Sirolimus Coated Balloon Research Articles

A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions.

Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive. This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions. To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths). The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

The future of sirolimus-coated balloon use in percutaneous coronary intervention.

The future of sirolimus-coated balloon use in percutaneous coronary intervention.

Paclitaxel-Coated Versus Sirolimus-Coated Eluting Balloons for Percutaneous Coronary Interventions: Pharmacodynamic Properties, Clinical Evidence, and Future Perspectives

Drug-coated balloons (DCBs) have emerged as an increasingly valuable option for the treatment of coronary artery disease (CAD). Percutaneous coronary intervention (PCI) with DCBs enables the localized delivery of antiproliferative drugs directly to the target coronary lesion, avoiding the need for permanent scaffold implantation. Historically, paclitaxel-coated balloons (PCBs) have been the most used device in this context. Paclitaxel interferes with intracellular microtubule function, leading to cell cycle arrest. However, its cytotoxicity at a higher dosage and narrow therapeutic range has raised some safety concerns. To address these issues, sirolimus-coated balloons (SCBs) have been introduced as an alternative. Sirolimus acts as a cytostatic agent with potent anti-inflammatory and antiproliferative properties and is characterized by a wider therapeutic range, potentially offering a safer profile. Several experimental and clinical studies comparing the safety and efficacy of PCBs versus SCBs have yielded mixed results. Recently, a novel DCB (SirPlux Duo), which simultaneously releases both paclitaxel and sirolimus, has been tested in a porcine coronary model with promising results. In this review, we will elucidate the mechanisms of action of paclitaxel and sirolimus, examine contemporary preclinical and clinical evidence comparing PCB and SCB angioplasty, and discuss novel devices that may enhance the safety and efficacy of PCI with DCBs.

Paclitaxel- or sirolimus-coated balloons used for ArterioVEnous fistulas-2 (PAVE-2): study protocol for a randomised controlled trial to determine the efficacy of paclitaxel- or sirolimus-coated balloons in arteriovenous fistulas used for haemodialysis

BackgroundIn view of the conflicting results from previous studies, the benefit of paclitaxel-coated balloons for arteriovenous fistulas is uncertain and equipoise remains. Although an industry-led trial testing the efficacy of sirolimus-coated balloons in AVFs is in progress, the benefit of sirolimus-coated balloons for arteriovenous fistulas is currently unknown. The purpose of this trial is to compare the efficacy of additional paclitaxel-coated or sirolimus-coated balloons on outcomes after a plain balloon fistuloplasty to preserve the patency of arteriovenous fistulae used for haemodialysis.MethodsThe study design is a multicentre randomised controlled trial. Following a successful plain balloon fistuloplasty, participants will be randomised to further treatment with a paclitaxel-coated balloon, a sirolimus-coated balloon, or an uncoated control balloon. We will recruit 642 patients, each with one or two treatment segments, over a 3-year period. Patients will remain in the trial and be followed up for 1 year. The primary endpoint is time to loss of treatment segment primary patency. Cox-proportional hazards models will be used to estimate hazard ratios for the time to loss of treatment segment primary patency for each treatment group relative to the control group. Analysis of the primary endpoint will be based on treatment segments rather than participants and a shared frailty will be estimated to account for the clustering of treatment segments within patients. Secondary endpoints are time to loss of primary patency at any treatment segment; time to end of access circuit primary patency; time to AVF abandonment; number of radiological or surgical interventions; adverse events; intima-media thickness and degree of stenosis at 3 months on ultrasound; and patient quality of life assessed by EQ-5D-5L and VASQoL.DiscussionThe three-armed design in this proposal will provide an answer on the efficacy of both paclitaxel- and sirolimus-coated balloons in the same trial. This trial is likely to provide a clear answer regarding the efficacy of drug-coated balloons for arteriovenous fistulas.Trial registrationISRCTN ISRCTN40182296. Registered on 4 August 2023.

Changes of angiography-derived coronary microcirculatory resistance before and after drug-coated balloon treatment

