- Berwanger O, Santucci EV, Silva PGM de B e, Jesuíno I de A, Damiani LP, Barbosa LM, et al. 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. JAMA. 2018 Apr 3;319(13):1331–40. EZProxy link
Some of you may have seen this before but recently heard about this trial published in JAMA last year. This was a RCT trial where patients with ACS and going on to have angiography were given a loading dose (80mg) of Atorvastatin or placebo i) NSTEMI – 2–12hrs prior to angiography/PCI or ii) STEMI – ASAP. This was reported as a negative trial with no reduction in 30 day major adverse cardiac events (MACE) in the ACS population. However, in post-hoc subgroup analysis (read what you will into this) the group that had a STEMI and received Atorvastatin had a >40% reduction in 30-day MACE.
This is a therapy that they will end up on anyway and is unlikely to do harm if the definitive treatment is not delayed. 80mg of Atorvastatin could be given whilst drawing up the lytics!
Note these were patients that went onto have PCI (which would hopefully be the majority of STEMI in NZ now) and it is unclear if re-perfusion by any means (lysis v primary PCI) will yield the same results but it is a big effect size.
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.