Prediction of neonatal coarctation of the aorta at fetal echocardiography: a scoring system.

INTRODUCTION: Coarctation of the aorta (CoA) is common and can lead to neonatal emergency. Despite its burden, antenatal detection of this condition remains inaccurate. OBJECTIVE: To evaluate the diagnostic performance of fetal echocardiography and to design a scoring system for risk stratification of CoA in suspected cases. DESIGN: A retrospective cohort study. SETTING: S. Orsola Hospital, Bologna, Italy. POPULATION: About 140 fetuses referred for suspected CoA to our tertiary center in a 9-year period. METHODS: The following parameters were systematically obtained at fetal echocardiography: ventricular disproportion, great vessels asymmetry, transverse aortic arch hypoplasia, flow turbulence, and Z-scores of the ascending aorta and of the aortic isthmus. Associated anomalies were recorded, if present. When CoA was not confirmed at birth, neonates were followed up for 12 months to identify also a tardive onset of this condition. MAIN OUTCOME MEASURES: The primary outcome was the presence of COA after birth. RESULTS: 108 fetuses were eligible for the purpose of the study. CoA was confirmed postnatally in 55 neonates (50.9%). Arch hypoplasia yielded the highest correlation with CoA. The affected neonates presented also significantly lower Z scores of the ascending aorta and of the aortic isthmus. Earlier gestational age at referral was positively correlated with neonatal CoA. An odds ratio-based multiparametric model was designed to build a scoring system (AUC 0.89). CONCLUSION: In our cohort, no single ultrasound parameter was sufficiently accurate to predict postnatal CoA. The scoring system permitted a better identification of the affected fetuses.

Impact of Elective, Uncomplicated Target Lesion Revascularization on Cardiac Mortality After Elective Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Disease.

This study sought to investigate the impact of elective, uncomplicated target lesion revascularization (TLR) on long-term cardiac mortality after percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) disease. Consecutive patients undergoing PCI for ULMCA disease between January 2003 and December 2015 in 1 interventional center in Northern Italy were included. Patients presenting with cardiogenic shock, ST-segment elevation myocardial infarction (MI), as well as those undergoing urgent or complicated TLR were excluded. The primary endpoint of the study was cardiac mortality. Among the 418 patients fulfilling the study criteria, 79 (18.46%) underwent elective, uncomplicated TLR. After a median follow-up of 5.5 years, there were 23 cardiac deaths among patients undergoing elective, uncomplicated TLR versus 50 in patients not undergoing TLR. After adjusting for possible confounders, TLR was an independent predictor of cardiac mortality (Hazard ratio [HZ] = 1.92, 95% confidence interval [CI]: 1.05 to 3.49; p = 0.03). Patients undergoing TLR had also significantly higher rates of the composite of cardiac death, MI and stroke compared with the no TLR group (adjusted HR = 1.76, 95% CI 1.14 to 2.72). In conclusion, elective, uncomplicated TLR after PCI of ULMCA disease is associated with increased risk of long-term cardiac mortality. Reducing the risk of TLR after PCI of ULMCA disease may potentially improve the survival of these patients.

Epidemiology and complications of late-onset sepsis: an Italian area-based study.

