Papel preditivo do escore de selvester em pacientes submetidos a troca transcateter de valva aórtica / Predictive role of selvester score in patients undergoing transcatheter aortic valve replacement

INTRODUÇÃO: O escore de Selvester é um escore eletrocardiográfico que estima e localiza a carga de fibrose miocárdica. Existem poucos dados sobre o impacto clínico da predição de fibrose em pacientes submetidos a troca transcateter de valva aórtica (TAVR). Este estudo avaliou o poder preditivo do escore de Selvester na sobrevida em pacientes com estenose aórtica (EA) submetidos a TAVR. MÉTODOS: Foram incluídos pacientes com estenose aórtica importante que realizaram eletrocardiograma pré-procedimento. Follow-up clínico foi obtido retrospectivamente. O desfecho primário foi morte por todas as causas e os secundários foram morte cardiovascular e MACE. RESULTADOS: 228 pacientes foram incluídos (idade média 81,5 ± 7,4 anos; 58,3% mulheres). Pacientes que morreram apresentaram escore de Selvester mais elevado (4,6 ± 3,2 vs. 1,4 ± 1,3; p < 0,001). Em um follow-up médio de 36,2 ± 21,2 meses, o escore de Selvester foi associado independentemente com mortalidade por todas as causas (HR, 1,65; 95% CI, 1,48-1,84; p < 0,001), mortalidade cardiovascular (HR, 1,59; 95% CI, 1,38-1,74; p < 0,001) e MACE (HR, 1,55; 95% CI, 1,30-1,68; p < 0,001). Após 5 anos, o risco de mortalidade foi diretamente correlacionado ao escore e o envolvimento da parede inferior do ventrículo esquerdo apresentou menor risco de mortalidade (HR, 0,42; 95% CI, 0,18-0,98; p = 0,046). Para o valor do escore de Selvester de 3, a área sobre a curva ROC foi de 0,92, 0,94 e 0,86 (p < 0,001) para 1, 2 e 3 anos, respectivamente. CONCLUSÃO: Valores elevados do escore de Selvester aumentam o risco de desfechos negativos em pacientes com EA submetidos a TAVR. O envolvimento das paredes anterior e lateral apresentam pior prognóstico.

Valvotomia percutânea com balão em pacientes com menos de 18 anos / Percutaneous balloon valvotomy in patients under 18 years

INTRODUÇÃO: Valvotomia mitral percutânea (VMP) é o tratamento de escolha em pacientes com estenose mitral reumática. Em pacientes jovens, o implante de uma prótese pode trazer diversas complicações no curto e longo prazo como durabilidade bastante reduzida. O OBJETIVO desse trabalho é descrever os resultados imediatos e acompanhar o follow-up desse grupo de pacientes. MÉTODOS: Foram selecionados, em uma coorte retrospectiva, pacientes que se submeteram a VMP com idade menor do que 18 anos devido a estenose mitral reumática. Os procedimentos e a ecocardiografia foram realizados em centro único. RESULTADOS: 58 pacientes (15,41±2,42 anos, 69% mulheres) foram submetidos a 66 procedimentos. A área valvar prévia foi de 0,87±1,94 cm2 e após o procedimento passou a ser 2,00±0,46cm2, com 74% de insuficiência mitral graduada como menor do que discreta, 98,5% tinham ritmo sinusal e o procedimento foi considerado sucesso em 89,4%, sucesso parcial em 6,1% e insucesso 4,5%. No acompanhamento de curto prazo, 19,7% evoluíram para necessidade de cirurgia, sendo 3% emergencial. 22 casos evoluíram para necessidade de redilatação, sendo 12 casos ainda com menos de 18 anos e os demais acima dessa idade. CONCLUSÃO: A VMP é o método de escolha para o tratamento da estenose mitral reumática em pacientes abaixo de 18 anos, de mostrando segurança e bons resultados. Nessa faixa etária a prevalência em homens foram significativamente superior.

Long-term analysis of pulmonary hypertension and tricuspid regurgitation after transcatheter aortic valve replacement

