Daily Cardiology Research Analysis

BACKGROUND: The preferred timing of treatment of nonculprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) remains uncertain. A comparison of immediate percutaneous coronary intervention (PCI) guided by instantaneous wave-free ratio (iFR) and deferred PCI guided by cardiac stress magnetic resonance imaging (MRI) in patients with STEMI and multivessel disease is warranted. METHODS: In this international, investigator-initiated, open-label, randomized, controlled trial, patients with STEMI and at least one nonculprit lesion who had undergone successful primary PCI were randomly assigned in a 1:1 ratio to immediate iFR-guided PCI (in lesions with >50% stenosis and an iFR of ≤0.89 [normal value, >0.89]) or deferred cardiac stress MRI-guided PCI within 6 weeks after randomization. The primary end point was a composite of death from any cause, recurrent myocardial infarction, or hospitalization for heart failure at 3-year follow-up. RESULTS: The trial included 1146 patients (558 in the iFR group and 588 in the MRI group) with a mean (±SD) age of 63±11 years; 78% were men. A total of 237 of 556 patients (42.6%) in the iFR group and 110 of 587 patients (18.7%) in the MRI group underwent nonculprit-lesion coronary-artery PCI. A primary-end-point event occurred in 50 patients (9.3%) in the iFR group and in 55 patients (9.8%) in the MRI group (hazard ratio, 0.95; 95% confidence interval, 0.65 to 1.40; P = 0.81). Serious adverse events occurred in 145 patients in the iFR group and in 181 in the MRI group. CONCLUSIONS: Among patients with STEMI who have undergone successful primary PCI, immediate iFR-guided PCI was not superior to deferred cardiac stress MRI-guided PCI of nonculprit coronary-artery lesions with respect to death from any cause, recurrent myocardial infarction, or hospitalization for heart failure at 3 years. (Funded by Philips Volcano and others; iMODERN ClinicalTrials.gov number, NCT03298659.).

BACKGROUND: In patients with prior coronary artery bypass grafting (CABG) presenting with graft failure, current guidelines recommend percutaneous coronary intervention (PCI) of the bypassed native coronary artery over PCI of the bypass graft. However, this recommendation relies solely on observational data. OBJECTIVES: This study compared clinical outcomes between a strategy of native vessel PCI with saphenous vein graft (SVG) PCI in post-CABG patients presenting with SVG failure. METHODS: The multicenter, randomized PROCTOR (Percutaneous Coronary Intervention of Native Coronary Artery versus Saphenous Vein Graft in Patients with Prior Coronary Artery Bypass Graft Surgery) trial included patients with significant SVG stenosis and a heart team-defined clinical indication for revascularization. Patients were randomly assigned (1:1) to either a strategy of native vessel PCI or SVG PCI using an interactive web-based randomization platform. The trial was conducted across 14 centers in Europe. We report the occurrence of major adverse cardiac events at 1 year following the index PCI, defined as the composite of all-cause mortality, nonfatal target coronary territory myocardial infarction (MI), or clinically driven target coronary territory revascularization, analyzed on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov (NCT03805048), and long-term follow-up is ongoing. RESULTS: Between January 2019 and December 2023, 220 patients (mean age 73 ± 7 years; 84% men [185/220 patients]) were randomized to a strategy of native vessel PCI (n = 108) or SVG PCI (n = 112). At 1 year, major adverse cardiac events occurred in 37 patients (34%) in the native vessel PCI group and 21 patients (19%) in the SVG PCI group (HR: 2.14; 95% CI: 1.25-3.65; P = 0.006). There was no significant difference in all-cause mortality (HR: 1.59; 95% CI: 0.45-5.64; P = 0.472), whereas both nonfatal target coronary territory MI (HR: 2.12; 95% CI: 1.08-4.17; P = 0.029) and clinically driven target coronary territory revascularization (HR: 2.19; 95% CI: 1.02-4.72; P = 0.044) occurred more frequently in patients assigned to native vessel PCI. The incidence of PCI-related MI was 13% in the native vessel PCI group and 1% in the SVG PCI group (HR: 14.85; 95% CI: 1.95-112.96; P = 0.009). CONCLUSIONS: In the randomized PROCTOR trial, SVG PCI was associated with improved 1-year clinical outcomes compared with native vessel PCI, primarily driven by lower rates of PCI-related MI and clinically driven target coronary territory revascularization.

IMPORTANCE: Atrial fibrillation (AF) ablation outcomes demonstrate attrition over time. Although observational studies have reported reduced arrhythmia recurrence after AF ablation with aggressive lifestyle and risk factor modification, evidence from randomized clinical trials is lacking. OBJECTIVE: To determine the impact of risk factor and weight management on AF ablation rhythm outcomes. DESIGN, SETTING, AND PARTICIPANTS: This was an open-label, multicenter, randomized clinical trial with 12-month follow-up conducted from July 2014 to September 2018. The setting included 3 sites in Adelaide, South Australia. Included in the analysis were consecutive patients with nonpermanent symptomatic AF undergoing first-time catheter ablation with a body mass index (BMI) greater than or equal to 27 (calculated as weight in kilograms divided by height in meters squared) and 1 or more additional cardiometabolic risk factors. Data were analyzed from September 2023 to August 2024. INTERVENTIONS: Patients were randomized 1:1 to lifestyle and risk factor management (LRFM) or usual care (UC) at catheter ablation. The LRFM group was treated in a structured, physician-led tailored clinic to reduce modifiable risk factors. The UC group was given information on management of risk factors by their treating physician but were not enrolled into the risk factor modification clinic. Both groups received guideline-directed care for management of AF by a team blinded to randomization. Pulmonary vein isolation was undertaken in each patient with additional ablation considered at the discretion of the electrophysiologist. MAIN OUTCOMES AND MEASURES: Proportion of patients free from AF in the 12-month period after ablation. RESULTS: Of 122 participants (mean [SD] age, 60 [10] years; 82 male [67%]; mean [SD] BMI, 33 [5]), 62 were randomized to LRFM, and 60 were randomized to UC. Primary end point at 12 months after ablation was observed in 38 patients (61.3%) in the LRFM group and 24 (40%) in the control group (P = .03). The hazard for recurrent arrhythmia over 12 months was 0.53 (95% CI, 0.32-0.89) for LRFM vs UC. AF symptom severity was significantly improved in the LRFM group compared with the UC group (mean difference, -2.0; 95% CI, -3.7 to -0.3). Patients in the LRFM group achieved a significantly improved risk factor profile compared with those in the UC group (mean difference, body weight, -9.0 kg; 95% CI, -11.1 to -6.8 kg and waist circumference, -7.0 cm; 95% CI, -9.4 to -4.5 cm were lower at 12 months in the LRFM group; systolic BP was lower at 12 months in the LRFM group, -10.8 mm Hg; 95% CI, -16.1 to -5.5 mm Hg, although there was no difference in diastolic BP, -3.5 mm Hg; 95% CI, -7.2 to 0.2 mm Hg). CONCLUSIONS AND RELEVANCE: Among patients with AF, elevated BMI, and 1 or more additional cardiometabolic risk factors, aggressive risk factor management reduced arrhythmia recurrence over the 12-month period after catheter ablation. These findings demonstrate the importance of LRFM for the maintenance of sinus rhythm after catheter ablation. TRIAL REGISTRATION: ANZCTR Registry Identifier: ACTRN12613000444785.