CLINICAL RESEARCH: CLINICAL TRIAL
Randomized Comparison of Minimally Invasive Direct Coronary Artery Bypass Surgery Versus Sirolimus-Eluting Stenting in Isolated Proximal Left Anterior Descending Coronary Artery Stenosis
Holger Thiele, MD*,*,
Patrick Neumann-Schniedewind, MD*,
Stephan Jacobs, MD ,
Enno Boudriot, MD*,
Thomas Walther, MD,
Friedrich-Wilhelm Mohr, MD,
Gerhard Schuler, MD* and
Volkmar Falk, MD
* Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany
Department of Cardiothoracic Surgery, Heart Center, University of Leipzig, Leipzig, Germany
Manuscript received December 17, 2008;
revised manuscript received February 24, 2009,
accepted March 3, 2009.
* Reprint requests and correspondence: Dr. Holger Thiele, Department of Internal Medicine/Cardiology, University of Leipzig–Heart Center, Strümpellstrasse 39, 04289 Leipzig, Germany (Email: thielh{at}medizin.uni-leipzig.de).
Objectives: 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
[ClinicalTrials.gov]
)
Key Words: atherosclerosis • bypass • coronary artery disease • drug-eluting stents • restenosis
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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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