Percutaneous Transluminal Angioplasty Group Research Articles

Optimal endovascular therapy technique for isolated intracranial atherothrombotic stroke-related large vessel occlusion in the acute to subacute stage.

Reocclusion after treatment is a concern in endovascular therapy (EVT) for isolated intracranial atherothrombotic stroke-related large vessel occlusion (AT-LVO). However, the optimal EVT technique for AT-LVO has not yet been investigated. This study evaluated the optimal EVT technique for AT-LVO in a real-world setting. We conducted a historical multicenter registry study at 51 centers that enrolled patients with AT-LVO. We divided the patients into three groups based on the EVT technique: mechanical thrombectomy alone (MT-only), percutaneous transluminal angioplasty (PTA), and stent deployment (Stent). MT alone was classified into the MT-only group, PTA and MT-PTA into the PTA group, and MT-Stent, MT-PTA-Stent, PTA-Stent, and Stent-only into the Stent group. The primary outcome was the incidence of reocclusion of the treated vessels within 90 days of EVT completion. We enrolled 770 patients and analyzed 509 patients. The rates in the MT-only, PTA, and Stent groups were 40.7, 44.4, and 14.9%, respectively. The incidence rate of residual stenosis >70% of final angiography was significantly higher in the MT-only group than in the PTA and Stent groups (MT-only vs. PTA vs. Stent: 34.5% vs. 26.3% vs. 13.2%, p=0.002). The reocclusion rate was significantly lower in the PTA group than in the MT-only group (adjusted hazard ratio [95% confidence interval], 0.48 [0.29-0.80]). Of the patients, 83.5% experienced reocclusion within 10 days after EVT. Alarmingly, a substantial subset (approximately 62.0%) of patients underwent reocclusion within 2 days of EVT. The incidence of modified Rankin scale scores of 0-2 90 days after EVT was not significantly different among the three groups. The incidences of symptomatic intracranial hemorrhage (ICH), any other ICH, and death were not significantly different. The incidence rate of reocclusion was significantly lower in the PTA group than in the MT-only group. We found no significant difference in reocclusion rates between the Stent and MT-only groups. In Japan, GP IIb/IIIa inhibitors are not reimbursed. Therefore, PTA might be the preferred choice for AT-LVOs due to the higher reocclusion risk with MT-only. Reocclusion was likely to occur within 10 days, particularly within 2 days post-EVT. EVT = endovascular treatment; LVO = large vessel occlusion; MT = mechanical thrombectomy; PTA = percutaneous transluminal angioplasty; ICH = intracranial hemorrhage; SD = standard deviation; IQR = interquartile range; HRs = hazard ratios; BMI = body mass index; LDL = low-density lipoprotein; HDL = high-density lipoprotein; DAPT = dual antiplatelet therapy; TAPT = triple antiplatelet therapy.

IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months

PurposeTo present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA. Materials and MethodsParticipants at 29 international sites were randomized 1:1 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit. ResultsTLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P < .001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P < .001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P = .040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P = .71). ConclusionsThis study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.

Comparison of percutaneous transluminal angioplasty and surgical revision after intraoperative dilatation with biliary tract probes for arteriovenous fistula stenosis at juxta-anastomosis.

Percutaneous transluminal angioplasty (PTA) is widely used for stenosis of vascular access (VA) for hemodialysis. We aimed to evaluate the effectiveness of both PTA and surgical revision after intraoperative dilatation with biliary tract probes for juxta-anastomotic stenosis in autogenous radiocephalic arteriovenous fistulas (RCAVFs). We performed a retrospective analysis of PTA and surgical revision after intraoperative dilatation with biliary tract probes; these were the first interventions after RCAVF establishment in 112 patients with juxta-anastomotic stenosis. Anatomical (number of stenoses) and clinical variables (age and gender of the patient, time of hemodialysis, AVF age, presence of diabetes mellitus, and cause of end-stage renal disease) were reviewed. Technical success, clinical success, and post-intervention primary patency were evaluated. Our study enrolled 35 patients in the PTA group and 77 patients in the surgical revision group. Clinical and technical success rates of both groups were 100%. There were no complications, such as bleeding or hematomas. Using the Kaplan-Meier method, the post-intervention primary patency rates at 3, 6, 9, 12, 18, and 24months in the PTA group were 100%, 94.28%, 77.1%, 60%, 54.29%, and 45.71%, respectively, and those in the surgical revision group were 100%, 94.81%, 92.2%, 90.91%, 81.82%, and 76.62%, respectively. The post-intervention primary patency rates at 9-24months in the surgical revision group were significantly higher than those in the PTA group (χ2 = 19.04, p < 0.0001). The post-intervention long-term primary patency rate of surgical revision after intraoperative dilatation with biliary tract probes is higher than that of PTA for the first intervention of patients with juxta-anastomotic stenosis in RCAVFs. The surgical revision method is safe and effective, especially in hospitals that have not yet carried out PTA.