BACKGROUND: Most studies regarding late-onset sepsis (LOS) address selected populations (i.e., neonates with low birth weight or extremely preterm neonates). Studying all age groups is more suitable to assess the burden of single pathogens and their clinical relevance. METHODS: This is a retrospective regional study involving paediatric departments and NICUs in Emilia-Romagna (Italy). Regional laboratory databases were searched from 2009 to 2012. Records of infants (aged 4 to 90 days) with a positive blood or cerebrospinal fluid (CSF) culture were retrospectively reviewed and analysed according to acquisition mode (whether hospital- or community-acquired). RESULTS: During the study period, there were 146,682 live births (LBs), with 296 patients experiencing 331 episodes of LOS (incidence rate: 2.3/1000 LBs). Brain lesions upon discharge from the hospital were found in 12.3% (40/296) of cases, with death occurring in 7.1% (23/296; 0.14/1000 LBs). With respect to full-term neonates, extremely preterm or extremely low birth weight neonates had very high risk of LOS and related mortality (> 100- and > 800-fold higher respectively). Hospital-acquired LOS (n = 209) was significantly associated with very low birth weight, extremely preterm birth, pneumonia, mechanical ventilation, and death (p< 0.01). At multivariate logistic regression analysis, catecholamine support (OR = 3.2), central venous line before LOS (OR = 14.9), and meningitis (OR = 44.7) were associated with brain lesions or death in hospital-acquired LOS (area under the ROC curve 0.81, H-L p = 0.41). Commonly identified pathogens included coagulase-negative staphylococci (CoNS n = 71, 21.4%), Escherichia coli (n = 50, 15.1%), Staphylococcus aureus (n = 41, 12.4%) and Enterobacteriaceae (n = 41, 12.4%). Group B streptococcus was the predominant cause of meningitis (16 of 38 cases, 42%). Most pathogens were sensitive to first line antibiotics. CONCLUSIONS: This study provides the first Italian data regarding late-onset sepsis (LOS) in all gestational age groups. Compared to full-term neonates, very high rates of LOS and mortality occurred in neonates with a lower birth weight and gestational age. Group B streptococcus was the leading cause of meningitis. Excluding CoNS, the predominant pathogens were Escherichia coli and Staphylococcus aureus. Neonates with hospital-acquired LOS had a worse outcome. Antibiotic associations, recommended for empirical treatment of hospital- or community-acquired LOS, were adequate.

Group B Streptococcus early-onset disease and observation of well-appearing newborns.

BACKGROUND: International guidelines lack a substantial consensus regarding management of asymptomatic full-term and late preterm neonates at risk for early-onset disease (EOS). Large cohorts of newborns are suitable to increase the understanding of the safety and efficacy of a given strategy. METHODS: This is a prospective, area-based, cohort study involving regional birth facilities of Emilia-Romagna (Italy). We compared cases of EOS (at or above 35 weeks' gestation) registered in 2003-2009 (baseline period: 266,646 LBs) and in 2010-2016, after introduction of a new strategy (serial physical examinations, SPEs) for managing asymptomatic neonates at risk for EOS (intervention period: 265,508 LBs). RESULTS: There were 108 cases of EOS (baseline period, n = 60; intervention period, n = 48). Twenty-two (20.4%) remained asymptomatic through the first 72 hours of life, whereas 86 (79.6%) developed symptoms, in most cases (52/86, 60.5%) at birth or within 6 hours. The median age at presentation was significantly earlier in the intrapartum antibiotic prophylaxis (IAP)-exposed than in the IAP-unexposed neonates (0 hours, IQR 0.0000-0.0000 vs 6 hours, IQR 0.0000-15.0000, p<0.001). High number of neonates (n = 531) asymptomatic at birth, exposed to intrapartum fever, should be treated empirically for each newborn who subsequently develops sepsis. IAP exposed neonates increased (12% vs 33%, p = 0.01), age at presentation decreased (median 6 vs 1 hours, p = 0.01), whereas meningitis, mechanical ventilation and mortality did not change in baseline vs intervention period. After implementing the SPEs, no cases had adverse outcomes due to the strategy, and no cases developed severe disease after 6 hours of life. CONCLUSIONS: Infants with EOS exposed to IAP developed symptoms at birth in almost all cases, and those who appeared well at birth had a very low chance of having EOS. The risk of EOS in neonates (asymptomatic at birth) exposed to intrapartum fever was low. Although definite conclusions on causation are lacking, our data support SPEs of asymptomatic newborns at risk for EOS. SPEs seems a safe and effective alternative to laboratory screening and empirical antibiotic therapy.

