Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease

Abstract

ImportanceIn patients with coronary artery disease, some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in low-density lipoprotein cholesterol (LDL-C). An alternative approach is to begin with moderate-intensity statins and titrate to a specific LDL-C goal. These alternatives have not been compared head-to-head in a clinical trial involving patients with known coronary artery disease.ObjectiveTo assess whether a treat-to-target strategy is noninferior to a strategy of high-intensity statins for long-term clinical outcomes in patients with coronary artery disease.Design, Setting, and ParticipantsA randomized, multicenter, noninferiority trial in patients with a coronary disease diagnosis treated at 12 centers in South Korea (enrollment: September 9, 2016, through November 27, 2019; final follow-up: October 26, 2022).InterventionsPatients were randomly assigned to receive either the LDL-C target strategy, with an LDL-C level between 50 and 70 mg/dL as the target, or high-intensity statin treatment, which consisted of rosuvastatin, 20 mg, or atorvastatin, 40 mg.Main Outcomes and MeasuresPrimary end point was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization with a noninferiority margin of 3.0 percentage points.ResultsAmong 4400 patients, 4341 patients (98.7%) completed the trial (mean [SD] age, 65.1 [9.9] years; 1228 females [27.9%]). In the treat-to-target group (n = 2200), which had 6449 person-years of follow-up, moderate-intensity and high-intensity dosing were used in 43% and 54%, respectively. The mean (SD) LDL-C level for 3 years was 69.1 (17.8) mg/dL in the treat-to-target group and 68.4 (20.1) mg/dL in the high-intensity statin group (n = 2200) (P = .21, compared with the treat-to-target group). The primary end point occurred in 177 patients (8.1%) in the treat-to-target group and 190 patients (8.7%) in the high-intensity statin group (absolute difference, –0.6 percentage points [upper boundary of the 1-sided 97.5% CI, 1.1 percentage points]; P < .001 for noninferiority).Conclusions and RelevanceAmong patients with coronary artery disease, a treat-to-target LDL-C strategy of 50 to 70 mg/dL as the goal was noninferior to a high-intensity statin therapy for the 3-year composite of death, myocardial infarction, stroke, or coronary revascularization. These 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.Trial RegistrationClinicalTrials.gov Identifier: NCT02579499

Treating Coronary Artery Disease With Treat-to-Target or High-Intensity Statin—Reply

“…Second, regarding sex difference in our study, there was no significant interaction between sex and statin therapy strategy (treat-to-target group vs high-intensity statin group) in terms of the primary end point (8.5% vs 9.1%; difference, −0.7% [95% CI, −2.7% to 1.3%] for men and 7.3% vs 7.6%; difference, −0.3% [95% CI, −3.2% to 2.7%] for women) as well as an achievement of LDL-C level below 70 mg/dL at 3 years (58.1% vs 60.6%; difference, −2.5% [95% CI, −6.6% to 1.6%] for men and 58.6% vs 57.2%; difference, 1.3% [95% CI, −5.2% to 7.9%] for women). Although the proportion of women was relatively low in our study, perhaps due to sex difference in epidemiology of coronary artery disease (a higher prevalence among men), it was higher compared with the previous randomized trial regarding intensive statin therapy . However, we agree with Kawada that the effect of sex should be cautiously considered, and further research focusing on sex and statin therapy is warranted.…”

“…In Reply We appreciate Dr Kawada’s comments about our study, which demonstrated that a treat-to-target LDL-C strategy of 50 to 70 mg/dL as the goal was noninferior to a high-intensity statin therapy for the 3-year composite of death, myocardial infarction, stroke, or coronary revascularization …”

Impact of institutional case volume of solid organ transplantation on patient outcomes and implications for healthcare policy in Korea

“…In an analysis of 315 adult patients who underwent lung transplantation at seven centers in Korea between 2007 and 2016, the median center case volume was four cases per year, with an overall in-hospital mortality rate of 25.7%. No statisti-cally significant difference was found in in-hospital mortality between low-volume centers (<5 cases/year) and high-volume centers (>5 cases/year) (32.4% vs. 23.8%; OR, 1.498; 95% CI, 0.811-2.758; P=0.197) [34]. The absence of a relationship between center case volume and mortality may have been due to the relatively small number of overall cases and centers performing lung transplantation.…”

The Case for Inclusion of a Lipid Panel in the Standard Precatheterization Laboratory Blood Draw—Stating What Should Be Obvious

“…Owing to this therapeutic inertia, 40% of high-risk patients with ASHD do not meet low-density lipoprotein cholesterol (LDL-C) goals . Addressing this by basing treatment on risk (rather than LDL-C levels) has been attempted, but many patients still do not achieve target LDL-C levels below 70 mg/dL with either strategy . Nonstatin lipid-lowering therapy also remains grossly underused; a simulation model estimated that for a population of patients with ASHD to reach LDL-C goals, up to 18.7% of patients would require the addition of ezetimibe and 14% would require the addition of a PCSK9 inhibitor .…”