Drug-coated Balloon Research Articles

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.

Ostial LCx: Achilles Heel of Left Main Bifurcation Angioplasty and How We Evolved in Its Management

In-stent restenosis (ISR) within bifurcation lesions of the left main (LM) coronary artery (LMCA) is challenging due to its complex anatomy and critical function. This case series highlights 3 patients with LM bifurcation ISR (Medina 1,1,1) post-index intervention using different stent strategies as follows: Case 1: A 58-year-old male developed distal LM bifurcation stenosis after ostial left anterior descending artery (LAD) stenting. Mini-culotte bifurcation angioplasty effectively managed this. Case 2: A 62-year-old male presented with neo-atherosclerosis-induced distal LM bifurcation ISR post-provisional LM-left anterior descending artery (LAD) stenting. A single-stent crossover with a drug-coated balloon in a large side branch achieved optimal flow restoration. Case 3: A chronic total occlusion in the right coronary artery and distal LM bifurcation ISR due to stent overhang into LMCA in a 72-year-old male was resolved with a string culotte technique. These cases underscore ISR management strategies tailored to patient-specific anatomy and clinical needs, advocating advanced imaging techniques like intravascular ultrasound and optical coherence tomography for procedural precision and safety.

Provisional stenting : drug-coated versus uncoated balloon for side branch in coronary bifurcation lesions: randomized study

Abstract Introduction The rePOT technique is a novel and easily applied approach for coronary bifurcations. Drug-Coated Balloon (DCB) angioplasty is increasingly being utilized in management of small vessels and coronary bifurcation lesions. Herein, we propose a new approach for treating coronary bifurcation lesions with the application of DCB to treat the side-branch in addition to the rePOT technique: the POT-sideDCB-POT technique. Materiel and Method: We described for the first time the POT-sideDCB-POT method for true bifurcation lesions (including the side-branch ostium), which is in line with the recommended management algorithm of the European Bifurcation Club8 consisting of a sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and respects the geometry of all the three bifurcation segments. Results Overall, 100 patients with CBLs treated with provisional stenting using DES were included from our studie,50 with DCB side branche and 50 with UCB With a follow-up duration of 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): −10.35%, 95% confidence interval (CI): −13.17 to−8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: −0.18 mm, 95% CI:−0.28 to−0.10, p < 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.45, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p < 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results. Conclusions For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.

Safety and feasibility of drug eluting and perfusion therapy for left main disease: JDEPTH-LM pilot study

Abstract Background Reducing cardiovascular events arising from ostial lesions of the left circumflex artery (LCx) remains an issue following percutaneous coronary intervention (PCI) for left main disease (LMD). Despite expert consensus recommendation for the drug coated balloon (DCB) use to address it, there are concerns in using DCB following the standard practice of crossover-stenting from the left main trunk (LMT) to left anterior descending artery (LAD). Specifically, utilizing a DCB in isolation for the ostial LCx after stenting may result in additional carina shift. The combination of a conventional balloon for LMT-LAD and a DCB for LMT-LCx in KBT could potentially cause hemodynamical instability due to prolonged occlusion time for the entire left coronary artery system. Accordingly, we hypothesized the combined usage of DCB and perfusion balloon (PB) could provide a safe and effective approach for drug-eluting therapy in ostial LCx lesion. This approach aims to facilitate prolonged inflation while maintaining coronary blood flow during KBT for LMD. Purpose The aim of this study was to assess the safety and feasibility of prolonged KBT with DCB and PB for LMD. Methods In this single-center prospective observational study, we enrolled patients of de-novo LMD with ostial LCx lesion, requiring crossover stenting for the LMT-LAD followed by conventional KBT (C-KBT). IVUS-guided procedure was mandated as per the study protocol. Following confirming the achievement of optimal left main PCI by IVUS, a double-effect KBT (W-KBT) was employed. This technique involved the use of a PB for the LMT-LAD and a DCB for the LMT-LCx, sized in a 1:1 ratio to the balloons used in C-KBT. Patients in cardiogenic shock, those requiring a two-stent technique for LMD, and individuals without achievement of TIMI3 flow in the LCx after C-KBT were excluded. The primary endpoint was procedural success, defined as device delivery and balloon inflation time ≥30 sec. Secondary endpoints included the total balloon inflation time (W-KBT time), the incidence of ST-change cases, time to ST-change (ST-change time), changes in blood pressure and heart rate (delta BP and delta HR, respectively), and the frequency of inotrope usage following W-KBT. Results Between January 2023 and December 2023, 12 patients were included among 73 patients with LMD who underwent PCI during this study period. Mean age was 73.8±7.2 years (91.7% men) and median SYNTAX score was 29 (IQR: 26.3 to 34.5). The incidence of ACS was 8.3%. Procedural success was achieved in 100% of cases. The results of secondary endpoints were as follows: median W-KBT time: 60 sec (IQR: 60 to 60); the incidence of ST-change: 50% (no cases with ST-elevation); mean ST-change time: 41.2±7.1 sec; mean delta BP: -13.7±11.4 mmHg; mean delta HR: -3.4±5.9 bpm; and the use of inotrope: 0%. Conclusion Within the limited sample size of this pilot study, the safety and feasibility of the "first-in-man" technique of W-KBT were confirmed.Procedure of W-KBTStrength of W-KBT

