Drug-coated Balloon Angioplasty Research Articles

Drug-Coated Balloon and Percutaneous Old Balloon Angioplasty for Hemodialysis Arteriovenous Graft Outlet Stenosis: A Single-Center Randomized Controlled Study

Drug-Coated Balloon and Percutaneous Old Balloon Angioplasty for Hemodialysis Arteriovenous Graft Outlet Stenosis: A Single-Center Randomized Controlled Study

Clinical Value of the Quantitative Flow Ratio to Predict Long-term Target Vessel Failure in Patients with In-stent Restenosis after Drug-coated Balloon Angioplasty.

The study sought to investigate the clinical predictive value of quantitative flow ratio (QFR) for the long-term target vessel failure (TVF) outcome in patients with in-stent restenosis (ISR) by using drug-coated balloon (DCB) treatment after a long-term follow-up. This was a retrospective study. A total of 186 patients who underwent DCB angioplasty for ISR in two hospitals from March 2014 to September 2019 were enrolled. The QFR of the entire target vessel was measured offline. The primary endpoint was TVF, including target vessel-cardiac death (TV-CD), target vessel-myocardial infarction (TV-MI), and clinically driven-target vessel revascularization (CD-TVR). The follow-up time was 3.09±1.53 years, and 50 patients had TVF. The QFR immediately after percutaneous coronary intervention (PCI) was significantly lower in the TVF group than in the no-TVF group. Multivariable Cox regression analysis indicated that the QFR immediately after PCI was an excellent predictor for TVF after the long-term follow-up [hazard ratio (HR): 5.15×10-5 (6.13×10-8-0.043); P<0.01]. Receiver-operating characteristic (ROC) curve analysis demonstrated that the optimal cut-off value of the QFR immediately after PCI for predicting the long-term TVF was 0.925 (area under the curve: 0.886, 95% confidence interval: 0.834-0.938; sensitivity: 83.40%, specificity: 88.00; P<0.01). In addition, QFR≤0.925 post-PCI was strongly correlated with the TVF, including TV-MI and CD-TVR (P<0.01). The QFR immediately after PCI showed a high predictive value of TVF after a long-term follow-up in ISR patients who underwent DCB angioplasty. A lower QFR immediately after PCI was associated with a worse TVF outcome.

Angiography-based Fractional Flow Reserve for the Prediction of Clinical Outcomes After Drug-coated Balloon or Plain Old Balloon Angioplasty.

AccuFFRangio is a novel method for fast computation of fractional flow reserve (FFR) based on coronary angiography and computational fluid dynamics. The association between the AccuFFRangio and clinical outcomes after drug-coated balloon (DCB) or plain old balloon angioplasty (POBA) remains to be investigated. This study included consecutive patients who underwent balloon angioplasty from December 2016 to October 2020. AccuFFRangio was calculated retrospectively based on the post-procedural angiography obtained immediately after angioplasty. The primary endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause death, vessel-related myocardial infarction, and repeat target vessel revascularization. A total of 169 patients were retrospectively analyzed in this study. Post-procedural AccuFFRangio (hazard ratio [HR] per 0.1 increase 0.33, 95% confidence interval [CI] 0.22-0.48, p < 0.001) was an independent predictor for MACE at 2-year follow-up. Post-procedural AccuFFRangio ≤ 0.87 was determined as the optimal cutoff value to predict MACE with an area under the curve (AUC) of 0.872 (95% CI 0.813-0.919, p < 0.001). AccuFFRangio measured immediately after balloon angioplasty is a promising predictor of unfavorable clinical outcomes.

Intravascular lithotripsy-assisted percutaneous deep vein arterialization for no-option chronic limb-threatening patients and heavily calcified tibial occlusive disease.

To report the first chronic limb-threatening ischemia (CLTI) patients who underwent an intravascular lithotripsy (IVL)-assisted percutaneous deep vein arterialization (pDVA). An 81-year-old patient presented with CLTI and a heavily calcified lesion of the popliteal artery and tibioperoneal trunk (TPT), with a distal tibial and foot arch occlusion. The patient underwent IVL and drug-coated balloon angioplasty for the distal popliteal artery and of the TPT to improve the inflow prior to pDVA. The wound situation remained stable without secondary procedure until the patient`s deaths due to complications of urosepsis 3months later. A 64-year-old patient with rest pain of the left limb with a single-vessel tibial run-off (peroneal artery) and occluded pedal arch was treated with 3.5mm IVL followed by a successful pDVA as mentioned above. IVL performed in the proximal posterior tibial artery to optimize the inflow to the circuit and change the compliance of the crossing point from the arterial to the vein system. The patient underwent repeat angioplasty of the plantar vein arch 5months after the index procedure and thereafter remained asymptomatic during 2years of follow-up. The combined use of IVL and pDVA could improve the patency of the reconstruction with clinical benefits in no-option CTLI patients.

The phenomenon of drug-coating embolism during lower extremity endovascular interventions with paclitaxel-coated balloon.

There is a risk of distal embolization lower extremity endovascular interventions. Possibly a drug-coating embolism caused by coating detachment from intravascular devices. This review focuses on providing updated information on distal embolism in endovascular revascularization of lower extremity arteries, including the use of drug-coated balloons. Drug-coating embolism is a special case of distal embolization during recanalization of the arteries of the lower extremities. Preclinical studies have demonstrated embolization of drug-coated balloons during angioplasty of lower extremity arteries. However, the clinical role of drug-coating embolism is not completely clear. A 2020 meta-analysis found an increased risk of major lower extremity amputation after drug-coated balloon angioplasty in patients with critical limb ischemia. But long-term research is emerging to support the safety of using these devices. Perhaps a more thorough assessment of the quality of life and the degree of compensation of lower limb ischemia with an intraoperative assessment of the frequency of peripheral embolizations using ultrasound emboli detection, as well as microcirculation with transcutaneous oximetry and laser Doppler flowmetry of the operated lower limb will allow a more detailed study of the phenomenon of drug-coating embolism and its impact on long-term clinical outcomes. According to the results of preclinical studies, the use of paclitaxel-coated balloons leads to an increase in the concentration of paclitaxel in distal skeletal muscles. However, paclitaxel concentration in skeletal muscle was significantly higher in first-generation DCBs. The non-target effects of drug-coating balloon are not fully understood and require further study. Understanding the phenomenon of drug-coating embolism can help physicians to better assess the patient risk and to minimize complications.

Effect of Drug-Coated Balloon Versus Stent Angioplasty in Patients With Symptomatic Intracranial Atherosclerotic Stenosis.

Drug-coated balloons (DCBs) have exhibited promising results in coronary and peripheral artery diseases, but conclusive evidence is lacking in intracranial vasculature. We assessed the safety and efficacy of DCBs vs stent angioplasty for symptomatic intracranial atherosclerotic stenosis (sICAS) and initially identified patients who might have benefited most from DCB treatment. A single-center, retrospective cohort study was conducted from June 2021 to May 2022 with 154 patients with sICAS divided into 2 treatment groups: a DCB group (with or without remedial stenting, n = 47) and a stent group (n = 107). The treatment outcomes were compared using 1:2 propensity score matching. The primary safety end point was perioperative stroke or mortality, and the primary efficacy end point was the rate of target vessel restenosis at 12 months. The degree of luminal change was analyzed as a subgroup, defined as the difference between the degree of stenosis at follow-up and immediately after intervention. One hundred eighteen patients were enrolled using propensity score matching, with 43 patients in the DCB group and 75 in the stent group. The incidence of perioperative adverse events was 2.3% in the DCB group and 8.0% in the stent group (P = .420). At a median follow-up of 12 months, the incidence of restenosis (11.9% [5/43] vs 28.0% [21/75], P = .045) and the median degree of stenosis (30% [20%, 44%] vs 30% [30%, 70%], P = .009, CI [0-0.01, 0.2]) were significantly lower in the DCB group than in the stent group. DCB angioplasty effectively prevented adverse events in the target vessel area and significantly reduced the degree of luminal change in the M1 segment of the middle cerebral artery (0 [0, 15%] vs 10% [0, 50%], P = .016). DCB angioplasty might be a safe and effective alternative to stent angioplasty to treat sICAS, particularly among patients with M1 segment of the middle cerebral artery stenosis.

A case of in-stent restenosis due to mechanical compression caused by the protrusion of calcified nodules successfully treated with a Jetstream™ atherectomy system followed by a drug-coated balloon angioplasty.

A case of in-stent restenosis due to mechanical compression caused by the protrusion of calcified nodules successfully treated with a Jetstream™ atherectomy system followed by a drug-coated balloon angioplasty.

Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty

BackgroundConcerns regarding restenosis after treatment with drug-coated balloons (DCB) remain. We aimed to identify the incidence of target lesion revascularization (TLR) and explore clinical, procedural, and other factors influencing it.MethodsSingle-center retrospective analysis of a prospective cohort PCI registry study included 80 patients (100 lesions) who underwent successful DCB angioplasty between January 2020 and October 2023 and follow-up angiography within 2 years of either planned or unplanned reason. Incidence and factors associated with TLR were analyzed.ResultsAngiographic evaluation was conducted within a median of 151 days (interquartile range: 109 days). During index procedure, 54% were complex lesions. Intravascular imaging (IVI) was performed in 80% of lesions. TLR occurred in 11% of the lesions and was less frequent in the IVI group compared to the angiography-alone group [6.3 vs. 54.5%; odds ratio: 0.156, 95% confidence interval (CI): 0.042–0.580; p = 0.002]. No association was found between baseline and lesion characteristics, lesion complexity, plaque morphology, pre-dilatation procedure balloon type, maximal inflation pressure, or length of DCB between the groups (p &amp;gt; 0.05). Multivariate analysis revealed that IVI utilization was independently associated with a lower TLR rate (adjusted odds ratio: 0.116, 95% CI: 0.020–0.669; p = 0.016).ConclusionIn DCB angioplasty, only IVI use exhibited a significant difference in the TLR rate among baseline lesion characteristics and lesion preparation and was independently associated with a lower TLR rate.

Plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty. The PLAMI study design

Plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty. The PLAMI study design

Excimer laser coronary angioplasty combined with drug-coated balloon in the treatment of in-stent restenosis.

The aim of this study is to investigate the safety and efficacy of excimer laser coronary angioplasty (ELCA) combined with drug-coated balloons(DCBs) in the treatment of in-stent restenosis (ISR), and to explore whether the contrast injection technique would improve the neointimal tissue ablation of ELCA. We studied patients diagnosed with ISR between January 2019 and October 2022 at two medical centers. These patients underwent DCB angioplasty guided by optical coherence tomography (OCT). Based on whether ELCA was performed before DCB treatment, patients were categorized into two groups: the ELCA + DCB group and the DCB group. All patients underwent clinical follow-up 1 year after the procedure. The primary endpoint was the 1-year rate of target lesion revascularization (TLR), which was defined as any repeat percutaneous intervention or bypass surgery on the target vessel conducted to address restenosis or other complications related to the target lesion. The secondary endpoints including immediate luminal gain (ΔMLA, defined as the difference in minimum lumen area before and after the intervention). A total of 85 lesions in 75 patients were included. The mean age of the study population was 64.2 ± 12.0 years, with 81.3% male. Baseline clinical characteristics were well-balanced, and procedural success was 100% in both groups. The ELCA + DCB group (n = 24) exhibited a greater ΔMLA compared to the DCB group (n = 61) (3.57 ± 0.79 mm² vs. 2.50 ± 1.06 mm², [95% confidence interval,CI: 0.57-1.69], p < 0.001), The reduction in 1-year TLR was more frequently observed in patients from the ELCA + DCB group compared to the DCB group (hazard ratio 0.33 [95% CI: 0.11-0.99]; log-rank p = 0.048). The exploratory analysis showed that ELCA with contrast infusion is associated with greater acute lumen gain compared to ELCA with saline infusion (p < 0.001). The combination of ELCA and DCB is a safe and effective treatment strategy for in-stent stenosis. Additionally, compared with saline injection, ELCA with contrast injection is associated with greater acute lumen gain. However, the optimal contrast agent concentration and long-term outcome of the contrast injection technique need confirmation through larger sample sizes and prospective studies.

Predictors of late lumen enlargement after drug-coated balloon angioplasty for de novo coronary lesions.

Late lumen enlargement (LLE) - a positive remodelling phenomenon - after drug-coated balloon (DCB) angioplasty for stable coronary disease contributes to a lower restenosis rate. However, lesion characteristics promoting LLE remain unclear. This study aimed to investigate predictive lesion characteristics for LLE using serial optical frequency domain imaging (OFDI) following DCB angioplasty for de novo coronary artery lesions. This retrospective, single-centre observational study included patients with angina pectoris who underwent paclitaxel-coated balloon angioplasty without stenting under OFDI guidance as well as follow-up OFDI. OFDI endpoints were lumen volume, plaque phenotype, and procedure-associated dissection. LLE was defined as a ≥10% increase in the lumen volume of the treated lesion at follow-up. Between August 2016 and December 2019, among patients with successful DCB angioplasty, 108 lesions (83 patients) had available follow-up imaging after a median of 6.1 months. LLE was detected in 44 (40.7%) lesions. Fibrous/fibrocalcific and layered plaques had significantly larger lumen volumes at follow-up than immediately after the index procedure, whereas lipid plaques exhibited no significant difference. Medial dissection with an arc >90° revealed an increased lumen volume. Multivariate analysis showed that layered plaques (odds ratio [OR] 8.73, 95% confidence interval [CI]: 1.92-39.7; p=0.005) and medial dissection with an arc >90° (OR 4.65, 95% CI: 1.63-13.3; p=0.004) were independent LLE predictors. Layered plaques and extensive medial dissection after DCB angioplasty were associated with higher LLE occurrence in de novo coronary lesions. These findings may be clinically applicable to DCB therapeutic strategies based on plaque features.

Drug-coated balloon versus drug-eluting stenting coronary angioplasty for ST-elevation myocardial infarction: a systematic review and meta-analysis of real-world studies

Abstract Funding Acknowledgements None. Introduction In the realm of ST-elevation myocardial infarction (STEMI), drug-eluting stent angioplasty (DES) is a well-established strategy for urgent revascularization. However, several challenges arise when selecting stents for these patients. These challenges include dealing with endothelial oedema and vasospasm during acute thrombotic occlusion. Moreover, there are concerns surrounding DES-related complications. These complications include the need for prolonged anti-platelet therapy, which increases the risk of bleeding, late stent thrombosis, and in-stent restenosis (ISR). In light of these issues, drug-coated balloons (DCB) have emerged as a compelling alternative. Purpose: This study aims to explore the safety and efficacy of DCB compared to conventional DES angioplasty in the management of STEMI. Methods A systematic literature search was conducted across electronic databases (PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, reference lists of relevant publications, and grey literature sources) for studies published from the inception of DCB up to 31st August 2023. Results Nine eligible studies, consisting of four randomised controlled trials and two retrospective propensity-matched studies, were included. These studies, all single-center, involved a total of 2,122 patients (934 in the DCB versus 1,188 in the DES group) over a median follow-up period of 15 months (ranging from 6 to 36 months). The meta-analysis showed no statistically significant differences between DCB and DES angioplasty in terms of technical success (OR: 1.82, 95% CI: 0.22-15.08, p = 0.58), major adverse cardiovascular events (MACE) (OR: 1.24, 95% CI: 0.60–2.56, p = 0.57), all-cause mortality (OR: 1.20, 95% CI: 0.83–1.75, p = 0.33), cardiac death (OR: 1.40, 95% CI: 0.47-4.17, p = 0.54), cardiovascular-related hospitalization (OR: 0.72, 95% CI: 0.32-1.65, p = 0.44), recurrent myocardial infarction (OR: 0.99, 95% CI:0.34-2.90, p = 0.99), target lesion revascularization (OR: 1.15, 95% CI: 0.56–2.34, p = 0.71), late luminal loss (SMD: -0.25mm, 95% CI: -1.05 to 0.54, p = 0.53), postoperative TIMI flow (OR: 1.16, 95% CI: 0.54-2.50, p = 0.71), fractional flow reserve (MD: 0.012, 95% CI -0.018 to 0.032, p = 0.27), and bleeding risk (7.2% in DCB versus 7.5% in DES). It's noteworthy that 8.2% of patients in the DCB group required bailout stenting due to coronary artery dissection type C, a rate 10 times higher than that in the DES group (p &amp;lt; 0.005). Additionally, DCB angioplasty displayed a statistically significant presence of residual stenosis compared to DES angioplasty (OR: 6.48, 95% CI: 1.13-37.2, p = 0.04). Conclusion DCB angioplasty demonstrates promise but presents unique challenges in STEMI management, particularly in complex scenarios requiring bailout stenting and residual stenosis. The study contributes to the ongoing discussion about the role of DCBs in optimizing STEMI treatment, highlighting their potential benefits and areas of concern.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery: Presented at the 2022 Vascular InterVentional Advances meeting, Las Vegas, NV, October 31 to November 3, 2022.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery: Presented at the 2022 Vascular InterVentional Advances meeting, Las Vegas, NV, October 31 to November 3, 2022.

