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.

TIger II vs JUdkins Catheters for Transradial Coronary Angiography (TIJUCA Study): A Randomized Controlled Trial of Radiation Exposure.

BACKGROUND: In high-expertise transradial (TR) centers, the radiation exposure to patients during coronary angiography (CAG) is equivalent to transfemoral use. However, there is no definitive information during TR-CAG regarding the use of a single, dedicated catheter to impart less radiation exposure to patients. OBJECTIVE: We compare the radiation exposure to patients during right TR-CAG with Tiger II catheter (Terumo Interventional Systems) vs Judkins right (JR) 4.0/Judkins left (JL) 3.5 catheters (Cordis Corporation). METHODS: This multicenter, randomized, and prospective trial included 180 patients submitted to right TR-CAG, with the primary objective of observing radiation exposure to patients through the measurement of fluoroscopy time, air kerma (AK), and dose-area product (DAP) using Tiger II (group 1) vs JR 4.0 and JL 3.5 Judkins catheters (group 2). Secondary outcomes included contrast volume usage and the need to use additional catheters to complete the procedure (the crossover technique). RESULTS: Group 1 demonstrated reduced fluoroscopy time (2.47 ± 1.05 minutes in group 1 vs 2.68 ± 1.26 minutes in group 2; P=.01) and non-significant reduction of AK (540.9 ± 225.3 mGy in group 1 vs 577.9 ± 240.1 mGy in group 2; P=.34) and DAP (3786.7 ± 1731.7 µGy•m² in group 1 vs 4058.0 ± 1735.4 µGy•m² in group 2; P=.12). Contrast volume usage (53.46 ± 10.09 mL in group 1 vs 55.98 ± 10.43 mL in group 2; P=.13) and the need for additional catheters (5.56% in group 1 vs 4.44% in group 2; P>.99) were similar between groups. CONCLUSION: The Tiger II catheter was able to reduce radiation exposure to patients submitted to TR-CAG through a significant reduction in fluoroscopy time.

Vascular Closure Devices Attenuate Femoral Access Complications of Primary Percutaneous Coronary Intervention.

OBJECTIVES: To compare severe complications related to radial access and those related to femoral access using vascular closure devices for patients undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: Femoral artery access is still used for acute myocardial infarction management; studies comparing state-of-the-art radial and femoral techniques are required to minimize bias regarding the outcomes associated with operator preferences. METHODS: We performed a randomized study comparing radial access with a compression device and anatomic landmark-guided femoral access with a hemostatic vascular closure device. The severe complication rates related to the access site were assessed until hospital discharge. A meta- analysis including studies with comparable populations reporting severe bleeding and major adverse cardiovascular event rates was performed. RESULTS: A total of 250 patients were included who underwent PCI between January 2016 and February 2019. Mean age was 61.5 ± 12.2 years, 73.2% were men, and 28.4% had diabetes. There were no differences between groups or in vascular access-related severe complication rates (8.0% for femoral group vs 5.6% for radial group; P=.45). Although radial access was associated with decreased vascular complications related to the access site when compared with the femoral approach (relative risk [RR], 0.64; 95% confidence interval [CI], 0.43-0.95), the meta-analysis did not show an impact on severe bleeding (RR, 0.74; 95% CI, 0.37-1.46) or severe cardiovascular adverse events (RR, 0.69; 95% CI, 0.30-1.58). CONCLUSIONS: Compliance with femoral artery puncture techniques and routine use of a vascular closure device promoted low severe complication rates.

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.

[Relationship between plasma C-reactive protein level and neointimal hyperplasia volume in patients with zotarolimus-eluting stents. Volumetric analysis by three-dimensional intracoronary ultrasound]. / Asociación entre la concentración plasmática de proteína C reactiva y el volumen de hiperplasia neointimal en pacientes tratados con implante de stent liberador de zotarolimus. Análisis volumétrico con ecografía intracoronaria tridimensional.

INTRODUCTION AND OBJECTIVES: C-reactive protein (CRP) is an inflammatory marker that predicts cardiac events in patients with coronary syndromes. However, data on the relationship between the CRP level and in-stent restenosis are contradictory. The objective of this study was to investigate the relationship between the basal CRP level and the neointimal hyperplasia volume measured by intracoronary ultrasound 4 months after implantation of a zotarolimus-eluting stent. METHODS: The study included 40 consecutive patients who underwent zotarolimus-eluting stent implantation. Patients were divided into quartiles according to their preprocedural CRP level. Intracoronary ultrasound was performed after stent implantation and at 4 months, and the neointimal hyperplasia volume was determined using Simpson's rule. Correlation and linear regression analyses were used to evaluate the relationships between variables. Multivariate analysis was used to identify variables that were independently related to neointimal hyperplasia volume. RESULTS: The patients' mean age was 58 (8) years, 55% were male, and 40% had diabetes mellitus. There was no difference in baseline characteristics between the quartiles. The hyperplasia volumes were 4.8 (4.2) microl and 15.8 (10.0) microl in the first and fourth quartiles, respectively (P< .001). There was a significant positive correlation between the CRP level and neointimal hyperplasia volume (r = 0.64, P=.0001). The CRP level, the postimplantation lumen volume, and the final deployment pressure were all independent predictors of neointimal hyperplasia. CONCLUSIONS: In this study, an independent correlation was observed between the CRP level before zotarolimus-eluting stent implantation and the neointimal hyperplasia volume at 4-month follow-up.