Efficacy of a novel method: VaSodilator injection via the over-the-wire lumen during drug-coated balloon dilatation to prevent the slow-flow phenomenon in treatment of femoropopliteal lesions.

In drug-coated balloon (DCB) angioplasty for femoropopliteal lesions, there are adverse effects of drug embolization on downstream non-target organs following the slow-flow phenomenon. We devised a novel method, known as VaSodilator injection via the over-the-wire lumen during DCB dilatation to prevent the slow-flow phenomenon in treatment of femoropopliteal lesions (V.S.O.P.), and evaluated its efficacy and safety. This single-center, retrospective, observational study analyzed 196 femoropopliteal lesions treated with IN.PACT Admiral between April 2018 and July 2023. The IN.PACT Admiral is a DCB consisting of a 0.035-inch over-the-wire (OTW) lumen balloon coated with high-dose paclitaxel. Regarding the V.S.O.P. method, we injected vasodilators through the OTW lumen during DCB dilation of the lesions. The cohort was classified into two groups according to the use of the V.S.O.P. method (V.S.O.P. group: n = 53; non-V.S.O.P. group: n = 143). The V.S.O.P. group had lower rates of hemodialysis (21% vs. 43%, p = 0.01) and higher rates of critical limb-threatening ischemia (56% vs. 23%, p < 0.01) and severe calcification lesions (Peripheral Arterial Calcium Scoring Systems score 3/4) (53% vs. 34%, p = 0.01) than the non-V.S.O.P. group. The occurrence of the slow-flow phenomenon was significantly lower in the V.S.O.P. group than in the non-V.S.O.P. group. The V.S.O.P. method could be an effective method for preventing the slow-flow phenomenon after DCB angioplasty for femoropopliteal lesions.

Early Tibial Vessel Recoil Following Treatment With the Bare Temporary Spur Stent System: Results From the DEEPER OUS Vessel Recoil Substudy.

PURPOSE: Vessel recoil is a common phenomenon occurring in the tibial vessels following balloon angioplasty. This study examined the occurrence and short-term impact of acute vessel recoil in a subset of patients treated with retrievable scaffold therapy (RST) via the Spur Peripheral Retrievable Scaffold System (Spur). METHODS: Patients with tibial disease underwent angiography immediately following RST, and then 15 minutes post-treatment. Vessel recoil was defined as a ≥10% decrease in lumen diameter after 15 minutes. Recoil was further analyzed by late lumen loss method, subsegmental late lumen loss method, and smallest segment to same segment method. Patient and vessel characteristics were evaluated. Functional recoil (acute vessel spasm), defined as no significant change in minimal lumen diameter (MLD) at baseline compared with 15 minutes post-treatment, was also evaluated. RESULTS: Of the 38 patients (40 lesions; 33 men [87%]; mean [SD] age 75.3 [8.2] years; 26 (68.4%) with diabetes mellitus); recoil was noted in 42.5% of vessels. Prior to treatment, 13 lesions (32.5%) were total occlusions, the mean lesion length was 64.7±30.4 mm, and 27.5% (11/40) were moderate or severely calcified. Mean treated lesion length was 97.8±39.6 mm. For lesions evaluable by duplex ultrasound, 86.7% of vessels (26/30) were patent at 6 months. There was no significant difference in patency between lesions with recoil and lesions without recoil (81.8% vs 89.5%); there was a trend toward patency in the non-recoil group. Two lesions had functional recoil (acute vessel spasm) and were patent at 6 months. There was no statistically significant correlation of recoil to comorbidities or lesion characteristics, including calcification, for which there was also no correlation to patency. CONCLUSION: Vessel recoil was noted in 42.5% of vessels treated with RST, whereas previous published rates with balloon angioplasty demonstrated vessel recoil up to 97%, suggesting that RST may impact vessel recoil. This exploratory study did not demonstrate a correlation between vessel recoil and patency at 6 months. CLINICAL IMPACT: Retrievable scaffold therapy may replace scoring devices and cutting devices for vessel preparation before definite (drug) therapy. Retrievable scaffold therapy supplements already established vessel preparation strategies in order to follow the concept of leaving nothing behaind. A temporary retrievable scaffold for changing vessel compliance and potentially releasing antiproliferative drugs represents a new interventional concept.

