Abstract

JACC

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TCTAP A-089

PREmier of Randomized COMparison of Bypass Surgery Versus AgnioplasTy -5 Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease: PRE-COMBAT-5 Trial

By Jinho Lee, Do-Yoon Kang, Jung-Min Ahn, Duk-Woo Park, Seung-Jung Park

Presenter

Jinho Lee

Authors

Jinho Lee1, Do-Yoon Kang2, Jung-Min Ahn2, Duk-Woo Park2, Seung-Jung Park2

Affiliation

Kyung Hee University Hospital, Korea (Republic of)1, Asan Medical Center, Korea (Republic of)2
View Study Report
TCTAP A-089
Stents (Bare-metal, Drug-eluting)

PREmier of Randomized COMparison of Bypass Surgery Versus AgnioplasTy -5 Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease: PRE-COMBAT-5 Trial

Jinho Lee1, Do-Yoon Kang2, Jung-Min Ahn2, Duk-Woo Park2, Seung-Jung Park2

Kyung Hee University Hospital, Korea (Republic of)1, Asan Medical Center, Korea (Republic of)2

Background

Newer drug-eluting stent (DES) with biodegradable polymer has been introduced to reduce the potential stent thrombosis related to durable polymers. The safety and efficacy of the biodegradable polymer sirolimus-eluting Orsiro stent (SES) in the treatment of unprotected left main coronary artery (ULMCA) stenosis has not been determined.

Methods

A total of 157 consecutive patients who implanted SES with biodegradable polymer for ULMCA stenosis between March 2014 to July 2021 were prospectively enrolled in the PRECOMBAT-5 registry. Clinical outcomes were compared with the 791 patients of PRECOMBAT-2 and 3 study who implanted everolimus-eluting stent (EES) for ULMCA stenosis. Differences in clinical characteristics between groups were adjusted using propensity-score matching. The primary outcome was the 1-year incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or target vessel revascularization (TVR). 

Results

The 1-year incidence of MACCE were comparable between SES and EES group in overall (6.4% vs. 11.0%; Hazard ratio [HR] 0.57; 95% confidence interval [CI] 0.29-1.09; p=0.08) and propensity-score matched population (6.3% vs. 7.6%; HR 0.81; 95% CI 0.35-1.87; p=0.62). The composite of death, MI, or stroke also did not differ between SES and EES in overall (4.5% vs. 4.7%; HR 0.94; 95% CI 0.43-2.10; p=0.80) and propensity-score matched population (4.5% vs. 4.5%; HR 0.98; 95% CI 0.34-2.82; p>0.99).

Conclusion

In the multi-center, prospective, real-world data,PRECOMBAT-5 registry, SES with biodegradable polymer showed a comparable 1-year incidence rate of MACCE, and compositeof death, MI, or stroke for ULMCA PCI with second-generation EES.