Design and Rationale of the National Tunisian Registry of Percutaneous coronary Intervention: Protocol for a Prospective, Multicenter Trial (Preprint)

BACKGROUND Coronary diseases remain the first cause of death in the world; the management of this condition has improved, thanks to new technical tools and multicentric registries. Recently in Tunisia, the number of intervention procedures has markedly increased, giving the explosion of cardiovascular risk factors among Tunisian people. OBJECTIVE The aim of the study was to investigate the in-hospital and one-year clinical outcome of patients treated with percutaneous coronary intervention (PCI) in Tunisia. METHODS We will conduct a prospective, multicentric, observational study including patients > 18 year-old who underwent a PCI between 31January and 30 June 2020. The primary end point are the occurrence of a major adverse cardiovascular event , defined as cardiovascular death, myocardial infarction, cerebrovascular accident, and target vessel revascularization with either repeat PCI or coronary artery bypass surgery (CABG). Secondary end-points consist in procedural success rate, stent thrombosis, and the rate of redo-PCI/CABG for in-stent restenosis. RESULTS Results will be available at the end of the study as well as the demographic profile and general risk profile of Tunisian patients undergoing PCI. The complexity level of procedures, as left main, bifurcation, chronic occlusion PCI will be analyzed and immediate as well as long term results will be determined. NATURE-PCI will be the first national multicentric registry of angioplasty in Africa. CONCLUSIONS This study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of contemporary coronary artery disease in this developing region. CLINICALTRIAL clinicaltrials.gov