Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease

Coronary Artery Disease Clinical Trial

Official title:

Comparison of "One-stop" Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01035034
• Other study ID #: 20091217
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2009
• Last updated: December 18, 2009
• Start date: December 2009

Study information

• Verified date: December 2009
• Source: China National Center for Cardiovascular Diseases
• Contact: Shengshou Hu, M.D.
• Phone: 0086-8838-8359
• Email: shengshouhu[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Hybrid MIDCAB/PCI
MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB. Device: Polymer-based Sirolimus-Eluting Stents (SES).
• PCI with DES
Polymer-based Sirolimus-Eluting Stents (SES)

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital	Beijing	Beijing
China	Institute of cardiovascular diseases & Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.		1 year	Yes
Secondary	Overall MACCE rate.		30 days after procedure and 2 years after enrollment	Yes
Secondary	Cardiac death.		30 days after procedure, 1 and 2 years after enrollment	Yes
Secondary	Documented myocardial infarction.		30 days after procedure, 1 and 2 years after enrollment	Yes
Secondary	Target lesion revascularization.		30 days after procedure, 1 and 2 years after enrollment	Yes
Secondary	Recurrence of Angina.		1 and 2 years after enrollment	Yes
Secondary	Cost-effectiveness analysis.		1 and 2 years after enrollment	Yes
Secondary	Quality of life.		6 months, 1 and 2 years after enrollment	Yes
Secondary	Rehospitalization.		6 months, 1 and 2 years after enrollment	Yes
Secondary	Stent thrombosis.		30 days after procedure, 6 months, 1 and 2 years after enrollment	Yes