Current Management of In-Stent Restenosis.

In-stent restenosis (ISR) remains the primary cause of target lesion failure following percutaneous coronary intervention (PCI), resulting in 10-year incidences of target lesion revascularization at a rate of approximately 20%. The treatment of ISR is challenging due to its inherent propensity for recurrence and varying susceptibility to available strategies, influenced by a complex interplay between clinical and lesion-specific conditions. Given the multiple mechanisms contributing to the development of ISR, proper identification of the underlying substrate, especially by using intravascular imaging, becomes pivotal as it can indicate distinct therapeutic requirements. Among standalone treatments, drug-coated balloon (DCB) angioplasty and drug-eluting stent (DES) implantation have been the most effective. The main advantage of a DCB-based approach is the avoidance of an additional metallic layer, which may otherwise enhance neointimal hyperplasia, provide the substratum for developing neoatherosclerosis, and expose the patient to a persistently higher risk of coronary ischemic events. On the other hand, target vessel scaffolding by DES implantation confers relevant mechanical advantages over DCB angioplasty, generally resulting in larger luminal gain, while drug elution from the stent surface ensures the inhibition of neointimal hyperplasia. Nevertheless, repeat stenting with DES also implies an additional permanent metallic layer that may reiterate and promote the mechanisms leading to ISR. Against this background, the selection of either DCB or DES on a patient- and lesion-specific basis as well as the implementation of adjuvant treatments, including cutting/scoring balloons, intravascular lithotripsy, and rotational atherectomy, hold the potential to improve the effectiveness of ISR treatment over time. In this review, we comprehensively assessed the available evidence from randomized trials to define contemporary interventional treatment of ISR and provide insights for future directions.

Comparison of Outcomes of Drug-Coated Balloons versus Plain Balloons in Secondary Interventions on Percutaneous Arteriovenous Fistulae

PurposeTo compare patency and reintervention outcomes after either plain old balloon angioplasty (POBA) or drug-coated balloon angioplasty (DCBA) for venous stenoses after percutaneous arteriovenous fistula (pAVF) creation. Materials and MethodsOne-hundred ninety-five pAVFs were successfully created during the study period, 141 using Ellipsys and 54 using Wavelinq. After pAVF creation, 95 patients (48.7%) required secondary percutaneous transluminal angioplasty (PTA) with either POBA (n = 55, 58%) or DCBA (n = 40, 42.1%). The most common site for PTA was the juxta-anastomotic segment (75.5%; 74/98). Univariate and multivariate Cox regression analyses were used to compare target lesion primary patency, access circuit primary patency, secondary patency, and reintervention rates in the POBA and DCBA cohorts. ResultsThirty-four of 55 (62%) patients in the POBA cohort and 14 of 40 (35%) patients in the DCBA cohort required reinterventions for pAVF restenosis. Mean number of follow-up days among patients treated with POBA was 1,030.4 (SD ± 342.9) and among those treated with DCBA was 744.4 (SD ± 403.5). The use of POBA compared with DCBA was not associated with target lesion and access circuit primary patency loss in multivariate analysis (hazard ratio [HR], 1.81; 95% CI, 0.93–3.51; P = .080; and HR, 1.77; 95% CI, 0.73–4.28; P = .210, respectively). However, time from fistula creation to the first PTA (days) was significantly associated with both outcomes (HR, 0.997; 95% CI, 0.994–0.999; P = .009; and HR, 0.997; 95% CI, 0.992–0.999; P = .021, respectively). There were no major adverse events. ConclusionsIn this retrospective single-center analysis of pAVFs, significantly more patients who underwent PTA with POBA after pAVF creation required reinterventions compared with PTA using DCBA, although the follow-up time of POBA was longer. In multivariate analysis, no significant differences were noted in the hazard of patency loss between POBA and DCBA.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. German Clinical Trials Register: DRKS00031245. The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Assessment of paclitaxel drug-coated balloon angioplasty for intracranial atherosclerotic disease based on high-resolution vessel wall magnetic resonance imaging.

To accurately assess the treatment effect of paclitaxel drug-coated balloon (DCB) angioplasty is essential for intracranial atherosclerotic disease (ICAD) patients. This study aimed to investigate the clinical feasibility of high-resolution vessel wall MRI (HR-VWI) in assessing ICAD with DCB angioplasty. Forty-five patients with intracranial atherosclerotic stenosis ≥ 70% confirmed by digital subtraction angiography (DSA) underwent HR-VWI before and after DCB angioplasty. Postoperative follow-up was performed after 6 months (±1 month). The differences of pre- and postoperative HR-VWI characteristics, including vessel and lumen area at maximal lumen narrowing (MLN), plaque area and length, degree of stenosis, plaque burden (PB), remodeling index, and plaque enhancement amplitude (PEA) were compared. The relationship between stenotic rate obtained using HR-VWI and DSA was evaluated. Each HR-VWI characteristic and clinical factor before DCB angioplasty was separately evaluated for the association with postoperative restenosis. After six months, lumen area of MLN, plaque length and area, degree of stenosis, PB, and PEA showed a significantly difference relative to the value before DCB angioplasty (all P < 0.05). Spearman correlation coefficients of 0.865 and 0.932 were revealed between DSA and HR-VWI regarding the stenotic rate analysis pre- and post-operation (both P < 0.05). ROC analysis showed PEA, plaque length, and PB before DCB angioplasty separately provided robust prediction of postoperative restenosis (area under the curve = 0.909, 0.814 and 0.743; all P < 0.05). Multivariable analysis revealed that PEA was an independent predictor of prognosis. The HR-VWI can accurately assess the treatment effect of DCB and robustly predict prognosis.

Repeat drug-coated balloon angioplasty for femoropopliteal lesions: 12-month results from a retrospective observational study

BackgroundThe clinical implications of restenosis after drug-coated balloon (DCB) treatment remain unclear. We compared the clinical outcomes between DCB angioplasty for restenosis and de novo femoropopliteal artery lesions. This single-center retrospective study included 571 patients (737 limbs) who underwent either repeat (54 patients, 64 limbs) or de novo DCB (517 patients, 673 limbs) without bailout stenting. After propensity score matching, 49 matched pairs were analyzed. The primary endpoint was the 1-year primary patency, with secondary endpoints including the freedom from target lesion revascularization (TLR), major adverse limb events (MALE), and early restenosis. Predictors of restenosis were identified using multivariable Cox regression analysis.ResultsThe repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43–18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17–33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08–16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21–73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01–0.44; p = 0.007).ConclusionsThe 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.

Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study.

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0mm (large group, n = 58) or < 3.0mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22-37] vs. 35% [26-42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels.

Plaque heterogeneity and the spatial distributions of its components dictate drug-coated balloon therapy

Drug-coated balloon (DCB) angioplasty is one of the potential approaches to alleviating in-stent restenosis and treating peripheral artery disease. An in-silico model has been developed for sirolimus drug eluted from an inflated balloon in a patient-specific arterial cross-section consisting of fibrous tissue, fibrofatty tissue, dense calcium, necrotic core, and healthy tissue. The convection-diffusion-reaction equation represents the transport of drug, while drug binding, both specific and non-specific, can be modelled as a reaction process. The Brinkman equations describe the interstitial flow in porous tissue. An image processing technique is leveraged for reconstructing the computational domain. The Marker and Cell, and Immersed Boundary Methods are used to solve the set of governing equations. The no-flux interface condition and convection do amplify the tissue content, and the regions of dense calcium and necrotic core limited to or extremely close to the interface pose a clinical threat to DCB therapy. Simulations predict the effects of the positioning and clustering of plaque components in the domain. This study demands extensive intravascular ultrasound-derived virtual histology (VH-IVUS) imaging to understand the plaque morphology and determine the relative positions of different plaque compositions about the lumen-tissue interface, which have a significant impact on arterial pharmacokinetics.