Key result
Sirolimus-coated balloons for coronary lesions in complex ACS patients resulted in a 4.8% MACE rate at 11 months, with no significant difference between de novo lesions and ISR (HR 0.239; P=0.509).
Why the study?
Sirolimus-coated balloons represent a novel option for in-stent restenosis and de novo lesions in small vessels, but procedural and clinical outcomes in complex ACS needed evaluation.
Does sirolimus-coated balloon treatment improve outcomes in complex ACS patients with in-stent restenosis or de novo small vessel lesions?
Observational (n=62)
No
Does sirolimus-coated balloon treatment improve outcomes in complex ACS patients with in-stent restenosis or de novo small vessel lesions?
Hazard Ratio: 0.239 (95% CI 0.003–16.761)
p-value: p=0.509
Sirolimus-coated balloons demonstrate a favorable safety and efficacy profile for treating in-stent restenosis and de novo small vessel lesions in patients presenting with acute coronary syndrome.
SCB use appears feasible in complex ACS; leaves open need for RCTs to confirm safety and efficacy before practice change.
Background. Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. Methods and Results. We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003–16.761, <a:math xmlns:a="http://www.w3.org/1998/Math/MathML" id="M1"> <a:mi>p</a:mi> <a:mo>=</a:mo> <a:mn>0.509</a:mn> </a:math> ). Conclusions. In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.
No takes yet. Share an insight, caveat, or question.
Caiazzo et al. (2020) conducted an observational in Acute Coronary Syndrome (ACS) (n=62). Sirolimus-coated balloons was evaluated on Major adverse cardiovascular events (MACEs) (HR 0.239, 95% CI 0.003-16.761, p=0.509). Sirolimus-coated balloons for coronary lesions in complex ACS patients resulted in a 4.8% MACE rate at 11 months, with no significant difference between de novo lesions and ISR (HR 0.239; P=0.509).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: