare the preoperative course in patients undergoing urgent HT according to the need for preoperative intra-aortic balloon counterpulsation (IABP). MATERIALS AND METHODS: We studied 102 consecutive patients including 23 patients with IABP who underwent urgent HT between January 2000 and September 2006. We excluded patients who received combination transplants, those who underwent repeat HT, and pediatric patients who underwent HT. The statistical methods used were the t test for quantitative variables and the chi(2) test for qualitative variables. A logistic regression model was constructed to assess the possible relationship between IABP and other variables on premature death within 30 days after HT. RESULTS: Mean (SD) patient-age was 50 (10) years. No significant differences were observed in baseline characteristics between the IABP and the non-IAPB groups. The IABP patient group had higher rates of acute graft failure (45.5% vs 35.4%; P = .46) and premature death (18.8% vs 14.8%; P = .67) and shorter long-term survival (40.6 [34.9] vs 54.5 [43.7] mo; P = .30). Multivariate analysis demonstrated no association between the need for IABP and increased frequency of premature death. CONCLUSIONS: Use of IABP is not associated with premature or late death. We recommend use of IABP in patients with acute decompensated heart failure to stabilize them before HT.

Effect of hypertension, diabetes, and smoking on development of renal dysfunction after heart transplantation.

BACKGROUND: Renal dysfunction is a serious problem after heart transplantation (HT). The objective of this study was to determine the cardiovascular risk factors associated with medium- to long-term dysfunction after HT. MATERIALS AND METHODS: We studied 247 consecutive patients who underwent HT between January 2000 and September 2006 who survived for at least 6 months. We excluded patients receiving combination transplants, those undergoing repeat HT, and pediatric patients undergoing HT. Mean (SD) follow-up was 72 (42) months. We defined renal dysfunction as serum creatinine concentration greater than 1.4 mg/dL during follow-up. Patients were considered to be smokers if they had smoked during the six months before HT, to have hypertension if they required drugs for blood pressure control, and to have diabetes if they required insulin therapy. Statistical tests included the t test and the chi(2) tests. We performed Cox regression analysis using significant or nearly significant values in the univariate analysis. RESULTS: Mean (SD) age of the patients who underwent HT was 52 (10) years, and 217 (87.9%) were men. Renal dysfunction was detected during follow-up in 135 (54.5%) patients. The significant variables at univariate analysis were smoking (61.4% vs. 43.2%; P = .01) and previous renal dysfunction (94.1% vs 52.7%; P = .001). Nearly significant variables were the presence of hypertension before HT (63.8% vs 51.1%; P = .09) and after HT (58.2% vs 44.8%; P = .082). At multivariate analysis, pre-HT smoking and previous renal dysfunction were significant correlates (P = .04 and P = .01, respectively). CONCLUSIONS: Renal dysfunction is common after HT. In our analysis, the best predictors were pre-HT dysfunction and smoking. Less important factors were advanced age and post-HT hypertension.

Hypertension after heart transplantation: predictive factors and number and classes of drugs for its management.

BACKGROUND: This study was performed to determine the factors that cause arterial hypertension after heart transplantation (HT) and the drugs used in its management. MATERIALS AND METHODS: We studied 247 consecutive patients who had undergone HT between 2000 and 2006 and who survived for at least 6 months. We excluded patients who received combination transplants, those who underwent repeat transplantation, and pediatric patients who had received transplants. Hypertension was defined as the need to use drugs for its control. Renal dysfunction was defined as serum creatinine concentration greater than 1.4 mg/dL, and diabetes as the need for an antidiabetes drug for its control. Statistical analyses were performed using the t test, the chi(2) test, and Cox regression. RESULTS: Mean (SD) patient age was 52 (10) years, and 87.4% of the patients were men. Follow-up was 72 (42) months. Hypertension was present in 33.3% of patients before HT and in 71.1% at some time after HT. The number of drugs used to control hypertension was 1.3 (0.5); one drug was used in 72.9% of patients. The most often used single class of drugs were calcium channel blockers (63.2%), followed by angiotensin-converting enzyme inhibitors (20%), and angiotensin receptor blockers (15.8%). Only pre-HT hypertension was significantly associated with greater use of antihypertensive drugs post-HT (mean [SD], 1.48 [0.65] vs 1.22 [0.41]; P = .005). At univariate analysis, only pre-HT hypertension was associated with the presence of post-HT hypertension (80.5% vs 65.5%; P = .02). At Cox regression analysis, recipient age (P = .02) and pre-HT hypertension (P = .004) were associated with post-HT hypertension. CONCLUSIONS: Hypertension is common after HT; however, in most patients, it can be controlled with a single antihypertensive agent. The most important factors in the development of hypertension are the presence of pre-HT hypertension and advanced age.

