突尼斯国家经皮冠状动脉介入治疗注册研究的设计与原理：一项前瞻性多中心观察性研究方案

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

作者信息

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

机构信息

Department of Cardiology, Hédi Chaker Hospital, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia.

Department of Cardiology, La Rabta Hospital, Faculty of Medicine of Tunis, University of Tunis, Tunis, Tunisia.

出版信息

JMIR Res Protoc. 2022 Aug 5;11(8):e24595. doi: 10.2196/24595.

DOI:10.2196/24595

PMID:35930353

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9391981/

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://clinicaltrials.gov/ct2/show/NCT04219761.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/24595.

摘要

背景

冠状动脉疾病仍是全球主要死因。近年来，由于新技术工具的发展和多中心登记系统的建立，该病的治疗有了显著改善。

目的

本研究旨在调查突尼斯接受经皮冠状动脉介入治疗（PCI）患者的院内及1年临床结局。

方法

我们将对2020年1月31日至2020年6月30日期间接受PCI的18岁以上患者进行一项前瞻性多中心观察性研究。主要终点是发生主要不良心血管事件，定义为心血管死亡、心肌梗死、脑血管意外，或通过再次PCI或冠状动脉旁路移植术（CABG）进行的靶血管血运重建。次要终点是手术成功率、支架血栓形成，以及因支架内再狭窄进行再次PCI/CABG的比率。

结果

本研究将分析接受PCI的突尼斯患者的人口统计学特征、一般风险特征及其终点。将分析手术的复杂程度以及左主干闭塞、分叉闭塞和慢性完全闭塞PCI情况，并确定即刻和长期结果。突尼斯PCI国家登记系统（NATURE-PCI）将是非洲首个国家多中心血管成形术登记系统。本研究已获得机构伦理委员会批准（0223/2020）。该试验由97名心脏病专家和2498名接受PCI且随访1年的患者组成。来自公共部门（15个实验室）和私营部门（13个实验室）的28个心导管实验室将在获得知情同意后纳入患者。在2498名患者中，1897名（75.9%）在公共部门接受治疗，601名（24.1%）在私营部门接受治疗。2020年3月突尼斯开始出现新冠疫情；719名患者（31.9%）在新冠疫情之前纳入，1779名（60.1%）在疫情期间纳入。患者纳入工作已完成，我们预计在2022年底公布结果。