Phenotypic profile of Ile68Leu transthyretin amyloidosis: an underdiagnosed cause of heart failure.

AIMS: Cardiac amyloidosis remains a great challenge for the cardiologist. One of the three main aetiological forms, transthyretin-related hereditary amyloidosis (ATTRm), can present with several phenotypes, depending mainly on the specific mutation. We aimed to characterize the phenotype of patients with ATTRm due to Ile68Leu mutation, comparing them to patients with wild-type transthyretin amyloidosis (ATTRwt). METHODS AND RESULTS: Data of 67 Ile68Leu ATTRm patients from two Italian referral centres (Bologna and Florence) were retrospectively analysed and compared to those of 82 ATTRwt patients. Fifty-five unaffected mutation carriers were also analysed. Cumulative disease onset was 50% at age 71. A total of 56/67 (84%) patients had a predominantly cardiac phenotype at presentation with concentric increase in left ventricular wall thickness [median 17 mm], and normal or near normal left ventricular ejection fraction (79% of patients). Low QRS voltages were present only in 29% of patients but voltage/mass ratio was low (0.5). Carpal tunnel syndrome was noted in 43%. The overall phenotypic profile was similar to ATTRwt but Ile68Leu ATTRm patients typically presented younger (median 71 vs. 78 years) and were more likely to have (mild) symptomatic neurological involvement (19% vs. 2%). Male prevalence was 44% in unaffected mutation carriers and 78% in affected patients. Age-adjusted survival was comparable between groups. CONCLUSIONS: Ile68Leu ATTRm is a cause of familial amyloidotic cardiomyopathy endemic in central-northern Italy and presents as hypertrophic/restrictive cardiomyopathy quite similar to ATTRwt. Male preponderance is present in affected patients but not in unaffected mutation carriers. Age-adjusted survival is similar to ATTRwt.

Meta-analysis of Clinical Outcomes of Electrical Cardioversion and Catheter Ablation in Patients with Atrial Fibrillation and Chronic Kidney Disease.

BACKGROUND: Chronic kidney disease (CKD) is associated with adverse outcomes in presence of atrial fibrillation (AF). However, the literature shows limited data on non-pharmacological management of AF in CKD patients. AIM: summarizing the available data on outcomes associated with electrical cardioversion (ECV) and AF catheter ablation (CA) in CKD patients. METHODS: We searched MEDLINE and the Cochrane Central Register of Controlled Trials and performed a metaanalysis. The primary outcome was recurrence of AF. The secondary outcomes were occurrence of thromboembolic events (TEs) and estimated glomerular filtration rate (eGFR) modification. RESULTS: Literature search yielded 26 eligible papers: 22 on CA and 4 concerning ECV. CKD patients presented more AF recurrences 30 days after ECV (OR 2.62, 95%CI 1.28-5.34; p <0.001). Patients with eGFR<60-68 ml/min and on dialysis presented a higher incidence of AF recurrences after CA, median follow up 26.0 and 29.9 months (HR 1.75, 95%CI 1.46-2.09, p <0.001; and HR 1.69, 95%CI 1.22-2.33, p <0.001; respectively). Periprocedural TEs were rare and not associated with CKD or dialysis. However, patients with CKD were at increased risk for delayed TEs after CA (HR 2.61, 95%CI 1.04-6.54; p <0.001). No significant modification of eGFR was associated with ECV or CA in the overall population. CONCLUSION: ECV and CA for sinus rhythm restoration/maintenance in AF patients, albeit theoretically promising, seem to be associated with lower efficacy at medium to long-term in patients with CKD. Further studies are needed to better define the role of ECV and CA in CKD.

Atrial fibrillation and prediction of mortality by conventional clinical score systems according to the setting of care.

