Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

Not Applicable

• Conditions: Multivessel Coronary Artery Disease
• Interventions: Procedure: coronary revascularization

• Registration Number: NCT04811586
• Lead Sponsor: Shanghai East Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-30
• Status Verified: 2021-03
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one-step Hybrid Coronary Revascularization (HCR)	coronary revascularization	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.
Percutaneous Coronary Intervention (PCI)	coronary revascularization	PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China