Influence of traditional cardiovascular risk factors in the recipient on the development of cardiac allograft vasculopathy after heart transplantation.

BACKGROUND: Cardiac allograft vasculopathy (CAV) is the leading cause of death heart transplant (HT) recipients after the first year. We assessed the influence of cardiovascular risk factors (CVRFs) in HT recipients on the development of CAV after 1 year of follow-up. MATERIALS AND METHODS: From 2001 to 2005, we studied 72 patients who received a HT and survived for at least 1 years. All patients underwent coronary arteriography and intravascular ultrasonography at 1 year after HT. Cardiac allograft vasculopathy was defined as intimal proliferation of 0.5 mm or more. The analyzed CVRFs were age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and smoking. We also considered the heart disease that was the reason for HT. The statistical tests used in the univariate analysis were the t and chi(2) tests. Logistic regression was performed with the variables obtained at univariate analysis. RESULTS: Mean (SD) recipient age at HT was 51 (9) years. Eighty patients (90.5%) were men. Dyslipidemia was significantly associated with a greater incidence of CAV at 1 year (68.3% vs 41.9%; P = .03). Ischemia, as opposed to all other causes, was also significantly associated with CAV (69.4% vs 44.4%; P = .03). Older age, hypertension, smoking history, and high body mass index were associated with a higher incidence of CAV, albeit without statistical significance. At multivariate analysis, dyslipidemia was the most significant CVRF (P = .045) for the development of CAV. CONCLUSIONS: Recipient dyslipidemia is a risk factor for the development of CAV in HT. The remaining traditional CVRFs are more weakly associated with CAV. After HT close monitoring of recipients with pretransplantation CVRFs is essential for early detection of CAV.

Impact of smoking on survival after heart transplantation.

INTRODUCTION: Smoking is an important risk factor in any population group. According to previous studies, having been a smoker before heart transplantation (HT) confers a greater likelihood of developing any type of tumor or other complication after HT. Our objective was to determine the impact of having been a smoker before HT on survival, respiratory complications during the postoperative period, and long-term tumor development. MATERIALS AND METHODS: After excluding combined transplantations, pediatric transplantations, and retransplantations, we retrospectively reviewed 288 HT performed between November 1987 and September 2006. We divided patients into nonsmokers (including those who quit smoking more than 1 year before HT (n = 163), exsmokers for less than 1 year (n = 76), and those who smoked until HT (n = 49). The statistical tests were chi-square, Student t, analysis of variance (ANOVA), and Kaplan-Meier curves. RESULTS: There were more male patients among smokers and exsmokers than nonsmokers (93.9% vs 96.1% vs 82%, respectively; P = .003). There were no differences in baseline characteristics between the groups. Exsmokers remained intubated for a longer time than smokers or nonsmokers (33.4 +/- 44.6 vs 14.2 +/- 7.3 vs 17.9 +/- 19.2, respectively; P = .05). We observed the same trend in recovery unit stay (7.9 +/- 10.5 days vs 4.4 +/- 1.88 days vs 4.84 +/- 3.49 days, respectively; P = .021). The development of any type of tumor was also more frequent among smokers and exsmokers, although not significantly. The survival rate was similar in nonsmokers and exsmokers, although higher than in smokers (89.57 vs 92.11% vs 81.63%, respectively; P = .031). We did not observe differences in the causes of death. CONCLUSIONS: Patients who smoke or have smoked until shortly before HT showed a poorer prognosis and a longer recovery unit stay. There was also a trend to increased tumor development.

Does amiodarone influence early mortality in heart transplantation?

