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Purpose: Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world experiences. Real-world evidence from a larger cohort is lacking, so we aimed to evaluate the real-world acute performance of IVL in the treatment of calcified PAD., Materials and Methods: The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm study. Patients with claudication or critical limb-threatening ischemia (CLTI) and at least moderate calcification were eligible. Independent predictors of procedural outcomes were assessed by multivariable analysis., Results: Between November 2017 and June 2021 across 30 global sites, 1373 patients with 1677 lesions (1531, 91.3% core lab evaluable) were enrolled. Diameter stenosis and lesion length was 80.6±17.6% and 93.5±74.3 mm, respectively. Target vessels included femoropopliteal (61%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Lesion characteristics included 31.1% chronic total occlusions (CTOs) and 19.3% long lesions (≥15 cm). At final assessment, residual stenosis was 23.8±11.3%, with 0.9% serious angiographic complications, no abrupt closures, distal embolization, no flow, or thrombotic events. Independent predictors of ≤30% residual stenosis were lesion length ≥15 cm (odds ratio [OR]=0.384), female sex (OR=1.850), age ≤75 years (OR=1.625), IVL balloon to artery ratio ≥1.0 (OR=1.538), and CTO lesions (OR=0.638). Lesion length ≥15 cm (OR=16.076) was an independent predictor of procedural complications., Conclusions: The Disrupt PAD III OS represents the largest assessment of IVL periprocedural outcomes in calcified PAD. It confirmed excellent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds., Clinical Impact: This final analysis of the PAD III OS represents the largest report of peripheral IVL utilization in daily clinical practice. The outcomes of this study indicate that previously reported procedural results in clinical trial settings can be translated to a broader patient population. Treatment with peripheral IVL in severely calcified stenotic lower limb lesions demonstrated consistent acute safety and stenosis reduction, even in complex patients across multiple vessel beds. In addition, the importance of proper IVL balloon sizing to achieve excellent acute stenosis reduction was confirmed by multivariate analysis., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.J.A. is a consultant to Abbott Vascular, BD Bard, Boston Scientific, Gore, Medtronic, Philips, and Shockwave Medical. S.A.P. receives institutional research support from Abbott Vascular, Boston Scientific, Shockwave Medical, TriReme Medical, Surmodics, Veryan Medical, MedAlliance, Concept Medical, and Acotec. He serves as an advisor to Abbott Vascular, Boston Scientific, BD, Cordis, Medtronic, Philips, and R3 Medical. He is a consultant to Terumo, Penumbra, Inari, and Canon and has equity in Advanced Nanotherapies, eFemoral, and Encompass Vascular. G.A. is a consultant and has education responsibilities for Shockwave Medical, Abbott Vascular, Phillips, and is CMO of Cordis. P.A.S. is a consultant to AngioSafe, Boston Scientific, Cordis, Endologix, Shockwave Medical, and W.L. Gore. He is on the Advisory Board of AngioSafe, Endologix, and Shockwave Medical. He receives institutional research support from Boston Scientific, Contego Medical, Endologix, MedAlliance, Micromedical Solutions, Philips, Reflow Medical, Shockwave Medical, SoundBite, and W.L. Gore. S.S.M. is a consultant for Shockwave Medical, Philips, Cardiovascular Systems Inc., and Medtronic. N.W.S. receives educational and research grants from Angiodynamics, Boston Scientific, Bard/BD, and Abbott and is an investigator on several Shockwave Medical studies. He is a consultant to Cardiovascular Systems, Inc, Abbott, Angiodynamics and Bard. A.M. is a consultant and trainer for Abbott, Phillips, and a speaker for Janssen. B.B. is a consultant and trainer for Medtronic Vascular, and a speaker for Shockwave Medical. W.A.G. is a consultant for Alucent, Boston Scientific Corporation, Edwards Lifesciences, efemoral, Medtronic, Phillips, W.L. Gore and Associates, Inc, and Shockwave Medical. He is performing contracted research for Boston Scientific Corporation, Edwards Lifesciences LLC, Medtronic, Phillips, and Shockwave Medical. G.T. is on the advisory board for BSC, Medtronic, and receives study support from B.Braun, Bold, BSC, Biotronic, Verian, Philips, and Shockwave Medical. E.Y.W. has no disclosures. J.F.M. has no disclosures. A.H. is a Medical Advisory Board Member for Medtronic, Gore, Philips, and Boston Scientific. He is a clinical investigator for Abbott, Bard-BD, Biotronik, Boston Scientific, Cagent, Cook, Efemoral, Endologix, Endospan, FluidX, Gore, Medtronic, Nectero, Philips, Reflow Medical, Shape Memory, Shockwave, Terumo, and TriReme. S.A.P. is a Clinical Trial Investigator for Abbott Vascular, Acotec, Boston Scientific, Concept Medical, MedAlliance, and Shockwave Medical. He is consulting or part of advisory boards for Abbott Vascular, Boston Scientific, Cordis, Medtronic, and Philips; receives grants or research support from Abbott Vascular, Shockwave Medical, Surmodics, and TriReme; conducts contracted research for Acotec, Concept Medical, and MedAlliance; a speaker for Inari, Penumbra, Shockwave Medical, and Teruma; and he is part of a DSMB for Boston Scientific.

