Cardiovascular

Registry of Percutaneous Coronary Interventions in Very Small-Caliber Vessels: Analysis of a Sirolimus-Eluting Stent and Other Contemporary Drug-Eluting Stents.

TL;DR

The Inspiron® sirolimus-eluting stent demonstrated acceptable safety and efficacy and provided comparable 12-month clinical outcomes to other contemporary drug-eluting stents in very small-caliber coronary vessels (≤2.25 mm).

Key Findings

The overall 12-month MACE rate in very small-caliber vessels treated with drug-eluting stents was 4.54%, with no difference between the Inspiron® stent and other contemporary DES.

  • MACE was defined as cardiac death, target lesion myocardial infarction, and clinically driven target lesion revascularization.
  • Overall MACE rate was 4.54% (36/793 patients).
  • Inspiron® MACE rate: 4.6% vs. other DES: 4.6%; p=1.000.
  • Individual endpoints were also similar between groups.

Stent thrombosis rates were similar between the Inspiron® stent and other contemporary DES in very small-caliber vessels.

  • Stent thrombosis occurred in 4 patients (1.0%) in the Inspiron® group vs. 2 patients (0.5%) in the other DES group.
  • Difference was not statistically significant (p=0.868).

A total of 783 drug-eluting stents were implanted in very small-caliber vessels (≤2.25 mm) at a Brazilian reference center between 2017 and 2021.

  • 47% of stents implanted were Inspiron® and 46.8% were other DES platforms.
  • The study was an observational study with a consecutive sample.
  • Outcomes were assessed in-hospital, at 30 days, 6 months, and 12 months.

The study population had a mean age of 64.7 years, was predominantly male, and had a high prevalence of diabetes mellitus.

  • Mean patient age was 64.7 ± 11 years.
  • 61% of patients were male.
  • 42% of patients had diabetes mellitus.

Percutaneous coronary intervention in very small-caliber vessels (≤2.25 mm) presents technical challenges and is associated with poorer outcomes compared to larger vessels.

  • The study defined very small-caliber vessels as those ≤2.25 mm in diameter.
  • The Inspiron® stent is a sirolimus-eluting stent manufactured in Brazil.
  • Prior to this study, data on the Inspiron® stent's performance in vessels smaller than 2.5 mm were lacking.

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Citation

Slaviero J, Manica A, Leite R, Borsa E, Schmidt M, Ogando R, et al.. (2026). Registry of Percutaneous Coronary Interventions in Very Small-Caliber Vessels: Analysis of a Sirolimus-Eluting Stent and Other Contemporary Drug-Eluting Stents.. Arquivos brasileiros de cardiologia. https://doi.org/10.36660/abc.20250145