No abstract

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

Background Coronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries. Objective The aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia. Methods We will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis. Results In this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022. 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 PCI in this limited-income region. Trial Registration Clinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761 International Registered Report Identifier (IRRID) RR1-10.2196/24595