Efficacy of initial and repeat DCB angioplasty of restenotic arteriovenous fistulas compared with plain angioplasty.

PURPOSE: To evaluate the effect of drug-coated balloon (DCB) with high-dose paclitaxel for the treatment of restenotic dysfunctional arteriovenous fistulas (AVFs). MATERIALS AND METHODS: In this single-arm, multicenter, prospective, observational study, 334 patients using IN.PACT AV DCB (Medtronic Inc., Plymouth, MN) for the first time in the restenotic lesion of dysfunctional AVF between April 2021 and March 2022 were registered. RESULTS: Procedural success, defined as <30% residual stenosis, was achieved in 96.7% of cases. During a median follow-up of 7.4 months, 179 target lesion reinterventions (TLRs) were observed, and the 6-month freedom from TLR was 73.2% (68.2%-78.2%). When compared with the previous plain percutaneous transluminal angioplasty, the median time to reintervention was significantly longer with DCB (9.1 [8.0-10.6] versus 3.2 [3.0-3.4] months; P<.001). Baseline characteristics that were independently associated with TLR were: months from the last intervention (adjusted hazard ratio, 0.50 [95% confidence interval, 0.40-0.62] per doubling; P<.001), partial lesion coverage by DCB (2.13 [1.10-4.12]; P=.024), and residual stenosis after DCB (2.19 [1.53-3.12] per 15% increase; P<.001) with its time interaction (0.91 [0.86-0.97] per month; P=.003). Of the 179 TLRs, 84 used DCB once again. The median time to reintervention was significantly longer for TLR using DCB (7.1 [6.2-9.7] versus 3.3 [3.1-4.0] months; P<.001). CONCLUSIONS: DCB with high-dose paclitaxel is effective at both the initial treatment in the restenotic lesion of dysfunctional AVF and during TLR after DCB use. However, partial lesion coverage by DCB and residual stenosis should be avoided.

A Meta-Analysis of 3-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small-Vessel Coronary Artery Disease.

Background: Drug-coated balloons (DCBs) may be a viable alternative to drug-eluting stents (DES) for de novo small caliber coronary artery lesions. However, there remains a lack of data regarding the long-term efficacy of this approach. Objectives: The purpose of this study was to compare the rates of major adverse cardiovascular events (MACE) after 3-year follow-up among patients randomized to DCB versus DES for the treatment of small caliber coronary arteries with reference vessel diameter between 2 and 3 mm. Methods: We systematically searched MEDLINE, EMBASE, and CENTRAL databases from their inception to July 2023 for randomized controlled trials comparing DCB versus DES for small caliber coronary artery disease. The primary end point was MACE at 3-year follow-up. Risk of bias was assessed using the Cochrane Risk of Bias Tool (RoB 2). Pooled risk ratios (RRs) and 95% CIs were estimated using random effects meta-analytic models. Results: Four randomized controlled trials (n = 1,402) were included. In total, 706 patients were randomized to DCB and 696 to DES. Participants were mostly male (74%), with a mean/median age ranging from 60 to 68 years. Pooled data across trials for MACE showed wide CIs, with little indication of DES superiority over DCB (RR: 0.71; 95% CI: 0.36-1.41). Most individual components of MACE were inconclusive. There was a potential signal for a reduction of target vessel thrombosis with DCB compared to DES (RR: 0.25; 95% CI: 0.06-1.08). Conclusions: Although sample sizes are small, 3-year outcomes suggest that DCB may be a reasonable alternative to DES for the treatment of small coronary arteries.

Multicenter randomized controlled trial to assess the effectiveness of PASSEO-LUX DCB® drug coated balloon compared to plain balloon angioplasty of arteriovenous fistulae for hemodialysis: Two-years results.

