Two-Year Real World Clinical Outcomes after Intravascular Imaging Device Guided Percutaneous Coronary Intervention with Ultrathin-Strut Biodegradable-Polymer Sirolimus-Eluting Stent
Authors: Nakao Sho , Ishihara Takayuki , Tsujimura Takuya , Hata Yosuke , Higashino Naoko , Kusuda Masaya , Mano Toshiaki 
Published: July 2023

Background

Biodegradable-polymer sirolimus-eluting stents (BP-SES) have excellent technology, including ultrathin struts and nanocoating that suppresses metal ion elution, and have demonstrated improved results in numerous large clinical trials. However, many of these reports have not used intravascular imaging, and there is little clinical data on imaging-guided percutaneous coronary intervention (PCI) 1 year after the implantation when the polymer disappears. The current study investigated the clinical outcomes 2 years after imaging-guided PCI with BP-SES and durable-polymer everolimus-eluting stents (DP-EES).

Methods

We retrospectively analyzed 2455 patients who underwent successful PCI with BP-SES or DP-EES between September 2011 and March 2021, and compared 2-year clinical outcomes of BP-SES (459 patients) with DP-EES (1996 patients). The outcome measures were target lesion revascularization (TLR) and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. Multivariate analysis using Cox proportional hazard model and inverse probability weighting (IPW) analysis based on the propensity score were used to evaluate the clinical outcomes.

Results

The 2-year cumulative incidences of TLR (BP-SES: 4.9% vs. DP-SES: 6.1%, p=0.304) and MACE (10.3% vs. 12.5%, p=0.159) were similar between the two groups. Multivariable and IPW analysis revealed the risks of TLR (p=0.388 and p=0.500) and MACE (p=0.139 and p=0.083) also had no significant difference. There was a significant interaction between none/mild and moderate/severe calcification with respect to MACE and TLR (adjusted p for interaction=0.036 and 0.029, respectively). The risk of MACE was significantly lower in BP-SES than in DP-EES in the lesions with none/mild calcification (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.30-0.91), while it was similar in those with moderate/severe calcification (aHR: 0.95; 95% CI: 0.58-1.55).

Conclusions

Compared with DP-EES, BP-SES demonstrated durable 2-year clinical outcomes. However, BP-SES showed better clinical performance than DP-EES for lesions with none/mild calcification.

Clinical Perspectives

What is Known

Durable 1-year results of biodegradable-polymer sirolimus-eluting stents (BP-SES: Orsiro) for complex lesions such as acute coronary syndrome (ACS), small vessels or calcified lesions have been reported compared with contemporary thin-strut (81 mm) durable-polymer everolimus-eluting stents (DP-EESs, Xience).

There are few reports comparing the long-term clinical outcomes of BP-SES and DP-EES in intravascular imaging device guided-percutaneous coronary intervention (PCI), although imaging-guided PCI has been reported to have better results than angiography-guided PCI.

What the Study Adds

BP-SES demonstrated comparable 2-year results after imaging-guided PCI with DP-EES.

BP-SES demonstrated a lower risk of MACE in none/mild calcification and a similar risk in moderate/severe calcification as DP-EES.