Purpose: To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions., Methods: A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100-450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100-350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories., Results: In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category., Conclusion: DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Purpose: To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries., Methods: The angiograms obtained in the THUNDER study (ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up. Furthermore, target lesion revascularizations (TLR) were documented up to 2 years., Results: In each group, 24 (56%) patients had a dissection after the intervention. At the 6-month follow-up, patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss (0.4 mm) than patients with dissection after treatment with uncoated balloons (1.9 mm, p=0.001) and a lower degree of stenosis (20% vs. 51%, respectively; p=0.003). Patients with severe dissection (grades C, D, or E) especially seemed to benefit from the PCBs, with late lumen loss of 0.4 mm vs. 2.4 mm for controls (p=0.05). The binary restenosis rate was also markedly lower in the PCB group (20%) than in the uncoated group (55%, p=0.02). In the 2-year follow-up, TLR was performed in 56% of patients in the control group compared to 10% of patients in the PCB group (p=0.002)., Conclusion: The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation.

Purpose: To present the 12-month results of a trial investigating the effects of dual antiplatelet therapy on target lesion revascularization (TLR) after balloon angioplasty ± stenting in the femoropopliteal segment., Methods: A prospective, randomized, single-center, double-blinded and placebo-controlled clinical trial randomly assigned 40 patients to receive pre- and postinterventional therapy with aspirin and clopidogrel. Another 40 patients received the same doses of aspirin and placebo instead of clopidogrel. Clopidogrel and placebo were stopped after 6 months, and patients remained on aspirin only. At 12 months after the intervention, 36 clopidogrel patients and 37 placebo patients were reevaluated., Results: At 6 months, clopidogrel patients had significantly lower rates of TLR compared to placebo patients [2 (5%) vs. 8 (20%), p=0.04]. After stopping clopidogrel/placebo after 6 months, there was no significant difference in TLR at 12 months after treatment [9 (25%) clopidogrel vs. 12 (32.4%) placebo, p=0.35]. Mortality was 0 vs. 1 in the placebo group at 6 months (p=0.32) and 0 vs. 3 at 12 months (p=0.08)., Conclusion: In contrast to the first report of a reduction in the TLR at 6 months, this advantage of dual antiplatelet therapy does not persist after stopping clopidogrel. Prolonged dual therapy (>6 months) should be considered in patients who are at high risk for restenosis.

