Igor Ribeiro de Castro Bienert

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial

Importance The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, −0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration clinicaltrials.gov Identifier: NCT01448642

Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial

To compare the radial versus femoral approach using Angio‐Seal for the incidence of access site complications among non‐ST‐segment elevation acute coronary syndrome patients undergoing invasive strategy.

Resolução do segmento ST após intervenção coronária percutânea primária: características, preditores de insucesso e impacto na mortalidade

BACKGROUND: ST-segment resolution is an important predictor of infarct-related artery patency and effective microcirculatory perfusion. The aim of this study was to compare patients with and without ST-segment elevation resolution and identify variables that are associated with failure of ST-segment resolution. METHODS: Between March 2012 and July 2013, 61 patients with ST-segment elevation acute myocardial infarction underwent primary percutaneous coronary intervention (PCI) and were included in a prospective registry. To compare the groups with and without ST-segment resolution, the chi-square test or Fishers exact test were used for qualitative variables and Students t test or Mann-Whitneys test for quantitative variables. Simple and multiple logistic regression models were used to identify variables associated with failure of ST-segment resolution. RESULTS: The group of patients without ST-segment resolution had higher heart rate, higher prevalence of diabetes mellitus, chronic renal failure and a trend towards longer ischemia time. There was a higher mortality rate in patients who did not achieve ST-segment elevation resolution. In the univariate analysis, heart rate, diabetes mellitus, chronic renal failure and ischemia time were associated with increased odds of not obtaining ST-segment resolution, losing significance in the multivariate model. CONCLUSIONS: Failure of ST-segment resolution is observed in up to one-third of patients undergoing primary PCI and requires new pharmacologic strategies or interventions to minimize it.

Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial

Background: Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high‐dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. Objectives: The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE‐PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. Design: The SECURE‐PCI study is a pragmatic, multicenter, double‐blind, placebo‐controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all‐cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. Summary: The SECURE PCI is a large randomized trial testing a strategy of early, high‐dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

Insucesso da Técnica Radial em Centro com Alto Volume de Procedimentos

Failure of the Transradial Approach in a High-Volume Center background: The mechanisms and predictors of failed transradial approach in centers dedicated to this technique are not well characterized and were the main objective of this analysis. methods: 6,808 consecutive patients undergoing transradial coronary procedures by operators with utilization rate greater than 90% were included. Simple and multiple logistic regression models were used to identify the predictors of failed transradial approach. Results: Transradial failure rate was 1.7%. Vascular complications were observed in 5%, with a prevalence of asymptomatic arterial occlusion and subcutaneous hematomas. Predictors of failure were female gender (OR = 1.87; 95% CI 1.29-2.71; p = 0.01), age > 70 years (OR = 1.78; 95% CI 1.06-2.98; p = 0.03) and presence of chronic peripheral arterial disease (OR = 5.71; 95% CI 2.40-13.54; p < 0.01). Conclusions: In a high-volume radial center, failure rate was < 2% and variables associated with technical failure were female gender, advanced age and peripheral arterial disease. DesCRIPToRs: Radial artery. Percutaneous coronary intervention. Hemorrhage. Ischemia.

Prognóstico tardio em jovens com coronariopatia estável: evolução em 10 anos após intervenção coronária percutânea

BACKGROUND: The late prognostic implications of stable coronary artery disease (CAD) in young patients are currently unknown. The objective of this study was to evaluate the prognosis of young adult patients diagnosed with stable CAD, treated by percutaneous coronary intervention (PCI) and followed-up for 10 years. METHODS: The study population consisted of young patients (age below the 10th percentile) of a group of 1,394 consecutive patients treated for stable CAD using the percutaneous approach. Patient characteristics were collected prospectively. After the procedure outpatient follow-up was performed, including the analysis of the electronic medical records and telephone contact, whenever required. The primary outcome was overall mortality and the secondary outcome was cardiovascular mortality. RESULTS: One hundred and forty patients were selected, with mean age of 43.7 ± 4 years (ranging from 26 to 48 years) and were predominantly males (76.4%). Diabetes mellitus was present in approximately one fifth of patients and half of them had a previous myocardial infarction. Patients were followed for an average of 94.6 ± 36.2 months and the overall mortality after 10 years was 6%, with cardiac mortality of 5.3%. All of the patients who died had a successful index procedure and only one of the cases did not have a previous myocardial infarction. CONCLUSIONS: In our clinical practice, young patients with chronic CAD treated by PCI demonstrated a good late prognosis.

Utilização de Pulseira Compressora Seletiva na Prevenção da Oclusão da Artéria Radial Após Procedimento Coronário Invasivo

ABSTRACT Use of a Selective Radial Compression Device to Prevent Radial Artery Occlusion After Coronary Invasive Procedure Background: In addition to providing greater comfort and convenience for the patient, the radial approach is associated to lower rates of vascular complications and major bleeding, with potential impact on morbidity and mortality. Thus, the adoption of strategies that reduce the risk of arterial occlusion after invasive procedures, enabling it to be reused, is desirable. Methods: Controlled prospective registry evaluating the impact of routine adoption of a selective radial compression device in patients with acute coronary syndrome without ST-segment-elevation undergoing early invasive stratification through the radial access. Arterial patency was assessed by the Barbeau test at hospital discharge and at the 30-day follow-up. Results: Fifty-nine patients were evaluated, of which 83% underwent ad hoc percutaneous coronary intervention. Mean age was 64 ± 12.2, 66.1% were male and 28.8% had diabetes melli-tus. The right radial access was used in 98.3% of cases, the number of catheters was 2.4 ± 0.6, with a diameter of 6 F in all cases, and the duration of the procedure was 32.4 ± 12.7 minutes. Spasm was reported in 10.2% of cases, hematoma > 5 cm in 3.4% and occlusion of the radial artery after the procedure and at 30 days in 6.8% and 3.4% of the cases, respectively.