Cardiovascular Disease Prevention in Patients With Atherosclerotic Renovascular Disease-Induced Resistant Hypertension: Further Considerations for 24-Hour BloodPressure Profiles.

Cardiovascular Disease Prevention in Patients With Atherosclerotic Renovascular Disease-Induced Resistant Hypertension: Further Considerations for 24-Hour BloodPressure Profiles.

IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons

PurposeTo present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Materials and MethodsAfter successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit. ResultsAt 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29–0.60; P < .001). ConclusionsTLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae.

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial.

Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions. The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI). The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR). Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm. The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs. gov: NCT02963649.

No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes

Background: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited. Objectives: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT). Methods: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected. Results: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929). Conclusions: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

FEMOROPOPLITEAL ANGIOPLASTY VS OPEN SURGERY FOR CHRONIC LIMB-THREATENING ISCHEMIA.

The aim: To compare the results of femoro-popliteal PTA vs open surgery in chronic limb-threatening ischemia (CLTI) and analyze clinical efficacy long-term results. Materials and methods: Between 2018 - 2019, 145 patients with CLTI who underwent femoro-popliteal arterial segment steno-occlusive lesions (SOL) unilateral revascu¬larization. Open surgery were performed for - 48 (33, 1℅), percutaneous transluminal angioplasty (PTA) for - 73 (50.3%), and were treated with hybrid surgical interventions for - 24 (16.6%). Results: During the analysis, no statistically significant difference was found among the three groups patients indicators. According to the diabetes patients indicator, the differences among the groups are statistically significant (p<0.001), diabetes was present in only 16.7% of open surgical intervention group patients, 45.8% of PTA group patients, 54.8% of the hybrid surgery group patients. In the overall comparison 2-year limb preservation after open surgery 93.8%, after PTA 91.7%, and after hybrid surgery 91.6%; amputations: open surgery - 6.2% PTA- 8.2 %, hybrid surgery -8.3%; exemption from surgical re-intervention: open surgery - 68.7%, PTA- 58.9%, hybrid surgery - 75%. There were no differences in limb preservation and amputation between open surgery, hybrid intervention, and PTA. A difference was found only in reintervention tactic among the open surgery and PTA groups as opposed to the hybrid surgery. Сonclusions: Limb salvage and CLTI patients survival after open surgery and PTA who were not performed major amputation in 2 years term after revascularization were comparable regardless of treatment method.

Drug-Coated Balloon Angioplasty Versus Standard Uncoated Balloon Angioplasty for Long Femoropopliteal Lesions: Post Hoc Analysis of the 24-Month Results of the AcoArt I Study

