Tailored treat-to-target strategy feasible vs. high-intensity regimen for CAD
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Key takeaways:
- A treat-to-target statin strategy was noninferior to a high-intensity statin strategy in CAD.
- The data highlight the need for intensive efforts to attain the target LDL in patients with CAD.
NEW ORLEANS — Among adults with CAD, a treat-to-target LDL strategy of 50 mg/dL to 70 mg/dL was noninferior to a high-intensity statin therapy for the 3-year composite of death, MI, stroke or coronary revascularization, researchers wrote.
The findings provide additional evidence supporting the suitability of a treat-to-target strategy that may allow a tailored approach with consideration for individual variability in drug response to statin therapy, Myeong-Ki Hong, MD, PhD, professor of medicine at Severance Cardiovascular Hospital, Yonsei University College of Medicine in Seoul, South Korea, said during a featured clinical research presentation at the American College of Cardiology Scientific Session.
“Intensive lowering of LDL cholesterol levels with statins is recommended in patients with coronary artery disease; however, a clinically effective strategy for the choice of statin intensity remains unclear,” Hong said during a presentation. “There are two ways: a treat-to-target strategy, in which statin intensity can be titrated to meet a target LDL cholesterol level. The second is where a high-intensity statin strategy can be initiated as well as maintained without monitoring of LDL cholesterol level.”
For the LODESTAR study, Hong and colleagues analyzed data from 4,400 adults with a diagnosis of CAD treated at 12 centers across South Korea, enrolled between September 2016 and November 2019. The mean age of participants was 65.1 years; 27.9% were women.
Researchers randomly assigned participants to the LDL target strategy, with an LDL level between 50 mg/dL and 70 mg/dL as the target (n = 2,200), or high-intensity statin treatment, which consisted of rosuvastatin 20 mg per day or atorvastatin 40 mg per day (n = 2,200).
For this study, the high-intensity statin therapy regimen was regarded as standard therapy and the treat-to-target strategy was considered the experimental therapy, Hong said, with a primary aim of noninferiority regarding clinical outcomes. The primary endpoint was a 3-year composite of death, MI, stroke or coronary revascularization.
The findings were simultaneously published in JAMA.
In the treat-to-target group, moderate-intensity and high-intensity dosing were used in 43% and 54% of participants, respectively. For the overall study period, in the treat-to-target group, statin intensity was uptitrated in 17% of participants, downtitrated in 9% of patients and maintained without changes in 73% of participants. In the treat-to-target group, 53% were taking a high-intensity statin at 1 year, 55% at 2 years and 56% at 3 years; the corresponding rates in the high-intensity statin therapy group were 93%, 91% and 89%, respectively.
At 3 years, the mean LDL level was 69.1 mg/dL in the treat-to-target group and 68.4 mg/dL in the high-intensity statin group (P = .21).
The primary endpoint occurred in 8.1% of the treat-to-target group and 8.7% in the high-intensity statin group, for an absolute difference of –0.6 percentage points (upper boundary of one-sided 97.5% CI, 1.1; P for noninferiority < .001).
In a Q&A session after the presentation, Hong said the data show that there are alternatives for statin prescribing that are safe.
“As a clinician who takes care of outpatients ... we have to think about the safety endpoint,” Hong said. “Even though the guideline recommends high-intensity statin for the outpatient, some patients complain of statin-related muscle symptoms. Some are nervous [to take statins]. We also have to think about adherence. Our study shows an alternative option for the physician.”