Dataset Information

Establishment of a Percutaneous Coronary Intervention Registry in Vietnam: Rationale and Methodology.

ABSTRACT: Background:In lower- and middle-income countries across Asia there has been a rapid expansion and uptake of percutaneous coronary intervention (PCI). However, there has been limited routine collection of related data, particularly around quality, safety and cost. The aim of this study was to assess the viability of implementing routine collection of PCI data in a registry at a leading hospital in Hanoi, Vietnam. Method:A Vietnamese data collection form and collection strategy were developed in collaboration with the Vietnam National Heart Institute. Information on patient characteristics, treatments, and outcomes was collected through direct interviews using a standardised form and medical record abstraction, while PCI data was read and coded into paper forms by interventional cardiologists. Viability of the registry was determined by four main factors: 1) being able to collect a representative sample; 2) quality of data obtained; 3) costs and time taken for data collection by hospital staff; and 4) level of support from key stakeholders in the institute. Results:Between September 2017 and May 2018, 1,022 patients undergoing PCI were recruited from a total of 1,041 procedures conducted during that time frame. The estimated mean time to collect information from patients before discharge was 60 minutes. Of the collected data fields, 98% were successfully completed. Most hospital staff surveyed indicated support for the continuation of the activity following the implementation of the pilot study. Conclusions:The proposed methodology for establishing a PCI registry in a large hospital in Vietnam produced high quality data and was considered worthwhile by hospital staff. The model has the potential opportunity for replication in other cardiac catheterisation sites, leading to a national PCI registry in Vietnam.

SUBMITTER: Vu HTT

PROVIDER: S-EPMC7218793 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Establishment of a Percutaneous Coronary Intervention Registry in Vietnam: Rationale and Methodology.

Vu Hoa T T HTT Nguyen Hoai T T HTT Pham Hung M HM Do Loi D LD Nguyen Quang N QN Norman Richard R Huxley Rachel R RR Pham Ngoc M NM Lee Crystal M Y CMY Reid Christopher M CM

Global heart 20200408 1

<h4>Background</h4>In lower- and middle-income countries across Asia there has been a rapid expansion and uptake of percutaneous coronary intervention (PCI). However, there has been limited routine collection of related data, particularly around quality, safety and cost. The aim of this study was to assess the viability of implementing routine collection of PCI data in a registry at a leading hospital in Hanoi, Vietnam.<h4>Method</h4>A Vietnamese data collection form and collection strategy were ...[more]

PMID: 32489803

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Project description:BackgroundCoronary 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.ObjectiveThe 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.MethodsWe 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.ResultsIn 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.ConclusionsThis 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 registrationClinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761.International registered report identifier (irrid)RR1-10.2196/24595.

Project description:ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008 consecutive PCI patients with stent implantation, without exclusion criteria.InterventionPeri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).Outcome measuresThe primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).Results53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).ConclusionsIndividualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.Trial registration numberhttp://www.clinicaltrials.gov; NCT01515345.

Dataset Information

Establishment of a Percutaneous Coronary Intervention Registry in Vietnam: Rationale and Methodology.

Publications

Establishment of a Percutaneous Coronary Intervention Registry in Vietnam: Rationale and Methodology.

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