Restenosis is a common complication after endovascular treatment of peripheral artery disease. Drug-coated balloon (DCB) treatment has been proven safe and effective in reducing the rate of restenosis for simple and short lesions. However, the clinical results of DCBs for long lesions are still very limited. This study aimed to evaluate the efficacy and safety of DCBs in the treatment of long femoropopliteal artery disease. And the results of this study will also complement the existing evidence of DCB treatment of long lesions. Patients with lesion length ≥ 15cm according to computed tomography angiography (CTA) or angiography in the AcoArt I Study were included into this study. Based on the balloon catheter used in treatment, patients were divided into the DCB group and the percutaneous transluminal angioplasty (PTA) group. The demographic, lesion, and procedural characteristics and 24-month follow-up results were compared between the 2 groups. The primary efficacy endpoints were angiographic late lumen loss (LLL) at 6 months or at the time of clinically driven target lesion revascularization (CD-TLR), primary patency (PP), freedom from CD-TLR, and changes in the ankle-brachial index (ABI) and Rutherford class during 24 months of follow-up. The safety endpoint was the occurrence of major adverse events. The total number of patients was 87, including 42 in the DCB group and 45 in the PTA group. There were no significant differences between the 2 groups in demographic, lesion,and procedural characteristics. The 6-month follow-up angiography showed that the LLL was significantly smaller in the DCB group than the PTA group (0.27 ± 0.90 mm vs 1.32 ± 0.91 mm; P < 0.001). At 24 months, compared with the PTA group, the DCB group had a significantly higher rate of freedom from CD-TLR (81.58% vs 43.18%; P < 0.001) and a significantly higher PP rate (46.88% vs 15.00%; P=0.003). The DCB group had a significantly higher ABI than the PTA group at 6, 12, and 24 months (P < 0.001, P=0.004 and P=0.018, respectively). The DCB group had a better Rutherford class than the PTA group at 6 and 12 months (P=0.033 and P=0.012, respectively); the Rutherford class did not significantly differ between the 2 groups at 24 months (P=0.127). The incidence of major adverse events did not significantly differ between the 2 groups. The effectiveness of the DCB is superior to a standard uncoated balloon in treating long lesions during 24 months of follow-up. Furthermore, the safety of the DCB is equivalent to that of PTA.

Covered Stents vs. Angioplasty for Common Iliac Artery In Stent Restenosis: A Retrospective Comparison

The optimal endovascular treatment for common iliac artery in stent re-stenosis has yet to be assessed. Treatment options include, among others, angioplasty alone and repeated stenting with covered stents. This study retrospectively compared patency and target lesion revascularisation of these treatments. All patients who underwent endovascular treatment of common iliac artery in stent re-stenosis between 2007 and 2017 were included retrospectively. The primary end point was freedom from re-stenosis. Secondary endpoints were target lesion revascularisation rate (TLR) and freedom from occlusion during follow up. Seventy-four interventions were included, consisting of 37 angioplasties and 37 covered stent placements in 57 patients. Freedom from re-stenosis at four years was 72.6% (95% confidence interval [CI] 51.8% - 88.7%) in the covered stent group vs. 43.5% (95% CI 25.9% - 59.8%) in the percutaneous transluminal angioplasty (PTA) group (p= .003). The target lesion revascularisation (TLR) rate was 16.4% (95% CI 7.1% - 35.6%) and 43.6% (95% CI 28.0% - 63.2%) respectively (p= .020). There was no difference in freedom from occlusion; this was 90.8% (95% CI 73.9% - 97.0%) in the covered stent group and 79.1% (95% CI 58.4% - 90.3%) in the PTA group (p= .49). The difference in freedom from re-stenosis and TLR remained significant after sensitivity and multivariable analyses. Covered stents offer better outcomes for common iliac artery in stent re-stenosis than angioplasty alone.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial

Randomized, controlled, multicenter trial at 45 centers in Austria, Germany, New Zealand, and the United States between February 2017 and May 2020 (Shockwave Medical Peripheral Lithoplasty System Study for PAD, Santa Clara, California [Disrupt PAD III]). There were 306 patients with moderate or severe calcification in a femoropopliteal artery who were allocated randomly to vessel preparation with intravascular lithotripsy (IVL) (n = 153) or percutaneous transluminal angioplasty (PTA) (n = 153) followed by definitive treatment with a drug-coated balloon or provisional stenting. Procedural success (66% vs 50%) and the percentage of lesions with residual stenosis of no more than 30% (66% vs 52%) were significantly greater in the IVL group, whereas flow-limiting dissections occurred significantly more frequently in the PTA group (1% vs 7%) after dilatation (5% vs 17%) and stent placement (5% vs 18%) were significantly greater in the PTA group. IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries.

Effect of umbilical cord blood stem cell transplantation on restenosis after endovascular interventional therapy for diabetic hindlimb vascular disease.

