A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives.

PURPOSE: Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. METHODS: Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. RESULTS: Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. DISCUSSION: Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019).

The efficacy of sirolimus- and paclitaxel-eluting stents: a meta-analysis of randomized controlled trials.

BACKGROUND: Drug-eluting stents prevent in-stent restenosis after percutaneous coronary intervention, and differences between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) may exist in the rates of target lesion revascularization, death, myocardial infarction and stent thrombosis. OBJECTIVE: To compare the efficacy of SES and PES with the efficacy of bare-metal stents for de novo coronary lesions in patients with stable or unstable angina. METHODS: A meta-analysis of randomized trials from MEDLINE, EMBASE and other electronic databases and conference proceedings was conducted. The efficacy of SES, PES with a polymer carrier (PPOL) and PES without a polymer carrier (PNPOL) was compared using random-effects models. RESULTS: Ten trials comprising 5041 patients were included in the meta-analysis. There was an absolute decrease in target lesion revascularization of 17% (95% CI 14% to 20%), 9% (95% CI 6% to 11%) and 3% (95% CI 0% to 6%) with SES, PPOL and PNPOL, respectively, with significant differences between SES and PPOL and between PPOL and PNPOL (P < 0.01 for both comparisons). However, sensitivity analysis using the OR of target lesion revascularization showed no difference between SES (OR 0.18 [95% CI 0.12 to 0.26]) and PPOL (OR 0.25 [95% CI 0.16 to 0.37]) (P = 0.26). There were no differences in the incidence of death, myocardial infarction or stent thrombosis, although the small number of events limited the power of these analyses. CONCLUSIONS: SES show a greater absolute reduction in target lesion revascularization than do PES, likely due to differences in the bare-metal stents used for comparison in the trials. Head-to-head comparisons are needed to directly address the differential efficacy of SES and PES.