Korean Circ J.  2019 Jan;49(1):69-80. 10.4070/kcj.2018.0097.

Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention

• Song PS
• Park KT
• Kim MJ
• Jeon KH
• Park JS
• Choi RK
• Song YB
• Choi SH
• Choi JH
• Lee SH
• Gwon HC
• Jeong JO
• Im ES
• Kim SW
• Chun WJ
• Oh JH
• Hahn JY

• KMID: 2430749
• DOI: http://doi.org/10.4070/kcj.2018.0097

Abstract

BACKGROUND AND OBJECTIVES
There are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI.
METHODS
Patients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up.
RESULTS
Of 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246-1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244-2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157-8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139-1.095; p=0.074) did not differ between 2 stent groups after complex PCI.
CONCLUSIONS
Clinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.

Keyword

Coronary artery disease; Percutaneous coronary intervention; Drug-eluting stents

MeSH Terms

Coronary Artery Disease
Death
Drug-Eluting Stents
Follow-Up Studies
Humans
Myocardial Infarction
Percutaneous Coronary Intervention*
Stents*

Figure

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  Figure 1 Study population. BP-BES = biodegradable polymer biolimus-eluting stents; DP-EES = durable polymer everolimus-eluting stents; PCI = percutaneous coronary intervention.

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  Figure 2 Kaplan-Meier curves for clinical outcomes in the propensity score matched population. TLF: cardiac death, TV-MI, and TLR. BP-BES = biodegradable polymer-biolimus-eluting stents; DP-EES = durable polymer-everolimus-eluting stents; FU = follow-up; TLF = target lesion failure; TLR = target lesion revascularization; TV-MI = target vessel-related myocardial infarction.

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  Figure 3 HRs for target lesion failure according to various subgroups in complex PCI. TLF: cardiac death, TV-MI, and TLR. Complexity was defined as left main PCI, bifurcation PCI, ≥2 lesions treated, total stent length >40 mm, or minimal stent diameter ≤2.5 mm. ACS = acute coronary syndrome; BP-BES = biodegradable polymer-biolimus-eluting stents; CI = confidence interval; DM = diabetes mellitus; DP-EES = durable polymer-everolimus-eluting stents; HR = hazard ratio; HTN = hypertension; PCI = percutaneous coronary intervention; TLF = target lesion failure; TLR = target lesion revascularization; TV-MI = target vessel-related myocardial infarction.

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  Figure 4 Kaplan-Meier curves for clinical outcomes of complex PCI in a landmark analysis between 6 months and 2 years. TLF: cardiac death, TV-MI, and TLR. BP-BES = biodegradable polymer-biolimus-eluting stents; CI = confidence interval; DP-EES = durable polymer-everolimus-eluting stents; FU = follow-up; HR = hazard ratio, PCI = percutaneous coronary intervention; TLF = target lesion failure; TLR = target lesion revascularization; TV-MI = target vessel-related myocardial infarction.

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