This study aimed to investigate the mechanism of human umbilical cord blood stem cell (HUCBSC) transplantation on restenosis after percutaneous transluminal angioplasty (PTA) for diabetic hindlimb vascular disease in rabbits. After successfully preparing a rabbit model of diabetic hindlimb vascular disease, 16 rabbits were randomly assigned to two groups. Of these, 8 rabbits received PTA surgery alone (PTA group), and the other 8 rabbits received PTA and HUCBSC (PTA+HUCBSC group) treatments. Five more healthy rabbits were set as healthy control (HC group). Samples were collected after 4 weeks of treatment. The expressions of regulator of calcineurin 1 (RCAN1) and calcineurin A (CnA) in the diseased artery were detected by immunofluorescence staining. The distribution of HUCBSCs was observed by pathological examination in transplanted artery, distal artery, and liver. Cytology experiments were applied to assess the levels of JAK and STAT3, and the migration and proliferation of human aortic vascular smooth muscle cells (HA-VSMC). In the rabbit model of diabetic vascular lesions in the hindlimbs, we found the stenosis of the femoral artery became more and more serious with time, and the expression level of PCNA positive cells was also gradually increased. The expression levels of RCAN1 and CnA in the PTA+HUCBSC group were significantly lower than those in PTA group. HUCBSC inhibited the migration and proliferation of HA-VSMC via JAK/STAT3 pathway. After HUCBSC local transplantation, HUCBSC had no distal tissue distribution. HUCBSC transplantation may prevent restenosis after PTA of diabetic hindlimb vascular disease through JAK/STAT3 pathway.

Virtual Reality-Assisted Percutaneous Transluminal Angioplasty for Interventional Treatment of Lower-Extremity Arteriosclerosis Obliterans.

This study was to evaluate the biomechanical characteristics of the vascular wall during virtual reality- (VR-) assisted percutaneous transluminal angioplasty (PTA) and its effect on the treatment of lower-extremity arteriosclerosis obliterans (LEAO). In this study, a three-dimensional (3D) model and a finite-element model of arteries were constructed first, and various fluid mechanics were analyzed. Then, the virtual expansion simulation (VES) of individualized PTA was performed based on the ABAQUS/Explicit module to analyze the interaction between the balloon and the blood vessel at different times and the changes in the vascular shape and structural stress distribution. Finally, an LEAO animal model was constructed. Based on conventional PTA (PTA group) and VR-assisted PTA (VR-PTA) treatment, the morphological changes of vascular lumen of the two animal models were evaluated. The results showed that the normal, stenotic blood vessels and blood models were successfully constructed; the pressure of the stenotic blood vessel at the stenosis decreased obviously and the shear stress of blood vessel wall increased compared with that of the normal blood vessels, and there may be a blood reflux area in the poststenosis stage. The simulation results of the VES showed that the maximum principal stress value at 3 mm of the marginal vessel was much lower than that at 5 mm (about 10% lower), so the maximum principal stress change within 2 mm of the balloon-expanded vessel was the most obvious. The treatment results of the animal model showed that the VR-PTA group showed an obvious increase in the diameter of the vascular lumen, a decrease in the intima and media area, and a decrease in the thickness of the vessel wall in contrast to the PTA group (P < 0.05), which had an important effect on the reconstruction and expansion of the vascular lumen. The VR-PTA treatment on LEAO was realized in this study, which provided critical reference for the follow-up application of VR technology in the evaluation of surgical plan and research on biomechanical mechanisms of restenosis after PTA.

Mid-term results and predictors of restenosis in patients undergoing endovascular therapy for isolated popliteal artery steno-occlusive disease

