Key result
PCI improves 12-month LVEF more than CABG in unprotected left main CAD, increasing it ~3%.
Why the study?
Unprotected left main coronary artery stenting is being investigated as an alternative to bypass surgery, but comparative early and late outcomes remain unclear.
Does percutaneous coronary intervention improve left ventricular ejection fraction at 12 months compared to coronary artery bypass grafting in patients with unprotected left main coronary artery stenosis?
RCT (n=105)
Does percutaneous coronary intervention improve left ventricular ejection fraction at 12 months compared to coronary artery bypass grafting in patients with unprotected left main coronary artery stenosis?
Absolute Event Rate: 3.3% vs 0.5%
p-value: p=0.047
In patients with unprotected left main coronary artery stenosis, PCI was associated with better early outcomes and a significant improvement in LVEF at 1 year compared to CABG, with similar long-term MACCE-free survival.
OBJECTIVES: The purpose of this study was to compare the early and late results of percutaneous and surgical revascularization of left main coronary artery stenosis. BACKGROUND: Unprotected left main coronary artery (ULMCA) stenting is being investigated as an alternative to bypass surgery. METHODS: We randomly assigned 105 patients with ULMCA stenosis to percutaneous coronary intervention (PCI; 52 patients) or coronary artery bypass grafting (CABG; 53 patients). The primary end point was the change in left ventricular ejection fraction (LVEF) 12 months after the intervention. Secondary end points included 30-day major adverse events (MAE), major adverse cardiac and cerebrovascular events (MACCE), length of hospitalization, target vessel failure (TVF), angina severity and exercise tolerance after 1 year, and total and MACCE-free survival. RESULTS: A significant increase in LVEF at the 12-month follow-up was noted only in the PCI group (3.3 +/- 6.7% after PCI vs. 0.5 +/- 0.8% after CABG; p = 0.047). Patients performed equally well on stress tests, and angina status improved similarly in the 2 groups. PCI was associated with a lower 30-day risk of MAE (p < 0.006) and MACCE (p = 0.03) and shorter hospitalizations (p = 0.0007). Total and MACCE-free 1-year survival was comparable. Left main TVF was similar in the 2 groups. During the 28.0 +/- 9.9-month follow-up, there were 3 deaths in the PCI group and 7 deaths in the CABG group (p = 0.08). CONCLUSIONS: Patients with ULMCA disease treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, LVEF had improved significantly only in the PCI group. After more than 2 years, MACCE-free survival was similar in both groups with a trend toward improved survival after PCI.
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Buszman et al. (2008) conducted an RCT in Unprotected left main coronary artery (ULMCA) stenosis (n=105). Percutaneous coronary intervention (PCI) vs. Coronary artery bypass grafting (CABG) was evaluated on Change in left ventricular ejection fraction (LVEF) 12 months after the intervention (p=0.047). Percutaneous coronary intervention significantly increased left ventricular ejection fraction at 12 months compared to CABG (3.3% vs 0.5%; p=0.047) in patients with ULMCA stenosis.
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