Remoção percutânea de fragmento de cateter intravascular: uma adaptação da caixa de ferramentas

The first report of an intravascular catheter fragmentation was published in 1954 and ever since we have observed a remarkable evolution in the techniques of intravascular foreign body removal. The pioneer description of non-surgical foreign body removal dates back to 1964, with the report of a guidewire fragment withdrawal using a bronchoscopy biopsy forceps. Despite the availability of several dedicated devices, materials may have to be adapted at times to achieve technical success. We report the case of a patient with a Port-a-Cath catheter in the left subclavian vein, which had been placed 5 years before and whose intravascular portion was broken during withdrawal. It was successfully removed using the percutaneous approach.

Timing of Loading Dose of Atorvastatin in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Insights From the SECURE-PCI Randomized Clinical Trial

Importance Loading doses of atorvastatin did not show reduction on clinical outcomes in the overall population of patients with acute coronary syndrome (ACS) enrolled in the Statins Evaluation in Coronary Procedures and Revascularization (SECURE-PCI) trial, but a potential benefit was identified in patients who subsequently underwent percutaneous coronary intervention (PCI). Objectives To determine whether periprocedural loading doses of atorvastatin are associated with decreased 30-day major adverse cardiovascular events (MACE) in patients with ACS undergoing PCI according to type of ACS and timing of atorvastatin administration before PCI. Design, Setting, and Participants Secondary analysis of a multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites that enrolled 4191 patients with ACS intended to be treated with PCI between April 18, 2012, and October 06, 2017. Interventions Patients were randomized to 2 loading doses of 80 mg of atorvastatin or matching placebo before and 24 hours after a planned PCI. By protocol, all patients (regardless of treatment group) received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures The primary outcome was MACE through 30 days, composed by all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization. Cox regression models adjusting for key baseline characteristics were used to assess the association between atorvastatin and MACE in patients undergoing PCI. Results From the overall trial population, 2710 (64.7%) underwent PCI (650 women [24.0%]; mean [SD] age, 62 [11.3] years). Loading atorvastatin was associated with reduced MACE at 30 days by 28% in the PCI group (adjusted hazard ratio [HR], 0.72; 95% CI 0.54-0.97; P = .03). Loading dose of atorvastatin was administered less than 12 hours before PCI in 2548 patients (95.3%) (45.1% < 2 hours and 54.3% between 2 and 12 hours). There was no significant interaction between treatment effect and timing of study drug administration. The treatment effect of loading atorvastatin was more pronounced in patients with ST-segment elevation myocardial infarction than in patients with non–ST-segment elevation ACS (adjusted HR, 0.59; 95% CI, 0.38-0.92; P = .02; HR, 0.85; 95% CI, 0.58-1.27; P = .43, respectively). Conclusions and Relevance In patients with ACS undergoing PCI, periprocedural loading doses of atorvastatin appeared to reduce the rate of MACE at 30 days, most clearly in patients with ST-segment elevation myocardial infarction. This beneficial effect seemed to be preserved and consistent, irrespective of the timing of atorvastatin administration, including within 2 hours before PCI. Trial Registration clinicaltrials.gov Identifier: NCT01448642.

Temporal Evaluation of Coronary Revascularization Procedures Performed through the Unified Health System (SUS) in Brazil: a 20-year overview

Fundamento: As taxas de mortalidade relacionadas a doenca aterosclerotica coronariana (DAC) vem reduzindo nas ultimas decadas devido, em parte, aos avancos nas tecnicas de revascularizacao. Objetivos: O objetivo deste estudo foi apresentar um visao dos ultimos 20 anos do tratamento da DAC pelo Sistema Unico de Saude (SUS) no Brasil. Metodos: Os dados foram obtidos atraves dos sistemas TABNET e SIGTAP do SUS e atraves do IBGE. Os procedimentos foram agrupados nas categorias de revascularizacao percutânea, cirurgica e percutânea primaria. Foram analisados o numero de autorizacoes de internacao hospitalar (AIH), duracao media de permanencia hospitalar, mortalidade hospitalar, valor do repasse total por procedimento e valores medios da AIH e dos servicos profissional e hospitalar. Resultados: Entre 1995 e 2015, houve aumento no numero de revascularizacoes cirurgicas (de 13.198 a 22.559) e percutâneas (de 10.522 a 66.345). De modo semelhante, o numero de angioplastias primarias apresentaram aumento entre 2004 e 2015 (de 1.901 a 8.524). Houve uma queda no tempo medio de permanencia hospitalar (de 14,4 a 12,8 dias) e da mortalidade hospitalar (de 7,6% a 5,9%) nas revascularizacoes cirurgicas e queda da permanencia hospitalar (de 5,3 dias a 3,7 dias) mas manutencao da taxa de mortalidade (2,2%) nas revascularizacoes percutâneas. Nas angioplastias primarias, o tempo medio de permanencia hospitalar variou de 5,3 a 5,6 dias e a taxa de mortalidade variou de 7,94% a 7,43% entre 2004 e 2015, respectivamente. O valor medio do repasse total para as revascularizacao cirurgicas variou de R