Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study

Abstract

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://ichgcp.net/clinical-trials-registry/NCT04219761.

International registered report identifier (irrid): RR1-10.2196/24595.

Keywords: 1-year outcome; Tunisia; artery disease; coronary; multicentric; national; percutaneous; percutaneous coronary intervention; registry.

Conflict of interest statement

Conflicts of Interest: None declared.

©Rania Hammami, Selim Boudiche, Tlili Rami, Nejeh Ben Halima, Ahmed Jamel, Bassem Rekik, Rym Gribaa, Ben Mrad Imtinene, Salma Charfeddine, Tarek Ellouze, Amine Bahloul, Ben Slima Hédi, Jamel Langar, Habib Ben Ahmed, Zied Ibn Elhadj, Mohamed Hmam, Mohamed Aymen Ben Abdessalem, Sabri Maaoui, Sana Fennira, Laroussi Lobna, Majed Hassine, Sami Ouanes, Drissi Mohamed Faouzi, Souad Mallek, Abdallah Mahdhaoui, Dghim Meriem, Walid Jomaa, Sofien Zayed, Tawfik Kateb, Nidhal Bouchahda, Fares Azaiez, Helmi Ben Salem, Morched Marouen, Aymen Noamen, Salem Abdesselem, Denguir Hichem, Hassen Ibn Hadj Amor, Farhati Abdeljelil, Amine Amara, Karim Bejar, Ben Hamda Khaldoun, Chiheb Hamza, Mohsen Ben Jamaa, Sami Fourati, Faycal Elleuch, Zeineb Grati, Slim Chtourou, Sami Marouene, Mohamed Sahnoun, Morched Hadrich, Maalej Mohamed Abdelkader, Hatem Bouraoui, Kamel Kamoun, Moufid Hadrich, Tarek Ben Chedli, Mohamed Akrem Drissa, Hanene Charfeddine, Nizar Saadaoui, Gargouri Achraf, Siala Ahmed, Mokdad Ayari, Marsit Nabil, Sabeur Mnif, Maher Sahnoun, Helmi Kammoun, Khaled Ben Jemaa, Gharbi Mostari, Nebil Hamrouni, Maazoun Yamen, Yassine Ellouz, Zahreddine Smiri, Amine Hdiji, Jerbi Bassem, Wacef Ayadi, Amir Zouari, Chedly Abbassi, Boujelben Masmoudi Fatma, Kais Battikh, Elyes Kharrat, Imen Gtif, Milouchi Sami, Leila Bezdah, Salem Kachboura, Mohamed Faouzi Maatouk, Sondes Kraiem, Gouider Jeridi, Elyes Neffati, Samir Kammoun, Youssef Ben Ameur, Wafa Fehri, Habib Gamra, Lilia Zakhama, Faouzi Addad, Mourali Mohamed Sami, Leila Abid. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.08.2022.

Figures

Figure 1

Repartition of the investigating centers in this study.