Safety and efficacy of low-dose versus high-dose paclitaxel-coated balloons in patients with femoropopliteal lesions: an updated and meta-analysis

Abstract Introduction Drug-coated balloons (DCBs) have reduced restenosis and reintervention of femoropopliteal lesions compared to uncoated percutaneous transluminal angioplasty (PTA). However, limited data are available on different dosages of the DCBs. Purpose We aimed to give a comprehensive analysis in this regard and update the current evidence. Methods We searched Scopus, Cochrane, PubMed, and WOS from inception till February 2024 to include all randomized controlled trials (RCTs) that addressed different dosages of DCBs in femoropopliteal lesions. The primary endpoint was all-cause death, primary patency, and amputation at six months, while the secondary outcomes were all-cause death, primary patency, and amputation at 12 months. Dichotomous data were pooled using Odds Ratio (OR) and 95% Confidence Interval (CI) in a random-effect model. Results A total of 21 studies, including 4081 patients in the analysis. Low-dose DCB was associated with high rates of primary patency compared to the standard dose at both 6 and 12 months of follow-up with the following values (OR: 2.46, 95% CI: 1.48 to 4.08, and 1.93, 95% CI: 1.5 to 2.49, receptively). Also, low-dose DCB reduced the incidence of clinically driven target lesion revascularization (CD-TLR) compared to the standard dose at 12 months (OR: 0.45, 95% CI: 0.31 to 0.65). Regarding high-dose DCB, higher primary patency rates were observed when compared to standard doses at 6 and 12 months (OR: 1.89, 95% CI: 1.19 to 2.99, and 5.47, 95% CI: 4.31 to 6.95, respectively). Moreover, high-dose DCB reduced the incidence of CD-TLR at 6 and 12 months of follow-up (OR: 0.33, 95% CI: 0.18 to 0.63, and 0.63, 95% CI: 0.48 to 0.84, respectively). Conclusion Low-dose DCBs were associated with higher primary patency without significant differences in all-cause mortality or amputation. On the other hand, high-dose DCBs were associated with a higher incidence of amputation without significant differences in other studied outcomes.Low dose Paclitaxel coated balloon vs CoHigh dose Paclitaxel coated balloon vs C

Drug-coated balloons in high-risk patients and diabetes mellitus: A meta-analysis of 10 studies.

Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher-risk subsets of patients, as in diabetes mellitus (DM). Drug-coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM. The present meta-analysis aimed at assessing the role of DCBs in patients with diabetes mellitus. Studies comparing DCB versus percutaneous coronary revascularization (PCI) with/without DES for PCI in high-risk populations (>30% DM) were included. The primary efficacy endpoint was overall mortality, secondary endpoints were myocardial infarction, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE). We included 10 studies, comprising 2026 patients. Among them, 1002 patients (49.5%) were treated with DCB and 1024 with DES implantation. Among the included studies, 6 only enrolled diabetic patients and 2 had a prevalence of diabetes of 50%. At a mean follow-up of 15.3 months, mortality rate was 3.8% (82 patients), significantly lower with DCB (3.2% vs. 4.9% with DES; odds ratio [OR] [95% confidence interval {CI}] = 0.61 [0.38, 0.97], p = 0.04 phet = 0.34. A similar reduction in favor of DCB was observed for MACE (13.6% vs. 17.6%; OR [95% CI] = 0.79 [0.61, 1.04], p = 0.09, phet = 0.25), while TLR was significantly reduced only in the diabetic-restricted sub-analysis. In the present meta-analysis, we showed a significant survival benefit and an absolute reduction in MACE and TLR with a DCB-based strategy as compared to DES in high-risk patients, mostly with DM. Future large-scale randomized trials, dedicated to this population, are deserved to confirm our findings. Complex coronary anatomies and diabetes mellitus (DM) represent the pitfall of drug eluting stents (DES), mainly due to inflammatory and thrombotic complications, which should be reduced with drug-coated balloons (DCB). We confirmed a significant advantage of DCB versus DES in the treatment of de novo lesions in high-risk patients and mainly in DM, reducing overall mortality, MACE and target lesion revascularization.

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

Biolimus A9 DEB for the Treatment of In-Stent Restenosis. 1-year outcomes of the REFORM trial

Abstract Background In recent years, drug-coated balloons (DCB) have established themselves as another tool in the arsenal of interventional cardiology devices for the treatment of in-stent restenosis (ISR) lesion. Aims The study was designed to compare the biolimus DCB to the paclitaxel-coated SeQuent PleaseTM DCB. Method This was a prospective, non-inferiority, randomized, multicenter, study conducted at 20 centers in 6 countries. The primary endpoint was in-segment % diameter stenosis (%DS) at six months. The study was powered to enrol 201 patients in at 2:1 randomization to either the biolimus DCB (BCB) or the SeQuent PleaseTM DCB (SQP). Key secondary endpoints included, late-lumen loss, binary restenosis, and target lesion failure (TLF) and myocardial infarction at 1 year. Results A total of 202 patients were randomised with 135 in the BCB group and 67 in the SQP group. Mean patient age was 68.9 ± 9.9 years in the BCB group compared to 68.2 ± 10.5 years in the SQP group. At 6 months, %DS was 41.8 ± 21.3 in the BCB group compared to 31.4 ± 17.7 in the SQP group (95% confidence for the difference: 3.5-16.9, p-value for non-inferiority 0.32). At 12 months, TLF was 23.74%, in the BCB group vs 17.07% in the control group, hazard ratio (HR) of 1.44 [95% CI: 0.72-2.88], p=0.28. There were more clinically driven revascularization in the BCB group (21.61%) compared to SQP (15.61%) [HR: 1.46, 95% CI: 0.71-3.01], p=0.29. More myocardial infarction were observed in the SQP group (BCB: 7.59% vs SQP: 3.77%, [HR: 0.48, 95% CI: 0.14-1.68], p=0.24)(see Figure). Conclusions In ISR patients, the REFORM study was not able to demonstrate non-inferioirity of the biolimus DCB compared to the SeQuent Please DCB.

Drug-coated balloon versus drug-eluting stent revascularization in the treatment of de novo acute myocardial infarction

Abstract Objective To assess the efficacy and safety of a drug-coated balloon (DCB) revascularization on percutaneous coronary intervention (PCI) in patients with de novo acute myocardial infarction (AMI). Background Data on DCB-only treatment in the context of AMI are limited. Methods A total of 96 patients with de novo AMI successfully treated with DCB alone were retrospectively enrolled. Visual residual stenosis ≤ 30% without flow-limiting dissection was considered a satisfactory pre-balloon angioplasty and followed by DCB treatment. We compared it with 96 propensity-matched patients treated with second-generation drug-eluting stent (DES) from the PTRG-DES registry (n = 13,160 patients). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding (Bleeding Academic Research Consortium bleeding type 3 or greater) at 1 year. Results Baseline clinical characteristics were comparable between the groups. The mean device diameter was larger in DES group (2.7 ± 0.3 mm vs. 3.1 ± 0.4 mm, P < 0.001). No abrupt vessel closure requiring treatment occurred after treatment with DCB. The MACE was comparable in both groups (6.2% in DCB group vs. 7.3% in DES group, P = 0.790) at 1-year follow-up. Conclusions In de novo AMI patients, DCB-only treatment approach had comparable clinical outcomes at 1-year follow-up. DCB-only treatment may be a safe and effective alternative to DES in carefully selected patients who had satisfactory pre-dilation results.

