Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

Multivessel Coronary Artery Disease Clinical Trial

— HCR-EAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811586
• Other study ID #: HCR-EAST
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2021
• Source: Shanghai East Hospital
• Contact: Qi Zhang, MD, PhD
• Phone: +86-21-38804518
• Email: zhangqnh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleeding events	individual component of MACCE	2 years
Secondary	Hospital duration (day)		up yo 2 years
Secondary	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
Secondary	Stent thrombosis event	stent thrombosis defined by Academic Research Consortium (ARC)	2 years