BACKGROUND: Atrial fibrillation (AF) is associated with high morbidity and mortality, also among anticoagulated patients. Our aim was to evaluate the predictive role for long-term mortality of a series of risk stratification scores associated with cardiovascular or thromboembolic outcomes (CHADS2, CHA2DS2-VASc, ATRIA, TIMI-AF), and bleeding complications (HAS-BLED) in an unselected population of patients with AF. METHODS: Single center, observational, prospective registry of consecutive patients with AF, undergoing clinical/echocardiographic evaluation in a University Hospital, as either in-patients or out-patients. We assessed the role of each single score as predictors of long-term survival according to clinical setting. RESULTS: We enrolled 1051 patients, mean age 72 ±â€¯12 years, who were followed for 797 ±â€¯298 days. All the tested scores showed a good performance in prediction of mortality, together with several clinical factors (older age, chronic heart failure, diabetes, renal impairment, previous transient ischemic attack, left ventricular ejection fraction). The values at C-statistics ranged between modest (0.608-0.684) of inpatients to good (0.708-0.751) in outpatients without any statistical difference between the scores, excepted a lower performance of HAD-BLED. CONCLUSIONS: Risk scores currently adopted for decision making on starting oral anticoagulation provide good prediction of long-term survival in unselected AF patients, especially in the outpatient setting.

Early infections in the intensive care unit after liver transplantation-etiology and risk factors: A single-center experience.

BACKGROUND: Infectious complications represent one of the main causes of perioperative morbidity and mortality of liver transplant recipients. The primary objective of this retrospective observational study was to evaluate incidence and etiology of early (within 1 month from surgery and occurring in the intensive care unit [ICU]) postoperative infections as well as donor- and recipient-related risk factors. METHODS: The data of 280 patients undergoing 299 consecutive liver transplant procedures from January 2012 to December 2015 were extracted from the Italian ICU registry database and hospital registries. Perioperative risk factors, etiology of infections, and antibiotic susceptibility of isolated microorganisms were taken into consideration. RESULTS: Global incidence of postoperative infections was 21%. Pneumonia was the most frequent infection and, globally, gram-negative bacteria were the most common agents. Septic shock was present in 22% of infection cases and hospital mortality was higher in patients with postoperative infection. Preoperative chronic obstructive pulmonary disease, malnutrition, preoperative ascites, encephalopathy, and early re-transplantation were significantly associated to post orthotopic LT infections. CONCLUSION: Infections represent a major cause of early postoperative morbidity and mortality. The impact of single risk factors and the results of their preoperative management should be further investigated in order to reduce the incidence and evolution of postoperative infections.

A systematic review on the validity and reliability of an emergency department triage scale, the Manchester Triage System.

OBJECTIVE: To conduct a systematic review to check the level of validity and reliability of the Manchester Triage System and the quality of reporting of literature on this topic. DESIGN: This is a systematic review based on the PRISMA guideline on reporting systematic reviews. DATA SOURCES: The systematic search of the international literature published from 1997 through 30 November 2012 in the PubMed, Embase, Cochrane Library, Cinahl, Web of Knowledge, and Scopus databases. REVIEW METHODS: This review included quantitative and qualitative research investigating the reliability and validity of the Manchester Triage System for the broad population of adults and children visiting the emergency department. After a systematic selection process, included studies were assessed on their quality by three researchers using the STARD guidelines. RESULTS: Twelve studies were included in the review. The studies investigated the inter- and intra-rater reliability using the "kappa" statistic; the validity was tested with many measures: validity in predicting mortality, hospital admission, under- and overtriage, used resources, and length of stay in the emergency department, as well as a reference standard rating. CONCLUSIONS: In this review, the Manchester Triage System shows a wide inter-rater agreement range with a prevalence of good and very good agreement. Its safety was low because of the high rate of undertriage and the low sensitivity in predicting higher urgency levels. The high rate of overtriage could cause unnecessarily high use of resources in the emergency department. The quality of the reporting in studies of the reliability and validity of the Manchester Triage System is good.

Pulmonary hypertension and systemic sclerosis: the role of high-resolution computed tomography.

