Paulo Caramori

Outcomes and predictors of mortality after transcatheter aortic valve implantation: Results of the Brazilian registry

The study sought to evaluate outcomes and predictors of mortality after transcatheter aortic valve implantation (TAVI).

Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial.

Objectives: We tested two novel drug‐eluting stents (DES), covered with a biodegradable‐polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti‐restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow‐up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9‐month in‐stent late loss (0.54–0.44 mm, 0.32–0.43 mm, vs. 0.90–0.45 mm respectively), and 1‐year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1‐year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1‐year re‐intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley‐Liss, Inc.

Lack of benefit from percutaneous intervention of persistently occluded infarct arteries after the acute phase of myocardial infarction is time independent: insights from Occluded Artery Trial

AIMS The Occluded Artery Trial (OAT) (n = 2201) showed no benefit for routine percutaneous intervention (PCI) (n = 1101) over medical therapy (MED) (n = 1100) on the combined endpoint of death, myocardial infarction (MI), and class IV heart failure (congestive heart failure) in stable post-MI patients with late occluded infarct-related arteries (IRAs). We evaluated the potential for selective benefit with PCI over MED for patients enrolled early in OAT. METHODS AND RESULTS We explored outcomes with PCI over MED in patients randomized to the </=3 calendar days and </=7 calendar days post-MI time windows. Earlier, times to randomization in OAT were associated with higher rates of the combined endpoint (adjusted HR 1.04/day: 99% CI 1.01-1.06; P < 0.001). The 48-month event rates for </=3 days, </=7 days post-MI enrolled patients were similar for PCI vs. MED for the combined and individual endpoints. There was no interaction between time to randomization defined as a continuous (P = 0.55) or categorical variable with a cut-point of 3 days (P = 0.98) or 7 days (P = 0.64) post-MI and treatment effect. CONCLUSION Consistent with overall OAT findings, patients enrolled in the </=3 day and </=7 day post-MI time windows derived no benefit with PCI over MED with no interaction between time to randomization and treatment effect. Our findings do not support routine PCI of the occluded IRA in trial-eligible patients even in the earliest 24-72 h time window.

The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): Influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone

BACKGROUND The Occluded Artery Trial (OAT) showed no difference in outcomes between percutaneous coronary intervention (PCI) versus optimal medical therapy (MED) in patients with persistent total occlusion of the infarct-related artery 3 to 28 days post-myocardial infarction. Whether PCI may benefit a subset of patients with preservation of infarct zone (IZ) viability is unknown. METHODS AND RESULTS The OAT nuclear ancillary study hypothesized that (1) IZ viability influences left ventricular (LV) remodeling and that (2) PCI as compared with MED attenuates adverse remodeling in post-myocardial infarction patients with preserved viability. Enrolled were 124 OAT patients who underwent resting nitroglycerin-enhanced technetium-99m sestamibi single-photon emission computed tomography (SPECT) before OAT randomization, with repeat imaging at 1 year. All images were quantitatively analyzed for infarct size, IZ viability, LV volumes, and function in a core laboratory. At baseline, mean infarct size was 26% ± 18 of the LV, mean IZ viability was 43% ± 8 of peak uptake, and most patients (70%) had at least moderately retained IZ viability. There were no significant differences in 1-year end-diastolic or end-systolic volume change between those with severely reduced versus moderately retained IZ viability, or when compared by treatment assignment PCI versus MED. In multivariable models, increasing baseline viability independently predicted improvement in ejection fraction (P = .005). There was no interaction between IZ viability and treatment assignment for any measure of LV remodeling. CONCLUSIONS In the contemporary era of MED, PCI of the infarct-related artery compared with MED alone does not impact LV remodeling irrespective of IZ viability.

Maintenance of Hemodialysis Arteriovenous Fistulas by an Interventional Strategy Clinical and Duplex Ultrasonographic Surveillance Followed by Transluminal Angioplasty

