Daily Cardiology Research Analysis

BACKGROUND: Coronary artery bypass grafting (CABG) is recommended over percutaneous coronary intervention (PCI) for patients with significant unprotected left main coronary artery disease. We aim to provide long-term outcome data comparing PCI with newer generation drug-eluting stents and CABG, which are scarce. METHODS: This previously published, prospective, randomised, open-label, non-inferiority trial enrolled patients with unprotected left main coronary artery stenosis at 36 hospitals in Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Norway, Sweden, and the UK. Eligibility was determined by a multidisciplinary heart team and defined by clinical criteria (chronic or acute coronary syndrome and a life expectancy of >1 year) and angiographic criteria (left main coronary artery diameter stenosis ≥50% or fractional flow reserve ≤0·80 in the left main ostium, mid-shaft, or bifurcation). Patients with ST elevation myocardial infarction within 24 h or considered at too high risk for CABG or PCI were excluded. Patients with angiographically confirmed significant left main coronary artery disease were randomly assigned (1:1) to PCI or CABG using an online system and stratified by site, sex, distal left main coronary artery bifurcation lesions, and diabetes. The primary outcome was the difference in 10-year all-cause mortality in the intention-to-treat (ITT) population, which was analysed using Kaplan-Meier estimates and unadjusted Cox regression. Patients were censored at the date of death, emigration, withdrawal, or loss to follow-up. Variation in all-cause mortality was assessed in prespecified subgroups. The trial is registered with ClinicalTrials.gov, NCT01496651 (active, not recruiting). FINDINGS: From Dec 9, 2008, to Jan 21, 2015, 1201 patients were randomly assigned to PCI (n=598) or CABG (n=603). 17 patients were lost to follow-up before 1 year. 592 patients in each group were included in the ITT population. Mean age was 66·2 years (SD 9·9) in the PCI group and 66·2 years (9·4) in the CABG group. 256 (22%) of 1184 participants were female and 928 (78%) were male. There was no difference in all-cause mortality at 10 years (136 [23%] of 592 in the PCI group and 145 [25%] of 592 in the CABG group; hazard ratio 0·93 [95% CI 0·74-1·18]; p=0·56). No significant difference in all-cause mortality with SYNTAX score was identified. INTERPRETATION: There was no significant difference in all-cause mortality at 10 years between PCI and CABG for patients with unprotected left main coronary artery disease and no additional complex lesions, indicating that PCI is equally as safe as CABG in patients eligible for both treatments. These results will aid heart teams in developing an individualised patient-centred strategy. FUNDING: Biosensors and Aarhus University Hospital.

BACKGROUND: Multiple coronary guidance strategies including angiography, physiology-based assessment, and intracoronary imaging are used to optimize percutaneous coronary intervention, yet their comparative effectiveness across clinical outcomes remains uncertain. METHODS: A comprehensive network meta-analysis incorporated fifty randomized studies evaluating angiography, FFR, iFR, IVUS, and OCT. The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes included all-cause mortality, cardiac death, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization. Random effects models were applied and interventions were ranked using SUCRA. RESULTS: A total of 50 studies involving 39,863 patients were included, of whom 29,571 were male and 10,031 were female. Across guidance modalities, 15,463 patients underwent angiography-guided PCI, 10,728 IVUS-guided, 6,001 FFR-guided, 3,512 iFR-guided, and 3,849 OCT-guided PCI. In the network meta-analysis, intravascular imaging strategies demonstrated favorable outcomes across evaluated endpoints. Compared with IVUS, angiography-guided PCI was associated with higher rates of major adverse cardiovascular events (RR 1.28, 95% CI 1.13-1.46), all-cause mortality (RR 1.30, 95% CI 0.98-1.63), myocardial infarction (RR 1.73, 95% CI 1.28-2.40), target lesion failure (RR 1.50, 95% CI 1.19-1.93), and stent thrombosis (RR 1.80, 95% CI 1.25-2.70). Physiology-guided PCI using iFR was associated with higher risk estimates for all-cause mortality (RR 1.72, 95% CI 1.06-2.79) and cardiac death (RR 2.21, 95% CI 1.24-4.24) compared with IVUS. OCT demonstrated outcomes comparable to IVUS, with no statistically significant differences in major adverse cardiovascular events (RR 1.00, 95% CI 0.80-1.28) or cardiac death (RR 0.86, 95% CI 0.47-1.59). Sensitivity analyses yielded similar estimates. Overall, probabilistic ranking analyses favored intravascular imaging strategies, although effect estimates among non-angiographic modalities overlapped. CONCLUSIONS: Advanced PCI guidance strategies using intravascular imaging or invasive physiological assessment are associated with improved clinical outcomes compared with angiography alone. However, no single non-angiographic modality demonstrates definitive superiority, supporting individualized selection of guidance strategies based on clinical and procedural context. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251238909, identifier CRD420251238909.

BACKGROUND: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) found a 36% reduction in major adverse cardiovascular events (MACE) with pitavastatin in people with HIV. Little is known about the relationship between lipid lowering and MACE in this population. We evaluated pitavastatin effects on lipids and examined mediation of pitavastatin effects on MACE through lipid lowering. METHODS: REPRIEVE was a randomised, double-blind, placebo-controlled phase 3 trial evaluating pitavastatin (4 mg daily) or placebo for prevention of MACE in people with HIV. Participants aged 40-75 years, on stable combination antiretroviral therapy (ART), and at low-to-moderate atherosclerotic cardiovascular disease risk with minimally elevated LDL were followed up for a median of 5·6 years. Centrally tested fasting lipids were captured at entry and annually thereafter. The primary MACE outcome, reported previously, was time to first MACE. Here, we report secondary outcomes on fasting lipids. Linear mixed-effects models were used for assessment of the pitavastatin effect on lipids, Cox regression for relationship of lipids to MACE, and Vansteelandt method for mediation analysis. FINDINGS: REPRIEVE enrolled 7769 participants from March 26, 2015, to July 31, 2019, in 12 countries across five Global Burden of Diseases super-regions. The median baseline LDL was 108 mg/dL, and similar across treatment groups. Pitavastatin effects were primarily observed on LDL, with a modest reduction in triglycerides and no apparent effect on HDL. Based on the longitudinal data modelling, the estimated treatment group difference in LDL at month 12 (pitavastatin minus placebo) was -30 mg/dL (95% CI -31 to -29), corresponding to a 30% reduction. The estimated risk of LDL of ≥100 mg/dL at month 12 was 0·18 in the pitavastatin group and 0·57 in the placebo group (relative risk 0·32, 95% CI 0·30-0·34). A 30% lower time-updated average LDL was associated with 20% lower risk of primary MACE (hazard ratio 0·80, 95% CI 0·68-0·94). Of the pitavastatin effect on MACE, 68% was estimated to be mediated through LDL, although with low precision (95% CI 15-574). INTERPRETATION: LDL is strongly related to MACE, and LDL lowering should be an important goal of primary cardiovascular prevention in people with HIV, even in those with minimally elevated LDL. Treatment should aim to achieve accepted primary care prevention targets for LDL. FUNDING: US National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare.