Research Protocol

Left Main Coronary Artery Stenting – An EMR based Single Tertiary Care Centre Experience

S. Aravindakumar1, Annup Balan2,*, Venkita S Suresh3

1Chief Consultant Interventional Cardiologist, Kauvery Hospital, Heart City-Trichy, India

2Associate Consultant, HIC & Microbiology, Kauvery Hospitals, India

3Group Medical Director, Kauvery Hospitals, India

*Correspondence: [email protected]

Background

The left main coronary artery supplies at least two-thirds of the left ventricle. Patients with significant LMCA disease are often symptomatic due to compromised blood supply that affects a large area of the myocardium. Severe stenosis of the left main coronary artery (LMCA) is often associated high risk of adverse cardiac events, and also a high risk of mortality. However, significant LMCA disease can be an incidental finding in stable patients undergoing coronary angiography.

The current revascularization strategies for patients with LMCA disease are coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). Both are known equally for their advantages over the other as well as for their limitations.

CABG is still considered the standard of care for the LMCA occlusion. The advances in device technology increased operators’ expertise, refinement of the procedural technique, and availability of advanced antithrombotic as well as antiplatelet therapy has made PCI a viable alternative technique for a significant proportion of patients. In general, PCI is associated with significantly lower periprocedural events and offers a more rapid recovery while CABG is known for its more durable revascularization.

Various RCTs have deciphered that stenting achieved differential effectiveness for mortality and clinical outcomes with first-generation drug-eluting stents (DES). The rate of repeat revascularization was noticed to be higher when compared to CABG. With the development of second-generation DES improved efficacy and safety in comparison were noticed. Subsequent RCTs revealed that PCI had achieved greater clinical recognition as a reasonable therapeutic intervention.

The EXCEL (Nordic-Baltic British Left Main Revascularization), as well as the EXCEL (Evaluation of Xience vs Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization), have both shown comparable outcomes of PCI with DES when compared to CABG.

As for the risk of repeat revascularization, the superior anti-restenotic properties of second-generation DES over the first-generation stents seem to provide protection against the need for further revascularization.

Materials and Methods

Study Population

Prospective Study

Data from consecutive patients from a single tertiary care hospital undergoing left main coronary artery PCI shall be collected. This shall be an exclusively EMR based study. The Heart team shall determine the contemporary practice guidelines, and revascularization strategies The Heart Team shall comprise Interventional Cardiologists, Cardiac Surgeons, and Physicians. Patients who don’t undergo PCI will be referred for CABG

Type of Study: EMR based Observational Study

Inclusion Criteria

  1. All patients presenting with ACS with LMCA disease
  2. Patients found to have incidental LMCA disease
  3. SYNTAX score

Exclusion Criteria

  1. ACS without LMCA involvement
  2. Patients requiring CABG

Procedure and Medication

The PCI strategy and the stent type are left to the treating physician’s discretion. ACS patients scheduled for PCI will receive the same dose of aspirin and ticagrelor or clopidogrel on the diagnosis. During the procedure, unfractionated heparin (100 U/kg) will be administered to all patients. The use of glycoprotein IIb/IIIa inhibitors will be left to the treating consultant. Post-procedure the patient will be on dual antiplatelet therapy as per the ESC 2021 guidelines.

Patient follow up

All patients will be followed up by clinical visit or by telephone at 1,6 and 12 months. Thereafter the patients will be followed up annually. Patients will be advised to return for complete evaluation if clinically indicated by symptoms or documentation of myocardial infarction.

Variables proposed to Study

Demographic details

Risk factors

  1. Smoker
  2. Diabetes
  3. Hypertension
  4. Dyslipidemia
  5. Prior MI
  6. Prior Stroke
  7. Insomnia

Vitals on Admission: Heart Rate/ Blood Pressure / SpO2

Laboratory Parameters

CBC/ Hb/ Urea/ Creatinine/ Sodium/ Potassium/ RBS ( On admission )

ECG Findings

ECHO parameters

Clinical Presentation

  1. STEMI
  2. NSTEMI
  3. Unstable angina

CAG Findings

  1. LMCA
  2. LAD
  3. LCX
  4. RCA

SYNTAX score

  1. Before Procedure
  2. After Procedure
  3. Unprotected LMCA
  4. Triple vessel Disease
  5. Total Occlusion

Puncture Site

IVUS/ OCT usage

IABP usage

Procedure

  1. Single Stent strategy
  2. Double Stent Strategy
  3. Provisional stenting

Stent Type

Medication at discharge

Death

Ethical Consideration

Consent shall be obtained from either the patient or a close family member of the patient prior to the Procedure. The consent shall have all the details regarding the option of the treatment as well as the outcomes of the procedure in the local language.

Results

The results of the studies shall be published at the periodic interval of time.

Dr.-S.-Aravindakumar

Dr. S. Aravindakumar

Chief Consultant Interventional Cardiologist

Dr.-Annup-Balan-B

Dr. Annup Balan B

Associate Consultant, HIC & Microbiology

Dr.-Venkita.-S.-Suresh

Dr. Venkita. S. Suresh,

Group Medical Director

Journals

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