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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 9  |  Issue : 2  |  Page : 47-51

Rajaie cardiovascular medical and research center-percutaneous coronary intervention registry: A real-world registry on coronary interventions in a tertiary teaching cardiovascular center


1 Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
2 Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences; Cardio-Oncology Research Center, Rajaie Cardiovascular Medical and Research Center, Tehran, Iran
3 Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran

Date of Submission13-Apr-2020
Date of Decision19-Apr-2020
Date of Acceptance11-May-2020
Date of Web Publication27-Jul-2020

Correspondence Address:
Prof. Majid Maleki
Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Vali-Asr Ave, Tehran
Iran
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/rcm.rcm_11_20

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  Abstract 


Introduction: Clinical registries are a targeted way of data collection aimed at finding a solution to a specific clinical inquiry. The present report introduces the Rajaie Cardiovascular, Medical and Research Center percutaneous coronary intervention (RHC-PCI) Registry. The primary objectives of the RHC-PCI Registry consist of monitoring different complex PCI procedures and their mutual impact on interventional cardiology programs. Methods: RHC is a large and well-known cardiovascular tertiary center in Iran. The RHC-PCI Registry was first launched in 2015, since which time it has collected >5000 parameters regarding the baseline, clinical, and procedural characteristics of various PCI procedures. Noncomplex coronary interventions, bifurcation stenting, left main interventions, chronic total occlusion (CTO) PCI, and bypass graft interventions comprise the major categories gathered by the RHC-PCI Registry. The main registry outcomes are comprised in-hospital mortality, major adverse cardiovascular events, vascular access site complications, and 6-month all-cause mortality. Results: In this primary report, we elaborate on the principal infrastructure of the RHC-PCI Registry and present a synopsis of the registry scope. During the first 40 months of the registry, 11,005 patients underwent PCI. The acute coronary syndrome was reported in 5043 (45.8%) patients. Bifurcation stenting, left main interventions, CTO PCI, and bypass graft interventions were performed in 1679 (15.2%), 236 (2.1%), 946 (8.5%), and 764 (6.9%) patients, respectively. The preferred access site was the femoral artery (n = 6614, 60%), and drug-eluting stents were deployed in 9230 (83.8%) patients. In-hospital mortality in the total registry data was reported in 104 (0.9%) patients. Conclusions: This report introduces the RHC-PCI Registry, its primary objectives, infrastructure, and preliminary results (the 3-year outcome).

Keywords: Chronic total occlusion, clinical registry, left main, percutaneous coronary interventions


How to cite this article:
Basiri HA, Khalilipur E, Sarreshtedari A, Zolfaghari R, Sadeghipour P, Alemzadeh-Ansari MJ, Mohebbi B, Rashidinejad A, Hosseini Z, Zahedmedhr A, Firouzi A, Noohi F, Kiavar M, Peighambari MM, Abdi S, Maadani M, Shakerian F, Kiani R, Mohebbi A, Momtahen M, Sadrameli MA, Sanati HR, Shafe O, Moosavi J, Moghadam Y, Golpira R, Maleki M. Rajaie cardiovascular medical and research center-percutaneous coronary intervention registry: A real-world registry on coronary interventions in a tertiary teaching cardiovascular center. Res Cardiovasc Med 2020;9:47-51

How to cite this URL:
Basiri HA, Khalilipur E, Sarreshtedari A, Zolfaghari R, Sadeghipour P, Alemzadeh-Ansari MJ, Mohebbi B, Rashidinejad A, Hosseini Z, Zahedmedhr A, Firouzi A, Noohi F, Kiavar M, Peighambari MM, Abdi S, Maadani M, Shakerian F, Kiani R, Mohebbi A, Momtahen M, Sadrameli MA, Sanati HR, Shafe O, Moosavi J, Moghadam Y, Golpira R, Maleki M. Rajaie cardiovascular medical and research center-percutaneous coronary intervention registry: A real-world registry on coronary interventions in a tertiary teaching cardiovascular center. Res Cardiovasc Med [serial online] 2020 [cited 2020 Oct 24];9:47-51. Available from: https://www.rcvmonline.com/text.asp?2020/9/2/47/290863




  Introduction Top


Percutaneous coronary intervention (PCI) is now the dominant method of revascularization. Since the first PCI was performed by Grüntzig and Hopff, the technique has been revolutionized and expanded to various advanced clinical scenarios.[1],[2] Serious controversies, however, persist over the specific indications of this treatment modality in those different scenarios,[3] with major uncertainties concerning the purported advantages of PCI over optimal medical therapy in various conditions ranging from chronic coronary syndrome to chronic total occlusion (CTO) revascularization.[4] Randomized controlled trials are deemed the optimal way to address these uncertainties; nonetheless, they are not only costly and time-consuming but also limited by restricted sample sizes and sometimes impossible to be designed for a specific clinical scenario.[5]

Clinical registries constitute a well-concerted and targeted data collection method devised to find a solution for a specific clinical query.[6] Such registries are instrumental in monitoring the technical success of a procedure in a real-world situation. From the first published population-based coronary procedure registries such as the National Cardiovascular Data Registry (NCDR) in the United States to the latest Cath PCI registries presented by the American College of Cardiology (ACC) and from the Melbourne Interventional Group CathPCI Registry in Australia to the Euro Heart Survey-PCI CathPCI Registry in the European Union, different countries and societies have developed their own registries to monitor their local acute and long-term procedural results with a view to mitigating unintentional complications and preventable pitfalls during coronary artery interventions.[7],[8],[9] While all the aforementioned registries have included a considerable number of teaching hospitals and academic centers, none of them have focused on the impact of various interventional cardiology fellowship programs on patient outcomes.

Rajaie Cardiovascular Medical and Research Center (RHC) is a tertiary cardiovascular center committed to the presentation of various cardiology-related fellowship programs. Widely deemed the largest cardiovascular center in Iran, RHC boasts approximately 3000 coronary intervention procedures per annum. It is, thus, the ideal setting for the evaluation of the quality of PCI in various real-world scenarios. The present report introduces the RHC-PCI Registry, together with its scope, objectives, and primary outcomes during the first 3 years since its launch.


  Methods Top


The RHC-PCI Registry was launched in May 2015 with the primary objectives of monitoring the technical success of coronary interventions in various settings, reporting major adverse cardiovascular events and all-cause mortality, and observing the quality of the educational programs of interventional cardiologists. The study has been approved by RHC ethic committee in January 2015. RHC, categorized as a level 3 cardiovascular center,[10] contains 6 catheterization laboratories (cath labs) with >25 interventional cardiology attendings supervising around 100 cardiology residents and between 18 and 20 interventional cardiology fellows yearly. The cath labs are equipped with state-of-the-art intravascular imaging modalities, Doppler ultrasound, and transesophageal echocardiography. All routine and advanced coronary and peripheral endovascular interventions on structural heart diseases are carried out in the RHC Cath Labs. An estimated 10,000 catheterization procedures, including 3000 PCI procedures, are performed each year in these labs.

Crucial to the establishment and success of a clinical registry is advanced information technology infrastructure, in conjunction with a high-quality database. RHC commenced the collection of patients' electronic angiographic data 10 years before the writing of this report, and the ensuing years have witnessed the evolution of a comprehensive registration fact sheet featuring valuable cardiac-related variables and procedural details essential to the formation of a summary of interventions, from admission to discharge. The fact sheet is filled out by interventional cardiology fellows and residents under the meticulous supervision of their attending professors after every coronary procedure. The data are then cleaned by the RHC Interventional Cardiology Committee, comprising ten attendings whose task is to investigate and corroborate the legibility and accuracy of the collected information. The RHC-PCI Registry confers a summary of noncomplex coronary interventions, bifurcation stenting, left main interventions (protected vs. unprotected), CTO PCI, bypass graft interventions, and PCI complications (e.g. stent thrombosis, in-stent-restenosis, and vascular access-site complications). The committee also reevaluates angiography reports on complex procedures and rechecks available recorded angioplasty data to ensure the authenticity of the results. Patients' main clinical features at presentation (e.g. chronic coronary syndrome or acute coronary syndrome [ACS]) and traditional coronary risk factors, alongside their cath lab report, are exclusively recorded by residents/fellows. A separate database is allocated to primary PCI in line with RHC's commitment to the Iranian Ministry of Health and Medical Education.


  Study Outcomes Top


The main outcomes of the RHC-PCI Registry consist of in-hospital mortality, major adverse cardiovascular events, vascular access-site complications, and 6-month all-cause mortality. All data are recorded in the total registry, with all subgroups predefined. Of note, a future sub-registry, termed “the CTO PCI Sub-registry,” will be reporting its specific outcomes with more details in due course. All the mentioned endpoints were defined in keeping with the latest recommendations of the ACC/American Heart Association Task Force on Clinical Data Standards.[11]


  Results Top


From May 2015 to September 2019, the information recorded in the RHC-PCI Registry shows 11,005 patients underwent PCI. A summary of the total registry data is depicted in [Table 1]. The total registry is classified into five major groups of lesions: noncomplex coronary lesions, bifurcational lesions, left main lesions (protected vs. unprotected), CTO lesions, and bypass graft lesions.
Table 1: Main baseline, clinical, and procedural characteristics of the rajaie cardiovascular medical and research center percutaneous coronary intervention registry

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The most frequent procedures were noncomplex coronary interventions (n = 7380, 67%). The procedures were performed more commonly in men (n = 8114, 73.7%), and hypertension was the dominant common cardiac risk factor (n = 6183, 56.1%). ACS was reported in over 5000 patients (n = 5043, 45.8%), comprising those with unstable angina (n = 1782, 35.3%), ST-elevation myocardial infarction (STEMI) (n = 1703, 33.7%), non-STEMI (n = 1085, 21.5%), and recent myocardial infarction referred for coronary angiography (n = 473, 9.3%). In RHC, the vascular access site was recently shifted from the femoral artery to the radial artery, but the preferred access site is still the femoral artery according to the registry data (n = 6614, 60%). In-hospital mortality in the total registry data was reported in 104 (0.9%) patients. Intra-aortic balloon pump (IABP) implantation because of' hemodynamic compromise or borderline systolic blood pressure was performed in 62 (0.5%) patients. In addition, stent deployment was carried out in 10,000 (90.8%) patients, of whom 9230 (92.3%) received drug-eluting stents.

A summary of the demographic and procedural data is presented in [Table 1] and [Figure 1].
Figure 1: Summary of 5 major procedural categories in the RHC-PCI Registry: RHC-PCI, Rajaie Cardiovascular Medical and Research Center-Percutaneous coronary intervention, CTO: Chronic total occlusion, LM: Left main

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Procedures due to stent thrombosis were detected in 66 patients: they were acute (<24 h) in 31 (47%) patients, subacute (24 h–1 month) in 11 (16.7%), late (1 month–1 year) in 9 (13.6%), and very late (>1 year) in 15 (22.7%). In-stent restenosis was observed in 269 (0.02%) patients, with the cases categorized based on the length of the restenosis and the duration after PCI as follows: diffuse (n = 113, 45.2%), localized (n = 137, 54.8%), <6 months post-PCI (n = 11, 4.8%), 6–12 months after PCI (n = 25, 11%), and >12 months following PCI (n = 159, 70%). The remainder of the cases were classified as “unknown durations after PCI.”


  Discussion Top


Cardiovascular disease has been the leading cause of death in the past 50 years, according to a report by the World Health Organization.[12] Coronary angiography and angioplasty have, however, modified the management and outcome of the patients with coronary artery disease.[13],[14] An eminently feasible way to enhance the surveillance and consequently, the safety and outcome of this group of patients is to handle substantial volumes of angioplasty data via a registry.[15],[16]

The current era has seen doubts raised over revascularization for chronic coronary syndrome [17] and a significant decline in the use of PCI in patients with stable coronary artery disease.[18] Conversely, what has increased in use is complex PCI and/or complex, high-risk, and indicated PCI (complex higher-risk indicated patient [CHIP]) on patients with more complex anatomy and comorbidities.[19] This decline in PCI volumes, along with the increase in procedural complexity, has a fundamental impact on interventional cardiology programs.[20] Nonetheless, there are very few guidelines addressing the mentioned issue and few registries have evaluated the impact of fellowship participation on PCI-related procedural outcomes.[19],[21]

The RHC-PCI Registry, established in a large tertiary teaching cardiovascular center, monitors the procedural and cardiovascular outcomes of patients undergoing various coronary interventions. RHC offers the most comprehensive interventional cardiology programs in the country, which enables the RHC-PCI Registry to evaluate the impact of the educational programs on the aforementioned outcomes in order that they can be customized more efficaciously. In this report, we introduce the RHC-PCI Registry as a real-world registry collecting information on such various facets of coronary interventions as noncomplex coronary interventions, bifurcation stenting, left main interventions (protected vs. unprotected), CTO PCI, bypass graft interventions, and PCI complications (from stent thrombosis and in-stent-restenosis to vascular access-site complications).

According to the RHC-PCI Registry, 11,005 PCI procedures were performed in the RHC Cath Labs. Apropos patient presentation, over 5000 patients (n = 5043, 45.8%) presented with ACS to the hospital. CHIP accounted for a significant number of our procedures (n = 3625, 32.9%). The preferred vascular access site was the femoral access in that it was chosen in 60% of the patients, as opposed to the bifurcational stenting group patients, of whom 58.2% underwent the procedure through the radial access. In light of the results of the latest trials demonstrating the benefits of the radial artery access site,[22] the policy vis-à-vis the access site in the RHC Cath Labs has recently been shifted from the femoral artery to the radial artery. Of all the procedures recorded in the RHC-PCI Registry, coronary stents were deployed in 90.8% and in-hospital death was reported in 0.9%.

The ACC-NCDR Registry has recently published its preliminary data analysis results, reporting that the average age of their patients was 64 years, 66% were male, 26% had diabetes mellitus, coronary stents were deployed in 77%, and death occurred in 1.4%.[23] Furthermore, the IABP was used in 10.5% of high-risk patients undergoing PCI.[24] The Korean percutaneous coronary intervention Registry from South Korea has also released its latest data analysis results, reporting that the median age of their patients was 66.0 years, 70.3% were male, 38% presented with ACS, the radial artery access was chosen in 56.1%, drug-eluting stents were deployed in 91%, and in-hospital death occurred in 2.3%.[25]

In our registry, the fewest cases of in-hospital death were recorded in the CTO stenting group (0.7%). The rate of in-hospital death in the European Registry of Chronic Total Occlusion (ERCTO) Registry and the Japanese Chronic Total Occlusion JCTO Registry was 0.3% and 0.2%, respectively.[26],[27] Furthermore, according to our registry, the majority of the in-hospital deaths were in the left main stenting group (4.2%), which was due to the complex and diffuse nature of the patients' coronary artery disease, in tandem with other concomitant comorbidities. The rate of in-hospital mortality in our registry is comparable with that reported by recent trials such as NOBLE and EXCEL, with the caveat that the latter two trials had follow-up periods of between 3 and 5 years.[28],[29],[30] It is deserving of note that we will be reporting the results of our registry's follow-up data analysis in due course.

The advisability of the use of the IABP as an interim device to alleviate hemodynamic compromise in high-risk patients undergoing PCI has been debated for many years.[31] According to our registry, in a pattern similar to in-hospital death, the fewest cases of IABP implantation were in the CTO group (0.2%), whereas the left main stenting group predictably accounted for the highest number of IABP implantation cases (2.7%). In many recent trials, the IABP has been employed for hemodynamic support in complicated procedures, with the usage rates ranging from 3% to 40% depending on the study population and patient characteristics.[32],[33],[34]


  Conclusions Top


This primary report of the RHC-PCI Registry aims to herald the establishment of our registry and present its 3-year primary outcomes. In an era that has seen a dramatic rise in the use of CHIP, our data will hopefully help to improve the current interventional cardiology fellowship programs.

Acknowledgment

The authors would like to thank Mr. Peyman Tabatabei for his kind collaboration in data extraction.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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