Reviwer  :  Dr. Dursun AKASLAN

Name of study : PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stentin Patients with Left Main Coronary Artery Disease)

Published in congress : ACC 21

Full text linki : https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.046039#:~:text=In%20this%2010%2Dyear%20follow,coronary%2Dartery%20bypass%20grafting%20in
Background :
Although coronary artery bypass grafting (CABG) has traditionally been the main treatment approach in the treatment of patients with left main coronary disease (LMCA), the use of drug-eluting stents is increasing day by day owing to the developments in stent technology. In European guidelines, surgical and percutaneous intervention is recommended as a class I indication in left main coronary patients with a Syntax score of <22. There are conflicting results between studies on this subject. In the NOBLE study, CABG remained the recommended treatment in this patient group, while in the EXCEL study in patients with a Syntax score <32, PCI was argued to be non-inferior to CABG. The 10-year survival data of the PRECOMBAT study were evaluated, considering that the long-term data of existing studies are more reliable.

Objective :
The aim of the study is comparative evaluation of unprotected left main coronary artery stenosis with Sirolimus-eluting Stent-Used percutaneous coronary intervention (PCI) and CABG.

Method :
The study was conducted in 13 different centers in Korea between 2004 and 2009. 600 patients were included in the study. The mean Syntax score was 24.6. The patients were randomly divided into 2 groups. Major cardiac or cerebrovascular events, defined as target vessel revascularization due to all-cause mortality, myocardial infarction, stroke, or ischemia, were determined as the primary endpoint.

Results :
At 10-year follow-up, the primary outcome was 29.8% in the PCI group and 24.7% in the CABG group((HR, 1.25 [95% CI, 0.93–1.69] p:NS ). Similarly, the 10-year composite incidence of death, MI, stroke and all-cause mortality did not differ significantly between the groups, however, target vessel revascularization due to ischemia was then 2-fold higher in the PCI group (16.1% vs. 8.0% p< 0.05 ).

Conclusion :
The PRECOMBAT study showed that PCI using a sirolimus-coated stent was non-inferior to CABG in patients with left main coronary disease.

Interpretation :
This study in Korean patients with unprotected left main coronary stenosis showed that percutaneous revascularization with sirolimus-coated stents was non-infeirior than CABG. Major adverse cardiac and cerebrovascular events were similar between groups at 10 years. During extended follow-up, performing CABG was more favorable than performing PCI for patients with left main coronary and three vessel disease when risk modification was made for major adverse cardiac and cerebrovascular events. This result is consistent with other evidence based studies suggesting that CABG is preferred over PCI in patients with a high SYNTAX score. Individual components of primary outcome were lower than expected and similar between the two groups, except for target vessel revascularization, which occurred more frequently in the PCI group. The SYNTAX score and EuroSCORE were lower in the PRECOMBAT study than in the SYNTAX study, so a lower than expected event rate may have been observed in the PRECOMBAT study. The inclusion of only Koreans in this study may raise a question mark regarding its results in other populations. While CABG is still considered the standard treatment for revascularization of left main coronary stenosis, accumulating data support the use of PCI in selected patients.