INTRODUCTION: transcatheter aortic valve replacement (TAVR) is increasingly utilized in treatment of aortic stenosis (AS). AS is commonly associated to pulmonary hypertension (PH) and tricuspid regurgitation (TR). We aimed to evaluate the long-term post-TAVR course of PH and TR. METHODS: Patients undergoing TAVR were screened for 24-month echocardiographic data on PH and TR. All echocardiograms were performed by a sing le team. Patients were divided in groups according to TR and PH (pulmonary systolic pressure ≥ or < 45 mmHg) grading at 24 months with follow-up of up to 96 months. Standardized clinical outcomes and survival were compared. RESULTS: 156 and 151 patients were se le cted for PH and TR follow-up, respectively. Mean follow-up was 42.23±17.53 months and 42.60±17.67 months for PH and TR groups. Maximum follow-up was 96 months. PH was reduced post-TAVR (32.7% pre-TAVR vs. 20.5% post-TAVR, p<0.001), but no significant difference in TR was found (11.9% pre-TAVR vs. 10.6% post-TAVR). Increased le ft atrial (LA) diameter (p = 0.002) was associated to maintenance PH. Moreover, increased LA diameter (p=0.015) and increased EuroSCORE II (p=0.041) were correlated to new onset PH. On a multivariab le Cox regression model, new onset PH (HR 6.17, 95% CI 1.71­22.29, p=0.005), diastolic dysfunction type II or III (HR 1.06, 95% CI 1.06-1.11, p=0.036) and LA diameter (HR 1.11, 95% CI 1.02­1.21, p=0.02) were independent predictors of long-term mortality. CONCLUSIONS: TAVR was ab le to reduce the severity of PH, but not TR, in this cohort. Additionally, long-term survival was affected by PH, diastolic dysfunction and LA sizing.

Intussuscepção uterina em uma cadela sem raça definida - relato de caso / Uterine intussusception in a crossbred female dog - case report

O presente relato descreve uma condição rara de intussuscepção uterina em uma cadela sem raça definida, quatro anos de idade, diagnosticada por meio de celiotomia exploratória e análise anatomopatológica. Foi realizada ovariossalpingo-histerectomia (OSH) como tratamento. Essa patologia geralmente requer manejo cirúrgico porque o diagnóstico inicial pode ser desafiador.(AU)

The present study describes a rare condition of uterine intussusception in a 4 year old crossbred female dog diagnosed by exploratory celiotomy and anatomopathological analysis. As treatment, a ovariohysterectomy (OH) was performed. This pathology usually requires surgical management because the initial diagnosis can be challenging.(AU)

Multivariate analysis of backcross progeny of Passiflora L. (Passifloraceae) for pre-breeding genotype selection.

The Ward-MLM procedure was used to evaluate genetic variation in four backcross progenies and in their parents, hybrid F1 HD13 and donor parent Passiflora sublanceolata. Sixteen quantitative descriptors and five qualitative characteristics of relevance to ornamental flower production were assessed. Using the pseudo-F and pseudo-T² criteria, we identified four groups among these plants in two evaluation periods. In both evaluations, the BC1 plants showed greater dissimilarity to their recurrent parent, but showed high genetic similarity with the P. sublanceolata parent. The first two canonical variables produced by the Ward-MLM procedure accounted for over 90% of the variation in both evaluation periods, enabling the representation of diversity through two-dimensional graphics. Groups II and IV were formed in the first assessment period. Groups I and IV formed in the second period and showed plants with selection potential. We found that it was essential to use both qualitative and quantitative variables for this analysis. Assessments of quantitative descriptors indicate that the selection of BC1 plants can be performed in any of the four progenies. Because of the similarities observed for some floral descriptors between BC1 and the P. sublanceolata parent, a second generation backcross was not recommended. However, the selection of BC1 plants for evaluation and direct use as an ornamental cultivar, or as a resource in other breeding programs, can be recommended.

ISSR markers in wild species of Passiflora L. (Passifloraceae) as a tool for taxon selection in ornamental breeding.

Inter simple sequence repeat (ISSR) molecular markers were developed and used to investigate interspecific genetic variation in 25 wild species of Passiflora preserved in an active germplasm bank (BAG-Passifloras); intraspecific diversity was also analyzed in P. cincinnata accessions. Of 31 primers tested, 20 identified polymorphic loci with a total of 331 bands, suggesting high polymorphism in the sample. Interspecific polymorphism was greater than intraspecific polymorphism. This is a common finding in studies of genetic variation using dominant markers. The ISSRs revealed species-specific amplification bands in 11 species; these bands ranged from 200 to 1000 bp, and they will be of use for developing SCAR markers for the identification of germplasm in further studies. The use of Jaccard's similarity coefficient to obtain a dendrogram by the UPGMA clustering method distributed the taxa into five major groups, with differences among grouping with respect to principal coordinate analysis. Despite the high cophenetic correlation coefficient (r = 0.94) of the dendrogram, taxonomic inconsistencies were observed; similar irregularities have been reported previously in studies using dominant markers. Intraspecific analysis of P. cincinnata accessions revealed a larger genetic distance between those from Bahia (P2) and from Minas Gerais (P2), indicating that both accessions have considerable potential as parents in a genetic improvement program for this species.

