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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Acute and Late Outcomes of Unprotected Left Main Stenting in Comparison With Surgical Revascularization

Pawel E. Buszman, MD, FACC^_*,,_*, Stefan R. Kiesz, MD, FACC^,, Andrzej Bochenek, MD^_*, Ewa Peszek-Przybyla, MD, Iwona Szkrobka, MD, Marcin Debinski, MD, Bozena Bialkowska, MD, Dariusz Dudek, MD^||, Agata Gruszka, MD, Aleksander Zurakowski, MD, Krzysztof Milewski, MD, Miroslaw Wilczynski, MD, Lukasz Rzeszutko, MD^||, Piotr Buszman^_*, Jan Szymszal, PhD^¶, Jack L. Martin, MD, FACC^# and Michal Tendera, MD, FACC^_*

^_* Medical University of Silesia, Katowice, Poland
San Antonio Endovascular and Heart Institute, University of Texas Health Science Center at San Antonio, San Antonio, Texas
American Heart of Poland, Ustron, Poland
Upper-Silesian Heart Centre, Katowice, Poland
^|| Jagiellonian University, Krakow, Poland
^¶ Silesian School of Engineering, Katowice, Poland
^# Bryn Mawr and Thomas Jefferson University, Philadelphia, Pennsylvania.

Manuscript received March 21, 2007; revised manuscript received September 10, 2007, accepted September 17, 2007.

^_* Reprint requests and correspondence: Dr. Pawel E. Buszman, Katowice 40-635, Ziolowa 45/47, Poland. (Email: pbuszman{at}ka.onet.pl).

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. (Study of Unprotected Left Main Stenting Versus Bypass Surgery [LE MANS study]; NCT00375063).

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass grafting   DES = drug-eluting stent(s)   LVEF = left ventricular ejection fraction   MACCE = major adverse cardiac and cerebrovascular events   MAE = major adverse events   PCI = percutaneous coronary intervention   TVF = target vessel failure   TVR = target vessel revascularization   ULMCA = unprotected left main coronary artery

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