PURPOSE: This study sought to evaluate, by means of a retrospective analysis, the relationship between pulmonary hypertension (PH) and fibrotic interstitial lung disease (ILD) in a population of 43 patients affected by systemic sclerosis. In addition, we assessed the role of high-resolution computed tomography (HRCT) in the diagnostic and therapeutic pathway for such patients. MATERIALS AND METHODS: Forty-three patients affected by progressive systemic sclerosis (PSS) and PH underwent functional, haemodynamic and HRCT evaluations between November 2001 and May 2011. Functional evaluation was performed through respiratory function testing and spirometry. Haemodynamic assessment was done with transthoracic echocardiogram (ECG) and right heart catheterisation. Semiquantitative evaluation of radiological involvement was performed using different measures: visual score, Goh's score, Wells' score and Warrick's score. RESULTS: Of 43 patients, 16 showed fibrotic ILD after a HRCT evaluation. The main pattern of ILD was identified with nonspecific interstitial pneumonia (NSIP). Our study also evaluated the relationship among radiological, functional and haemodynamic indexes; different correlations were found to be significant, in particular, Wells' and visual scores ≥40% correlated significantly with diffusion capacity for carbon monoxide (DLCO); Wells' score also correlated significantly with percentage of predicted forced vital capacity (FVC), percentage of predicted forced expiratory volume in 1 s (FEV1) and composite physiologic index (CPI). If presence of Inoesophagopathy evaluated with HRCT was included, this sign correlated significantly both with DLCO (p=0.03) and mean pulmonary arterial pressure (mPAP) (p=0.03), considering total population. CONCLUSIONS: Our findings confirm the diagnostic role of HRCT in evaluating the extent of lung damage in systemic sclerosis. Furthermore, a significant correlation between mPAP and esophagopathy suggests a possible positive predictive value of this sign in identifying a subphenotypic category of patients affected by systemic sclerosis in whom we can find a more severe visceral impairment and a more frequent vascular involvement.

Effects of myocardial fibrosis assessed by MRI on dynamic left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy: a retrospective database analysis.

BACKGROUND: While implications of myocardial fibrosis on left ventricular (LV) function at rest have been studied in hypertrophic cardiomyopathy (HCM), the pathophysiological consequences on dynamic LV outflow tract (LVOT) gradient have so far not been investigated in detail. OBJECTIVE: To evaluate the influence of myocardial fibrosis, detected by MRI as late-gadolinium enhancement (LGE), on LVOT gradient in HCM. DESIGN: Retrospective database analysis. SETTING: A single Italian cardiomyopathies referral centre. PATIENTS: Seventy-six HCM patients with normal ejection fraction at rest. INTERVENTIONS: Patients underwent cardiac MR and performed bicycle exercise echocardiogram within a month. RESULTS: LGE was present in 54 patients (71%), ranging from 0.2% to 32.4% of LV mass. There was a weak correlation between the amount of fibrosis and LVOT gradient variation during exercise in the overall population (r=-0.243, p=0.034) and a stronger correlation in patients with obstructive HCM at rest (r=-0.524, p=0.021). Patients with an LVOT gradient increase ≥50 mm Hg during exercise had a significantly lesser extent of fibrosis than those with an increase <50 mm Hg (0.7% (IQR 0-2.4) vs 3.2% (IQR 0.2-7.4), p=0.006). The extent of fibrosis was significantly lower among the highest quartiles of LVOT gradient increase (p=0.009). CONCLUSIONS: In patients with HCM and normal ejection fraction at rest, myocardial fibrosis was associated with a lower increase in LVOT gradient during exercise, probably due to a lesser degree of myocardial contractility recruitment. This negative association was more evident in patients with an obstructive form at rest.

Congenital syphilis in Italy: a multicentre study.

