Clinical trial NCT04811586: Efficacy and Safety of One-Stage Hybrid Coronary Revascularization
Official title: Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multivessel Coronary Artery Disease
Keywords: hybrid coronary revascularization (HCR)
percutaneous coronary intervention (PCI)
coronary artery bypass graft (CABG)
multivessel coronary artery disease
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 2 years
Secondary outcomes:
measure: Bleeding events
timeFrame: 2 years
measure: Hospital duration (day)
timeFrame: up yo 2 years
measure: Rate of complete revascularization at index hospitalization
timeFrame: 2 years
measure: Stent thrombosis event
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Qi Zhang, MD, PhD
role: STUDY_DIRECTOR
References: