Clinical trial NCT01035034: Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease
Official title: Comparison of "One-stop" Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2009-12-18
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with percutaneous coronary intervention (PCI) in selected patients with multivessel coronary artery disease.

Detailed description: Rationale and purpose of this study:

"One-stop" (also named simultaneous) hybrid coronary revascularization has emerged as a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). The benefits of "one-stop" hybrid procedure compared with conventional PCI are unclear, however.

This study is a single center randomized clinical trial to compare the safety and efficacy of "one-stop" hybrid procedure with conventional PCI in the treatment of selected patients with multivessel CAD requiring revascularization with suitable coronary anatomy.

Sample size:

We examined the results of SYNTAX trial and of the hybrid procedures published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 18% for PCI/stenting and 8% for the hybrid group. The sample calculated for this trial is 480 patients.

Design/Methodology:

Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional PCI with SES in 480 patients with suitable anatomy who need revascularization.

Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional PCI with SES.

Randomization:

Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional PCI with SES. An expertise-based randomization will be used.

The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study.

Study intervention:

Candidates will be randomized to receive "one-stop" hybrid procedure or conventional PCI.

Eligibility criteria: Inclusion Criteria:

* Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\] territory)
* Denovo lesions of LAD , with obstruction \>=70%, especially chronic totally occlusion (CTO), severe calcification or bifurcation lesion of the LM;
* Angiographic characteristics of non-LAD lesion(s) amiable to PCI/stenting;
* Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
* Evaluated by both cardiac surgeon and cardiologist together.

Exclusion Criteria:

* Need for emergent CABG;
* Prior CABG;
* Prior PCI with stenting within 6 months of study entry;
* Stroke with 6 months of study entry;
* Overt congestive heart failure;
* Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
* Hemodynamic instability;
* Situations in which complete revascularization is not possible served;
* Allergy to radiographic contrast, aspirin or clopidogrel.
* Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels \<1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
* Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
* History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.

Primary outcomes:
measure: Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
timeFrame: 1 year
Secondary outcomes:
measure: Overall MACCE rate.
timeFrame: 30 days after procedure and 2 years after enrollment
measure: Cardiac death.
timeFrame: 30 days after procedure, 1 and 2 years after enrollment
measure: Documented myocardial infarction.
timeFrame: 30 days after procedure, 1 and 2 years after enrollment
measure: Target lesion revascularization.
timeFrame: 30 days after procedure, 1 and 2 years after enrollment
measure: Recurrence of Angina.
timeFrame: 1 and 2 years after enrollment
measure: Cost-effectiveness analysis.
timeFrame: 1 and 2 years after enrollment
measure: Quality of life.
timeFrame: 6 months, 1 and 2 years after enrollment
measure: Rehospitalization.
timeFrame: 6 months, 1 and 2 years after enrollment
measure: Stent thrombosis.
timeFrame: 30 days after procedure, 6 months, 1 and 2 years after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Institute of cardiovascular diseases & Fuwai hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Shengshou Hu, M.D.
role: STUDY_DIRECTOR
References: