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. 2019 Jan;49(1):69-80.
doi: 10.4070/kcj.2018.0097. Epub 2018 Aug 24.

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

Pil Sang Song #  1 , Kyu Tae Park #  2 , Min Jeong Kim  1 , Ki Hyun Jeon  1 , Jin Sik Park  1 , Rak Kyeong Choi  1 , Young Bin Song  2 , Seung Hyuk Choi  2 , Jin Ho Choi  2 , Sang Hoon Lee  2 , Hyeon Cheol Gwon  2 , Jin Ok Jeong  3 , Eul Soon Im  4 , Sang Wook Kim  5 , Woo Jung Chun  6 , Ju Hyeon Oh  7 , Joo Yong Hahn  8
Affiliations

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

Pil Sang Song et al. Korean Circ J. 2019 Jan.

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.

Keywords: Coronary artery disease; Drug-eluting stents; Percutaneous coronary intervention.

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Conflict of interest statement

The authors have no financial conflicts of interest.

Figures

Figure 1
Figure 1. Study population.
BP-BES = biodegradable polymer biolimus-eluting stents; DP-EES = durable polymer everolimus-eluting stents; PCI = percutaneous coronary intervention.
Figure 2
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.
Figure 3
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.
Figure 4
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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