PURPOSE: To compare primary patency after angioplasty with drug-coated balloon (DCB)-Passeo-18Lux, BIOTRONIK versus uncoated balloon in dysfunctional peripheral vascular access (PVA) for hemodialysis. MATERIAL AND METHODS: A total of 133 patients from four hospitals were randomized to receive DCB or plain old balloon angioplasty (POBA) after satisfactory treatment (residual stenosis <30%) with high pressure balloon (HPB). The primary endpoint was clinical patency of PVA 2 years after angioplasty. Secondary endpoints included the relationship between the location of stenosis and patency and also, other covariates. Mortality at 2 years was compared between both groups. RESULTS: Patency measured in days after angioplasty was higher in fistulae dilated with DCB than HPB. Kaplan-Meier survival curves showed the next percent of success (free time restenosis) after DCB versus POBA at 6 months-77.1% versus 58.2% (160.41-143.72 days until restenosis), 12 months-51.4% versus 44.3% (274.1-237.23), 18 months-38.6% versus 38% (350.74-305.18), and 24 months-37.1% versus 30.4% (419.04-369.1). At 6 months, this difference was statistically significant (p = 0.018), but not at 12 (p = 0.225), 18 (p = 0.471), or 24 months (p = 0.236). Mortality was similar in both groups. CONCLUSIONS: DCB angioplasty resulted in superior target lesion primary patency (TLPP)-free survival at 6 months of follow-up. No significant improvements in TLPP-free survival long term were observed. Mortality observed at 1 and 2 years was similar in DCB and POBA: there was no significant difference, and a safety study demonstrated no difference between the two groups (complications and mortality): DCB is safe to use in stenosis treatment in patients who are PVA carriers. LEVEL OF EVIDENCE: Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.

Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.

BACKGROUND: We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined. METHODS: 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. RESULTS: At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. CONCLUSIONS: In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).

Successful treatment of acute left main coronary artery disease with a drug-coated balloon under left ventricular unloading using Impella: a case report.

Background: Although the efficacy and safety of drug-coated balloons (DCBs) for acute left main coronary artery (LMCA) disease have not yet been proven, stentless percutaneous coronary intervention with a DCB is preferred for patients with high bleeding risk requiring a shorter duration of dual antiplatelet therapy. Mechanical circulatory support may improve haemodynamics in patients with cardiogenic shock caused by acute LMCA disease. Case summary: A 74-year-old man diagnosed with acute congestive heart failure underwent emergency coronary angiography (CAG) at our hospital owing to ischaemic changes on the electrocardiogram (ECG), indicating acute LMCA disease. Coronary angiography revealed severe LMCA ostial stenosis. Immediately after CAG, mechanical circulatory support was initiated using Impella CP® for haemodynamic collapse with abrupt ST-segment elevation in the precordial leads. The haemodynamics stabilized with a dramatic improvement in the ECG. We treated the culprit ostial lesion with inflation of a cutting balloon followed by DCB delivery because of an episode of haematochezia. Subsequently, his cardiac function recovered fully. Discussion: A case of acute LMCA disease was successfully treated with a DCB under haemodynamic support using Impella CP. The left ventricular (LV) unloading with Impella was indicated to contribute to stable haemodynamics, even during long inflation with the DCB, and the immediate recovery of LV function. Haemodynamic support using Impella may be effective, especially in cases requiring repeated and longer inflation of balloon catheters accompanied by extensive myocardial ischaemia.

Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches.

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.

Retrospective analysis of the drug-coated balloon-only strategy for chronic total occlusion coronary lesions.

Background: The effects of the drug-coated balloon (DCB)-only strategy in the treatment of chronic total occlusion (CTO) coronary lesions remain controversial. Patients who underwent an in-stent restenosis (ISR) CTO percutaneous coronary intervention (PCI) had a significantly poorer prognosis than those who underwent a de novo CTO PCI. This retrospective analysis evaluated the efficacy and safety of the DCB-only strategy in the treatment of CTO lesions, and the factors associated with adverse events in the patients. Methods: Patients with CTO lesions who were treated with the DCB-only strategy from 1 January 2016 to 1 May 2021 were retrospectively enrolled in this study. The patients were stratified into the ISR and de novo (primary) groups. All the patients were re-admitted to the hospital and underwent clinical and/or angiographic follow-up. Results: Of the 68 patients with CTO lesions, 38 (55.9%) were categorized as having ISR, and 30 (44.1%) were categorized as having de novo lesions. The outcomes measured included target lesion revascularization (TLR), lumen gain after intervention, and late lumen loss (LLL). After an average follow-up period of 16 months, a total of 15 patients experienced target lesion failure (13 in the ISR group and 2 in the de novo group). The rate of major adverse cardiac events (MACEs) was significantly lower in the de novo group than the ISR group (10% vs. 39%, P=0.004). There was a significant difference in LLL between the two groups, with the de novo group showing a decrease (-0.04±0.83 mm) and the ISR group showing an increase (0.97±1.45 mm) (P=0.03). The univariable Cox proportional hazard analyses revealed that the incidence of TLR was independently associated with the stenosis type (either ISR or de novo lesions) [odds ratio (OR): 7.28; 95% confidence interval (CI): 1.494-35.464; P=0.01]. Male gender (OR: 3.726; 95% CI: 1.014-12.818; P=0.03) and body mass index (BMI) (OR: 1.246; 95% CI: 1.022-1.518, P=0.03) were also associated with the incidence of TLR. However, after adjusting for the variables of age, gender, and BMI, no significant association was found between MACE occurrence and ISR (OR: 4.156, 95% CI: 0.734-23.522; P=0.11). Conclusions: Treatment using the DCB-only strategy was found to be beneficial for patients suffering from CTO coronary lesions, especially those presenting with de novo lesions.

Drug-Coated Balloon Angioplasty vs Plain Balloon Angioplasty in patients with coronary In-Stent Restenosis: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: In-stent restenosis (ISR) remains a significant challenge in interventional cardiology despite advancements in stent technology. Drug-coated balloons (DCBs), which deliver antiproliferative agents directly to the vessel wall, have emerged as a promising alternative to plain balloon angioplasty for ISR treatment. This meta-analysis evaluates the efficacy of DCBs compared to plain balloon angioplasty in patients with coronary ISR. METHODS: A comprehensive search of PubMed and Embase was conducted on June 27, 2024. The search identified randomized controlled trials comparing DCBs and plain balloon angioplasty for ISR treatment. Six trials involving 1,322 patients met the inclusion criteria. Quality was assessed with the Cochrane Risk of Bias tool. Data extraction and statistical analysis were performed using RevMan software, assessing heterogeneity with the I2 statistic and publication bias using funnel plots. RESULTS: The analysis showed that DCBs significantly reduced late in-stent and in-segment luminal loss (P < 0.001) and target lesion revascularization (P = 0.02) compared to plain balloon angioplasty. Major adverse cardiovascular events and the combined endpoint of target lesion revascularization, myocardial infarction, and death also showed highly significant improvements with DCB treatment (P < 0.00001 and P = 0.0002, respectively). However, no significant effect was observed on myocardial infarction and mortality rates. CONCLUSION: DCBs significantly reduce in-stent late luminal loss, target lesion revascularization, and major adverse cardiovascular events compared to plain balloon angioplasty.

Mean Pressure Gradient and Fractional Flow Reserve at A Superficial Femoral Artery Dissection after Drug-Coated Balloon Angioplasty.