Chlamydophila pneumonia and increased TLR4 gene expression in leukocytes are associated with acute myocardial infarction.

We investigated the relationship of the positivity for Chlamydophila pneumoniae (Cpn) and Mycoplasma pneumonia (Mpn), inflammatory and metabolic markers, and mRNA expression and polymorphisms of the TLR2, TLR4, IL-6 and TNFA genes with acute myocardial infarction (AMI). Two hundred and eighteen individuals (98 AMI and 120 non-AMI) were selected at two Clinical Centers. Blood samples were drawn to extract DNA and RNA and to measure laboratory variables including anti-Cpn IgM and IgG. Cpn and Mpn genomic DNA as well as TLR2, TLR4, IL-6 and TNFA mRNA expression were evaluated by quantitative real-time PCR (qPCR). Gene polymorphisms were detected by PCR-HRM. AMI patients had higher positivity for Cpn-DNA (17.3%) than non-AMI group (6.7%, p=0.018). In addition, Cpn-DNA positivity was an independent predictor of risk for AMI (OR: 2.56, CI: 1.08 - 6.04, p=0.031). Positivity for anti-Cpn IgG and Mpn-DNA was similar between AMI and non-AMI (> 0.05). TLR4 mRNA expression was higher in AMI than non-AMI individuals (p=0.005). CD14 -260C> T, TNFA -308A> G, TLR2 c.2258G> A, TLR4 c.896A> G and TLR4 c.1196> T variants were not associated with increased risk for AMI (p> 0.05). In the AMI group, individuals carrying CD14 -260CC genotype had higher hsCRP levels than CT/TT carriers (p=0.041). These results are suggestive that Cpn-DNA positivity and increased TLR4 mRNA expression in blood leukocytes may be associated with AMI and could be useful markers to evaluate the severity and progression of the atherosclerotic disease in AMI patients.

Fishing human monoclonal antibodies from a CHO cell supernatant with boronic acid magnetic particles.

In this work we have evaluated the potential of boronic acid functionalized magnetic particles for the one-step capture of a human monoclonal antibody (mAb) from a Chinese hamster ovary (CHO) cell culture supernatant. For comparison, Protein A coated magnetic particles were also used. The most important factor influencing the overall process yield and product purity in boronic acid particles was found to be the binding pH. Basic pH values promoted higher purities while resulting in decreased yields due to the competing effects of molecules such as glucose and lactate present in the cell culture supernatant. After optimization, the particles were successfully used in a multi-cycle purification process of the mAb from the CHO feedstock. Boronic acid particles were able to achieve an average overall yield of 86% with 88% removal of CHO host cell proteins (HCP) when the binding was performed at pH 7.4, while at pH 8.5 these values were 58% and 97%, respectively. In both cases, genomic DNA removal was in excess of 97%. Comparatively, Protein A particles recorded an average overall yield of 80% and an HCP removal greater than 99%. The adsorption of the mAb to the boronic acid particles was shown to be mediated by strong affinity interactions. Overall, boronic acid based purification processes can offer a cost-effective alternative to Protein A as the direct capturing step from the mammalian cell culture.

TCF7L2 variant genotypes and type 2 diabetes risk in Brazil: significant association, but not a significant tool for risk stratification in the general population.

BACKGROUND: Genetic polymorphisms of the TCF7L2 gene are strongly associated with large increments in type 2 diabetes risk in different populations worldwide. In this study, we aimed to confirm the effect of the TCF7L2 polymorphism rs7903146 on diabetes risk in a Brazilian population and to assess the use of this genetic marker in improving diabetes risk prediction in the general population. METHODS: We genotyped the single nucleotide polymorphisms (SNP) rs7903146 of the TCF7L2 gene in 560 patients with known coronary disease enrolled in the MASS II (Medicine, Angioplasty, or Surgery Study) Trial and in 1,449 residents of Vitoria, in Southeast Brazil. The associations of this gene variant to diabetes risk and metabolic characteristics in these two different populations were analyzed. To access the potential benefit of using this marker for diabetes risk prediction in the general population we analyzed the impact of this genetic variant on a validated diabetes risk prediction tool based on clinical characteristics developed for the Brazilian general population. RESULTS: SNP rs7903146 of the TCF7L2 gene was significantly associated with type 2 diabetes in the MASS-II population (OR = 1.57 per T allele, p = 0.0032), confirming, in the Brazilian population, previous reports of the literature. Addition of this polymorphism to an established clinical risk prediction score did not increased model accuracy (both area under ROC curve equal to 0.776). CONCLUSION: TCF7L2 rs7903146 T allele is associated with a 1.57 increased risk for type 2 diabetes in a Brazilian cohort of patients with known coronary heart disease. However, the inclusion of this polymorphism in a risk prediction tool developed for the general population resulted in no improvement of performance. This is the first study, to our knowledge, that has confirmed this recent association in a South American population and adds to the great consistency of this finding in studies around the world. Finally, confirming the biological association of a genetic marker does not guarantee improvement on already established screening tools based solely on demographic variables.

Obesity and obstructive sleep apnea-hypopnea syndrome.

Obstructive sleep apnea-hypopnea syndrome involves recurring episodes of total obstruction (apnea) or partial obstruction (hypopnea) of airways during sleep. Obstructive sleep apnea-hypopnea syndrome affects mainly obese individuals and it is defined by an apnea-hypopnea index of five or more episodes per hour associated with daytime somnolence. In addition to anatomical factors and neuromuscular and genetic factors, sleep disorders are also involved in the pathogenesis of sleep apnea. Obesity affects upper airway anatomy because of fat deposition and metabolic activity of adipose tissue. Obstructive sleep apnea-hypopnea syndrome and metabolic syndrome have several characteristics such as visceral obesity, hypertension and insulin resistance. Inflammatory cytokines might be related to the pathogenesis of sleep apnea and metabolic syndrome. Sleep apnea treatment includes obesity treatment, use of equipment such as continuous positive airway pressure, drug therapy and surgical procedures in selected patients. Currently, there is no specific drug therapy available with proven efficacy for the treatment of obstructive sleep apnea-hypopnea syndrome. Body-weight reduction results in improvement of sleep apnea, and obesity treatment must be emphasized, including lifestyle changes, anti-obesity drugs and bariatric surgery.

Use of rapamycin-impregnated stents in coronary arteries.

FIM STUDY: We investigated the 2-year safety and efficacy of sirolimus-eluting stents. Thirty patients had a single 18-mm sirolimus-eluting coronary stent implanted. Twenty-eight patients underwent angiographic and intravascular ultrasound follow-up at 2 years. No death occurred during the study period. No patient developed in-stent restenosis. One patient had a 52% in-lesion stenosis that required repeated revascularization and another patient underwent target vessel revascularization. Neointimal hyperplasia volume was minimal at 2 years in both groups. This study demonstrates the 2-year safety and efficacy of sirolimus-eluting stenting. The slow release formulation showed slight superiority over the fast-release formulation in preventing late lumen loss, which was minimal in both groups. RAVEL TRIAL: This-study was a randomized, double-blind study that included 238 patients at 19 medical centers (15 in Europe, 3 in Brazil, and 1 in Mexico). Patients were eligible for the study if they were between 18 and 85 years of age, and had been given a diagnosis of stable or unstable angina or silent ischemia. Additional eligibility criteria were presence of a single primary target lesion in a native coronary artery that was 2.5 to 3.5 mm in diameter and that could be covered by an 18-mm stent stenosis of 51% to 99% of the luminal diameter and a flow rate of grade 1 or higher according to the Thrombolysis in Myocardial Infarction. RESULTS: One hundred twenty patients were randomly assigned to receive the sirolimus-eluting stent, and 118 were assigned to receive the standard stent. At 6 months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01 +/- 0.33 mm) than in the standard-stent group (0.80 +/- 0.53 mm, P <.001). None of the patients in the sirolimus-stent group, as compared with 26.6% of those in the standard-stent group, had restenosis of >/=50% of the luminal diameter (P <.001). There were no episodes of stent thrombosis. During a follow-up period of up to 1 year, the overall rate of major cardiac events was 5.8% in the sirolimus-stent group and 28.8% in the standard-stent group (P <.001). The difference was due entirely to the higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSION: Patients with angina who received sirolimus-eluting stents for the treatment of single, primary lesions in native coronary arteries had no angiographic evidence of late luminal loss or in-stent restenosis at 6 months, no episodes of thrombosis, and a very low rate of cardiac events at 1 year.

Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up.

BACKGROUND: We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year. METHODS AND RESULTS: Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n=30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the >/=50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2+/-5% obstruction volume, GIII) and at 12 months (GI=2+/-5% and GII=2+/-3%). CONCLUSIONS: This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.

Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients: insights from the Arterial Revascularization Therapy Study (ARTS) trial.

BACKGROUND: Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. METHODS AND RESULTS: Patients (n=1205) were randomly assigned to stent implantation (n=600; diabetic, 112) or CABG (n=605; diabetic, 96). Costs per patient were calculated as the product of each patient's use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, P<0.001) and nondiabetic patients treated with stents (76.2%, P=0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were $12 855 and $16 585 (P<0.001) and in the nondiabetic groups, $10 164 for stenting and $13 082 for surgery. CONCLUSIONS: Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status.

