MACE in Different Drug-Eluting Stents

Completed

• Conditions: Coronary Artery Disease; Stent Restenosis
• Interventions: Device: drug eluting stents

• Registration Number: NCT06470529
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

In this retrospective cohort study, all patients from Iranian registry were recruited and follow up after 5 years were recorded for MACE, and its relation to type and demographic data were evaluated

Detailed Description

This retrospective cohort study involved 4,438 individuals who received a PCI from March 2019 to February 2021. Data was obtained from the Iranian Network of Cardiovascular Research Registry ( which registered post PCI patients all around Iran in more than 40 public and private hospitals) and the database of Professor Kojuri Cardiology Clinic (Niyayesh St., Shiraz, Iran, www.kojuriclinic.com). After each procedure, expert cardiologists recorded baseline demographic data, prior medical history, angiography, and angioplasty reports.

Demographic data such as age, gender, body mass index (BMI), family history of CAD, prior CAD history, hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HLP), and kidney diseases were obtained from the database. Data on the prevalence of cigarette smoking, opium addiction, and alcohol addiction were collected. Additionally, information on clinical manifestations of the disease, including stable angina, unstable angina, ST-elevation myocardial infarction (STEMI), and non-ST elevation myocardial infarction (NSTEMI), was extracted.

According to the American Heart Association (AHA), stage 1 hypertension is defined as a systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg ; Hypertension was defined as stage 1 or higher blood pressure. DM was defined according to The American Diabetes Association as having a hemoglobin A1c level of at least 6.5%, a fasting plasma glucose (FPG) level of 126 mg/dl or higher, an oral glucose tolerance test (OGTT) level of 200 mg/dl or greater, or a random plasma glucose level of 200 mg/dl or above . For defining dyslipidemia, based on the 2019 AHA guideline, a low-density lipoprotein cholesterol (LDL-C) level exceeding 160 mg/dl or a non-high-density lipoprotein cholesterol (non-HDL-C) over 190 mg/dl were considered . Individuals with ≤1 month of smoking cessation were considered current smokers .

Angiography and angioplasty data Angiography and angioplasty data were gathered, including the type and location of coronary artery lesions and the type, location, size, diameter, and number of stents. Drug-eluting stents encompass a variety of types, notably the biolimus-eluting stent (BES), amphilimus-eluting stent (AES), SES, ZES, PES, and EES. Within the BES category, a notable example is the BioMatrix™ stent, while SES includes options like BioMimeTM, Orsiro®, Cre8, SUPRAFLEX, ULTIMASTERTM, and Coroflex® ISAR. ZES variants include the Resolute Onyx™ and Resolute Integrity™ stents, whereas EES comprises options such as Promus PREMIER, Promus Element™, and XIENCE™. Polymer-coated drug-eluting stents (PC-DES) include BioMatrix™, BioMimeTM, Orsiro®, SUPRAFLEX, ULTIMASTERTM, Resolute Onyx™, Resolute Integrity™, Promus PREMIER, Promus Element™, and XIENCE™. Conversely, polymer-free drug-eluting stents (PF-DES) are exemplified by Cre8 and Coroflex® ISAR. Regarding generational classification, the first generation includes BioMimeTM, Orsiro®, Cre8, SUPRAFLEX, ULTIMASTERTM, and Coroflex® ISAR. Notable second-generation members are Promus PREMIER, Promus Element, and XIENCE™, alongside Resolute Onyx™ and Resolute Integrity™. Finally, the BioMatrix™ stent represents the third generation.

Data of ballooning, including predilatation, postdilatation, and the number of balloons used were collected. Different angioplasty techniques, including kissing and overlapping were collected .Coronary legions were classified according to the ACC/AHA classification: type A: \<10 mm, non-angulated, smooth, little calcification, not totally occlusive, not ostial, no major branch involvement, no thrombus; type B: 10-20 mm, eccentric, moderately tortuous, 45-90º, irregular, moderate to heavy calcification, ostial, bifurcation lesions, some thrombus (subcategories: B1: one characteristic; B2: two or more characteristics), and type C: diffuse, extremely angulated, \>90º, inability to protect major side branch, degenerated vein graft .

Follow-up Patients were contacted by phone to explain the study plans and obtain informed consent. They were asked about MACEs occurring within two years following angioplasty, which includes myocardial infarction, acute heart failure, stroke, and death from cardiac diseases, as well as any revascularization. Additionally, the date of MACE occurrence after angioplasty was recorded, and information on non-cardiac-related deaths was collected.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-07-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4159

Inclusion Criteria

• Patients with coronary angioplasty who received at least one type of DES

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Exclusion Criteria

• Patients who received multiple types of stents
• Patients who need emergency operation post PCI

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCI	drug eluting stents	Post PCI patients with drug eluting stents

Primary Outcome Measures

Name	Time	Method
Major adverse coronary events	5 years	Total sum of Myocardial infarction (MI), Hospital admission, Death, reoperation or re PCI,

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of