Abstract Background Stent expansion is crucial for percutaneous coronary intervention (PCI) in left main coronary artery disease (LMD), characterized by aorto-ostial lesions composed mainly of fibrous or calcified tissue. In crossover stenting from the left main trunk (LMT) to the left anterior descending artery (LAD), stents must adapt to substantial changes in tapered vessel diameter. Recently, a novel platinum-chromium everolimus-eluting stent was developed, designed for large proximal vessels with strong axial and radial strength. Purpose This study aimed to evaluate the expansion performance of this stent in PCI for LMD (LM-PCI). Methods This was a single-centre, prospective observational study. Since the first-in-man deployment of this stent in Japan in November 2023 at our institution, all LM-PCI cases performed through December 2024 utilized this stent. The study included 50 consecutive patients undergoing LM-PCI with the novel stent (NS group) and a historical cohort of 50 consecutive LM-PCI cases using conventional cobalt-chromium everolimus-eluting stents (CS group). Stent expansion performance was assessed using intravascular ultrasound, evaluated by independent observers blinded to clinical data. Primary endpoint was stent expansion rate, defined as (minimum stent area MSA/vessel area at the MSA site) x 100. Secondary endpoints included the eccentricity index of the stent and the frequency of substantial stent malapposition, defined as 400 μm distance between the struts and the arterial wall. Results The mean age was 73.4 ± 9.1 years (87% male). Baseline characteristics, including age, sex, coronary risk factors, clinical presentation, were comparable between the two groups (p 0.05 for all). Stent diameters were significantly greater in the NS group (3.61 ± 0.21 mm² vs. 3.34 ± 0.33 mm², p0.001), likely due to the current availability of NS only in sizes ≥3.5 mm. The proximal optimization technique was performed in 100% of cases in both groups. No significant differences were observed between the groups in baseline stenosis severity (73.4 ± 9.4% vs. 74.0 ± 9.5%, p=0.74), the prevalence of severely calcified lesions (46.0% vs. 44.0%, p=1.0), or eccentric plaques (56.0% vs. 54.0%, p=1.0). However, stent expansion rates were significantly greater in the NS group both in the proximal LMT: 47.7 ± 6.0% vs. 44.3 ± 6.0% (p=0.0054); and ostial LAD: 48.5 ± 5.1% vs. 42.2 ± 6.9% (p0.0001). The eccentricity index was relatively higher (79.2 ± 9.9% vs 75.4 ± 10.0% p=0.06), but the difference does not reach statistical significance. The frequency of substantial stent malapposition was significantly lower in the NS group (6.0% vs. 26.0%, p=0.012). Conclusion The novel platinum-chromium everolimus-eluting stent demonstrated superior expansion performance compared to conventional cobalt-chromium everolimus-eluting stents in LM-PCI, with higher expansion and lower malapposition rates, suggesting significant advantages for treating LMD.
Warisawa et al. (Sat,) studied this question.