Objective. A native arteriovenous fistula (NAF) is a widely used access location for hemodialysis (HD). Monitoring of the NAF followed by percutaneous transluminal angioplasty (PTA) as needed may reduce the incidence of NAF failure according to nonrandomized studies. The aim of this randomized study was to determine whether an interventional strategy consisting of clinical and duplex ultrasonographic (DUS) surveillance of NAFs followed by PTA reduces the rate of the need of central venous dialysis catheters (CVCs) and NAF thrombosis in patients undergoing HD. Methods. A total of 108 patients with 111 functioning NAFs in an HD program were randomized to control and interventional strategy groups. The control group received standard care: clinical and hemodynamic NAF assessment followed by vascular surgeon consultation in cases of dysfunction. In the interventional group, the patients underwent clinical monitoring and systematic DUS surveillance every 3 months. Cases with access dysfunction underwent angiography followed by PTA for stenosis of 50% or greater. Primary outcomes were the need of temporary CVCs and fistula thrombosis. Results. Fifty‐eight NAFs were randomized to the control group, and 53 were randomized to the interventional group. Groups had similar baseline characteristics. The interventional strategy showed a significant reduction in the CVC need (25.9% versus 7.5% for control and interventional groups, respectively; P = .021). No significant difference was observed for thrombosis rates (24.1% versus 17.0%; P = .487). The composite end point of NAF thrombosis or CVC need was reduced by the interventional strategy (44.8% versus 20.8%; P = .033). Conclusions. This randomized study indicates the benefit of a surveillance program for maintenance of NAFs based on clinical and DUS surveillance followed by PTA of major stenosis.

Egg consumption and coronary atherosclerotic burden

OBJECTIVE To verify the association between egg consumption and coronary atherosclerotic burden. DESIGN Observational study. SETTING Cardiac catheterization laboratory. PARTICIPANTS Adult patients referred for coronary angiography. MEASUREMENTS Socio-demographic data (age, education level, and occupation), cardiovascular risk factors (smoking, systemic hypertension, dyslipidemia, diabetes, and family history of coronary artery disease), and egg-eating habits were assessed using a research questionnaire. Egg consumption was divided into three categories: less than one egg a week; one egg a week; and more than one egg a week. Coronary atherosclerotic burden was assessed by a blinded interventional cardiologist using the Friesinger Score (FS) obtained from the coronary angiography. This score varies from 0 to 15 and evaluated each of the three main coronary arteries separately. For this analysis, the FS was divided into three categories: 0-4, 5-9, and 10-15. RESULTS The study sample was composed of 382 adult patients; 241 patients (63.3%) were male. The average age was 60.3 ± 10.8 years (range 23-89 years). The egg-eating category was inversely associated with dyslipidemia (p < 0.05) but not with the other cardiovascular risk factors. A significant association was found between egg consumption and FS (p < 0.05), showing that patients who ate more than one egg a week had a lower coronary atherosclerotic burden. By multivariate analysis, the atherosclerotic burden was independently associated with sex, age, hypertension and egg consumption. CONCLUSION In this observational study of patients undergoing coronary angiography, the consumption of more than one egg per week was associated with a lower coronary atherosclerotic burden.

Association between self-reported oral health, tooth loss and atherosclerotic burden

Previous studies have suggested that oral diseases may influence the development of atherosclerosis. The aim of this study was to test the hypothesis that poor self-reported oral health (SROH) and tooth loss are positively associated with coronary atherosclerotic burden (CAB). 382 consecutive subjects undergoing coronary angiography were included. Socio-demographic characteristics, cardiovascular risk factors and oral health status were collected using a standardized questionnaire, including data on SROH and use of dental prosthesis. Number of teeth and anthropometric measures were collected through clinical examinations. CAB at coronary angiography was quantified using the Friesinger score (FS). Prevalence ratios (PR) were calculated with Poisson regression analyses. Mean age was 60.3 ± 10.8 years, with 63.2% males. In the bivariate analysis, there was a significant association (p < 0.05) between CAB and age (> 60y) (PR = 1.01, 95%CI = 1.02-1.16), male gender (PR = 1.11, 95%CI = 1.03-1.19), smoking (PR = 1.08, 95%CI = 1.01- 1.16), hypertension (PR = 1.12, 95%CI = 1.03-1.22), diabetes (PR = 1.17, 95%CI = 1.05-1.21), poor SROH (PR = 1.22, 95%CI = 1.02-1.46) and tooth loss (< 20 teeth present) (PR = 1.10, 95%CI = 1.02-1.19). The use of dental prosthesis was not associated with CAB. The multivariate models, adjusted for age, gender, smoking, hypertension, diabetes and dyslipidemia showed that poor SROH (p = 0.03) and tooth loss (p = 0.02) were independently associated with CAB, confirming the study hypothesis.

Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry.