OBJECTIVES: Residual dissection is a concern in endovascular treatment with a DCB, and there is limited knowledge of hemodynamics at a dissection lesion. Therefore, the objective of this study is to evaluate the mean pressure gradient (MPG) and fractional flow reserve (FFR) at a residual dissection after DCB angioplasty for the superficial femoral artery (SFA). METHODS: A total of 59 cases with residual SFA dissection treated with DCB angioplasty at a single center were analyzed retrospectively. The dissection was classified into 6 types (A-F). The primary endpoints were MPG and FFR at a residual dissection lesion after DCB angioplasty, using evaluation with a pressure wire. RESULTS: The median lesion length was 70 (40-130) mm with 24% popliteal involvement, and 11 cases (18%) had chronic total occlusion. A completion angiogram revealed dissection of types A (n = 33, 56%), B (n = 18, 31%), C (n = 7, 12%), and D (n = 1, 2%). The median MPGs in type A, B, and C cases were 0 (0-2), 0 (0-4), and 3 (0-6) mmHg, with a significant lower in type C cases than in type A cases (A vs C, P = .021). The median FFRs in type A, B, and C cases of 1.0 (.98-1.00), 1.0 (.96-1.00), and .98 (.95-1.00) did not differ significantly among dissection types (A vs B, P = .86; A vs C, P = .055; B vs C, P = .15). CONCLUSIONS: This is the first report of hemodynamics at a SFA dissection. The results suggest that low-grade dissection (types A or B) does not affect MPG and FFR at a SFA lesion. This indicates that a bailout stent may be unnecessary for patients with dissection of types A or B. A further investigation is needed to determine whether a scaffold is required for a SFA lesion with type C dissection.

Drug-coated balloon angioplasty versus drug-eluting stent implantation in ACS patients with different angiographic patterns of in-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions. METHODS: Patients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics. RESULTS: For focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39-1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40-1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29-0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19-0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26-0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15-0.54; p < 0.001). CONCLUSIONS: The clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.

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

INTRODUCTION: Percutaneous 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. METHODS: Net 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. RESULTS: Among 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. CONCLUSIONS: SCB 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.

Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention.

Background: There are limited clinical data on drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients with complex coronary artery lesions. Objectives: The goal of the current study was to investigate the efficacy of DCB in patients undergoing PCI for complex coronary artery lesions. Methods: From an institutional registry of patients with de novo complex coronary artery lesions, 126 patients treated with DCB-based PCI were compared with 234 propensity score-matched patients treated with DES-only PCI. Complex coronary artery lesions were defined as the presence of at least 1 of the following: bifurcation, chronic total occlusion, unprotected left main disease, long lesion ≥38 mm, multivessel disease, lesion requiring ≥3 devices, or severe calcification. The primary endpoint was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization. Results: Baseline characteristics were comparable between the 2 groups. DCB-based PCI showed a comparable risk of TVF vs DES-based PCI (7.6% vs 8.1%; HR: 0.81; 95% CI: 0.33-1.99; P = 0.638). The risks of cardiac death (5.0% vs 5.7%; HR: 0.78; 95% CI: 0.24-2.49), target vessel-related myocardial infarction (0.9% vs 1.3%; HR: 2.65; 95% CI: 0.26-27.06), and target vessel revascularization (3.5% vs 2.0%; HR: 1.30; 95% CI: 0.30-5.67) were also comparable between the 2 groups. Conclusions: DCB-based PCI showed comparable risks of TVF vs those of DES-only PCI in patients with complex coronary artery lesions. DCB might be considered as a suitable alternative device to DES in patients undergoing complex PCI. (Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815).

Off-Label Use of Peripheral Paclitaxel Drug-Coated Balloons in Management of Recurrent Coronary In-Stent Restenosis.

Background: While not available for clinical use in the United States, dedicated drug-coated balloons (DCB) are currently under investigation for the management of coronary in-stent restenosis (ISR). Peripheral drug-coated balloons (P-DCB) have been used off-label for coronary ISR. Further data regarding this practice are needed. We aimed to describe outcomes in patients who underwent off-label P-DCB angioplasty for coronary ISR. Methods: We analyzed data on P-DCB angioplasty for coronary ISR at a single high-volume center between April 1, 2015, and December 30, 2017. Demographic and procedural details were collected, with systematic follow-up as clinically indicated. Results: Data from 31 patients treated with P-DCB angioplasty (mean age 68.0 ± 10.7 years) with coronary ISR (17 recurrent and 14 first time) were analyzed. Most patients presented with high-grade angina (81%) or myocardial infarction (13%). Treated ISR lesions were in native coronary arteries (68%), saphenous vein grafts (SVG, 23%), and the left internal mammary artery (10%). Diffuse intrastent ISR was common (69%) with a mean lesion length of 21.7 ± 12.4 mm. No postprocedural myocardial infarction occurred and 1 nonprocedural mortality occurred during index admission. At follow-up (median: 283, interquartile range [IQR]: 354 days), repeat angiography was performed in 19 patients (median: 212, IQR: 188 days), and 11 patients had target lesion recurrent ISR (Kaplan-Meier event-free survival estimate: 44.7%, 95% CI, 26.1%-76.5%). Conclusions: In the absence of availability of dedicated coronary DCB, treatment of coronary ISR using P-DCB angioplasty was feasible, although follow-up demonstrated continued risk for recurrent ISR in this high-risk population.

A Comparison of 2 Paclitaxel-Coated Balloon Systems in Treatment of De Novo Coronary Artery Lesions.

Background: In percutaneous coronary intervention (PCI) of de novo lesions, drug-coated balloons (DCB) have been shown to be a promising strategy to improve clinical outcomes of patients with small vessel disease. Evidence of this strategy in PCI of de novo coronary lesions in a real-world setting is limited. The objective of this study was to compare the 12-month outcomes of 2 paclitaxel-coated balloon systems for the treatment of all de novo coronary artery lesions. Methods: All patients who were treated for de novo coronary artery stenosis with either SeQuent Please or In.Pact Falcon DCB at a single center from January 2014 to December 2018 were included. The primary end point was the composite of cardiac death, nonfatal myocardial infarction, and target vessel revascularization (3-point major adverse cardiovascular events) at 12 months. Results: A total of 496 patients with 623 lesions, of which 144 were treated with SeQuent Please and 352 were treated with In.Pact Falcon were included in the study. Baseline patient, lesion and procedural characteristics at baseline were similar between groups. At 12-month follow-up, 3-point major adverse cardiovascular event outcomes were similar (4.2% vs 2.3% respectively; P = .272). Deaths due to cardiovascular events were few and similar between groups (2.7% vs 1.1% respectively; P = .20). Conclusions: Both paclitaxel DCB systems have similar efficacy and safety outcomes, suggesting that both may be an appropriate treatment choice for patients with de novo lesions. However, a larger randomized controlled study is needed to confirm these findings.

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

PURPOSE: Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. METHODS: This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. RESULTS: A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). CONCLUSIONS: This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. CLINICAL IMPACT: One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

Comparison of the efficacy of drug-coated balloon angioplasty and conventional balloon angioplasty in the endovascular treatment of thrombosed arteriovenous dialysis fistulas.

INTRODUCTION: To evaluate the efficacy and safety of paclitaxel-coated balloon angioplasty in the treatment of thrombosed arteriovenous fistulas. METHODS: This prospective, randomized, controlled study investigated the use of drug-eluting balloons in the treatment of the thrombosis of arteriovenous fistulas (AVFs) at our center between January 2018 and January 2023. A total of 246 patients were included in the study. The mean age of the patients was 61.3 ± 11.5 years. Of the patients, 150 (61%) were male and 96 (39%) were female. Angioplasty was performed using a plain balloon (PB) in 126 patients (51.2%) and a drug-coated balloon (DCB) in 120 (48.8%). The control images of the patients were obtained at the sixth and 12th months. Patency was evaluated during the follow-up. RESULTS: There was no significant difference between the two groups in terms of age, gender, hypertension, hyperlipidemia, diabetes, fistula location, or stenosis length. No significant difference was observed between the groups regarding the number of complications observed during and after the procedure. At the end of the sixth month, the patency rate was found to be 86.7% in the DCB group and 78.6% in the PB group. The 12th-month patency rate was 77.5% in the DCB group and 57.9% in the PB group. A significant difference was detected between the two groups in relation to the 6th- and 12th-month patency rates (p = 0.034 and p = 0.046, respectively). CONCLUSION: Drug-coated balloon angioplasty is an effective approach to the treatment of thrombosed AVFs, especially in terms of prolonging primary patency and reducing the need for secondary procedures.