AbstractBackground and aimThere is only a limited number of major publications on the outcome of interventions for isolated popliteal artery stenosis. The purpose of this study was to report our results on mid-term patency and predictors of restenosis.Patients and methodsThis single-center retrospective study included 61 symptomatic patients (males, N = 33; median age, 65.1 years [IQR, 60.7–71.9 years]; Rutherford grade 4–6, N = 14) with at least two patent crural arteries, whose atherosclerotic stenoses/occlusions were treated with percutaneous transluminal angioplasty (PTA) or stenting (using self-expanding bare-metal Astron Pulsar stents) between 2011 and 2018.ResultsTwenty-six patients had PTA, while 35 underwent stenting. The median follow-up was 29 months (IQR, 10–47 months). The primary patency rates were not significantly different (P = 0.629) between PTA and stenting groups. Restenosis developed in nine patients (34.6%) in the PTA group, and in 12 (34.3%) in the stenting group. Restenotic lesions required re-intervention in nine cases (100%) in the PTA group, and in eight (66.7%) in the stenting group. Restenosis developed significantly less frequently (P = 0.010) in patients with a popliteal/P1 stent; the primary patency rates were also significantly better (P = 0.018) in patients with a popliteal/P1 stent when compared to popliteal/P2 plus multi-segment stents. Cox regression analysis identified lesion location as a predictor of in-stent restenosis (HR, 2.5; 95% CI, 1.2–5.5; P = 0.019).ConclusionStenting was not superior when compared to PTA (if selective stenting was not considered as loss of patency). Follow-up should be more thorough in patients undergoing popliteal/P2 or multi-segment stenting.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial.

The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease. Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification. The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis≤30% without flow-limiting dissection) prior to DCB or stenting. In patients receiving IVL (n=153) or PTA (n=153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p=0.01) and the percentage of lesions with residual stenosis≤30% (66.4% vs. 51.9%; p=0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p=0.03). Post-dilatation (5.2% vs. 17.0%; p=0.001) and stent placement (4.6% vs. 18.3%; p<0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p=0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p=1.0) at 30days were comparable between groups. IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193).

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group (n = 30) or percutaneous transluminal angioplasty group (n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

Abstract No. 493 Is there any benefit from VIATORR stent overdilation?

VIATORR stent has become the standard of care in transjugular intrahepatic portosystemic shunt (TIPS) placement due to its longer primary and secondary patency rates. However, TIPS shunt maintenance with percutaneous transluminal angioplasty (PTA) with or without stent extension may be needed in many patients. In our practice we routinely overdilate 10-mm VIATORR stents using a 12-mm high-pressure angioplasty balloon if the portosystemic pressure gradients are still inadequate after 10-mm PTA. We intend to retrospectively evaluate the efficacy and safety of this approach. IRB approval was obtained. We enrolled TIPS shunt revision cases with initial TIPS placement indication of either ascites or secondary variceal bleeding prophylaxis from 2010 to -2019. After applying exclusion criteria, 78 cases were recruited to this study, with 40 cases in the 10-mm PTA group as the control and 38 in the 12-mm PTA group. The post-procedural effect on hepatic encephalopathy, 30-day MELD scores and pertinent lab values including serum creatinine (sCr), total bilirubin (TBili), platelet count (PLT) and International Normalized Ratio (INR) plus the secondary patency duration were analyzed. Major and minor complications were evaluated to establish a safety profile. Baseline demographic characteristics of both patient groups were similar (P > 0.05). Multivariate logistic regression was conducted, which did not show any significantly different effect on hepatic encephalopathy, 30-day MELD score and lab values including sCr, TBili, PLT, or INR, or secondary patency duration between the 2 groups. Among all enrolled cases, there were no minor or major complication at 30-day follow-up. VIATORR stent overdilation with 12 -mm PTA may be a safe and effective technique to achieve the target intraprocedural portosystemic gradient when 10 -mm PTA is not adequate. This approach may avoid the need for a parallel TIPS placement procedure.

