BackgroundThe prevalence of significant obstructive coronary artery disease with complex lesions is high in patients who have low extremity artery disease (LEAD). However, intermediate- or long-term cardiovascular prognosis of LEAD patients undergoing percutaneous transluminal angioplasty (PTA) remains poor. Accordingly, prophylactic coronary revascularization may modify short- and long-term cardiovascular outcomes of LEAD patients receiving PTA. Because myocardial ischemic symptoms are often masked in LEAD and the accuracy of non-invasive stress tests is usually limited, a high-quality randomized controlled trial aimed at the investigation of the prognostic role of coronary evaluation strategies before PTA is warranted.Methods/DesignThe proposed study is designed as a prospective, multi-center, open-label, superiority, randomized controlled trial. The study is conducted in high-volume centers for PTA and coronary revascularization in Taiwan. To meet the inclusion criteria, the patients must be at least 20 years old, have known LEAD, and have been admitted for elective PTA. We plan to enroll 450 participants who are randomly allocated to a routine group (routine coronary angiography without a previous non-invasive stress test before PTA) and a selective group (selective coronary angiography based on the results of non-invasive stress tests before PTA) with 1:1 ratio. Besides, we expect to enroll about 250 additional participants, who are not willing to be randomly assigned, in the registration group. The choice of revascularization procedure depends on the operator’s or cardiovascular team’s suggestion and the patient’s decision. Clinical follow-up will be performed 30 days after PTA and every 6 months until the end of the 1-year follow-up for the last randomly assigned participant. The primary endpoint is the composite major adverse cardiac event on long-term follow-up. Pre-specified secondary and other endpoints are also evaluated. Those assessing biomarkers and clinical endpoints are all blinded after assignment to interventions.DiscussionThe results of the trial will, for the first time, support better decision-making for coronary evaluation before PTA in LEAD. If favorable, routine coronary angiography followed by revascularization will improve cardiovascular outcomes in LEAD patients undergoing PTA.Trial registrationClinicalTrials.gov identifier: NCT02169258 (registered on 21 June 2014); registry name: Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1237-0) contains supplementary material, which is available to authorized users.
1-5 years) follow-up for non-paroxysmal AF ablation showing a high recurrence rate after a single procedure. 3,4 However, the data on the very-long-term (>5 years) efficacy of ablation in patients with non-paroxysmal AF, especially for those who undergo repeated ablations, is unclear. For instance, whether the efficacy of ablation can extend beyond 5 years and the risk factors for these verylate recurrences are still undetermined. In this study, we investigated the 10-year radiofrequency catheter ablation A trial fibrillation (AF) is the most common arrhythmia in clinical practice, and catheter ablation of AF through pulmonary vein (PV) isolation, introduced more than 20 years ago, remains the cornerstone of AF ablation strategy. 1 With the improvement in technologies, the indication for catheter ablation has broadened to non-paroxysmal AF patients based on evidence showing better efficacy than antiarrhythmic drug (AAD) therapy. 2 There have been some reports of the mid-to long-term
BackgroundVentricular premature complex (VPC) is one of the most common ventricular arrhythmias. The presence of VPC is associated with an increased risk of heart failure (HF).MethodWe designed a single-center, retrospective, and large population-based cohort to clarify the role of VPC burden in long-term prognosis in Taiwan. We analyzed the database from the National Cheng Kung University Hospital-Electronic Medical Record (NCKUH-EMR) and NCKUH-Holter (NCKUH-Holter). A total of 19,527 patients who underwent 24-h Holter ECG monitoring due to palpitation, syncope, and clinical suspicion of arrhythmias were enrolled in this study.ResultsThe clinical outcome of interests involved 5.65% noncardiovascular death and 1.53% cardiovascular-specific deaths between 2011 and 2018. Multivariate Cox regression analysis, Fine and Gray's competing risk model, and propensity score matching demonstrated that both moderate (1,000–10,000/day) and high (>10,000/day) VPC burdens contributed to cardiovascular death in comparison with a low VPC burden (<1,000/day).ConclusionA higher VPC burden via Holter ECG is an independent risk factor of cardiovascular mortality.
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