Sirolimus-coated balloon versus drug-eluting stent for complex coronary lesions. A propensity matched comparison

Sylwia Iwańczyk1, Florin-Leontin Lazar2, Horea-Laurentiu Onea2

  • 1Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland; DCB Academy, Milano, Italy.

Insights

Sirolimus-coated balloon (SCB) angioplasty shows improved safety and efficacy over drug-eluting stents (DES) in complex coronary artery disease. SCB significantly reduces major bleeding and net adverse cardiovascular events, offering a promising alternative for selected patients.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Technology Evaluation

Background:

  • Drug-eluting stents (DES) are standard for complex coronary artery disease (CAD) but have associated stent-related events.
  • Sirolimus-coated balloon (SCB) angioplasty is an emerging alternative requiring comparative evaluation.
  • Complex PCI necessitates thorough assessment of novel treatment modalities.

Purpose of the Study:

  • To compare the safety and efficacy of SCB-based angioplasty versus new-generation DES.
  • To evaluate outcomes in patients with complex coronary artery disease undergoing PCI.
  • To determine the incidence of net adverse cardiovascular events (NACE) between SCB and DES treatments.

Main Methods:

  • A comparative study analyzing data from the EASTBOURNE (SCB) and COMPLEX (DES) registries.
  • Propensity score matching was used to create comparable patient groups (512 patients analyzed).
  • Primary endpoint was NACE, defined as death, target lesion revascularization, myocardial infarction, or major bleeding (BARC).

Main Results:

  • SCB angioplasty demonstrated significantly lower NACE rates compared to DES (3.9% vs. 10.5%, p=0.003) at 1-year follow-up.
  • Major bleeding events were substantially reduced with SCB (0.4% vs. 6.6%, p=0.001).
  • Adjusted Cox models revealed a significantly lower hazard of NACE (HR 0.23) and all-cause mortality (HR 0.07) with SCB.

Conclusions:

  • SCB angioplasty offers an advantage over DES in treating complex CAD, reducing NACE and major bleeding without compromising ischemic outcomes.
  • SCB angioplasty presents a viable alternative to DES for carefully selected patients with complex coronary lesions.
  • The findings support SCB as a potentially safer treatment option in complex PCI settings.
Abstract

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