Drug-coated balloon versus drug-eluting stent for de novo culprit lesion in acute coronary syndromes: a report from nationwide registry in japan

Abstract Background Randomized trials have demonstrated the non-inferiority of DCB strategy compared to DES strategy for ACS [1-3]. However, generalizability in clinical settings remains unclear. Purpose This study aims to compare the outcomes between drug-coated balloon (DCB) and drug-eluting stent (DES) strategies in percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) within a nationwide procedure-based registry. Methods This is a retrospective analysis of a cohort study from a prospective, nationwide registry from January 2017 to December 2020 in Japan, focusing on ACS patients who underwent DCB or DES strategy for a single de novo lesion. One-year incidence of all-cause death, cardiovascular death, non-cardiovascular death, non-fatal ACS, stroke, and major bleeding events were compared. Subgroup analysis included lesion-based and ST-elevation myocardial infarction/non-ST-elevation ACS stratification. Results Among 5,212 propensity-matched ACS patients, DCB and DES strategies showed no significant differences in one-year incidence of all-cause death (4.5% vs. 4.6%, hazard ratio [HR]: 0.92, 95% confidence interval [CI]: 0.72-1.19), cardiovascular death (2.5% vs. 2.5%, HR: 0.90, 95% CI: 0.64-1.26), non-cardiovascular death (2.0% vs. 2.1%, HR: 0.96, 95% CI: 0.65-1.42), and non-fatal ACS (1.7% vs. 2.0%, HR: 1.04, 95% CI: 0.70-1.54). DCB showed higher stroke occurrence (0.8% vs. 0.3%, HR: 2.33, 95% CI: 1.06-5.08) but lower major bleeding events (1.4% vs. 2.3%, HR: 0.65, 95% CI: 0.43-0.99) (Figure 1). Subgroup analyses did not reproduce these findings (Figure 2). Conclusions ACS patients using the DCB strategy demonstrated clinical outcomes equivalent to those undergoing the DES strategy at one year. Further investigation with an extended follow-up is necessary to confirm these findings.

Percutaneous coronary intervention of in-stent restenosis: A three-arm analysis from SWEDEHEART

Abstract Background During the last decades, there have been substantial improvements in treatment techniques for percutaneous coronary intervention (PCI). Yet, in-stent restenosis (ISR) continues to pose significant challenges as they account for 10% of all PCI cases and are associated with worse outcome compared to de-novo lesions. When assessing ISR with PCI, balloon angioplasty with drug-coated balloons (DCB) is frequently used. Purpose Despite frequent use of DCB, there is a lack of long-term data ensuring the safety of DCB for ISR as no randomized trial has extended beyond a 3-year follow-up. We aimed to study the long-term outcome and conducted a nationwide three-arm investigation on the outcome of ISR, comparing DCB with drug-eluting stents (DES) or plain old balloon angioplasty (POBA) within a 5-year follow-up. Methods We conducted a nationwide analysis using the SWEDEHEART (Swedish Web System for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry. The SWEDEHEART registry was used to include any ISR undergoing coronary angiography between June 11, 2013, and December 31, 2020. Target lesion revascularization (TLR) was the primary outcome. Secondary outcomes included all-cause mortality, myocardial infarction, and any PCI. The outcomes were analysed using a multivariable Cox regression model. Results A total of 9304 segments from 7987 patients were eligible. Compared to POBA, the use of DCB was associated with lower rates of TLR, hazard ratio (HR) 0.62 (95% confidence interval [CI]: 0.50-0.78), all-cause mortality, HR 0.60 (95% CI: 0.50-0.72), and any PCI, HR 0.78 (95% CI: 0.66-0.93). No difference was observed for myocardial infarction. Compared to DES, the use of DCB was associated with higher rates of TLR, HR 1.24 (95% CI: 1.08-1.42). No difference was observed for all-cause mortality, cardiovascular mortality, myocardial infarction, or any PCI. Conclusions In this nationwide analysis including any ISR undergoing PCI, the use of DCB showed superior outcomes compared to POBA within 5 years but higher rates of repeat revascularizations compared to DES. While DES demonstrated lower TLR rates than DCB, the lack of mortality differences indicates that DCB is a viable option, particularly for patients where DES might not be suitable, but that DES should be considered as the first line strategy.Table 1.5-year outcomeFigure 1.Kaplan-Meier curves

