Polymer-free Biolimus-A9 coated thin strut stents for patients at high bleeding risk 1-year results from the LEADERS FREE III study

Abstract

Background: In patients at high bleeding risk (HBR), the LEADERS FREE (LF) trial established the safety and efficacy of a polymer-free drug coated (Biolimus-A9) stainless steel stent (SS-DCS) with 30 days of dual antiplatelet treatment (DAPT). In LEADERS FREE III, we studied a new cobalt-chromium thin-strut stent (CoCr-DCS) in HBR patients.

Methods: The CoCr-DCS shares all of the design features of the SS-DCS but has a CoCr stent platform with strut thickness of 84-88 μm. The primary safety endpoint was a composite of cardiac death, myocardial infarction (MI), and definite/probable stent thrombosis. The primary efficacy endpoint was clinically indicated target lesion revascularization. Outcomes were compared to those of LF (non-inferiority to SS-DCS for safety and superiority to SS-BMS for efficacy). Additional propensity-matched comparisons were performed to account for baseline differences.

Results: We recruited 401 HBR patients using identical criteria to the LF trial. At 1 year, the primary safety endpoint was reached by 31/401 (8.0%) of patients treated with the CoCr-DCS versus 35/401 (8.9%) for the propensity-matched cohort (HR: 0.89, [0.55-1.44], p < 0.001 for non-inferiority, 0.62 for superiority). The efficacy endpoint was reached by 16/401 (4.2%) of CoCr-DCS patients versus 41/401 (10.6%) in the propensity-matched cohort (HR: 0.4 [0.2:0.7]) (p = 0.007 for superiority). There was no statistical difference between CoCr-DCS and SS-DCS in terms of efficacy (HR: 1.46 [0.68-3.15], p = 0.33).

Conclusions: The new thin-strut CoCr-DCS proved non-inferior to the SS-DCS for safety, and superior to the BMS for efficacy in HBR patients treated with 30 days of DAPT.

Keywords: CLIN-clinical trials; DES-stent; PCI-percutaneous coronary intervention (PCI); drug eluting.

FIGURE 1

Use of clinical criteria to select high bleeding risk patients. Selection criteria for high bleeding risk are depicted for the LEADERS FREE III (LFIII) trial and the LEADERS FREE (LF) trial population. *There were no significant differences except for expected poor compliance for medication (p > 0.05). CoCr‐DCS (LF III), thin‐strut Biolimus‐A9 drug‐coated cobalt‐chromium stent used in Leaders Free III; SS‐DCS, stainless steel Biolimus‐A9 drug‐coated stent, used in Leaders Free; SS‐BMS, Gazelle™ bare metal stent, used in Leaders Free; PCI, percutaneous coronary intervention; NSAID, non‐steroidal anti‐inflammatory drugs; DAPT, dual anti‐platelet therapy [Color figure can be viewed at wileyonlinelibrary.com]

FIGURE 2

Clinical outcomes: Primary safety endpoint—(A) comparison with full LF cohort; (B) comparison with propensity matched cohort. Primary efficacy endpoint—(C) comparison with full LF cohort; (D) comparison with propensity‐matched cohort. Definite/probable stent thrombosis; (E) comparison with full LF cohort; (F) comparison with propensity‐matched cohort. CoCr‐DCS (LF III), Thin‐strut Biolimus‐A9 drug‐coated cobalt‐chromium stent used in Leaders Free III; SS‐DCS, stainless steel Biolimus‐A9 drug‐coated stent, used in Leaders Free; SS‐BMS, Gazelle ™ bare metal stent, used in Leaders Free; MI, myocardial infarction; ST, stent thrombosis; ci‐TLR, clinically indicated target lesion revascularization [Color figure can be viewed at wileyonlinelibrary.com]