The use of amiodarone before transplantation has been linked to an increased number of complications, acute graft failures, and early mortality after a heart graft. We undertook a retrospective, descriptive, case-controlled study involving early mortality and acute graft failure. The 396 consecutive patients included 25 subjects who had been prescribed amiodarone for at least 30 days before transplantation. We excluded retransplantations, pediatric transplantations, and combined transplantations. The endpoints were early mortality and acute graft failure. No significant differences were observed in early mortality and acute graft failures. The multivariate analysis did not reveal any variable that correlated with early mortality. Our study did not support the idea that amiodarone constituted a negative predictor of early survival or acute graft failure.

Incidence of development of obesity after heart transplantation according to the calcineurin inhibitor.

BACKGROUND: Development of obesity after heart transplantation (HT) is a common complication, largely attributed to immunosuppressive therapy. The objective of this study is to compare the incidence of development of obesity after HT, according to the calcineurin inhibitor (CNI) used (cyclosporine [CsA] vs tacrolimus [Tac]). METHODS: We studied 101 consecutive HT patients from November 2006 to December 2010. A diagnosis of overweight-obesity was made by a body mass index of ≥25 kg/m(2), which was assessed before HT and at 1 year after HT. Patients were randomly assigned to the administration of CsA or Tac by a simple randomization method using a computer program (56% received CsA and 44% Tac). RESULTS: Of the 101 patients, 77% were men, and ischemic heart disease was the most common indication for HT. At baseline, there were no differences in weight between groups treated with CsA or Tac. The mean weight for each group was 71.5 ± 12 and 75 ± 14 kg, respectively (P = .2). The weight increase was greater among CsA patients: after HT, the weight gain was 6.9 ± 11 kg in the CsA group, whereas a minimal weight loss of 0.03 ± 14 kg (P = .008) was experienced in the group treated with Tac. The multivariate analysis showed that only CsA treatment was an independent predictor of development of obesity 1 year after HT (odds ratio, 3.84; 95% CI, 1.04-14.21; P = .01). CONCLUSION: Weight gain after HT may be related to the CNI used and CsA seems to be the CNI that produces the greatest increase.

Is age a limiting factor for access to transplantation?

As a result of increased life expectancy and quality of life, there is an increasing number of patients older than 65 years of age who require the possibility of heart transplantation (HTx). Traditionally, recipient age older than 65 years has been considered a contraindication for performing a HTx because these patients have more comorbidities, are more affected by the adverse effects of immunosuppressive drugs, and obtain a smaller benefit in the medium and long term. Therefore, given the shortage of donors, priority was given to younger recipients. In recent years, studies have been published demonstrating that HTx in this population segment is possible. These results indicate that despite suffering more infections and having longer hospital stays, these patients have fewer rejections, with an overall survival in the medium and long term similar to that of HTx in younger patients. These results have been achieved partly as a result of appropriate selection of recipients and emergence of new immunosuppressive agents that has allowed their use to be individualized to the characteristics and comorbidities of each patient. Despite the latest advances, longer-term multicenter studies are required to clarify the role of alternate lists and the impact of new ventricular assist devices in this population segment.

Long-term prognostic implications of metabolic syndrome in heart transplant recipients.