Long-term outcomes following DCB vs. DES for ISR treatment

Abstract Background The-long term outcomes of patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. Purpose This study aims to investigate the outcomes of patients with drug-eluting stents (DES)-ISR presenting with CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. Methods Consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin-DES or paclitaxel-DCB for DES-ISR were enrolled. Primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint [DOCE: cardiac death, TLR or target vessel myocardial infarction (TV-MI)]. Propensity-score matching was used to adjust for baseline differences. Results A total of 846 patients were included in the pooled analysis, of whom 381 (45%) were treated with a thin-DES and 465 (55%) with paclitaxel-DCB. Patients who received thin-DES compared with those who received paclitaxel-DCB had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74], P<0.001) TVR (HR, 0.56 [95% CI, 0.39-0.86], P<0.001) and DOCE (HR, 0.63 [95% CI, 0.45-0.88], P=0.007).The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33–0.88], P=0.013), TVR (HR, 0.57 [95% CI, 0.41–0.80], P=0.009), and DOCE (HR, 0.65 [95% CI, 0.42–0.99], P=0.046) between the thin-DES and DCB group, respectively. Conclusions In long term observation in patients with CCS undergoing PCI of ISR, the use of thin-DES is associated with reduced rates of TLR, TVR and DOCE compared with patients treated with DCB.

Impact of the lower extremity arterial calcification score on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease

Abstract Background Severe calcification, assessed using the peripheral artery calcification scoring system (PACCS), is associated with poor clinical outcomes after endovascular treatment (EVT) for de novo femoropopliteal lesions. However, the PACCS classification is a qualitative assessment performed in the angiographic room, and there are no established indicators for the quantitative assessment of calcification prior to treatment. Purpose We aimed to investigate the impact of the lower extremity arterial calcification score (LEACS) calculated using non-contrast lower limb computed tomography on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Methods We retrospectively analyzed the clinical outcomes of 141 consecutive patients treated at our center for de novo femoropopliteal artery disease using a drug-coated balloon between April 2018 and December 2022. Patients who did not undergo lower limb computed tomography before EVT were excluded from the analyses. LEACS was determined based on the method used to calculate the Agatston score for the coronary arteries. Each patient’s score consisted of a sum of calcification scores from ostium of superficial artery to the popliteal artery at the knee joint of treated limb. The primary and secondary outcomes measured were primary patency and clinically-driven target vessel revascularization (CD-TVR) at 1 year. Cox proportional hazards analysis was used to explore independent predictors of clinical outcomes. The study population was divided into higher and lower LEACS groups based on the cut-off value (1750), which best discriminated patency, and the outcomes were compared between the two groups. Results In the higher and lower LEACS groups, the mean age was 75.1 ± 9.1 years and 75.5 ± 11.0 years (p = 0.87) and the mean lesion length was 170.3±102.8 mm and 157.7±112.1 mm (p = 0.64), respectively. The higher LEACS group showed significantly lower 1-year patency than the lower LEACS group (53.5% vs. 84.3%, log-rank, p = 0.041). In addition, freedom from 1-year CD-TVR was significantly lower in the higher LEACS group than in the lower LEACS group (66.8% vs. 93.7%, p = 0.047). The Cox proportional hazard analysis showed that the higher LEACS group was an independent predictor of 1-year restenosis (odds ratio: 2.80, 95% confidence interval: 1.24–8.84, p=0.037), along with a small (< 5 mm) reference vessel diameter (odds ratio: 3.55, 95% confidence interval: 1.44–9.53, p=0.028). Conclusion Higher LEACS scores were independently associated with clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Non-contrast lower limb computed tomography is an acceptable and feasible option for predicting the outcomes in patients with de novo femoropopliteal artery disease prior to treatment.

