Conventional Balloon Angioplasty Research Articles

Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty

<i>Backgroud</i>: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. <i>Objective</i>: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. <i>Patients and Methods</i>: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. <i>Results</i>: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. <i>Conclusion</i>: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.

Impact of a stent-less percutaneous coronary intervention strategy using directional coronary atherectomy and a drug coated balloon for left main and ostial lesions

Abstract Background With the advent of drug eluting stents (DESs), the restenosis rate has markedly decreased. However, even with DESs, problems remain unsolved for bifurcated lesions including left main trunk (LMT) and right coronary artery (RCA) ostial lesions. In the era of directional coronary atherectomy (DCA) alone, an optimal DCA provides a significantly lower residual stenosis and lower angiographic restenosis than conventional balloon angioplasty, despite failing to reach a statistical significance for reducing late clinical events as compared to balloon angioplasty (Circulation 1998; 97:322–31.). Purpose This study aimed to examine the safety and effectiveness of stent-less percutaneous coronary intervention (PCI) using DCA and drug coated balloons (DCBs). Methods From November 2017 to June 2019, a stent-less PCI for LMT and ostial lesions was performed in 32 consecutive cases (male 24/female 8; mean age 70.9±9.8). A stent-less PCI was performed using SeQuent Please™ DCB after an ATHEROCUT™ DCA, and procedural success was obtained in all cases (6 cases with LMT, 18 with left anterior descending ostial, 6 with left circumflex ostial, and 2 with RCA ostial lesions). Results The percent plaque area (%PA) decreased from 70.0±7.7% at baseline to 51.6±8.1% after the DCA and to 46.1±9.0% after the DCBs. All patients completed a follow up coronary angiography after 6 months and no restenosis was observed. No major adverse cardiac events occurred in any cases including target lesion revascularizations. In 29 cases that the lumen was confirmed with IVUS at 6 months of follow-up, the lumen area (LA) had expanded significantly from 8.0±2.3 mm2 at baseline (post DCBs) to 8.9±2.7 mm2 at 6 months (P=0.023, Figure 1A). Local paclitaxel may induce late lumen enlargement (LLE) after a DCA/DCB. The group in which the LA increased during the chronic phase was defined as the Increased group and the group in which the LA decreased during the chronic phase was defined as the Decreased group. When comparing the LDL-Cho level pre DCA between the two groups, the LDL-Cho level in the Increased group was significantly low (74.0±25.8 mg/dl vs. 101.0±33.6 mg/dl, P=0.050, Figure 1B). Conclusions Stent-less PCI using DCA and DCBs for bifurcated lesions including LMT and RCA ostial lesions was effective, safe, and useful. Furthermore, a chronic LLE effect by DCBs is expected. In addition, intensive lipid-lowering therapy may also contribute to the chronic outcome after DCA/DCBs. Funding Acknowledgement Type of funding source: None

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials.

BackgroundRestenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access.MethodsA comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately.ResultsEleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).ConclusionDCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938)

Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants (P < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants (P = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7; P = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%; P = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03; P = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14; P = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020 Online supplemental material in available for this article.

Survival After Coronary Revascularization With Paclitaxel-Coated Balloons

BackgroundDrug-coated balloons (DCBs) are accepted treatment strategies for coronary in-stent restenosis and are under clinical investigation for lesions without prior stent implantation. A recently published meta-analysis suggested an increased risk of death associated with the use of paclitaxel-coated devices in the superficial femoral artery. The reasons are incompletely understood as potential underlying pathomechanisms remain elusive, and no relationship to the administered dose has been documented. ObjectivesThe purpose of this analysis was to investigate the available data on survival after coronary intervention with paclitaxel-coated balloons from randomized controlled trials (RCTs). MethodsPubMed, Web of science, and the Cochrane library database were searched, and a meta-analysis from RCT was performed comparing DCB with non-DCB devices (such as conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) for the treatment of coronary in-stent restenosis or de novo lesions. The primary outcome was all-cause death. The number of patients lost to follow-up was observed at different time points. Risk estimates are reported as risk ratios (RRs) with 95% confidence intervals (CIs). ResultsA total of 4,590 patients enrolled in 26 RCTs published between 2006 and 2019 were analyzed. At follow-up of 6 to 12 months, no significant difference in all-cause mortality was found, however, with numerically lower rates after DCB treatment (RR: 0.74; 95% CI: 0.51 to 1.08; p = 0.116). Risk of death at 2 years (n = 1,477, 8 RCTs) was similar between the 2 groups (RR: 0.84; 95% CI: 0.51 to 1.37; p = 0.478). After 3 years of follow-up (n = 1,775, 9 RCTs), all-cause mortality was significantly lower in the DCB group when compared with control treatment (RR: 0.73; 95% CI: 0.53 to 1.00; p = 0.047) with a number needed to treat of 36 to prevent 1 death. A similar reduction was seen in cardiac mortality (RR: 0.53; 95% CI: 0.33 to 0.85; p = 0.009). ConclusionsIn this meta-analysis, the use of paclitaxel DCBs for treatment of coronary artery disease was not associated with increased mortality, as has been suggested for peripheral arteries. On the contrary, use of coronary paclitaxel-coated balloons was associated with a trend toward lower mortality when compared with control treatments.

Assessment of Microvasculature After Intervention as a Predictor of Wound Healing in Patients With Tissue Loss

ObjectivesThis study investigated the correlation between vascular flow reserve (VFR) values and wound healing rate in patients with critical limb ischemia. BackgroundPeripheral VFR may be useful for predicting complete wound healing after endovascular therapy (EVT). However, published reports included small numbers of patients from single centers and long-term outcomes remain unknown. MethodsThis was a prospective multicenter study that consecutively enrolled 104 patients (115 limbs) who received EVT for ischemic ulcerations. All lesions were treated with conventional balloon angioplasty. After EVT, VFR was measured using a pressure/temperature guidewire. The study endpoints were correlation between VFR values and wound healing rate at 3 months and 1 year. ResultsThe median VFR was 2.9. A total of 110 and 104 limbs completed the 3-month and 1-year follow-up, respectively. The 3-month and 1-year wound healing rates were 49% and 76%, respectively. VFR was significantly associated with the 3-month and 1-year wound healing (p < 0.001 for both). The crude hazard ratios of VFR (per 2-fold increase) for the 3-month and 1-year wound healing were 2.6 (1.7 to 3.9) and 2.9 (2.0 to 4.2), respectively. The estimated median time to wound healing was 5.0 (3.2 to 7.2) months, 3.3 (2.8 to 4.9) months, and 2.5 (2.0 to 3.0) months, when the VFR value was 2.4, 2.9, and 3.9, respectively. ConclusionsPost-procedure VFR is significantly associated with wound healing. VFR, measured in the catheterization laboratory, is useful in clinical risk stratification for patients with critical limb ischemia after EVT. (Predictor of Wound Healing in Patients with Critical Limb Ischemia-Multicenter Prospective Study; UMIN000012746)

4:12 PM Abstract No. 50 Quality of life outcomes from a randomized controlled trial comparing drug-eluting balloon to conventional balloon angioplasty for below-the-knee arteries in patients with critical limb ischemia

To report the quality of life (QOL) results of a randomized controlled trial comparing drug-eluting balloon (DEB) to conventional balloon (CB) angioplasty for below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI). In this investigator-initiated, dual center, blinded, randomized controlled trial (NCT02129634), 138 patients (93 males) with mean age of 62.6 years (std = 9.9), were randomized to either DEB (n = 70) or CB angioplasty (n = 68). 94.2% of the patients had diabetes and 52.9% had end-stage renal failure (ESRF). QOL measured with the EQ-5D over the follow-up period of 12 months were compared between the 2 groups after adjustment for baseline utility scores. Baseline QOL were similar in both groups. There was no significant difference in adjusted QALY gained at 12 months in both groups. The 6-month target lesion angiographic primary patency (primary endpoint) (DEB 41.9% vs. CB 37.8%, P = 0.479) and 12-month limb salvage rate (DEB 75.0% vs. CB 84.6%, P = 0.097.) were not statistically significant. The 12-month amputation-free survival (AFS) was however better in the CB group (DEB 54.1% vs. CB 77.3%, log rank test P = 0.016). The use of DEB angioplasty for BTK interventions for CLI did not show superiority in the QALY gained at 12 months compared with CB angioplasty. The 6-month angiographic patency of target lesion and 12-month limb salvage rate were also similar. AFS was however significantly different at 12 months, in favor of the CB group.

