N/A
Completed N=224
A Prospective Randomized Study for Comparison of Y-Composite Grafts
Source: ClinicalTrials.gov NCT01051986 ↗Enrolled (actual)
224
Serious AEs
6.3%
Results posted
Jan 2014
Primary outcomePrimary: 1 Year Graft Patency Rates — 97.1; 97.1 percentage of distal anastomoses
Summary
The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1 Year Graft Patency Rates |
97.1; 97.1 | — |
| SECONDARY Overall Survival |
97.8; 97.6 | — |
| SECONDARY Freedom From Cardiac Death |
100; 99.1 | — |
| SECONDARY Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) |
91.1; 94.4 | — |
| SECONDARY Early Angiographic Patency Rates |
99.5; 98.8 | — |
Eligibility Criteria
Inclusion Criteria
- age equal or more than 40
- age equal or less than 75
- patients who agree to the enrollment
Exclusion Criteria
- Patients with heart failure (left ventricular ejection fraction < 25%)
- patients who have intractable ventricular arrhythmia
- patients who has been treated for cancer
- patients who has infectious disease
- patients who are planned to undergo combined cardiac surgery
- patients who has medical co-morbidity with expected survival less than 1 year
- patients who has a problem using right internal thoracic artery or saphenous vein
- patients with a history of previous cardiac surgery
- Patients with chronic renal failure
- patients who undergo emergency operation
Data sourced from ClinicalTrials.gov (NCT01051986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.