Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry

Cortese, Bernardo; Palma, Gaetano Di; Latini, Roberto; Elwany, Mostafa; Orrego, Pedro Silva; Seregni, Romano

doi:10.1016/j.carrev.2017.03.025

Cited by 44 publications

(13 citation statements)

References 17 publications

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“…Finally, only paclitaxel‐coated balloons were used in the included studies. Newer sirolimus‐coated balloons are currently available and have shown promising results …”

Section: Discussionmentioning

confidence: 99%

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Megaly

Rofael

Saad

et al. 2018

Cathet Cardio Intervent

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Background Percutaneous coronary intervention (PCI) of small‐vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug‐coated balloons (DCBs) in SVD has received limited study. Objectives To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. Methods We performed a meta‐analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. Results Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow‐up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug‐eluting stents (DES). During a mean follow‐up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04–0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08–0.37, P = <0.00001) compared with noncoated balloon angioplasty. Conclusion The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

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“…Finally, only paclitaxel‐coated balloons were used in the included studies. Newer sirolimus‐coated balloons are currently available and have shown promising results …”

Section: Discussionmentioning

confidence: 99%

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Megaly

Rofael

Saad

et al. 2018

Cathet Cardio Intervent

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“…Since, its introduction several small studies have confirmed the safety and efficacy of this device, in different settings. The FASICO study, 3 first showed the short‐term efficacy and safety in an all comer small populations of 32 patients; the primary endpoint of procedural success was obtained in 100% of patients, while the rate of MACE, coprimary endpoint, was very low, with just three cases of TLR.…”

Section: Discussionmentioning

confidence: 99%

Long‐term follow‐up after sirolimus‐coated balloon use for coronary artery disease. Final results of the Nanolutè study

El-Mokdad

Palma

2020

Cathet Cardio Intervent

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Objectives To test the long‐term efficacy of a sirolimus‐coated balloon (SCB). Background Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in‐stent restenosis (ISR). We here present the 24 months clinical data. Methods All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel‐myocardial infarction (MI). Results A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow‐up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). Conclusion The Nanoluté prospective registry is the first long‐term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

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“…Several small-sized studies have been conducted on the topic, mostly including a heterogeneous spectrum of clinical conditions and lesion settings. Since SCBs introduction in Europe in 2016, Cortese et al first reported the procedural effectiveness of SCBs in 32 patients with coronary artery disease and a stable clinical presentation in 66% of cases [ 10 ]. Of note, 47% of patients underwent PCI for ISR, and procedural success was achieved in all patients.…”

Section: Discussionmentioning

confidence: 99%

“…Nowadays, the vast majority of DCBs available on the market are paclitaxel-coated, since paclitaxel, with its lipophilic property, guarantees rapid cellular uptake with a homogeneous distribution, allowing for a lasting effect on smooth muscle cells. However, in 2016, a new sirolimus-coated balloon (SCB, Magic Touch®, Envision Scientific PVT, India) obtained the CE mark, and little clinical evidence on its effectiveness have been produced to date, mainly in stable settings [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry

Caiazzo

Michele

Galluzzi

et al. 2020

Journal of Interventional Cardiology

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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, p = 0.509 ). 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.

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Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry

Cited by 44 publications

References 17 publications

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Long‐term follow‐up after sirolimus‐coated balloon use for coronary artery disease. Final results of the Nanolutè study

Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry

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