Comparative Effectiveness of Drug-Coated Balloon vs Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A Meta-analysis

Purpose: To compare the effectiveness and safety outcomes of drug-coated balloon angioplasty (DCBA) vs conventional balloon angioplasty (BA) for arteriovenous fistula (AVF) stenosis. Materials and Methods: A systematic review was conducted of PubMed and Embase databases from 1966 to May 2019 to identify English-language articles evaluating DCBA vs BA for the treatment of AVF stenosis. Data extracted from each study were synthesized to evaluate target lesion revascularization (TLR), technical success, and mortality for the 2 approaches. Meta-analyses were performed on these outcomes using random effects models to estimate the odds ratios (ORs) and 95% confidence intervals (CIs). Subgroup and sensitivity analyses were performed. Results: Twelve studies [6 randomized controlled trials (RCTs) and 6 cohort studies] comprising 979 patients were included in this meta-analysis. The pooled results showed that AVFs treated with DCBA had significantly fewer TLRs at 6 months (OR 0.31, 95% CI 0.14 to 0.69, p=0.004) and 12 months (OR 0.45, 95% CI 0.21 to 0.97, p=0.04) than BA. The 2 approaches had similar technical success rates (OR 0.22, 95% CI 0.03 to 1.43, p=0.11). Additionally, the pooled OR of 12-month mortality was 0.71 (95% CI 0.20 to 2.51, p=0.60), indicating no significant difference between DCBA and BA. Subgroup analysis based on study design showed the superiority of DCBA to BA in cohort studies but not RCTs, which had high heterogeneity. Significant publication bias was found in the cohort studies. Conclusion: In de novo or recurrent AVF stenosis, DCBA appears to be an effective procedure associated with lower 6- and 12-month TLR compared with BA. However, larger and randomized controlled studies are warranted to draw definitive conclusions.

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infrapopliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was conducted. Medical databases and online content were last screened in September 2019. The primary safety and efficacy endpoint was amputation-free survival defined as freedom from all-cause death and major amputation. Target lesion revascularization (TLR) constituted a secondary efficacy endpoint. Summary effects were synthesized with a random-effects model. Some 8 randomized controlled trials with 1,420 patients (97% CLI) were analyzed up to 1 year follow-up. Amputation-free survival was significantly worse in case of paclitaxel (13.7% crude risk of death or limb loss compared to 9.4% in case of uncoated balloon angioplasty; hazard ratio 1.52; 95% confidence interval: 1.12-2.07, p = .008). TLR was significantly reduced in case of paclitaxel (11.8% crude risk of TLR versus 25.6% in control; risk ratio 0.53; 95% confidence interval: 0.35-0.81, p = .004). The harm signal was evident when examining the high-dose (3.0-3.5μg/mm2) devices, but attenuated below significance in case of a low-dose (2.0 μg/mm2) device. Actual causes remain largely unknown, but non-target paclitaxel embolization is a plausible mechanism.