BACKGROUND: Metabolic syndrome (MS) increases the risk of cardiovascular events due to endothelial dysfunction. There are few studies evaluating the impact of MS on the survival of heart transplantation (HTx) patients. AIM: The aim of this study was to study the impact of MS in the early period and on the long-term survival after HTx. MATERIALS AND METHODS: We studied 196 HTx patients with a minimum survival of 1 year post-HTx. A diagnosis of MS was made at 3 months after HTx, if at least 3 of the following criteria were met: triglyceride levels ≥150 mg/dL (or drug treatment for hypertriglyceridemia); high-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men and <50 mg/dL in women (or drug treatment to raise HDL-C levels); diabetes mellitus on drug treatment or fasting glucose levels ≥100 mg/dL; blood pressure ≥130/85 mm Hg (or on antihypertensive drug treatment); and body mass index (BMI) ≥30. We used the Kaplan-Meier method (log-rank test) to calculate long-term survival and Student t and chi-square tests for comparisons. RESULTS: Among 196 patients, 96 developed MS. There were no differences between the groups with versus without MS in recipient gender, underlying etiology, smoking, pre-HTx diabetes, or immunosuppressive regimen. However, differences were observed between groups in age (MS: 53 ± 9 vs non-MS: 50 ± 12 years; P = .001); pre-HTx creatinine (MS: 1.2 ± 0.3 vs non-MS: 1.0 ± 0.4 mg/dL; P = .001); BMI (MS: 27.3 ± 4 vs non-MS: 24.6 ± 4; P = .001); pre-HTx hypertension (MS: 48% vs non-MS: 17%; P < .001); and dyslipidemia (MS: 53% vs non-MS: 37%; P = .023). Long-term survival was better among the non-MS group, but the difference did not reach significance (MS: 2381 ± 110 vs non-MS: 2900 ± 110 days; P = .34). CONCLUSIONS: The development of MS early after HTx is a common complication that affects nearly 50% of HTx patients. The prognostic implication of this syndrome on overall survival might occur in the long term.

Proliferation signal inhibitors in heart transplantation: a 5-year experience.

INTRODUCTION: Calcineurin inhibitors (CNI) are associated with multiple complications, especially renal dysfunction and tumor development. Proliferation signal inhibitors (PSI) show renal protection and an antineoplastic effects, and may retard allograft vasculopathy. The objective of the current study was to present our initial experience center with PSI therapy. MATERIALS AND METHODS: We analyzed all heart transplants (HT) performed in our center who received a PSI at any time. We assessed the clinical profiles, indications for and strategies of PSI introduction, complications, causes of discontinuation, and renal functional evolutions. RESULTS: Among 604 HT performed in our center, 82 patients (13.5%) received a PSI: sirolimus (n=2) or everolimus (n=80). Their mean age was 53±12 years and 90% were men. PSI introduction occurred at 75±53 months posttransplantation. The strategy was CNI minimization in 17% of cases, and total conversion from CNI in 83%. The PSI indication was renal dysfunction (40%), tumors (38%), allograft vasculopathy (17%), and other reasons (5%). After PSI introduction, 15.8% of patients suffered a rejection episode and 20%, a significant infection. The PSI discontinuation rate was 8.5%: due to infection (2.4%), edema (1.2%), inadequate cicatrization (1.2%), and other reasons (3.7%). Creatinine was 1.68±0.64 mg/dL the year before and 1.72±0.79 mg/dL at and 1.82±1.61 mg/dL 1 year after PSI conversion. CONCLUSION: PSIs showed few complications with a low withdrawal rate, and maintained renal function. The main indications for their use were renal dysfunction, tumors, or development of allograft vasculopathy.

Timing, etiology, and location of first infection in first year after heart transplantation.

BACKGROUND: Infections are the leading cause of death in the first year after heart transplantation (HTx) after the postoperative period. OBJECTIVE: To describe the timing, etiology, and location of the first infection occurring in the first year after HTx. PATIENTS AND METHODS: The study included 604 HTx procedures performed at our center from November 1987 to September 2009. Infections were classified as those requiring hospital admission or that prolonged hospital stay. Infection was established on the basis of clinical findings and supplementary test results. Etiologic diagnosis was established at microbiological culture. Infections were categorized as bacterial, viral, fungal, protozoal, or of unknown origin, and were grouped according to microorganism family. Time to occurrence of infection is given as mean (interquartile range). Locations considered were systemic, pulmonary, genitourinary, cutaneous, oropharyngeal, mediastinal, sternal, gastrointestinal, and other. RESULTS: Mean (SD) patient age was 51 (12) years, and 83.8% of patients were men. Almost half of all patients (42.9%) experienced some type of infection in the first year after HTx. The most frequently occurring infections were bacterial (49.6%) and viral (38.7%), with fewer fungal (6.3%), protozoal (1.2%), and of unknown origin (4.3%). Staphylococci were the most commonly isolated organisms (10.5%) in bacterial infections, cytomegalovirus (21.1%) in viral infections, and Candida (2.3%) and Aspergillus (2.3%) in fungal infections. Early-onset infections (n=2; 1-7 days) were caused by Candida spp, and late-onset infections (n=110; 14-182 days) by a mixed group of bacteria. The sternum was the site of early-onset infections (n=9; 6-14 days), and the genitourinary tract was the site of late-onset infections (n=110; 28-180 days). CONCLUSIONS: Nearly half of HTx recipients experience a significant infection during the first year posttransplantation. Early-onset infections occur in critical care units, are caused by nosocomial organisms, and involve the sternum or mediastinum, whereas late- onset infections have a more varied etiology and preferentially affect the skin and genitourinary tract.

