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The likelihood of stent failure directly correlates with the complexity of underlying coronary artery disease. The biodegradable-polymer biolimus-eluting stent (BP-BES) has a relatively thick strut (120 μm) stainless steel platform, and the unfavorable effect of thick struts may be clinically apparent, particularly in vessels with complex features. We sought to evaluate the safety and efficacy of BP-BES compared with durable-polymer everolimus-eluting stents (DP-EES, 89 μm) in patients undergoing complex percutaneous coronary intervention (PCI).
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 1 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-year follow-up.
Of 1,999 patients in the registry, 1,145 (57.3%) underwent complex PCI: 521 patients treated with BP-BES; and 624 patients with DP-EES. In the propensity-score matching (481 pairs), baseline characteristics were well-balanced between groups, the risks of TLF (adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246-1.359, p = 0.209), cardiac death (adjusted HR, 0.787; 95% CI, 0.244-2.539, p = 0.689), TV-MI (adjusted HR, 1.128; 95% CI, 0.157-8.093, p = 0.905), TLR (adjusted HR, 0.390; 95% CI, 0.139-1.095, p = 0.074), and definite or probable stent thrombosis (adjusted HR, 4.342; 95% CI, 0.484-38.927; p = 0.189) did not differ between 2-stent groups after complex PCI. Additionally, complex PCI was not associated with higher risks of TLF, cardiac death, TV-MI, and definite or probable stent thrombosis except TLR (adjusted HR, 3.209; 95% CI, 1.099-9.370; p = 0.033) compared with non-complex PCI.
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 high-risk complex PCI.