CRT-200.04 Ultrasound Plasty to Improve Outcome of Percutaneous Angioplasty in Below-the-Knee Lesions: 24 Months Results of the ULYSSE Registry

To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound using a new dedicated ultrasound catheter following a conventional balloon angioplasty to treat calcified below-the-knee (BTK) lesions. The ULYSSE registry was a prospective, nonrandomized single-center registry that

Recanalization of flush and stent occlusions in the superficial femoral artery under real-time ultrasound guidance

Objectives. To evaluate the usefulness of real-time ultrasound (US) guidance in cannulating superficial femoral artery (SFA)flush and SFA in-stent occlusions. Methods. A total of 37 patients were treated under real-time US guidance, among whom 22 were treated for flush and 15 for stent occlusions. In all cases, the axial and longitudinal US images were examined to confirm the guidewire's location. Results. All attempts to cannulate lesions were successful. The initial and adjunctive procedures were conventional balloon angioplasty, catheter-directed thrombolysis with urokinase and conventional balloon angioplasty, stenting, stent grafting, drug-coated balloon (DCB) angioplasty, and rotational atherectomy and DCB angioplasty in 8, 4, 5, 2, 1, and 1 cases of the 22 flush occlusions, respectively, and in 9, 1, 0, 0, 2, and 0 cases of the 15 stent occlusions, respectively. No complications associated with the procedures occurred in any case. Conclusion. Real-time US guidance can be used for precise and effective cannulation of flush occlusions of SFA or totally occluded SFAin-stents with reduced extra-radiation exposure to the operator and patient.

Factors Related to the Success of Endovascular Therapy with Plain Old Balloon Angioplasty of Central Vein Stenosis in Haemodialysis Patients

Introduction: Central venous stenosis (CVS) or occlusion is a severe complication in hemodialysis patients, which significantly decreases the patency of all vascular dialysis access components, including arteries and branches, AV anastomosis, peripheral veins, and central veins. The main etiology of CVS is mostly secondary to the placement of temporary or permanent dialysis catheters in the subclavian vein, internal jugular vein, and femoral vein. Standard endovascular therapy for central venous stenosis is conventional balloon angioplasty. Method: This is a retrospective study using medical records from June 2013 to August 2018. Patients who underwent plain old balloon angioplasty (POBA) procedures in the CVS condition due to the installation of hemodialysis catheter access were included in this study. The analysis was performed to assess the characteristics and data distribution of each variable. Results: Significant factors related to the success of endovascular procedure in patients with central venous stenosis with POBA were the onset of clinical symptoms (&lt;3 months; p &lt;0.001), duration of catheter placement (&lt;2.5 months; p &lt;0.001), history of previous catheter placement (no more than once, p &lt;0.001), initial stenosis (&lt;80; p &lt;0.001), and diameter of POBA (≥ 10 mm; p &lt;0.001). Conclusion: Some factors influenced the success of the POBA procedure for overcoming CVS. The need to understanding the use of hemodialysis catheter access according to the guideline is important. Keywords: central venous stenosis, endovascular therapy, plain old balloon angioplasty

Drug Coated Balloons vs. Conventional Balloon Angioplasty for Bypass Vein Graft stenosis – A Randomized Controlled Trial