Abstract Background Drug coated balloon (DCB) is a treatment option for a lesion in a small coronary artery. The effect of DCB is proven in mechanistic and clinical outcomes, however, its influence on the microvascular function has not been elucidated. In addition, because there are differences in the types of drugs and coatings among different DCBs, their effects on microvascular function may vary. Angiography-derived microcirculatory resistance (AMR) is a novel angiographic parameter calculated from angiography-derived quantitative flow ratio and flow velocity estimation. AMR is reported to have a good correlation with the wire-based index of microvascular resistance. Purpose To investigate the AMR in coronary vessels treated with sirolimus or paclitaxel coated balloon. Methods This is a subanalysis of the TRANSFORM I (The TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon) trial. TRANSFORM I is a prospective, randomized, multi-center, open-label noninferiority trial conducted in Europe that enrolled 121 patients (126 vessels) with stabilized acute coronary syndrome or chronic coronary syndrome who had at least one de novo coronary artery lesion in a small coronary vessel. Patients were randomized 1:1 to treatment with the sirolimus coated balloon (SCB) or paclitaxel coated balloon (PCB). The SCB is coated with phospholipid encapsulated sirolimus nanocarrier, whereas the PCB is coated with crystalline paclitaxel. In this subanalysis, angiography at baseline and post-procedure were analyzed to calculate the AMR by an imaging core lab. Coronary microvascular dysfunction (CMD) was defined as AMR≧2.5 mmHg*s/cm. Results In the total of 126 vessels, 63 were included in each of the SCB and PCB group. Angiography both at baseline and post-procedure were analyzable for AMR in 59 vessels in SCB and in 59 vessels in PCB group. In SCB group, the median AMR increased significantly after procedure (baseline; 2.03 [1.58-2.42], post-procedure;2.21 [1.78-2.53], p=0.03). However, the proportion of vessels with CMD did not significantly change (baseline; 22.0% [13/59], post-procedure; 32.2% [18/59], p=0.19) (Figure). In the PCB group, the median AMR increased significantly after procedure (baseline; 2.22 [1.66-2.53], post-procedure;2.45 [1.93-2.96], p=0.003). Furthermore, the proportion of vessels with CMD significantly increased (baseline; 27.1% [16/59], post-procedure; 47.5% [28/59], p=0.046) (Figure). The AMR measurement was not significantly different between SCB and PCB at baseline (p=0.53), but it was significantly higher in PCB than in SCB at post-procedure (p=0.04). Conclusion After DCB treatment, AMR significantly increased in both arms. The proportion of the vessel with CMD after procedure did not significantly change in the SCB group but increased in the PCB group. The potential mechanism of increase in AMR after DCB treatment (e.g. embolization of small crystals) may warrant further investigation.Proportion of AMR≥2.5

Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population.

Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice. To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions. We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure. The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

TCT-44 Angiographic and Clinical Impact of Balloon Inflation Time in Percutaneous Coronary Interventions With Sirolimus-Coated Balloon: A Subanalysis of the EASTBOURNE Study

TCT-44 Angiographic and Clinical Impact of Balloon Inflation Time in Percutaneous Coronary Interventions With Sirolimus-Coated Balloon: A Subanalysis of the EASTBOURNE Study

TCT-448 Real-World Application of Sirolimus-Coated Balloons in Acute Coronary Syndrome

TCT-448 Real-World Application of Sirolimus-Coated Balloons in Acute Coronary Syndrome

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Sirolimus-coated balloon versus drug-eluting stent for complex coronary lesions. A propensity matched comparison

IntroductionPercutaneous 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. MethodsNet 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. ResultsAmong 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. ConclusionsSCB 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.

300.03 - One-Year Results of the DEEPER LIMUS Trial: The Bare Temporary Spur Stent System in Combination With a Sirolimus-Coated Balloon

300.03 - One-Year Results of the DEEPER LIMUS Trial: The Bare Temporary Spur Stent System in Combination With a Sirolimus-Coated Balloon

Magic Touch sirolimus-coated balloon: animal and clinical evidence of a coronary sirolimus drug-coated balloon.

The Magic Touch sirolimus-coated balloon (SCB) was recently introduced in Europe and features robust clinical technology different from other devices on the market. This device is able to deliver a sufficient sirolimus dose to the target segment to reduce neointimal proliferation with very little exposure downstream and no apparent adverse effects at sustained high drug concentrations. The SCB represents a promising novelty within the drug-coated balloon arena due to its mid-term efficacy and safety in the treatment of coronary artery disease, especially in de novo and small-vessel coronary lesions. The purpose of this article is to provide an up-to-date overview of the currently available animal and clinical trial results, as well as to highlight ongoing trials on the Magic Touch SCB.

Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis.

Although use of sirolimus-based analogs has shown superiority over paclitaxel in drug-eluting stents, the relative efficacy of these two agents released from drug-coated balloons (DCB) is unclear. The present meta-analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel-coated balloons (PCB) versus sirolimus-coated balloons (SCB) for either in-stent restenosis or native de novo lesions. The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow-up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random-effects models. A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9-12 months of follow-up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75-1.35) between the two groups. On follow-up angiography at 6-9 months, MLD (WMD 0.10, 95% CI 0.02-0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD -0.11, 95% CI -0.23-0.02) and diameter stenosis (WMD -3.33, 95% CI -8.11-1.45). Among patients undergoing DCB-only PCI, the risk of TLF was similar during 9-12 months of follow-up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow-up angiography.

