SECURE-PCI: Atorvastatin loading in planned PCI fails to reduce 12-month MACE
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Among patients with ACS, periprocedural loading doses of atorvastatin before planned PCI did not reduce MACE at 12 months compared with placebo, according to new data from the SECURE-PCI trial.
As Healio previously reported, in the 30-day results of SECURE-PCI, a loading dose of atorvastatin did not reduce MACE in the overall cohort, but did when only patients who actually underwent PCI were analyzed. The 12-month findings were published in a research letter to JAMA.
No impact on MACE
At 12 months, researchers found no significant difference in MACE, defined as all-cause mortality, acute MI, stroke and unplanned coronary revascularization, in patients who underwent PCI with prior atorvastatin loading doses compared with those who received placebo (atorvastatin, 11.3%; placebo, 12.1%; HR = 0.94; 95% CI, 0.76-1.14). No components of MACE nor secondary CV outcomes differed between atorvastatin and placebo.
“After 12 months, periprocedural loading doses of atorvastatin compared with placebo did not reduce MACE in patients with ACS and planned invasive management,” Renato D. Lopes, MD, MHS, PhD, professor of medicine in the division of cardiology at Duke University Medical Center, Duke Clinical Research Institute, and colleagues wrote. “In addition, there were no significant differences in the subgroup of patients undergoing PCI despite a reduction in the rate of MACE with atorvastatin being observed at 30 days (Berwanger O, et al. JAMA. 2018;doi:10.1001/jama.2018.2444; Lopes RB, et al. JAMA Cardio. 2018;doi:10.1001/jamacardio.2018.3408). The short-term effect in the PCI group could be related to the reduction in inflammation with atorvastatin that may have dissipated with time, or the result at 30 days may have been due to immortal time bias or a lack of adjustment for multiple comparisons.”
Moreover, in patients who actually underwent PCI, 11.2% of the atorvastatin group and 12.9% of the placebo group experienced MACE at 12 months (absolute difference, 1.7 percentage points; 95% CI, 0.82 to 4.22; HR = 0.82; 95% CI, 0.63-1.06).
“You're going to have to use statins no matter what for the patients, so you might as well start right away, at the presentation of the patient in the hospital with an ACS event, and I think the SECURE-PCI trial give some reasonable data to support that,” Lopes said in an interview. “Particularly in patients who are undergoing PCI and presenting with STEMI.”
To assess the 12-month outcomes of the SECURE-PCI trial, researchers contacted participants via telephone to collect data on vital status and MACE.
“Limitations include that data at 12 months were reported by patients and subject to recall bias, data may not be generalizable to other countries with different approaches to treatment of ACS, no data were available on patient treatment over 12 months and no information on low-density lipoprotein cholesterol reduction was available at 12 months,” the researchers wrote.
Future research
“Future research might not necessarily be with statins. It might be with other drugs that reduce cholesterol levels and that might also have further effects other than just LDL lowering such as PCSK9 inhibitors,” Lopes told Healio. “The question is whether or not there is a role for a loading dose or two doses of these drugs in the first week or so of the ACS presentation.” – by Scott Buzby
Disclosures: Lopes reports he received grants from Amgen; personal fees from Bayer, Boehringer Ingelheim and Portola; and grants and personal fees from Bristol-Myers Squibb, GlaxoSmithKline, Pfizer and Sanofi Aventis. Please see the study for all other authors’ relevant financial disclosures.
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