BACKGROUND The aim of this study is to evaluate the predictors of permanent pacemaker (PPM) implantation after TAVI. METHODS Between January 2008 and February 2012, 418 patients with severe aortic stenosis underwent TAVI and were enrolled in a Brazilian multicenter registry. After excluding patients who died during the procedure and those with a previous PPM, 353 patients were included in the analysis. RESULTS At 30 days, the overall incidence of PPM implantation was 25.2%. Patients requiring PPM were more likely to be older (82.73 vs. 81.10 years, p=0.07), have pre-dilation (68.42% vs. 60.07%, p=0.15), receive CoreValve (93.68% vs. 82.55%, p=0.008), and have baseline right bundle branch block (RBBB, 25.26% vs. 6.58%, p<0.001). On multivariable analysis, CoreValve vs. Sapien XT (OR, 4.24; 95% CI, 1.56-11.49; p=0.005), baseline RBBB (OR, 4.41; 95% CI, 2.20-8.82; p<0.001), and balloon pre-dilatation (OR, 1.75; 95% CI, 1.02-3.02; p=0.04) were independent predictors of PPM implantation. CONCLUSION PPM implantation occurred in approximately one-fourth of cases. Pre-existing RBBB, balloon pre-dilatation, and CoreValve use were independent predictors of PPM after TAVI. The type of prosthesis used and pre-balloon dilatation should be considered in TAVI candidates with baseline RBBB.

Associação de diferentes medidas e índices antropométricos com a carga aterosclerótica coronariana

BACKGROUND The association between anthropometric parameters and atherosclerotic burden is not well established and few studies have addressed this issue. OBJECTIVE To evaluate the association of different anthropometric parameters with the coronary atherosclerotic burden. METHODS Adult patients undergoing coronary angiography were enrolled in the study. Sociodemographic characteristics and cardiovascular risk factors were collected through a standardized questionnaire. Weight, height, waist circumference (WC), abdominal circumference (AbC), hip circumference (HC) and neck circumference (NC) were measured and body mass index (BMI), waist-hip ratio (WHR), abdominal circumference-hip ratio (AbCHR) and waist-height ratio (WHtR) were calculated. The atherosclerotic burden at the coronary angiography was measured through Friesinger score (FS). Significant atherosclerosis was considered when FS ≥ 5. RESULTS The sample consisted of 337 patients, of whom 213 were men (63.2%). The mean age was 60.1 ± 10 years. Only WHR (r = 0.159 and p = 0.003) showed a significant linear correlation with the coronary atherosclerotic burden as measured by FS. When the sample was stratified by gender, we found a significant correlation between womens AbCHR (r = 0.238 and p = 0.008) and WHR (r = 0.198 and p = 0.028) with FS. Men showed no correlation between anthropometric parameters and FS. After adjusting for gender, age, hypertension, smoking and DM, no anthropometric parameter was associated with coronary atherosclerotic burden as measured by FS in the total sample or when separated by gender. CONCLUSION No anthropometric parameter was an independent risk factor for coronary atherosclerotic burden.

Uma comparação entre a intervenção coronariana percutânea de resgate e primária realizadas no infarto agudo do miocárdio: relato multicêntrico de 9.371 pacientes

OBJECTIVE: To perform a comparative analysis of in-hospital results obtained from AMI patients who underwent rescue or primary PTCA. METHODS: From the Brazilian Interventional National Registry (CENIC), we selected all consecutive patients who underwent a percutaneous coronary intervention for myocardial infarction (< 24 hours), between 1997 and 2000, analyzing those undergoing a rescue (n=840) or a primary (n=8,531) procedure, and comparing their in-hospital results. RESULTS: Rescue patients were significantly younger males with anterior wall infarctions, associated with left ventricular dysfunction, but had less multivessel disease, compared with those treated with primary intervention. Coronary stents were implanted in at similar rates (56.9% vs. 54.9%; P=0.283). Procedural success were lower for rescue cases (88.1% vs. 91.2%; P<0.001), with higher mortality (7.4% vs. 5.6%; P=0.034), compared with the primary intervention group; target vessel revascularization (< 0.5%), emergency bypass surgery (< 0.3%) and reinfarction (< 2.6%) rates were similar for both strategies. Multivariate analysis identified the rescue procedure as a predictor of in-hospital death [OR(CI=95%) = 1.60 (1.17-2.19); P=0.003]. CONCLUSION: Patients who underwent a rescue coronary intervention had higher in-hospital death rates compared with those who underwent a primary coronary intervention.