Purpose: To provide evidence for the safety and efficacy of the Proteus embolic capture balloon in lower limb interventions and to evaluate its indications for use., Methods: The study was designed as a prospective, multicenter, non-randomized, single arm study enrolling 123 patients (78 men; mean age 68 years). The primary endpoint was rate of freedom from death, amputation, and target vessel revascularization (TVR) at 30 days post procedure. Follow-up was performed at 30 days and at 12 months., Results: The freedom from death, amputation, and TVR rate was 95.9% (118/123). Procedure and device success rates were 98.7% (218/223) and 97.8% (156/158), respectively. TVR and death rates at 12 months were 18.8% and 4.1%, respectively. Histological analysis identified particles in 100% of the balloons. The median number of particles per subject was 339 (range 63-4361). Medians of particle size and total particle area were 0.8 (range 0.3-8.3) and 1.0 mm(2) (range 0.1-237) per balloon, respectively. Particles >1 mm were found in 37% (53/143) of the balloons analyzed. Higher mean number, length, and surface area of particles were found in long lesions (909±1057, 2.6±2.3 mm, and 18.2±44.2 mm(2), respectively; all p<0.0001 vs. short lesions). Additionally, longer particles were found in total occlusions (2.5±2.5 mm, p<0.0001), and a higher mean particle count was found in thrombotic lesions (1785±1821, p<0.05). De novo lesions had more thrombotic material than any other type of lesion., Conclusion: Proteus demonstrated good particle capture ability, making it a useful tool in situations where embolism is anticipated, such as complex lesions with calcified or thrombotic material and/or lesions with high plaque burden (i.e., long and totally occluded).

Purpose: To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery., Methods: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41-87) with femoropopliteal CTOs averaging 86 mm in length (range 10-340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate., Results: The primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time for successful crossing was 5.3 minutes (range 0.4-22). Of the 32 cases successfully crossed with the ENABLER-P System, all but 1 was successfully recanalized. One (3%) device-related complication occurred when the wire was advanced into a side branch when treating a 300-mm-long flush ostial SFA occlusion; the resulting perforation was managed with a covered stent without further sequelae., Conclusion: This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral CTOs.

Purpose: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov )., Methods: The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites., Results: Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months., Conclusions: These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Purpose: To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents., Methods: Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months., Results: Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups., Conclusion: These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.

Purpose: To evaluate the technical performance, safety, and 1-year clinical efficacy of polytetrafluoroethylene (PTFE)-covered nitinol stents in the treatment of atherosclerotic iliac and superficial femoral artery (SFA) disease., Methods: The multicenter, prospective, nonrandomized COVENT study involved 98 patients (70 men; mean age 64+/-10 years) who received PTFE-covered nitinol stents in 107 arteries (60 iliac and 47 SFAs) after predilation. The average lesion length was 50 mm in the SFA and 45 mm in the iliac arteries. Postdilation was performed when necessary. Duplex ultrasound and ankle-brachial index (ABI) were performed at discharge and at 1, 6, and 12 months in follow-up., Results: In total, 130 stents were placed successfully in 97 (99%) of 98 patients. One stent was misplaced during deployment and required subsequent surgical removal. The average stenosis grade was reduced from 98% to 6% in the SFAs and from 96% to 4% in the iliac arteries after covered stent placement. There was a significant rise of the mean ABI from 0.64 at baseline to 0.97 and 0.95 at 1 and 12 months, respectively (p<0.001). There were 7 primary covered stent occlusions (6.5% of 107 stented lesions: 3 not treated, 2 bypassed, 2 dilated or stented) and 5 (4.7%) recurrent in-stent occlusions (1 bypassed, 2 dilated, 2 untreated) during the 1-year follow-up. Primary patency rates were 92% at 6 months and 89.8% at 12 months for the entire cohort. Secondary patency rates were 98% and 95.6%, respectively. No statistically significant differences were observed in the primary patency rates for the SFAs (89.3% at both 6 and 12 months) versus the iliac arteries (94.3% at 6 months and 90.7% at 12 months)., Conclusions: Primary implantation of PTFE-covered nitinol stents in the iliac and superficial femoral arteries is technically feasible, safe, and effective, with excellent 1-year patency.