Mycophenolate acid vs mycophenolate mofetil therapy.

BACKGROUND: Mycophenolate mofetil (MMF) is included in the basic immunosuppression regimen in heart transplantation (HTx). Classically, the mycophenolic acid (MPA) concentration has not been considered to provide clinical information. OBJECTIVE: To perform a comparative analysis of MMF dosage and MPA concentration and their effect on post-HTx renal function. PATIENTS AND METHODS: Sixty patients underwent HTx between January 2007 and April 2009, and were followed up at 4 scheduled visits in 6 months. The standard MMF dose was 1000 mg/12 h, with adjustment according to clinical criteria. The MPA concentration was determined using an enzyme-multiplied immunoassay (EMIT 2000; Siemens Healthcare Diagnostics Inc, Deerfield, Illinois), without change in dosage. The correlation between mean MMF dosage and MPA concentrations at all visits vs renal function values was analyzed using serum creatinine concentration, creatinine clearance (CrCl; Modification of Diet in Renal Disease), and glomerular filtration rate (GFR; Cockcroft-Gault formula). RESULTS: Mean (SD) patient age was 50 (13) years, and 45 of 60 (75.4%) were men. Pre-HTx values were as follows: creatinine concentration, 1.13 (0.47) mg/dL; CrCl, 81.59 (36.84) mL/min/1.73 m2; and GFR, 77.46 (30.60) mL/min. In the first 6 months post-HTx, significant negative correlations were observed between mean MPA concentration and creatinine concentration (r=.42; P=.001), CrCl (r=-.36; P=.01), and GFR (r=-.45; P=.001). No correlation was observed with mean MMF dosage. CONCLUSION: There are important differences in the relationship of MPA concentration vs MMF dosage and post-HTx renal function. Although studies with a larger number of patients are needed, treatment guided by MPA concentration seems reliable for evaluation of renal function.

Lymphomas in heart transplant recipients: do antivirals protect against the neoplastic effect of anti-CD3 monoclonal antibody?

INTRODUCTION AND AIM: After cardiac allograft vasculopathy, tumors are the second leading cause of death among heart transplantation (HT) patients after the first year. Lymphomas are tumors of lymphocytic origin whose development has been associated with the use of anti-CD3 monoclonal antibody (OKT3). Some studies suggest that the use of acyclovir could counteract this effect. Our aim was to investigate the impact of gancyclovir on OKT3 and lymphoma development after HT. MATERIALS AND METHODS: We included all 239 HTs performed in our center from 1989 to 2002. We divided patients into those who received gancyclovir treatment (prophylaxis, pre-emptive therapy, or for cytomegalovirus infection) versus those who did not receive this agent at any time during follow-up (88 vs 151 patients). The statistical methods were Student's t and chi-square tests. RESULTS: There were no differences in the baseline characteristics of the patients--gender, recipient age, etiology leading to HT, diabetes, and dyslipidemia--except for a higher rate of hypertension among the group who did not receive gancyclovir (73.7 vs 60.2%; P=.03). None of the 7 patients who developed lymphomas during the follow-up received gancyclovir (0 vs 4.6%; P=.040). CONCLUSIONS: Antivirals may have a relevant role to neutralize potential neoplastic effects (especially lymphomas) associated with the use of OKT3 induction therapy.

Can we accept donors who have suffered a resuscitated cardiac arrest?

