Polymer Free Stent in Acute Coronary Syndrome

Polymer Free Drug Eluting Stent in Non ST Elevation Acute Coronary Syndrome

To evaluate the short term out comes of the polymer free stents in patients presented with non ST elevation acute coronary syndrome (which include ST depression myocardial infarction and unstable angina ) after percutaneous coronary intervention .

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Device: Inserting polymer free drug eluting stent in the coronary arteries

Detailed Description

One of the treatment options for CAD is a percutaneous coronary intervention through balloon angioplasty or stent insertion . Although the restenosis rate can be reduced by using bare metal stents , the in-stent restenosis (ISR) rate is still high at around 20%-30% .

increased rates of stent thrombosis were reported with first-generation DESs.(5) The high rate of late and very late stent thrombosis is caused by a long duration of drug elution, which can delay endothelial healing and prolong metallic structure exposure to blood vessel .

Conventionally, DES (drug eluting stents ) are coated with permanent polymers that facilitate drug release and remain long after drug elution is complete. These permanent polymers can cause delayed healing, impaired stent strut endothelialization , and a hypersensitivity reaction, which can culminatein ST (stent thrombosis ).

Research has led to the design of the newer DES (drug eluing stents) that have biodegradable polymers, novel coatings, or are completely polymer free. The polymer-free technology has the potential advantage to reduce the inflammatory and prothrombotic risks related to the utilization of polymers .

• Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)who will be subjected to the early invasive strategy . Polymer-free drug eluting stents will be used for these patients instead of the usually used polymer-permanent drug eluting stents .
• Patients with NST-ACS who will meet the inclusion and exclusion criteria will be subjected to the following during the admission in the ICU :
• History of the patient concerning :
• Analysis of presenting complaint . Past history of previous similar complaints or the coarse of his illness if he is known to have IHD(ischemic heart disease ) before . Risk factors ( Diabetus mellitus , hypertension , smoking ,....) .Any other co-morbidities and therapeutic history .
• Examination will be done with special concern payied for:
• Blood pressure, heart rate, respiratory rate, Jugular Venous Pressure (JVP), cardiac examination and chest auscultation .
• Investigations in the form of:
• Serial 12 lead ECG .
• Laboratory investigations : (Complete Blood Count (CBC) , Prothrombine time and concentration ,Kidney function ,HCV-Ab , HBs-Ag , HIV Ab , Creatine kinase (CK and CK-MB ) and Troponin at admission and 6 hours later ) .
• Imaging:
• Echocardiographic evaluation with certain emphasis on the following parameters (Wall motion abnormalities ,systolic function , diastolic function and cardiac dimensions).
• TIMI (Thrombolysis in Myocardial Infarction ) risk score will be calculated to every patient .
• Each of the following criteria constitutes one point for TIMI scoring :
• Age ≥65 years
• Three or more risk factors for coronary artery disease (CAD) (family history of CAD, hypertension, hypercholesterolemia, diabetes mellitus, tobacco use)
• Known CAD (stenosis >50%)
• Aspirin use in the past 7 days
• Severe angina (≥2 episodes in 24 hours)
• ST deviation ≥0.5 mm
• Elevated cardiac marker level
• Syntax score will be caiculated during PCI .
• Early invasive strategy with percutaneous coronary intervention will be done for these patients using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .
• The patients will be followed for 6 months after the intervention .
• The patients included in the study will be followed up and re-evaluated at one month and six months after the intervention ( by telephon calls and office visits )
• Re-evaluation will include asking about and analysing symptoms of IHD after the PCI , compliance to the medications .
• Examination: Vital signs , JVP , chest and heart examination .
• 12-lead ECG and cardiac enzymes if needed .
• Follow up Echocardiography will be done at six months .
• Patients will be subjected to follow up diagnostic coronary angiography six months of PCI (whenever possible).
• Six months views after the index procedure coronary angiography will be evaluated by quantitative coronary angiography (QCA) with edge detection method used for evaluation of coronary lesion in index and follow up procedures. Minimal luminal diameter (MLD), Reference vessel diameter (RVD), Percent diameter stenosis %DS), Acute Gain, Late loss and Late loss index will be estimated.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients from 18 to 85 years of both genders presented with NSTE-ACS with TIMI score ( ≥ 3), who will be subjected to early invasive strategy, whose coronary angiography shows de novo coronary artery disease (CAD) with a stenotic lesion ≥ 70 % requiring use of 2 stents or less.

Exclusion Criteria:

• • Patients with NSTEACS who will be subjected to conservative strategy.

  • Patients whose coronary angiography shows CAD with significant lesions not candidate for PCI like target lesion location in the left main stem or multi vessel disease .
  • In-stent restenosis .
  • Stenosis in bypass graft .
  • Raised renal chemistry (serum creatinine > 2 mg/dl) .
  • Known allergy to the contrast media or other medications used during and after percutaneous coronary intervention .
  • Contraindication to antiplatelet (Asprin, Clopidogrel) or heparin therapy e.g. significant external or internal bleeding and active peptic ulcer .
  • Severly impaired LV systolic function (LVEF < 35%).
  • Malignancies or other co-morbid conditions (for example, severe liver, renal, and pancreatic disease) with life expectancy<6 months or that may result in protocol non-compliance .
  • Pregnancy .
  • Previous enrolment in this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Invasive Strategy group; Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)-which include ST depression myocardial infarction and unstable angina- who will be subjected to the early invasive strategy . Polymer-free drug eluting stents will be used for these patients instead of the usually used polymer-permanent drug eluting stents .

Device: Inserting polymer free drug eluting stent in the coronary arteries; • Early invasive strategy with percutaneous coronary intervention will be done for the patients presenting with NST ACS who meet the inclusion criteria using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Major adverse cardiac events (MACE)	Recurrent angina pectoris, post-infarction angina, new or recurrent myocardial infarction.; Target lesion revascularization (TLR).; Target vessel revascularization (TVR).; Left ventricular dysfunction.; Cardiac arrhythmias.; Cardiac death.	During six months after the intervention .
Mortality rate	Mortality rate in patients underwent the intervention	Within six months of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Instent restenosis	defined as > 50% instent diameter restenosis on the follow up coronary angiogram.	six months after the intervention

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: polymer free stent

Drug and device information, study documents

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