Pulmonary vein isolation (PVI) is the cornerstone of interventional treatment for atrial fibrillation. Patients with persistent atrial fibrillation have relatively high recurrence rates after catheter ablation irrespective of treatment strategy. Randomized data suggest that adding substrate modification to PVI at the first ablation procedure does not improve arrhythmia-free survival. To date, real-world data from experienced centers is limited. The German Ablation registry maintained by the Institut für Herzinfarktforschung Ludwigshafen, Germany included 909 patients with persistent atrial fibrillation (AF). 645 underwent isolated PVI (PVI-only) and 264 received additional substrate modification (PVI-plus). The primary endpoint was defined as freedom from AF after 1 year documented by ECG. Mean procedure time was longer in the PVI-plus group (203 ± 75 min vs. 186 ± 68 min; p = 0.002) with no significant difference in acute procedural success (94
BACKGROUND:Approximately one half of patients undergoing transcatheter aortic-valve implantation (TAVI) have concomitant coronary artery disease. Although percutaneous coronary intervention (PCI) is often performed before TAVI, the preferred treatment strategy has not been established. METHODS:We conducted an international, open-label, randomized, noninferiority trial at 48 centers in Europe. Patients with severe aortic stenosis and coronary artery disease were randomly assigned in a 1:1 ratio to a strategy of either TAVI before PCI (TAVI-first group) or PCI before TAVI (PCI-first group). The primary end point was a composite of death from any cause; nonfatal myocardial infarction; ischemia-driven revascularization; rehospitalization related to the valve, procedure, or heart failure; or life-threatening, disabling, or major bleeding at 1 year after randomization. The noninferiority margin was 6.6 percentage points, with testing for noninferiority of TAVI first as compared with PCI first. RESULTS:A total of 986 patients underwent randomization: 498 were assigned to the TAVI-first group and 488 to the PCI-first group. A primary end-point event occurred in 105 patients (22.2%) in the TAVI-first group and in 112 patients (24.2%) in the PCI-first group (risk difference, -2.0 percentage points; 95% confidence interval, -7.4 to 3.4; P<0.001 for noninferiority). Serious adverse events occurred in 264 patients in the TAVI-first group and in 273 patients in the PCI-first group. CONCLUSIONS:Among patients with severe aortic stenosis and coronary artery disease, a strategy of TAVI before PCI was noninferior to a strategy of PCI before TAVI with respect to the primary end point at 1 year. (Funded by University Hospital Zurich and others; TAVI PCI ClinicalTrials.gov number, NCT04310046.).
BACKGROUND:In the PARADIGM-HF trial, sacubitril/valsartan improved outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Because patients enrolled in randomized trials often differ from those in routine care, we assessed the proportion and characteristics of patients fulfilling PARADIGM-HF eligibility criteria in historical German HFrEF datasets and used the PARADIGM-HF enalapril arm as descriptive clinical context. METHODS AND RESULTS:We analyzed 7605 HFrEF patients enrolled between 1994 and 2013 in three German datasets (EVITA-HF, HeLuMa, INH). Full eligibility, including natriuretic peptide (NP) criteria, was assessable in 4442 patients and confirmed in 1828 (41.2%). Mean age was 63.8 ± 13.3 years, 23.1% were female, and ischemic heart disease was the predominant etiology (51.7%). Compared with non-PARADIGM patients, PARADIGM-like patients were older, had lower LVEF, higher NP concentrations, and more comorbidities. In an exploratory pooled Cox analysis, the unadjusted HR of the PARADIGM-like patients for one-year all-cause mortality was 1.17 (95% CI 0.97-1.40) and was attenuated to 1.08 (95% CI 0.90-1.30) after adjustment for age, sex, NYHA functional class III/IV, LVEF, and renal function. Descriptive contextualization against the PARADIGM-HF enalapril arm showed overlap in clinical characteristics but also differences in disease severity, biomarker concentrations, and ascertainment conditions. CONCLUSIONS:In these historical German HFrEF datasets, full PARADIGM-HF eligibility including NP criteria was confirmed in 41.2% of patients with completely assessable eligibility information, indicating that PARADIGM-HF included a high rate of patients seen in routine care. PARADIGM-like compared to non-PARADIGM-like patients exhibited a more advanced clinical profile.
