12-month SECURE-PCI Results add Context to Original Findings

March 10, 2020 – Patients with acute coronary syndrome undergoing PCI had a benefit 30 days after being treated with loading dose atorvastatin, but this benefit did not extend to the 12-month results.

Although initial results from SECURE-PCI suggested that patients treated with periprocedural loading doses of atorvastatin and undergoing percutaneous coronary intervention (PCI) experienced a reduced risk of major adverse cardiovascular events (MACE), extended follow-up showed no significant difference.

The 12-month results, which were recently published in JAMA, expand upon the initial study, which followed patients for 30 days.

Renato Lopes, MD, PhDSECURE-PCI, conducted by the Brazilian Clinical Research Institute and the HCor Research Institute in collaboration with the DCRI, randomized over 4,000 patients in Brazil with acute coronary syndrome (ACS) and planned invasive management to either a loading dose of atorvastatin or placebo before and after their procedures. Although the initial study found no difference in rates of MACE for the overall population, a preplanned subgroup analysis found a statistically significant difference in patients undergoing PCI.

However, the new results, which are based on patient-reported data after 12 months, suggest this benefit is not long-term. The DCRI’s Renato Lopes, MD, PhD, study co-chair, said the differences in the results at 30 days could be attributable to the acute and sub-acute benefits of atorvastatin—reduced inflammation—dissipating over time, or to potential biases.

“These results provide more information about how best to treat and monitor patients with acute coronary syndrome undergoing percutaneous coronary intervention,” Lopes said. “While a periprocedural dose of atorvastatin may lead to short-term benefit in this population, particularly in patients with ST-elevation myocardial infarction undergoing PCI, this benefit of an acute loading dose of statins was not sustained in the 12 month results. It is important to remember that after the initial 24 to 48 hours from PCI, every patient was treated with statins. Thus, the use of loading dose statin in clinical practice for patients presenting with ACS undergoing PCI may be a reasonable approach that could be especially useful for hospitals that do not use a statin regimen in the first 24 to 48 hours. It will be important to continue to monitor these patients for major adverse cardiovascular events and make sure that they all use an appropriate dose of statin for long-term secondary prevention as recommended by national and interactional guidelines.”

The trial was co-chaired by Otavio Berwanger, MD, PhD, and other DCRI contributors to the study include John Alexander, MD, MHS, and Christopher Granger, MD.