Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

NCT04811586 | Unknown DMC

• 1 other identifier: HCR-EAST
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Multivessel Coronary Artery Disease

Keywords

hybrid coronary revascularization (HCR); percutaneous coronary intervention (PCI); coronary artery bypass graft (CABG); multivessel coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bleeding events

  2 years

• Hospital duration (day)

  up yo 2 years

• Rate of complete revascularization at index hospitalization

  2 years

• Stent thrombosis event

  2 years

Study Arms (2)

one-step Hybrid Coronary Revascularization (HCR)

EXPERIMENTAL

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

Percutaneous Coronary Intervention (PCI)

ACTIVE COMPARATOR

PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab.

Procedure: coronary revascularization

Interventions

coronary revascularization PROCEDURE

to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

Percutaneous Coronary Intervention (PCI); one-step Hybrid Coronary Revascularization (HCR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years and older
• signed the informed consent
• indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels
• 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
• Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR
• Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3\~12 months
• Willing to comply with 2-year clinical follow-up

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Qi Zhang, MD, PhD

  Shanghai East Hospital

  STUDY DIRECTOR

Central Study Contacts

Qi Zhang, MD, PhD

CONTACT

+86-21-38804518; zhangqnh@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: December 30, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CN (1)