Introduction - Stenosis and restenosis are known complications of endovascular treatment of native arteries and bypass vein grafts in peripheral arterial disease (PAD). (1,2) This may lead to loss of the bypass graft, which can be a problem due to the limited availability of autologous vein material. Drug-coated balloons seem to be effective in the treatment of native artery stenosis (3). The biomechanical and anatomical properties of vein grafts differ greatly from native arteries, and less is known about the potential of drug-coated devices in this field. One randomized trial did not demonstrate benefit from use of DCBs over BA in bypass vein grafts. (4) Similar results were observed in a retrospective study comparing BA to DCB in peripheral grafts (5). The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of vein graft stenoses. Design: Single-center, parallel, randomized controlled trial. Block randomized by sealed envelope 1:1. Methods - 60 patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to drug-coated balloon (DCB) (n=30) or standard balloon angioplasty (BA) (n=30). Follow-up was 1 year. Primary outcome measures were target lesion revascularization (TLR) and graft occlusion. Primary assisted patency and secondary patency were also assessed. Results - 57 cases were ultimately included in the study. 3 randomized cases were excluded due to primary technical failure (graft rupture during predilatation and bail-out stenting (N=2), aborted procedure (N=1)). Six patients died during follow-up (DCB 4, BA 2) and one patient underwent major amputation (BA group). 23 patients underwent re-revascularization of the same segment (DCB 10/29, 34.5 % vs. BA 13/28, 46.4 %, p=0.333). The overall TLR-rate at one year was 34.5 % and 46.4 % in the DCB and BA groups respectively (p=0.33). 5/57 (8.8 %) grafts occluded during the follow-up, 1/29 (3.4 %) and 4/28 (14.3 %) in the DCB and BA groups respectively (p=0.36). Secondary patency was 100 % in the DCB group compared to 89.3% in the BA group (p=0.076). In subanalysis including only de novo lesions TLR was significantly lower in grafts that were treated with DCB compared to BA (15 % vs. 18.9 %, P=0.03). Conclusion - There is a trend toward benefit from DCBs in the treatment of graft stenosis; this difference is significant in previously untreated lesions. There has been hesitation towards using drug-coated balloons as a first choice in the treatment of graft stenosis. Our results suggest that this hesitation might be unfounded, especially in de novo lesions. More data is needed to accurately select which lesions will benefit from DCBs. Furthermore; histological studies on paclitaxel uptake and response in the arterialized venous wall are warranted.

Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease

BackgroundAtherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment. MethodsIn this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up. ResultsThis real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04). ConclusionsBoth DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.

Turbo-Power™ Laser Atherectomy Combined with Drug-coated Balloon Angioplasty is Associated with Improved One-Year Outcomes for the Treatment of Tosaka II and III Femoropopliteal In-stent Restenosis

BackgroundFemoropopliteal (FP) artery in-stent restenosis (ISR) is associated with high rates of re-intervention and occlusion. The combined use of laser atherectomy (LA) with balloon angioplasty (BA) is superior to conventional balloon angioplasty (BA). Drug-coated balloons (DCBs) when combined with LA have provided additional efficacy for the treatment of FP-ISR. The aim of this study was to investigate the combination of DCB + LA with the recently approved Turbo-Power™ (Spectranetics Inc., Colorado Springs, CO, USA) LA device. MethodsThis was a dual-center retrospective study enrolling 78 consecutive patients with Tosaka type II (n = 18) or III (n = 60) FP-ISR. The lesions were treated with either Turbo-Power™ LA followed by DCB (n = 27) or with other LA devices followed by plain BA (LA + BA; n = 51) from 2015 to 2017. A Cox regression analysis was performed to examine the association between the two groups in terms of target lesion revascularization (TLR) and occlusion rates over a follow up period of 12 months. Kaplan-Meier survival curves were estimated and compared with the log-rank test. ResultsThe overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™ + DCB: 7.4% vs LA + BA: 11.8%, p = .7). The 12-month KM estimates for freedom from TLR were 90.9% in the Turbo-Power™ + DCB group vs 55.7% in the LA + BA group (p = .005). Among Toasaka III lesions, the 12 m-KM survival estimates for freedom from TLR were 88.9% in the Turbo-Power™ + DCB group vs 54.2% in the LA + BA group (p = .009). The 12 m-KM estimates for freedom from re-occlusion were 89.0% in the Turbo-Power™ + DCB group vs 58.9% in the LA + BA group (p = .070). ConclusionsTurbo-Power™ laser atherectomy combined with DCB exerted synergistic mechanism of actions and improved 12-month TLR rates for the treatment of complex FP-ISR lesions.

Drug-coated balloon angioplasty superior to conventional balloon angioplasty for stenotic arteriovenous fistula lesions: With caution

The key finding of this study is that stenotic peripheral arteriovenous fistulas (AVF) lesions treated with drug-coated balloon angioplasty (DCB) had a significant improvement in the 6-month and 12-month primary patency rates when compared with those lesions treated with conventional balloon angioplasty.1 Treatment of central venous stenosis was also significantly improved with DCB, although this is more controversial because there are no large diameter drug-coated balloons (10-14 mm) that are approved in the United States.

Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease

BackgroundWith the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons. MethodsThis is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest. ResultsIn total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017). ConclusionsPatients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States.

IF03. Prospective Randomized Controlled Trial Comparing Drug-Eluting Versus Conventional Balloon Angioplasty Below the Knee in Critical Limb Ischemia: The 6-Month Results

To report the 6-month Results of a prospective randomized, controlled trial comparing drug-eluting balloon (DEB) angioplasty versus conventional balloon (CB) angioplasty for below the knee arteries in patients with critical limb ischemia (CLI). In this investigator-initiated, prospective, multicenter, randomized controlled trial (NCT02129634), 138 CLI patients (93 males and 45 females) with a mean age of 62.6 years (standard deviation [SD], 9.9), were randomized 1:1 to either DEB group (n = 70) or CB group (n = 68). Of these patients, 94.2% were diabetics and 52.9% had end-stage renal failure. The primary end point was angiographic primary patency rate of target lesions at 6 months. Efficacy analysis was analyzed by generalized linear model adjusted for end-stage renal failure status in an intention-to-treat population. Missing data for primary end point was imputed by multiple imputation. Patient demographics were similar between the two groups. The mean lesion length treated was 90.3 mm (SD, 73.9) for the DEB group and 81.8 mm (SD, 71.8) for the CB group (difference, 8.5 mm; 95% confidence interval [CI], -16.2 to 33.2; P = .498). There was no statistical difference in the 6-month angiographic patency rates (DEB 41.9% vs CB 37.8%; risk difference, 6.2%; 95% CI, -11.0% to 23.4%; P = .479) and 6-month limb salvage rates (DEB 77.9% vs CB 84.8%; risk difference, 8.8%; 95% CI, -21.7% to 4.7%; P = .188). The 6-month amputation-free survival was worse in the DEB group and the difference was statistically significant (DEB 69.6% vs CB 80.3%; P = .030). The serious adverse event rate at 6 months was similar between the two groups. Our data showed no statistically significant differences in 6-month target lesion angiographic patency and limb salvage rate between DEB and CB groups in below the knee angioplasty for CLI. However, the 6-month amputation-free survival is significantly worse in the DEB group.

Prognostic Impact of Scoring Balloon Angioplasty After Rotational Atherectomy in Heavily Calcified Lesions Using Second-Generation Drug-Eluting Stents: A Multicenter Registry-Based Study

We aimed to assess the impact of scoring balloon angioplasty (SBA) after rotational atherectomy (RA) on long-term clinical outcomes in patients who underwent percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES). The long-term outcomes associated with SBA after RA in severely calcified lesions is unknown. Using the J2T ROTA registry data, we evaluated the clinical events of patients who underwent PCI using RA for heavily calcified lesions from January 2004 to December 2015. A total of 307 patients who underwent PCI with second-generation DES were analyzed and divided into the SBA (n = 96) and conventional balloon angioplasty (CBA) groups (n = 211). Eighty-two and 189 patients comprised the "SBA after small burr (SBA-SB)" and "CBA after small burr (CBA-SB)" subgroups, respectively, for the subgroup analysis. Study endpoints were incidence of 3-year major adverse cardiac events (MACE), target vessel revascularization (TVR), and target lesion revascularization (TLR). Kaplan-Meier analysis revealed that the incidence of 3-year cumulative MACE, TVR, and TLR were comparable between groups, and that the incidences of 3-year cumulative MACE, TVR, and TLR were significantly lower in the SBA-SB subgroup than in the CBA-SB subgroup (log-rank p = 0.008; log-rank p = 0.047; log-rank p = 0.045; respectively). Multivariate Cox regression model indicated that SBA after RA was an independent predictor of MACE (hazard ratio: 0.337; 95% confidence interval: 0.139 to 0.817; p = 0.016). Additional SBA following RA was associated with lower MACE incidence in patients undergoing RA with a small-sized burr.

Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Purpose: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty. Materials and Methods: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting. Results: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting. Conclusion: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed.