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

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.

Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.

BACKGROUND: For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS-BCS) with 30 days of dual antiplatelet treatment (DAPT). The LEADERS FREE III (LF III) trial investigated clinical outcomes after PCI with the next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients. AIMS: To report the final 3-year results of the LF III trial and compare them to LF II. METHODS: LF III was a prospective, multicentre, open-label single-arm study to evaluate the safety and efficacy of the CoCr-BCS stent. The primary safety endpoint was the composite of cardiac death (CD), myocardial infarction(MI) or definite/probable stent thrombosis (ST). The primary efficacy endpoint was clinically driven target lesion revascularisation (cd-TLR). We performed a propensity-matched comparison to the 3-year outcomes of LF II. RESULTS: After 3 years, CD/MI/ST had occurred in 57 patients (15%, 95% CI 11.8% to 19%) and cd-TLR in 23 (6.2%, 95% CI 4.1% to 9.2%) patients. In a propensity-matched comparison of patients treated with the CoCr-BCS versus the SS-BCS, there were similar rates of CD (6.6% vs 7.8%, p=0.50), MI (7.1% vs 8.3%, p=0.47) and definite/probable ST (1.1% vs 2%, HR 0.56, 95% CI 0.16 to 1.93, p=0.35). The rates of cd-TLR were 5.3% with CoCr-BCS versus 9.8% with SS-BCS (HR 0.54, 95% CI 0.31 to 0.96, p=0.03). CONCLUSION: LF III confirms the long-term safety and efficacy of the CoCr-BCS in HBR patients treated with 1 month of DAPT. TRIAL REGISTRATION NUMBER: NCT02843633, NCT03118895.

Is direct coronary stenting the best strategy for long-term outcome? Results of the multicentric randomized benefit evaluation of direct coronary stenting (BET) study.

BACKGROUND: Preliminary trials of direct coronary stenting have demonstrated the benefits of this approach. It lowers procedural cost, time, and radiation exposure compared with predilatation. Nevertheless, the long-term outcome after direct stenting remains less well known. METHODS: Between January and September 1999, 338 patients were randomly assigned to either direct stent implantation (DS+, n = 173) or standard stent implantation with balloon predilatation (DS-, n = 165). Clinical follow-up was performed. RESULTS: Baseline characteristics were similar in the 2 groups. Procedural success was achieved in 98.3% of patients assigned to DS+ and 97.5% of patients assigned to DS- (not significant). Clinical follow-up was obtained in 99% of patients (mean 16.4 +/- 4.6 months). Major adverse cardiac events--defined as whichever of the following occurred first; cardiac death, myocardial infarction, unstable angina, new revascularization--were observed at a higher rate in the DS+ group than in the DS-, but this difference was not significant (11.3% vs 18.2%, P = not significant). The difference in target lesion revascularization rate in the DS+ group (7%) and DS- group (5.2%) was also not significant. Multivariate analysis showed that direct stenting had no influence on long-term major adverse cardiac events rate. Independent relationships were found between long-term major adverse cardiac events rate and final minimal lumen diameter <2.48 mm (relative risk [RR] 0.449, CI 0.239-0.845, P =.013), prior myocardial infarction (RR 2.028, CI 1.114-3.69, P =.02), and hypertension (RR 1.859, CI 1.022-3.383, P =.042). CONCLUSION: The main finding that emerges from this randomized study is that the influence of direct stenting on long-term need for new target lesion revascularization does not differ from that of stenting with balloon predilatation.