Safety and efficacy of single antiplatelet therapy in a large cohort of patients treated with sirolimus-coated balloon: Post hoc analysis from the prospective EASTBOURNE registry

BackgroundDrug coated balloons (DCB) are potentially less thrombogenic than drug eluting stents (DES). AimsTo explore the safety and the feasibility of single antiplatelet therapy in percutaneous coronary intervention with sirolimus-coated balloons. MethodsThe All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE) is a prospective investigator-driven registry assessing the performance of a novel sirolimus-coated balloon (SCB) in a real-world population. This prespecified post hoc analysis aimed at comparing the outcome in patients prescribed either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT); choice of antiplatelet agent and duration of the regimen were at operator's discretion in both groups. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were bleeding grade 3–5 according to The Bleeding Academic Research Consortium (BARC) criteria and major adverse cardiovascular events (MACE) at 12 months follow-up. ResultsAmong 2123 patients enrolled in the study between September 2016 and November 2020, 113 patients (5.8 %) received SAPT while 1826 patients (94.1 %) received DAPT after SCB. The majority of the patients underwent DCB PCI for de novo lesions (n = 1091, 56.3 %) while 848 patients (47.7 %) had DCB revascularization for in-stent restenosis. No cases of TLR occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. Moreover, no differences in terms of TLR were observed between SAPT vs DAPT regimens nor in case of de novo treatment with an overall rate of TLR at 12 months of 7.7 % for SAPT and 5.6 % for DAPT (p = 0.6). The cumulative rate of MACE at 12 months was not different between SAPT and DAPT regimens (n = 12 [11.2 %] vs. n = 162 [8.9 %], p = 0.4), and results were consistent in the de novo and in-stent restenosis groups. ConclusionsOur post hoc analysis of the EASTBOURNE registry suggests that the use of single antiplatelet agent after sirolimus-DCB PCI for both de novo or in-stent restenosis lesions is safe and effective and can help to contain the risk of bleeding in a selected population. Condensed abstractThe manuscript aims to explore the feasibility of a single antiplatelet regimen following angioplasty using drug coated balloon with sirolimus. Among 2123 patients treated with sirolimus coated balloon (SCB), 113 patients (5.8 %) received a single antiplatelet therapy (SAPT) while 1826 patients (94.1 %) received dual antiplatelet therapy DAPT. No cases of target lesion revascularization occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. The cumulative rate of major adverse cardiovascular events at 12 months was not different between SAPT and DAPT regimens and results were consistent in the de novo and in-stent restenosis groups.

Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study

IntroductionPercutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30–60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB). MethodsWe conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (>30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2–5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow <3) were also addressed. ResultsA total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, p = 1.00] as well MACE (p = 0.683), death (p = 0.102), non-fatal MI (p = 0.822), and BARC 2–5 bleedings (p = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow <3 was higher in the short SCB inflation time, as compared to the standard strategy. ConclusionsShort vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.

Two-year outcomes of sirolimus-coated balloon angioplasty for coronary artery disease: the EASTBOURNE Registry.

Two-year outcomes of sirolimus-coated balloon angioplasty for coronary artery disease: the EASTBOURNE Registry.

The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore – 12 Months Results of the PRISTINE Registry

PurposeThe aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore.MethodsPRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis < 30%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest.ResultsSeventy five patients were included. There were 50 (68.0%) males; mean age, 69.0 ± 10.7 years. CLTI severity was based on the Rutherford Scale (R5 = 51; R6 = 17). Significant co-morbidities included diabetes mellitus (n = 68; 91.0%) and end-stage renal failure (n = 28; 37.0%). 112 atherosclerotic lesions were treated (TASC II D = 58 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4 ± 13.9 cm. Primary vessel patencies at 6 and 12 months were 64/86 (74%) and 43/74 (58%) and freedom from clinically driven TLR were 72/86 (84%) and 55/74 (74%) respectively. AFS was 61/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1 ± 0.55 at baseline to 1.1 ± 2.05 (p < 0.05) at one year and there was a wound healing rate of 38/48 (79%) at the same timepoint.ConclusionsThe Selution SLR™ drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS.Level of EvidenceLevel 2b, Individual Cohort Study.Graphical

A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial

BackgroundSirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising. ObjectivesThe authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population. MethodsThis multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data. ResultsThe mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13). ConclusionsThe SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.

MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial

ObjectivesSirolimus coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There is currently no long term clinical data for this novel treatment for PAD. We present the 3 year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below the knee arteries (BTK). MethodsXTOSI pilot study is a prospective, single-arm, open-label, single centre trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation free survival (AFS), overall survival and ulcer free status. ResultsAt 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3% and ulcer free status in remaining survivors with intact limbs was 100%.For femoropoliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70% and overall survival was 70%. For BTK lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6% and overall survival was 58.6%. ConclusionsSCB in the XTOSI pilot study showed promising clinical results sustained to 3 years and no long term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.

Balón liberador de sirolimus en el tratamiento del síndrome coronario agudo y crónico: el estudio PEACE, un subanálisis del registro EASTBOURNE

Introduction and objectivesThe PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS). MethodsThis was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events. ResultsBaseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure. ConclusionsThis SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.