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Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a
Rania Hammami1, Selim Boudiche2, Tlili Rami3
1Department of Cardiology, Hédi Chaker Hospital, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia.
Insights
This study analyzed percutaneous coronary intervention (PCI) outcomes in Tunisia, establishing the first national registry (NATURE-PCI) to track patient results and procedure complexities. The findings will inform interventional cardiology practices in the region.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Epidemiology
Background:
- Coronary artery disease is a leading global cause of mortality.
- Recent advancements in technical tools and multicentric registries have improved disease management.
- Limited data exists on percutaneous coronary intervention (PCI) outcomes in North Africa.
Purpose of the Study:
- To investigate the in-hospital and 1-year clinical outcomes of patients undergoing PCI in Tunisia.
- To establish the National Tunisian Registry of PCI (NATURE-PCI), the first national registry of angioplasty in Africa.
- To analyze demographic and risk profiles, procedure complexity, and clinical endpoints in Tunisian PCI patients.
Main Methods:
- Prospective, multicentric observational study.
- Inclusion of patients >18 years undergoing PCI between January 31, 2020, and June 30, 2020.
- Primary endpoint: Major adverse cardiovascular event (cardiovascular death, myocardial infarction, cerebrovascular accident, target vessel revascularization). Secondary endpoints: procedural success, stent thrombosis, redo PCI/CABG for in-stent restenosis.
Main Results:
- The study enrolled 2498 patients from 28 catheterization laboratories (15 public, 13 private).
- 1897 patients (75.9%) were treated in the public sector, 601 (24.1%) in the private sector.
- Patient enrollment occurred before (31.9%) and during (60.1%) the COVID-19 pandemic in Tunisia.
Conclusions:
- The NATURE-PCI registry provides valuable real-world data on interventional cardiology practice in Tunisia.
- Findings offer insights into PCI utilization in a limited-income region.
- The study contributes to clinical epidemiology and informs future cardiovascular care strategies in Tunisia.
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.
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