INTRODUCTION AND AIMS: The shortage of donor organs has prompted increased acceptance of hearts from donors with more comorbidities. With increasing frequency, hearts are being offered from patients who have undergone a resuscitated cardiac arrest (RCA). Our aim was to compare the rate of complications in the postoperative and follow-up periods, depending on whether the transplanted organ came from a donor who had undergone an RCA. MATERIALS AND METHODS: We included all 604 heart transplantations (HTs) performed in our center from 1987 to 2009, including 25 recipients who received an organ from a donor who had undergone RCA. We considered RCA to be an in-hospital cardiac arrest that was resuscitated from the onset, with a duration of <30 minutes, and with total recovery of cardiac and hemodynamic function. We analyzed ischemia time, incidence of acute graft failure (AGF), intubation period, recovery room stay, and long-term survival. The statistical methods were Student t and chi-square tests. RESULTS: There were no differences in baseline characteristics, except that patients in the RCA group were younger (47±13 vs 51±11 years; P=.50). There were also no differences between the RCA group and the other patients in ischemia time (151±50 vs 154±53 minutes; P=.826), incidence of AGF (33% vs 24.7%; P=.311), hours of intubation (76±204 vs 72±249; P=.926), days of recovery room stay (6±7 vs 8±6; P=.453), or survival after HT (53±54 vs 53±52 months; P=.982). CONCLUSIONS: Patients receiving a heart from a patient with an in-hospital RCA and subsequent hemodynamic stability have a similar outcomes to other HT patients.

Post-heart transplant tumors: chronology and impact on survival.

INTRODUCTION AND AIMS: Tumors are the second leading cause of death beyond the first year heart transplantation (HT). The aim of our study was to establish a chronology for the occurrence and the impact on overall survival of de novo neoplasms after HT. MATERIALS AND METHODS: We included 597 patients undergoing HT from January 1987 to December 2008. De novo tumors were classified into groups: Kaposi's sarcoma, melanoma, epidermoid skin carcinoma, other skin tumors, lung neoplasms, bladder tumors, prostate adenocarcinoma, digestive tumors, lymphomas, and other tumors. We based the study on the median value and interquartile range of the tumors to estimate their occurrence. Survival rates were calculated using Kaplan-Meier curves and the log-rank tests. We included only patients with survivals beyond 1 year after HT. RESULTS: A total of 109 tumors developed during the follow-up. There were no differences in the survival of patients who lived more than 1 year regarding the development or not of a tumor (155±8 vs 179±6 months; P=.177). CONCLUSIONS: The incidence of tumor occurrence after HT was high (18.25%). There were several periods in which the occurrence of certain tumors was more frequent, while other periods appeared to be tumor-free. As most tumors were skin cancers, their impact on overall survival was low.

Preliminary results of a prospective randomized study of cyclosporine versus tacrolimus in the development of cardiac allograft vasculopathy at 1 year after heart transplantation.

INTRODUCTION AND AIMS: Cardiac allograft vasculopathy (CAV) is the leading cause of death after the first year post-heart transplantation (HT). Numerous factors have been implicated in the development of CAV. The aim of this prospective randomized study was to assess the impact of cyclosporine (CsA) and tacrolimus (Tac) on the development of CAV. MATERIALS AND METHODS: From November 2006 to October 2008, 49 HT patients in our center were randomized to receive CsA or Tac. The additional treatment for all patients consisted of daclizumab induction and maintenance treatment with mycophenolate mofetil (1 g/12 hours) and steroids (withdrawal was not attempted). Thirteen patients died before coronary arteriography plus intravascular ultrasound of the left anterior descending artery was performed at 1 year after HT. Hence, the final number of patients included was 36 (18 per group). We considered significant CAV to be the presence of intimal proliferation>1 mm and/or>0.5 mm in 180°. The statistical methods were Student t and chi-square tests. RESULTS: There were no differences in baseline characteristics between the two groups. Nor were there significant differences in maximum intimal proliferation between the groups (CsA 0.65±0.29 vs Tac 0.82±0.51 mm; P=.292) or in the development of significant CAV when both criteria were combined (CsA 31.6% vs Tac 38.9%; P=.642). CONCLUSIONS: One year after HT, no differences were detected in the development of significant CAV according to the type of calcineurin inhibitor used when combined with daclizumab induction and maintenance treatment with mycophenolate mofetil and steroids.