The use of primary stenting or balloon percutaneous transluminal coronary angioplasty for the treatment of acutely occluded saphenous vein grafts. Results from the Brazilian National Registry--CENIC. Central Nacional de Intervenções Cardiovasculares.

OBJECTIVE: We conducted a comparative analysis of the in-hospital outcomes of patients who underwent primary percutaneous transluminal angioplasty (PTCA) or stent implantation because of an acute myocardial infarction (AMI) related to an acute vein graft occlusion. METHODS: Since 1991 the Brazilian Society of Hemodynamic and Interventional Cardiology has maintained a large database (CENIC). From these, we selected all consecutive patients, who underwent primary PTCA or stenting in the first 24 hours of AMI, with the target vessel being an occluded vein graft. Immediate results and major coronary events occurring up until hospital discharge were analyzed. RESULTS: During this period, 5,932 patients underwent primary PTCA or stenting; 158 (3%) of the procedures were performed because of an acute vein graft occlusion. Stenting was performed in 74 (47%) patients. Patients treated with stents had a higher success rate and lower mean residual stenosis compared with those who underwent primary balloon PTCA. The incidence of reinfarction and death were similar for stenting and balloon PTCA. CONCLUSION: Primary percutaneous treatment of AMI related to acute vein graft occlusion is still an uncommon practice. Primary stenting improved luminal diameter and offered higher rates of success; however, this strategy did not reduce the in-hospital reinfarction and death rate, compared with that occurring with PTCA treatment.

Acute myocardial infarction in progressively elderly patients. A comparative analysis of immediate results in patients who underwent primary percutaneous coronary intervention.

OBJECTIVE: Analysis of the in-hospital results, in progressively elderly patients who undergo primary percutaneous coronary intervention (PCI) in the first 24 hours of AMI. METHODS: The patients were divided into three different age groups (60/69, 70/79, and > or =80 years) and were treated from 7/95 until 12/99. The primary success rate and the occurrence of major clinical events were analyzed at the end of the in-hospital phase. Coronary stent implantation and abciximab use were employed at the interventionist discretion. RESULTS: We analyzed 201 patients with age ranging from 60 to 93 years, who underwent primary PCI. Patients with ages above 70 were more often female (p=.015). Those with ages above 80 were treated later with PCI (p=.054), and all of them presented with total occlusion of the infarct-related artery. Coronary stents were implanted in 30% of the patients. Procedural success was lower in > or =80 year old patients (p=.022), and the death rate was higher in > or =70 years olds (p=.019). Reinfarction and coronary bypass surgery were uncommon events. A trend occurred toward a higher combined incidence of major in-hospital events according to increased age (p=.064). CONCLUSION: Elderly patients (> or =70 years) presented with adverse clinical and angiographic profiles and patients > or =80 years of age obtained reduced TIMI 3 flow success rates after primary PTCA, and those > or =70 years had a higher death rate.

Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.

BACKGROUND: Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents. METHODS AND RESULTS: Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus-coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months. CONCLUSIONS: The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.

One-year follow-up after primary coronary intervention for acute myocardial infarction in diabetic patients. A substudy of the STENT PAMI trial.

OBJECTIVE: This analysis was undertaken to determine the composite incidence of cumulative adverse events (death, reinfarction, disabling stroke, and target vessel revascularization) at the end of the first year after acute myocardial infarction, in diabetic patients who underwent coronary stenting or primary coronary balloon angioplasty. METHODS: From the STENT PAMI trial, we analyzed the 6-month angiographic and 1-year clinical outcomes of 135 diabetic (112, noninsulin dependent) patients who underwent the randomization process of the trial and compared them with 758 nondiabetic patients. RESULTS: Coronary stenting did not significantly reduce the primary composite clinical end point when compared with PTCA (20 vs. 30%, p=0.2). A significant benefit from stenting was observed in patients with noninsulin dependent diabetes, with a trend toward a lesser need for new revascularization procedures (10 vs. 21%, p<.001), with a significant reduction in the primary composite clinical end point at 1 year (12 vs. 28%, p=. 04). At 6 months, the restenosis rate were significantly reduced only in nondiabetic patients (18 vs. 33%, p<. 001). Diabetic patients had the same restenosis rate (38%) either with stenting or balloon PTCA. CONCLUSIONS: Coronary Stenting in diabetics noninsulin dependent offered a significant reduction in the composite incidence of major clinical adverse events compared with balloon PTCA.