Novel balloon catheter containing therapeutic mRNA with smart RNA switch alleviate restenosis after vascular injury

Abstract Background Cardiovascular diseases are the leading cause of death worldwide, and vascular intervention is an effective method for ischemic heart diseases. However, vascular restenosis significantly affects the long-term therapeutic outcomes, which mainly caused by excessive proliferation of vascular smooth muscle cells (VSMCs). While drug-eluting stents and drug-coated balloons have successfully decreased the incidence of restenosis by inhibiting the VSMCs proliferation, they concurrently suppress the repair of endothelial cells (ECs) and re-endothelialization, thereby increasing the risk of late thrombotic events and mortality. Consequently, it is urged to develop novel high-selectively therapeutic devices to overcome vascular restenosis. In current mRNA therapies of cardiovascular diseases, there are few effective systems for cell-specific expression. Therefore, we propose to utilize RNA editing (based on ADAR1 RNA editing) to investigate a smart RNA molecular switch capable of cell-specific recognition and selectively releasing payload in targeted cells or tissues for cell precision therapy. However, the application of gene editing in the cardiovascular system faces challenge of low delivery efficiency. We innovatively take the balloon as a specific and efficient tool to delivery therapeutic mRNA, which may be a potential therapy for vascular restenosis. Objective We investigated therapeutic mRNA containing a smart RNA switch to selectively suppress the VSMCs proliferation while promoting re-endothelialization and delivered by balloon as a novel therapy in vascular restenosis animal models. Results For RNA switch high-throughput screening, we utilized PiggyBac transposon system to establish monoclonal overexpressing cell lines and chose the cell strain with expression levels closely mimicking VSMCs and ECs. We found the most effective RNA switch from dozens of potential candidates which could specifically recognize VSMCs but not ECs. Therapeutic mRNA sequences containing the RNA switch efficiently initiated payload translation in VSMCs while maintaining payload silence in primary vascular endothelial cells, which effectively and selectively inhibited VSMCs excessive proliferation and promoted endothelial repair. Additionally, we developed an interventional balloon delivery system for mRNA drugs, achieving in situ delivery to cardiovascular lesions in vivo, demonstrating therapeutic effects consistent with cellular phenotypes in animal models. Conclusion We suggest that the smart RNA switch can serve as a novel, cell-specific therapeutic tool for restenosis and other cardiovascular diseases. Additionally, utilizing a balloon for mRNA delivery represents a new paradigm for mRNA therapy and gene editing in the cardiovascular field.

Drug-coated balloon for de-novo coronary artery lesions exceeding 2.5 mm in diameter: optical coherence tomography analysis and clinical follow-up

Abstract Objective To investigate the precise changes in the lumen and lesions, and clinical outcomes after DCB treatment for de-novo coronary lesions exceeding 2.5 mm in diameter through a detailed analysis of OCT. Methods This is a prospective study including 53 consecutive patients with 55 de-novo coronary lesions, who underwent DCB angioplasty-only between January 2021 and April 2022. Quantitative coronary angiography (QCA) and OCT were performed before percutaneous coronary interventions (PCI), immediately after PCI, and at 6-9 months follow-up after PCI. Target lesion failure (TLF) was the primary endpoint of the present study. Multivariate logistic regression analysis was performed to identify the predictors or risks for late lumen enlargement (LLE). Results A total of 52 patients were successfully treated with DCB. The median follow-up was 7 months, and the incidence of TLF was 7.5%. After the DCB procedure, 43 patients had their scheduled angiographic and OCT examination. QCA demonstrated that the late lumen loss was -0.79 ± 0.28 mm. OCT demonstrated LLE in 79.1% and dissection healing in 65.1% of lesions. After multivariable logistic analysis, type B dissection (odds ratio [OR] 2.92, 95% confidence interval [CI] 1.34-7.41, p = 0.037) was found to be a predictor of LLE, but lipid plaque (OR 0.09, 95% CI 0.01-0.63, p = 0.015) was a risk of LLE. Conclusions This is the first and largest prospective study to assess the outcomes of DCB treatment for de-novo coronary lesions exceeding 2.5 mm in diameter and the detection of significant vessel enlargement and dissection healing guide by OCT. DCB could be a novel, safe and effective treatment for de-novo coronary lesions exceeding 2.5 mm in diameter through a detailed analysis of OCT.Representative coronary angiography (CAGRepresentative optical coherence tomogra

