MACE in Different Drug-Eluting Stents

Comparative Evaluation of Incidence of Cardiovascular Events Among Different Drug-Eluting Stent Types

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Stent Restenosis
• Intervention / Treatment: Device: drug eluting stents

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 Type: Observational
• Enrollment (Actual): 4159

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 713481433
      • Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients all around the Iran, from 40 hospitals, who undergone PCI as elective or emergency patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCI; Post PCI patients with drug eluting stents	Device: drug eluting stents; different types of drug eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse coronary events	Total sum of Myocardial infarction (MI), Hospital admission, Death, reoperation or re PCI,	5 years

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; drug eluting stents; Major adverse coronary events (MACE)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: IR.SUMS.MED.RED.1402.409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data was available based on rational request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No