Mid‐term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population

Abstract

Background Use of drug coated balloons (DCBs) in coronary intervention is escalating. There is a plethora of data on Paclitaxcel‐DCB. However, when it comes of stents, Limus‐drugs are preferred over Paclitaxel. There is very limited data on Sirolimus coated balloons (SCB). MagicTouch‐SCB (Concept Medical, FL) elutes Sirolimus via nano‐technology and have been used in our centers since March 2018. We report a mid‐term follow‐up with this relatively novel‐technology. Methods and results We retrospectively analyzed all patients treated with MagicTouch‐SCB between March‐2018 and February‐2019. Results are reported as cardiac‐death, target‐vessel myocardial‐infarction (TVMI), target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE). During the study period, 288‐patients (373‐lesions) with a mean age of 65.8 were treated with MagicTouch‐SCB. 84% (n = 241) were male, 155 (54%) were in the setting of acute coronary syndrome, 38% (n = 110) had diabetes and 62% (n = 233) were in de‐novo lesions. Most lesions treated were in the LAD/diagonal‐system (n = 170; 46%). Pre‐dilatation was performed in 92% (n = 345) of cases. Bailout stenting was required in 9% lesions (n = 35). The mean diameter and length of SCBs were 2.64 ± 0.56 mm and 24 ± 8.9 mm respectively. During a median follow‐up of 363 days (IQR: 278–435), cardiac death and TVMI occurred in 5‐patients (1.7%) and 10‐patients (3.4%) respectively, TLR per‐lesion was 12%. The MACE rate was 10%. There were no documented cases of acute vessel closure. Conclusions The results from mid‐term follow‐up with this relatively new technology SCB is encouraging with a low rates of hard endpoints and acceptable MACE rates despite complex group of patients and lesion subsets.

How to perform a successful drug‐coated balloon angioplasty? Tips and tricks

“…2,3 However, their use has also been extended to de novo lesions, especially in patients and lesion subsets where stents are not ideal such as small vessels, diffuse disease, side-branches, and patients with high-bleeding risk (HBR) who may not be able to take dual antiplatelet therapy for an extended period. [4][5][6][7] The Use of DCBs in coronary intervention is escalating due to a consistent trickle of positive data. Current data supports the use of DCBs in small vessels as they are found to be non-inferior to stents and some studies even show superiority.…”

Procedural optimization of drug‐coated balloons in the treatment of coronary artery disease

“…DCB treatment has received a class 1A recommendation for the treatment of both bare metal stent (BMS) and DES ISR in the 2018 ESC guidelines on myocardial revascularization 25 . Afterward, various studies have trials were performed to evaluate whether DCB are effective in de‐novo coronary lesions, specifically in small coronary vessels, or to assess the safety and efficacy of newer generation DCBs 7,26‐30 . Regarding small de novo lesions, the BASKET‐SMALL 2 trial and RESTORE‐SVD trial showed that DCB was noninferior to DES in regards of clinical outcomes 7,26 .…”

“…Recently, the PICCOLETO II presented that the Elutax SV DCB was superior for late lumen loss compared with a DES 30 . Moreover, Basavarajaiah et al evaluated the efficacy and safety of a novel Sirolimus coated balloons, the MagicTouch‐SCB (Concept Medical, FL), showing low rates of hard endpoints and acceptable MACE rates 28 . This DCB applied a technique of encapsulating the poor lipophilic limus‐drug in a lipophilic nano‐carrier, so as to overcome the Achilles heel for Limus‐drugs to be used in balloon technology.…”

“…25 Afterward, various studies have trials were performed to evaluate whether DCB are effective in de-novo coronary lesions, specifically in small coronary vessels, or to assess the safety and efficacy of newer generation DCBs. 7,[26][27][28][29][30] Regarding small de novo lesions, the BASKET-SMALL 2 trial and RESTORE-SVD trial showed that DCB was noninferior to DES in regards of clinical outcomes.…”

Drug-Coated Balloons: Drugs Beyond Paclitaxel?

“…With its long and successful history in coronary drug-eluting stents (DES), sirolimus has attracted the attention of researchers investigating new DCB technologies. Sirolimus-coated balloons have so far shown promising results in inhibition of restenosis after percutaneous coronary interventions (PCIs) in a small number of patients included in clinical studies [4][5][6][7][8]. Furthermore, a wide range of other drugs with potential antiproliferative, anti-inflammatory, or antithrombotic actions might be candidates for balloon coating.…”