Randomized Comparison of Minimally Invasive Direct Coronary Artery Bypass Surgery Versus Sirolimus-Eluting Stenting in Isolated Proximal Left Anterior Descending Coronary Artery Stenosis
The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated proximal left anterior descending (LAD) coronary artery disease.
Background
Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction.
Methods
A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months.
Results
Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). Clinical symptoms improved significantly in both treatment groups in comparison with baseline, and the percentage of patients free from angina after 12 months was 81% versus 74% (p = 0.49).
Conclusions
In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms. (MIDCAB Versus DES in Proximal LAD Lesions; NCT00299429)
Key Words
atherosclerosis
bypass
coronary artery disease
drug-eluting stents
restenosis
Abbreviations and Acronyms
DES
drug-eluting stent(s)
IQR
interquartile range
LAD
left anterior descending
LIMA
left internal mammary artery
MACE
major adverse cardiac events
MIDCAB
minimally invasive direct coronary artery bypass
PCI
percutaneous coronary intervention
SES
sirolimus-eluting stent(s)
SF-36
Short Form 36
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This work was supported by an unrestricted grant from Cordis, Germany.