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Published on: May 14, 2013
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.
Introduction:
Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI.
Methods:
Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions.
Results:
Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group.
Conclusions:
SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.
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