OBJECTIVE: To study the prevalence of congenital syphilis and its risk factors in Italy. STUDY DESIGN: Prospective study from 1 July 2006 to 30 June 2007. Data on mother-child pairs were collected for every syphilis seropositive mother. RESULTS: Maternal syphilis seroprevalence at delivery was 0.17%. 207 infants were born to 203 syphilis seropositive mothers. In 25 newborns it was possible to diagnose congenital syphilis (20/100,000 live births). Maternal risk factors included age <20 years, no antenatal care and no adequate treatment. The infected babies were more often preterm or weighed <2000 g at birth. DISCUSSION: Many syphilis seropositive mothers were foreign born but the risk of an infected newborn was not higher in foreign-born than in Italian seropositive women. The significant factors were lack of antenatal screening and inadequate maternal treatment. CONCLUSION: Syphilis is a re-emerging infection in Italy. Prevention strategies should include antenatal serological tests for all pregnant women and treatment for infected mothers.

Non-invasive methods can predict oesophageal varices in patients with biliary atresia after a Kasai procedure.

BACKGROUND: After a Kasai procedure, 70% of patients with biliary atresia develop chronic liver disease with portal hypertension and oesophageal varices. AIMS: To investigate the role of new non-invasive parameters in predicting the presence of varices in patients with biliary atresia after a Kasai procedure and to identify the cut-off values of these parameters in predicting the presence of varices. METHODS: 31 patients with biliary atresia who had undergone a Kasai portoenterostomy were studied. Clinical, biochemical and abdominal ultrasound examination, liver stiffness measurement (LSM), LSM-spleen diameter to platelet ratio score (LSPS) and upper digestive endoscopy were performed. RESULTS: 15 (47%) patients had oesophageal varices (Group A) and 16 had no varices (Group B). Median values of LSM (kPa) and LSPS were significantly higher in Group A than in Group B (LSM: 17.0 vs. 7.5, respectively; p=0.0001; LSPS: 19.62 vs. 2.94, respectively; p=0.0001). The optimal cut-offs for predicting oesophageal varices were: LSM>10.6 kPa (sensitivity: 87%, specificity: 87.5%, PPV: 87%, NPV: 87.5%, and AUC: 0.92) and LSPS ≥9.2 (sensitivity: 91%, specificity: 92%, PPV: 91%, NPV: 92%, and AUC: 0.96). CONCLUSIONS: Non-invasive methods can predict the presence of oesophageal varices in patients with biliary atresia; the sequential use of two non-invasive methods improves accuracy.

Natural history of gallstone disease: Expectant management or active treatment? Results from a population-based cohort study.

BACKGROUND AND AIMS: The knowledge of natural history is essential for disease management. We evaluated the natural history (e.g. frequency and characteristics of symptoms and clinical outcome) of gallstones (GS) in a population-based cohort study. METHODS: A total of 11 229 subjects (6610 men, 4619 women, age-range: 29-69 years, mean age: 48 years) were studied. At ultrasonography, GS were present in 856 subjects (338 men, 455 women) (7.1%). GS were followed by means of a questionnaire inquiring about the characteristics of specific biliary symptoms. RESULTS: At enrollment, 580 (73.1%) patients were asymptomatic, 94 (11.8%) had mild symptoms and 119 (15.1%) had severe symptoms. GS patients were followed up for a mean period of 8.7 years; 63 subjects (7.3%) were lost to follow up. At the end of the follow up, of the asymptomatic subjects, 453 (78.1%) remained asymptomatic; 61 (10.5%) developed mild symptoms and 66 (11.4%) developed severe symptoms. In subjects with mild symptoms, the symptoms disappeared in 55 (58.5%), became severe in 23 (24.5%), remained stable in 16 (17%); in subjects with severe symptoms, the symptoms disappeared in 62 (52.1%), became mild in 20 (16.8%) and remained stable in 37 (31.1%). A total of 189 cholecystectomies were performed: 41.3% on asymptomatic patients, 17.4% on patients with mild symptoms and 41.3% on patients with severe symptoms. CONCLUSIONS: This study indicates that: (i) asymptomatic and symptomatic GS patients have a benign natural history; (ii) the majority of GS patients with severe or mild symptoms will no longer experience biliary pain; and (iii) a significant proportion of cholecystectomies are performed in asymptomatic patients. Expectant management still represents a valid therapeutic approach in the majority of patients.

