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.

Association between periodontal disease and acute coronary syndrome.

OBJECTIVE: To evaluate the relationship between PD and ACS and the association of PD and periodontitis in ACS patients. METHODS: Fifty-eight ACS patients and 57 controls with no history of coronary artery disease (CAD) were included in the study. VARIABLES: arterial hypertension, diabetes, dyslipidemia, obesity, history of CAD, cigarette smoking, and interleukin-1beta gene polymorphism. RESULTS: One hundred and fifteen subjects were enrolled in the study. In the ACS group, 58 patients were evaluated, 32 of whom (55.2%) were male and 26 (44.8%), female. In the control group, 57 subjects were evaluated, 32 (56.1%) of whom were male and 25 (43.9%), female. Periodontal disease was diagnosed in 26 (44.8%) ACS patients and 15 (26.6%) control patients (beta2 = 4.43, p = 0.04). In a logistic regression analysis, the odds ratio for association between PD and ACS was 1.8 (95% CI: 1.0-5.0); p = 0.24. The odds ratio for association of periodontitis with ACS was 4.5 (95% CI: 1.3-15.6); p = 0.019. CONCLUSION: No independent association was found between PD and ACS. There was an independent association between periodontitis and ACS.

Associação entre doença periodontal e síndrome coronariana aguda / Association between periodontal disease and acute coronary syndrome

OBJETIVO: Analisar a relação entre a DP e SCA e verificar a associação entre a DP e periodontite em pacientes com SCA. MÉTODOS: Foram incluídos 58 pacientes com diagnóstico de SCA e 57 controles, sem história de doença arterial coronariana (DAC). Variáveis: hipertensão arterial, diabete, dislipidemia, obesidade, história de DAC, tabagismo e polimorfismo genético do gene da interleucina-1beta. RESULTADOS: Fizeram parte do estudo 115 indivíduos. No grupo SCA, 58 pacientes foram avaliados, sendo 32 (55,2 por cento) do sexo masculino e 26 (44,8 por cento) do sexo feminino. No grupo controle, 57 indivíduos, sendo 32 (56,1 por cento) do sexo masculino e 25 (43,9 por cento) do sexo feminino. Verificou-se DP em 26 (44,8 por cento) pacientes com SCA e em 15 (26,6 por cento) pacientes do grupo controle (beta2 = 4,43, p = 0,04). Análise pela regressão logística, para a associação entre DP e SCA, demonstrou RC de 1,8 (IC 95 por cento: 1,0-5,0); p = 0,24. A associação de periodontite com SCA apresentou RC: 4,5 (IC 95 por cento: 1,3-15,6); p = 0,019. CONCLUSÃO: Não observamos associação independente entre a DP e SCA. Houve associação independente entre periodontite e SCA.

OBJECTIVE: To evaluate the relationship between PD and ACS and the association of PD and periodontitis in ACS patients. METHODS: Fifty-eight ACS patients and 57 controls with no history of coronary artery disease (CAD) were included in the study. Variables: arterial hypertension, diabetes, dyslipidemia, obesity, history of CAD, cigarette smoking, and interleukin-1beta gene polymorphism. RESULTS: One hundred and fifteen subjects were enrolled in the study. In the ACS group, 58 patients were evaluated, 32 of whom (55.2 percent) were male and 26 (44.8 percent), female. In the control group, 57 subjects were evaluated, 32 (56.1 percent) of whom were male and 25 (43.9 percent), female. Periodontal disease was diagnosed in 26 (44.8 percent) ACS patients and 15 (26.6 percent) control patients (beta2 = 4.43, p = 0.04). In a logistic regression analysis, the odds ratio for association between PD and ACS was 1.8 (95 percent CI: 1.0-5.0); p = 0.24. The odds ratio for association of periodontitis with ACS was 4.5 (95 percent CI: 1.3-15.6); p = 0.019. CONCLUSION: No independent association was found between PD and ACS. There was an independent association between periodontitis and ACS.