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Midterm results of endovascular treatment of ateriovenous fistula stenosis at Dong Nai General Hospital

Introduction: AVF stenosis is a common complication, leading to impaired dialysis function, increased risk of occlusion and increased mortality. Endovascular intervention treatment of AVF stenosis is an important technique in the management of dialysis patients, particularly at local hospitals. Methods: This is a retrospective study performed at Dong Nai general hospital from 2022-2024. Results: The success rate of endovascular intervention to treat AVF stenosis at Dong Nai General Hospital is 91%, 3-month primary patency was 93.1% and 6-month primary patency was 86.2%. Drug-coated balloons (DCB) shows superior effectiveness compared to conventional balloons (PBA) with a lower restenosis rate. Conclusion: Endovascular intervention to treat AVF stenosis at Dong Nai General Hospital has good short term and midterm results. Drug-eluting balloons have a statistically significantly lower mid-term restenosis rate than conventional balloons. Implementing this technique at provincial hospitals helps reduce the burden on central hospitals and reduce medical costs for chronic kidney failure patients requiring hemodialysis.

Development of a Porcine Model of Arteriovenous Fistula Venous Stenosis Treated with Percutaneous Transluminal Angioplasty

To develop a porcine model for arteriovenous fistula (AVF) venous stenosis treated with percutaneous transluminal angioplasty (PTA) and compare outcomes of plain balloon angioplasty (POBA) to IN.PACT paclitaxel drug-coated balloons (DCB). Twelve castrated male Yorkshire pigs (4-5 months, 35-45kg) underwent renal artery embolization to induce chronic kidney disease (CKD). Twenty-eight days later, AVF was created by anastomosing the left external jugular vein to left common carotid artery. The pigs were divided into a pilot group (n=6) for optimizing the AVF technique (euthanized at day 4) and a definitive group (n=6) for validating PTA outcomes (euthanized at day 42). Stenosis developed at juxta-anastomosis 28 days later and was treated with POBA [pilot group (n=6), definitive group (n=3)] or DCB [definitive group only (n=3)]. Definitive group underwent biweekly 4D Flow MRI scans. All animals developed CKD, with significant increases in BUN (median increase: 2.6 to 3.2 mmol/L, P<0.001) and creatinine (median increase: 100 to 187 μmol/L, P<0.001). In the pilot group, one animal had an infected fistula, and AVF patency was 1/5. In the definitive group, the patency was 5/6 because the AVF technique was modified by resecting the sternomastoid muscle and increasing the spatulation. At day 42 post PTA, DCB treated AVF outflow vein showed increasing blood flow compared to POBA (DCB 209.8 ± 64.42 mm2 vs POBA 170.9 ± 95.52 mm2 p = 0.934). A porcine model of AVF venous stenosis treated with PTA was developed, with blood flow trends favoring DCB over POBA.

Contemporary Use of Drug-Coated Balloons for Coronary Angioplasty: A Comprehensive Review.

The interventional treatment of coronary artery disease (CAD) has undergone significant improvements thanks to technological innovations. Nowadays, percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is the standard of care for the treatment of CAD. Nevertheless, the non-negligible incidence of in-stent restenosis (ISR) and suboptimal results in various anatomical settings has led to the development of drug-coated balloons (DCBs). DCBs are catheter-based balloons whose surface is coated with an anti-proliferative drug (mainly Paclitaxel or Sirolimus) loaded onto the balloon surface with different technologies and dose concentrations. In the beginning, these devices were used for the treatment of ISR showing an excellent efficacy profile in the inhibition of intimal hyperplasia. Subsequently, several studies evaluated their use in other angiographical and clinical contexts such as de novo lesions, small vessel disease, diffuse coronary disease, bifurcation lesions, acute coronary syndromes, high-bleeding risk and diabetic patients. This comprehensive review aims to describe the main DCB platforms on the market, their fields of application with the main supporting studies and their future perspectives.

Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.

Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions. This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed. A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039). Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects. Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects.