Efficacy and Safety of One-Stage Hybrid Coronary Revascularization (HCR-EAST)

Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease

Coronary revascularization could be accomplished either by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). PCI with drug-eluting stent (DES) implantation is featured by minimal invasive, low complication and rapid rehabilitation. CABG is characterized by improved long-term, event-free survival attributable to the use of left internal mammary artery (LIMA) graft. Hybrid coronary revascularization (HCR) consists of LIMA bypass to left anterior coronary descending artery (LAD) by minimal invasive direct coronary artery bypass (MIDCAB) and PCI of other stenosed coronary arteries with DES implantation. One-step HCR entails LIMA-LAD anastomosis performed through MIDCAB, immediately followed by PCI for non-LAD lesions, sometimes for diagonal branch, in the hybrid operating room. Limited data are available in comparing one-step HCR to PCI alone for the treatment of multivessel coronary artery disease(MVD). The current EAST-HCR study will investigate the efficacy and safety of one-step HCR for patients with MVD, as comparing to PCI alone.

Study Overview

• Status: Recruiting
• Conditions: Multivessel Coronary Artery Disease
• Intervention / Treatment: Procedure: coronary revascularization

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Zhang, MD, PhD; Phone Number: +86-21-38804518; Email: zhangqnh@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital
      • Contact: Qi Zhang, MD, PhD; Phone Number: +86-21-38804518; Email: zhangqnh@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 Years and older
2. signed the informed consent
3. indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels
4. anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI
5. Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR
6. Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3~12 months
7. Willing to comply with 2-year clinical follow-up

Exclusion Criteria:

1. Previous cardiac or thoracic surgery
2. Previous PCI of the LM and/or LAD within 12 months
3. Totally occluded left main vessel
4. Cardiogenic shock or LVEF <30%
5. Previous STEMI within 30-day prior to randomization
6. Concomitant vascular or other cardiac disease with plan of surgical treatment
7. Indication for chronic oral anticoagulation therapy
8. Previous stroke history within 6-month prior to randomization
9. Survival expectation less than 3 years due to non-cardiac illness
10. Allergy or hypersensitivity to any of the study drugs or devices used in the trial
11. Enrolled in additional clinical study
12. Informed consent not available or noncompliance with follow-up
13. Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one-step Hybrid Coronary Revascularization (HCR); One-step HCR is defined as off-pump MIDCAB LIMA-LAD revascularization immediately followed by PCI for at-least one non-LAD lesion(or LAD-diagonal lesion) with DES implantation in a hybrid operating room.	Procedure: coronary revascularization; to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
Active Comparator: Percutaneous Coronary Intervention (PCI); PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab.	Procedure: coronary revascularization; to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	the occurrence of MACCE at 2 years' clinical follow-up, including all-cause death, myocardial infarction, stroke, and repeated revascularization	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events	individual component of MACCE	2 years
Hospital duration (day)		up yo 2 years
Rate of complete revascularization at index hospitalization	rate of complete revascularization at index hospitalization (defined by Quantitative flow ration[QFR] or Fraction flow reserve[FFR])	2 years
Stent thrombosis event	stent thrombosis defined by Academic Research Consortium (ARC)	2 years

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Study Director: Qi Zhang, MD, PhD, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery bypass graft (CABG); multivessel coronary artery disease; hybrid coronary revascularization (HCR); percutaneous coronary intervention (PCI)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: HCR-EAST

Drug and device information, study documents

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