Abstract
Background and purposes
Drug-coated balloons (DCB) currently represent an alternative to drug-eluting stents (DES) for the treatment of in-stent restenosis and they are also variably used for small coronary vessel and bifurcation lesion management. All DCB variably elute paclitaxel as an anti-proliferative drug. The first sirolimus coated balloon (SCB) received the CE mark in 2016, but its clinical performance has not been shown yet.
Methods and results
FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March and July 2016 at the first European centre that used this device. All patients were prospectively enrolled in a dedicated database. Primary endpoint was procedural success; co-primary endpoint was the rate of major adverse cardiac events at short-term follow-up. The 32 patients (34 lesions) enrolled had at least 6-month clinical follow up available. Forty-five percent had diabetes and indication to PCI was ISR in 47% of the cases. Lesions were always pre-dilated and device deployment was successful in all the cases. Procedural success was achieved in 100% of patients. We observed 3 cases of TLR at follow-up.
Conclusions
SCB shows high immediate technical performance and adequate short-term efficacy and safety. The ongoing EASTBOURNE registry will shed light on mid-and long-term performance of this device in an adequately powered population.
Highlights
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Sirolimus-coated balloon represents an absolute novelty in interventional cardiology.
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A complex population was enrolled, and technical performance of the device was high.
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Short-term clinical outcome was also promising.
1
Introduction
Since the advent of the latest generation of drug-eluting stents (DES), percutaneous coronary interventions (PCI) have expanded their indications, and currently these devices are considered the standard revascularization treatment for de novo coronary lesions . Although new generation DES have potent antiproliferative properties and provide excellent clinical and angiographic long-term results , they still imply some limitations, including an increased bleeding risk associated with the need for a prolonged dual antiplatelet therapy (DAPT) and the risk of late and very late stent thrombosis . Moreover, given the increasing complexity of coronary interventions, the adoption of hybrid revascularization strategies are a valid alternative to a solo -DES PCI .
Drug-coated balloons (DCB) have been developed in recent years to overcome some of the DES limitations . Their goal is to provide mechanical expansion of the stenosis combined with the release of an anti-proliferative drug, without leaving a foreign body. There is an established indication for the use of DCB in the treatment of in-stent restenosis and they are also variably used in small coronary vessels and bifurcations . Until 2016, all DCBs available in Europe eluted paclitaxel, a highly lipophilic drug with narrow therapeutic window.
In April 2016 a new sirolimus-coated balloon (SCB, Magic Touch ® , Envision Scientific PVT, India), obtained the CE Mark. This device shares a new delivery system and is able to release an effective and well recognized anti-proliferative drug, but to this day it has not yet been adequately tested in contemporary-era PCI.
2
Methods
The FAtebenefratelli SIrolimus COated-balloon (FASICO) is an all-comer prospective registry of the first consecutive patients, who had at least one lesion treated with SCB between April and July 2016 at the first European center that had the device available for use after obtaining the CE Mark. The aim of the study was to demonstrate the acute performance and the 6-month efficacy and safety of this device in a real world, complex population.
2.1
SCB: technical details
The device under investigation consists in a latest-generation monorail delivery system compatible with 5-Fr guiding catheters. The low-profile distal tip and the rigid hypotube, along with the technique of drug deposition, allow high deliverability and trackability. Available balloon sizes range between 1.5–4 mm in diameter and 10–40 mm in usable lengths.
The balloon is coated with sirolimus in a uniform manner through the use of a spray coating. The technology specifically designed for this device (Nanolutè®) consists in the encapsulation of sirolimus in a protective lipophilic package, which allows the diffusion and penetration into the arterial wall during balloon inflation, overcoming the low lipophilicity of sirolimus. This package consists of nano-sized drug particles of 100–300 nm diameter. The total dose of the drug corresponds to 1.25 mg/mm 2 of surface of the balloon, well within the therapeutic window of sirolimus.
Animal studies have shown that only 10% of the drug is lost during transit, then about 56% is released with the first balloon inflation, which should last 40–60 s; an additional 20% of the drug may be administered with an eventual 2nd inflation, while only 14% remains on the balloon.
The blood concentration reaches its peak within the following 30 min, and then disappears within 24 h, while tissue concentration is still detectable after 14 days. The drug persists on the vessel wall after the balloon inflation for 15–30 days; basically, the pharmacokinetic properties of this SCB reflect to the ones of latest-generation paclitaxel-coated balloons ( Fig. 1 ).
2.2
Study population
All types of clinical settings and coronary lesions were enrolled in this registry, including acute coronary syndromes, in-stent restenosis, long lesions and calcified vessels. We included all the attempted PCIs with SCB. The clinical and lesion complexity of the enrolled population reflect current population in Europe. The only exclusion criteria were vessel dimensions that exceeded those of the device tested, and those cases where we opted for another treatment strategy. All the patients treated with SCB entered a dedicated database and were followed up prospectively.
2.3
Study procedure
The procedure was performed according to international guidelines and local protocols. SCBs were inflated for a minimum of 30 s, but preferably for 60 s if they were well tolerated by the patient. Following local practice and the Italian GISE Position Document on DCB-PCI , we were committed to always carefully prepare the lesions and avoid stent implantation afterwards unless strictly needed. Lesion length and vessel reference diameter were assessed by visual estimation as during routine activity in our catheterization laboratory. As per local practice and expert consensus, all treated lesions were evaluated after at least 15 min before removing the guiding catheter for the assessment of potential acute vessel recoil . A DAPT of at least 1 month was recommended in case of de novo lesion treatment and 3 months in case of ISR, unless longer DAPT was clinically indicated ( e.g. , ACS) .
2.4
Endpoints
We individuated 2 primary endpoints for the current analysis. The first consisted in the immediate technical and clinical performance of this device in terms of procedural success, defined as final % diameter stenosis <50% with 3 TIMI flow and the absence of in-hospital adverse events. The co-primary endpoint was the rate of major adverse cardiac events (MACE), a total of cardiac death, myocardial infarction-MI, TLR at the longest available follow-up. MI was defined according to the universal definition . TLR was defined as repeat PCI or coronary artery bypass grafting for the target segment or in the adjacent proximal or distal 5 mm segments. All patients enrolled had to have at least 6 months clinical follow up available.
2
Methods
The FAtebenefratelli SIrolimus COated-balloon (FASICO) is an all-comer prospective registry of the first consecutive patients, who had at least one lesion treated with SCB between April and July 2016 at the first European center that had the device available for use after obtaining the CE Mark. The aim of the study was to demonstrate the acute performance and the 6-month efficacy and safety of this device in a real world, complex population.
2.1
SCB: technical details
The device under investigation consists in a latest-generation monorail delivery system compatible with 5-Fr guiding catheters. The low-profile distal tip and the rigid hypotube, along with the technique of drug deposition, allow high deliverability and trackability. Available balloon sizes range between 1.5–4 mm in diameter and 10–40 mm in usable lengths.
The balloon is coated with sirolimus in a uniform manner through the use of a spray coating. The technology specifically designed for this device (Nanolutè®) consists in the encapsulation of sirolimus in a protective lipophilic package, which allows the diffusion and penetration into the arterial wall during balloon inflation, overcoming the low lipophilicity of sirolimus. This package consists of nano-sized drug particles of 100–300 nm diameter. The total dose of the drug corresponds to 1.25 mg/mm 2 of surface of the balloon, well within the therapeutic window of sirolimus.
Animal studies have shown that only 10% of the drug is lost during transit, then about 56% is released with the first balloon inflation, which should last 40–60 s; an additional 20% of the drug may be administered with an eventual 2nd inflation, while only 14% remains on the balloon.
The blood concentration reaches its peak within the following 30 min, and then disappears within 24 h, while tissue concentration is still detectable after 14 days. The drug persists on the vessel wall after the balloon inflation for 15–30 days; basically, the pharmacokinetic properties of this SCB reflect to the ones of latest-generation paclitaxel-coated balloons ( Fig. 1 ).
2.2
Study population
All types of clinical settings and coronary lesions were enrolled in this registry, including acute coronary syndromes, in-stent restenosis, long lesions and calcified vessels. We included all the attempted PCIs with SCB. The clinical and lesion complexity of the enrolled population reflect current population in Europe. The only exclusion criteria were vessel dimensions that exceeded those of the device tested, and those cases where we opted for another treatment strategy. All the patients treated with SCB entered a dedicated database and were followed up prospectively.
2.3
Study procedure
The procedure was performed according to international guidelines and local protocols. SCBs were inflated for a minimum of 30 s, but preferably for 60 s if they were well tolerated by the patient. Following local practice and the Italian GISE Position Document on DCB-PCI , we were committed to always carefully prepare the lesions and avoid stent implantation afterwards unless strictly needed. Lesion length and vessel reference diameter were assessed by visual estimation as during routine activity in our catheterization laboratory. As per local practice and expert consensus, all treated lesions were evaluated after at least 15 min before removing the guiding catheter for the assessment of potential acute vessel recoil . A DAPT of at least 1 month was recommended in case of de novo lesion treatment and 3 months in case of ISR, unless longer DAPT was clinically indicated ( e.g. , ACS) .
2.4
Endpoints
We individuated 2 primary endpoints for the current analysis. The first consisted in the immediate technical and clinical performance of this device in terms of procedural success, defined as final % diameter stenosis <50% with 3 TIMI flow and the absence of in-hospital adverse events. The co-primary endpoint was the rate of major adverse cardiac events (MACE), a total of cardiac death, myocardial infarction-MI, TLR at the longest available follow-up. MI was defined according to the universal definition . TLR was defined as repeat PCI or coronary artery bypass grafting for the target segment or in the adjacent proximal or distal 5 mm segments. All patients enrolled had to have at least 6 months clinical follow up available.
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