Percutaneous Transluminal Angioplasty In The Treatment Of Diabetic Foot

Background: Diabetic foot is the foot tissue damage, ulceration, secondary segmental necrosis in diabetic patients. The prevalence of diabetes is predominantly due to long-term high blood sugar, high blood lipids in the state, the systemic arterial prone to atherosclerosis, lower limb arteries are more prone to endometrial damage, and then there is stenosis or occlusion, distal extremity ischemia, Leading to diabetic foot ulcers. Objective: To assess the value of percutaneous transluminal angioplasty (PTA) in the surgical treatment of the diabetic foot. Methods: Retrospective analysis of 83 cases of diabetic foot patients, 95 limbs, 95 wounds were conscripted from September 2011 to September 2014 in our hospital. Rendering to whether the PTA treatment is not accepted PTA treatment of the conventional treatment group 43 cases (wound 51) and PTA treatment of PTA group 40 cases (44). The granulation growth rate of the wound was intended at 3, 6, 9, and 12 days after debridement. The spell of wound preparation was logged before operation. According to the Wagner classification, the survival rate of the skin graft and the healing of the suture in the 2 groups were statistically analyzed. Statistics of two groups of patients were followed up for six months, the monthly review of ABI, and ulcer recurrence. Data were processed with χ² test and t-test. Results: The good rate of granulation growth of the wound in the conventional treatment group was slower than that of the control group. The good granulation growth rate of the wound was less than 20% on the 12th day after treatment. The granulation growth rate of the wound in the PTA group increased visibly from the 9th day, all grow well. On the 9th and 12th day of treatment, the granulation growth rate of the wound in PTA group was ominously advanced than that in the conventional treatment group (P&lt;0.01). The time of wound preparation was (24 ± 10) days in the conventional treatment group, which was significantly higher than that in the PTA group (15 ± 3) days, t=5.709, P&lt;0.01. The Wagner 2,3,4 grade wounds were suggestively greater in the PTA group than in the conventional treatment group (χ2=6.741~24.498,P&lt;0.01). ABI was significantly higher in the PTA group than in the conventional treatment group (t=5.411~9.583,P&lt;0.01). There was no recurrence of the ulcer in the 4 months before the follow-up. There were 1 and 2 cases of ulcer recurrence in the 5- and 6-months follow-up. There was no recurrence in the PTA group after 6 months follow-up. Conclusion: PTA is effective in the surgical treatment of diabetic foot patients, and has assured clinical application value.

Percutaneous Transluminal Angioplasty in the Treatment of Diabetic Foot

Background: Diabetic foot is the foot tissue damage, ulceration, secondary segmental necrosis in diabetic patients. The prevalence of diabetes is predominantly due to long-term high blood sugar, high blood lipids in the state, the systemic arterial prone to atherosclerosis, lower limb arteries are more prone to endometrial damage, and then there is stenosis or occlusion, distal extremity ischemia, Leading to diabetic foot ulcers. Objective: To assess the value of percutaneous transluminal angioplasty (PTA) in the surgical treatment of diabetic foot. Methods: Retrospective analysis of 83 cases of diabetic foot patients, 95 limbs, 95 wounds were conscripted from September 2011 to September 2014 in our hospital. Rendering to whether the PTA treatment is not accepted PTA treatment of the conventional treatment group 43 cases (wound 51) and PTA treatment of PTA group 40 cases (44). The granulation growth rate of the wound was intended at 3, 6, 9, and 12 days after debridement. The spell of wound preparation was logged before operation. According to the Wagner classification, the survival rate of the skin graft and the healing of the suture in the 2 groups were statistically analyzed. Statistics of two groups of patients were followed up for six months, the monthly review of ABI, and ulcer recurrence. Data were processed with χ² test and t test. Results: The good rate of granulation growth of the wound in the conventional treatment group was slower than that of the control group. The good granulation growth rate of the wound was less than 20% on the 12th day after treatment. The granulation growth rate of the wound in the PTA group increased visibly from the 9th day, all grow well. On the 9th and 12th day of treatment, the granulation growth rate of the wound in PTA group was ominously advanced than that in the conventional treatment group (P &lt;0.01). The time of wound preparation was (24 ± 10) days in the conventional treatment group, which was significantly higher than that in the PTA group (15 ± 3) days, t = 5.709, P &lt;0.01. The Wagner 2, 3, 4 grade wounds were suggestively greater in the PTA group than in the conventional treatment group (χ2 = 6.741 ~ 24.498, P &lt;0.01). ABI was significantly higher in the PTA group than in the conventional treatment group (t = 5.411 ~ 9.583, P &lt;0.01). There was no recurrence of ulcer in the 4 months before the follow-up. There were 1 and 2 cases of ulcer recurrence in the 5 and 6 months follow-up. There was no recurrence in the PTA group after 6 months follow-up. Conclusion: PTA is effective in the surgical treatment of diabetic foot patients, and has assured clinical application value.

Angioplasty versus stenting for iliac artery lesions

Angioplasty versus stenting for iliac artery lesions