P3316Long-term clinical outcomes of the bifurcation intervention: 3-year clinical follow-up for biodegradable-polymer biolimus A9-eluting stents vs. durable-polymer everolimus or zotarolimus-eluting stents

Abstract

Background: Bifurcation is an important lesion subset encountered in daily practice of interventional cardiology. Recent studies have shown that the clinical outcome of the 2‐stent technique is not significantly worse than those of the 1‐stent technique in contemporary practice using second generation coronary stents. Purpose: Thick‐strut, biodegradable‐polymer biolimus A9‐eluting stents (BPBESs) are newer but concerned that long‐term clinical outcomes may be worse, especially in complex lesion subsets such as bifurcation, compared to other thinstrut drug eluting stents using durable but stable polymers. We used a large‐scale multicenter stent registries in Korea to verify the hypothesis that BP‐BESs were not worse than durable polymer drug‐eluting stents (DP‐DESs), regardless of the 1‐stent or 2‐stent technique. Methods: Patients with BP‐BESs were recruited from the prospective Biolimus‐ Korea‐3000 registry and DP‐DESs were obtained from four other prospective registries (everolimus‐eluting stents from the HOST‐Excellent and Excellent‐Prime registries, zotarolimus‐eluting stents from the HOST‐Resolinte and Resolute‐ Korea registries). From January 2004 to November 2014, a total of 3007 (for BPBESs) and 10165 (for DP‐DESs) patients were consecutively enrolled for these 5 large‐scale registries with an unrestricted, open‐label, multicenter, prospective manner. Of the patients who were followed up to 3 years, only those with bifurcation lesions were included in the analysis. For more practical analysis, propensity score matching was performed to reflect the significant differences on the lesional and procedural characteristics. Clinically‐driven target lesion revascularization (CD‐TLR) was chosen for the primary efficacy outcome. Results: A total of 787 lesions were followed up to 3 years for BP‐BESs, and 2474 patients were followed for DP‐DESs. 696 pairs of lesions for each cohort were collected after the matching process. Dedicated 9‐ or 13‐month angiographic followup was performed in only a small number of patients in both groups. (8.9% for both cohorts, p=1.000). Of these matched lesions, 3‐year CD TLR rates were not higher than expected (5.5% for BP‐BESs and 4.3% for DP‐DESs). These rates were comparable to each other even after adjusting the 1‐ or 2‐stenting technique (HR for BP‐BESs 1.271, 95% CI 0.787‐2.053, p=0.327), and there was no significant interaction between stenting technique and stent type (p for interac‐ tion=0.524). However, at least in this matched cohort, the 2‐stent technique had a higher risk for CD‐TLR compared to the 1‐stent technique (4.3% vs. 10.6%, HR 2.606, 95% CI 1.423‐4.774, p=0.002). Conclusion: Regardless of the stenting technique, BP‐BES showed a similar CDTLR rate compared to DP‐DES, confirming that BP‐BES could still be an effective treatment option for complex lesion subsets such as bifurcation.