Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study
Authors: Hammami Rania , Boudiche Selim , Rami Tlili , Ben Halima Nejeh , Jamel Ahmed , Rekik Bassem , Gribaa Rym , Imtinene Ben Mrad , Charfeddine Salma , Ellouze Tarek , Bahloul Amine , Hédi Ben Slima , Langar Jamel , Ben Ahmed Habib , Ibn Elhadj Zied , Hmam Mohamed , Ben Abdessalem Mohamed Aymen , Maaoui Sabri , Fennira Sana , Lobna Laroussi , Hassine Majed , Ouanes Sami , Mohamed Faouzi Drissi , Mallek Souad , Mahdhaoui Abdallah , Meriem Dghim , Jomaa Walid , Zayed Sofien , Kateb Tawfik , Bouchahda Nidhal , Azaiez Fares , Ben Salem Helmi , Marouen Morched , Noamen Aymen , Abdesselem Salem , Hichem Denguir , Ibn Hadj Amor Hassen , Abdeljelil Farhati , Amara Amine , Bejar Karim , Khaldoun Ben Hamda , Hamza Chiheb , Ben Jamaa Mohsen , Fourati Sami , Elleuch Faycal , Grati Zeineb , Chtourou Slim , Marouene Sami , Sahnoun Mohamed , Hadrich Morched , Mohamed Abdelkader Maalej , Bouraoui Hatem , Kamoun Kamel , Hadrich Moufid , Ben Chedli Tarek , Drissa Mohamed Akrem , Charfeddine Hanene , Saadaoui Nizar , Achraf Gargouri , Ahmed Siala , Ayari Mokdad , Nabil Marsit , Mnif Sabeur , Sahnoun Maher , Kammoun Helmi , Ben Jemaa Khaled , Mostari Gharbi , Hamrouni Nebil , Yamen Maazoun , Ellouz Yassine , Smiri Zahreddine , Hdiji Amine , Bassem Jerbi , Ayadi Wacef , Zouari Amir , Abbassi Chedly , Fatma Boujelben Masmoudi , Battikh Kais , Kharrat Elyes , Gtif Imen , Sami Milouchi , Bezdah Leila , Kachboura Salem , Maatouk Mohamed Faouzi , Kraiem Sondes , Jeridi Gouider , Neffati Elyes , Kammoun Samir , Ben Ameur Youssef , Fehri Wafa , Gamra Habib , Zakhama Lilia , Addad Faouzi , Mohamed Sami Mourali , Abid Leila 
Published: October 2021

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