In Hospital and 30 Days Results of the Prospective, Observational, Multicenter and Controlled “real world” WALTZ Registry

Abstract

Purpose: To evaluate and describe in-hospital and 30 days clinical outcomes in a real world population treated with a new BMS design and with multiple vessel disease and/or left main coronary artery disease (CAD). Methods: Since August 2016 to March 2017, 201 consecutive patients undergoing coronary stent implantation in 12 centers in Argentina were included in our registry. Multiple vessel disease and/or unprotected left main disease, acute coronary syndromes , including ST elevation myocardial infarction (MI) and coronary arteries with 70% or more of diameter stenosis, were inclusion criteria. On the other hand, in-stent restenosis, protected left main stenosis or impossibility to receive double antiplatelet therapy for at least one month constitute the exclusion criteria. Primary endpoint was hard clinical end points, defined as any cause of death, MI or cerebrovascular accident. Major adverse cardiac events (MACE) are defined as the incidence of cardiac death, MI, and any ischemic driven lesion revascularization (TLR). Incidence of definitive and possible stent thrombosis (SET) was also analyzed. Baseline and residual Syntax and ERACI score risks were analyzed and compared. Results: The average age was 61.5 +/-12 years, 80.1% were men, with a 31.3% of known coronary artery disease and 24.4% with history of MI. The 67.2% of patients had an ACS, of which 31.8% had ST elevation MI. 46.8% of patients had multiple vessel disease and 1.34 vessels per patient were treated in the index procedure. Dual antiplatelet therapy was used in 100% of patients, 52.3% received clopidogrel as charging dose, 11.4% of prasugrel and 36.3% ticagrelor as preferred thyenopiridines. 30 days MACE was 1.5% and cardiac death or any death was 0.5%.Significant differences in baseline (p=0.001) and residual (p<0.01) between Syntax and ERACI score were found. No patients developed stent thrombosis. Conclusions: In this prospective multicenter observational registry performed in 12 centers of Argentina showed a high 30 days quality PCI performance in a real-world CAD population.

One-Year Follow-Up Results From the Observational, Multicenter, Prospective, and Controlled Registry: The WALTZ All-Comers Study

“…In-hospital and 30-day results were published in detail elsewhere previously. 13,14 Patient population and study group (201 patients) are described in Figure 1; 9.7% of the screened population from 11 sites in Argentina were selected and included in the registry.…”

“…Protocol and study design were already previously mentioned. 13,14 All investigators reviewed and approved final version of the manuscript. A complete list of investigators responsible for patient inclusion appears in Appendix 1.…”