Left ventricular function after ST-elevation myocardial infarction in patients treated with primary percutaneous coronary intervention and abciximab or tirofiban (from the Facilitated Angioplasty with Tirofiban or Abciximab [FATA] Trial).

Abciximab therapy during primary percutaneous coronary intervention (PCI) has shown to ameliorate left ventricular (LV) function recovery in patients with ST elevated myocardial infarction. High-dose bolus tirofiban has similar effect on platelet inhibition. Whether this is associated with comparable efficacy on LV function recovery remains unclear. We sought to evaluate the impact on LV function of high-dose bolus tirofiban or abciximab in patients undergoing primary PCI with the predictors of favorable (> or = 50%) LV ejection fraction (EF) and LV function recovery at 30 days. We studied 314 patients (abciximab n = 154; tirofiban n = 160) undergoing primary PCI in the randomized Facilitated Angioplasty with Tirofiban or Abciximab (FATA) Trial. LVEF was assessed within 48 hours and at 30 days after primary PCI. In patients with systolic dysfunction at baseline, LV function recovery was defined by either increase of LVEF > or = 10% compared with baseline or LVEF > or = 50%. Similar LVEF was observed in the 2 groups postprocedure (abciximab 49.7 +/- 10.1% vs tirofiban 49.3 +/- 10.1%, p = 0.9) and at 30 days (abciximab 53.1 +/- 9.8% vs tirofiban 52.5 +/- 10.2%, p = 0.6). Independent predictors of 30-day LVEF > or = 50% were preprocedure Thrombolysis In Myocardial Infarction flow class >0 (odds ratio = 2.4, 95% confidence interval 1.32 to 4.34), anterior location (odds ratio = 0.25, 95% confidence interval 0.15 to 0.42), and age (odds ratio = 0.97, 95% confidence interval 0.95 to 0.99). Preprocedure Thrombolysis In Myocardial Infarction flow grade >0 was the only predictor of LV function recovery (odds ratio = 6.73, 95% confidence interval 2.69 to 16.88). In conclusion, this study showed no difference in LV function recovery in patients undergoing primary PCI treated either with abciximab or high-dose bolus tirofiban. Preprocedure Thrombolysis In Myocardial Infarction flow grade >0 seems to be the most important predictor of favorable LVEF and LV function recovery at 30 days.

Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial.

AIMS: To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR). METHODS AND RESULTS: The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab (n = 341) or HDB tirofiban (n = 351). Primary endpoint was the rate of complete (> or =70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort (P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Delta -3.4%, 95% confidence interval -10.35 to +3.56), which falls beyond the predefined Delta +/- 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups. CONCLUSION: This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.

Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization.

OBJECTIVES: To see whether use of a sirolimus-eluting stent (SES) is superior to a third-generation thin-strut, cobalt-chromium stent (CCS) in terms of in-segment late loss at 9 months in patients with symptomatic coronary artery disease. BACKGROUND: Stent-strut thickness has been shown to be strictly related with risk of in-stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick-strut bare metal control stents. METHODS: The primary outcome measure of this single-center, single-blind randomized comparative trial was 9-month in-segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher) or a CCS (Vision). RESULTS: In-segment late loss was significantly lower in the SES group (0.18 +/- 0.40 mm vs 0.58 +/- 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in-segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS (P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients (P = 0.65). CONCLUSIONS: In patients with de-novo coronary lesions at medium risk of restenosis the anti-proliferative effect of SES is greater than that of a thin-strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority.