The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the ...efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions.
The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. The methodological quality of the included studies was evaluated with the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to assess the level of evidence for each outcome. The fixed effects model was chosen to combine the data when I2 < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results.
Four RCTs were included. The meta-analysis showed that atherectomy combined with BA was associated with improved technical success rate (risk ratio RR 0.22, 95% confidence interval CI 0.13-0.38, p < .001; I2 = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07–0.32, p < .001; I2 = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13–0.47, p < .001; I2 = 0; high quality). No statistically significant difference was found in target lesion revascularisation (TLR), primary patency, mortality, major adverse event (MAE), or ankle brachial index (ABI) after one year follow up.
Compared with BA alone, atherectomy combined with BA may not improve primary patency, TLR, mortality rate, or ABI, but may reduce the need for bailout stenting and the incidence of flow limiting dissection and increase the technical success rate in FP arterial diseases. More studies are warranted to further confirm the conclusion.
The authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD).
The midterm outcome of DCB versus ...uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated.
A total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events.
The DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events.
The superiority of DCB versus PTA in the efficacy of FPAD treatment persists at 24-month follow-up and the safety of DCB is equivalent to that of PTA.
In recent years, EVT has come to play an important role in revascularization of the femoropopliteal artery region, however the number of cases that cannot be treated with EVT is increasing, and the ...importance of bypass surgery has been reaffirmed. We will provide an overview of revascularization of the femoropopliteal artery region in accordance with JCS/JSVS 2022 Guideline on the Management of Peripheral Arterial Disease.
BACKGROUNDDrug-coated balloons (DCB) are frequently used to treat femoropopliteal artery disease. However, patency loss occurs in ≥10% of patients within 12 months posttreatment with poor ...understanding of the underlying mechanisms. OBJECTIVESThe authors sought to investigate the determinants of DCB failure in femoropopliteal disease. METHODSData from randomized clinical trials (IN.PACT SFA, MDT-2113 SFA Japan) and 2 prespecified imaging cohorts of the IN.PACT Global Clinical Study were included. Influential procedural characteristics were evaluated by an independent angiographic core laboratory. The primary endpoint was DCB failure (patency loss during follow-up). Additional endpoints were binary restenosis and clinically driven target lesion revascularization. Multivariable analyses evaluated the clinical, anatomical, and procedural predictors of DCB failure. RESULTSIncluded were 557 participants with single lesions and 12-month core laboratory-adjudicated duplex ultrasonography. Key clinical characteristics were as follows: mean age 68.8 years, 67.5% male, 87.6% with hypertension, 76.9% with hyperlipidemia, 40.5% with diabetes mellitus, 90.5% in Rutherford Classification Category (RCC) 2 to 3, and 9.5% in RCC 4 to 5. Average length and reference vessel diameter (RVD) were 16.37 cm and 4.66 mm, respectively; 49.7% of lesions were totally occluded. In multivariable analysis, only residual stenosis >30% was associated with patency loss, whereas residual stenosis >30% and smaller preprocedure RVD were associated with increased binary restenosis risk. RCC >3 and residual stenosis >30% were associated with increased 12-month clinically driven target lesion revascularization risk. CONCLUSIONSPatency loss after DCB treatment was influenced by procedural and clinical factors. Residual stenosis >30%, smaller preprocedure RVD, and higher RCC may be considered predictors of increased risk of DCB failure and its components in femoropopliteal artery disease. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease INPACT SFA I; NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery SFA and Proximal Popliteal Artery PPA INPACT SFA II; NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery MDT-2113 SFA; NCT01947478; IN.PACT Global Clinical Study; NCT01609296).
Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. The primary endpoint from ...the Disrupt PAD III randomized controlled trial (RCT) demonstrated superior procedural success in patients treated with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA). The present study evaluates primary patency after 1 and 2 years in this randomized population.
The Disrupt PAD III RCT enrolled 306 patients with moderately-to-severely calcified femoropopliteal arteries treated with IVL (n = 153) or PTA (n = 153) prior to DCB treatment or stenting. The powered secondary effectiveness endpoint was primary patency at 1 year, defined as freedom from clinically driven target lesion revascularization plus freedom from restenosis determined by duplex ultrasound. Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency.
Primary patency at 1 year was significantly greater in the IVL arm (80.5% vs 68.0%, P = .017). The requirement for provisional stenting was significantly lower in the IVL group (4.6% vs 18.3%, P < .0001). Freedom from clinically driven target lesion revascularization (IVL: 95.7% vs PTA: 98.3%, P = .94) and restenosis rates (IVL: 90.0% vs PTA: 88.8%, P = .48) were similar between the 2 groups at 1 year. At 2 years, primary patency remained significantly greater in the IVL arm (70.3% vs 51.3%, P = .003).
The Disrupt PAD III RCT secondary endpoint of superior 1-year primary patency was achieved, confirming the consistent safety and effectiveness of IVL followed by DCB treatment to facilitate a durable approach for patients with heavily calcified femoropopliteal arteries largely without stent requirement.
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•Disrupt PAD III compared endovascular therapy of calcified peripheral arteries.•Intravascular lithotripsy was superior to angioplasty for procedural success.•At 1 year, intravascular lithotripsy was superior for primary patency.•Intravascular lithotripsy is a safe and durable therapy for calcific plaque.
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 30 days 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)
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We evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD).
In this prospective, ...multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment.
During the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period.
We found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.
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The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation ...SP) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions.
This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months.
During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83-7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07-3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00-2.69, p=0.048).
By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons.
The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.
Purpose:
Despite widespread use of anti-restenosis devices, drug-coated balloons (DCBs) and drug-eluting stents (DESs), their appropriate use for femoropopliteal (FP) lesions has not been well ...investigated and the risk factors for restenosis have not been compared. To investigate risk factors associated with restenosis after endovascular therapy using DCB and DES for contemporary FP lesions.
Materials and methods:
This single-center, retrospective, observational study evaluated 378 FP lesions in 273 patients treated with DCB (278 lesions in 193 patients) or DES (120 lesions in 106 patients). The DCB used was high-dose DCB (IN.PACT, Admiral. Medtronic, Inc.) and DES was fluoropolymer-based DES (ELUVIA, Boston Scientific). Vessel preparation failure was defined as a residual stenosis of ≥50% and a dissection grade of D or greater on pre-dilatation angiography. The outcome measure was restenosis, and factors associated with restenosis in the DCB and DES groups were assessed using a Cox proportional hazards model.
Results:
The 2-year restenosis rate was not significantly different between the DCB and DES groups (29%±4% vs. 24%±5%, p=0.42). Interaction analysis demonstrated that popliteal lesions and plaque burden of ≥50% were restenosis-related factors for DES but not for DCB, whereas vessel preparation failure was a factor for DCB but not for DES (p<0.05). Vessel diameter of <6 mm and nodular calcification were risk factors in both groups (p<0.05).
Conclusion:
In contemporary FP lesions, smaller vessels and nodular calcification were shared restenosis-related factors for high-dose DCB and fluoropolymer-based DES. Popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB.
Clinical Impact
Shared and differential restenosis-related factors after endovascular therapy using high-dose drug-coated balloons (DCBs) and fluoropolymer-based drug-eluting stents (DESs) in contemporary femoropopliteal (FP) lesions are unclear. This single-center retrospective study included 378 FP lesions in 273 patients with lower-extremity arterial disease (high-dose DCB, 278 lesions in 193 patients; fluoropolymer-based DES, 120 lesions in 106 patients). Smaller vessels and calcified nodules were shared restenosis-related factors for both high-dose DCB and fluoropolymer-based DES, whereas popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB.
Background:The effect of treatment with paclitaxel-containing devices (PTXD) on mortality in patients with peripheral artery disease remains controversial.Methods and Results:An independent ...patient-level meta-analysis of 12 clinical trials (1,389 PTXD patients and 1,192 non-PTXD patients) was conducted. This study included 7 pivotal trials and 5 post-marketing surveillance studies on endovascular treatment for femoropopliteal artery by 6 companies. The primary endpoint was all-cause death, and 5-year cumulative mortality was estimated by a Kaplan-Meier curve. Cox proportional hazard model was used to calculate the hazard ratio (HR) and confidential interval (CI). During the median follow up of 3.0 years, 459 patients died. The cumulative 5-year mortality for the entire cohort was significantly lower in the PTXD than in the non-PTXD group (24.4% vs. 27.4%, respectively; HR, 0.81; 95% CI, 0.67–0.97; P=0.023), but this difference was no longer significant after adjustment for relevant covariates (HR, 1.01; 95% CI, 0.39–2.58; P=0.987). The Cox proportional hazard model revealed that sex, hyperlipidemia, Type 2 diabetes, hemodialysis, Rutherford category, and age above 75 years were significantly associated with 5-year mortality, but treatment with PTXD was not.Conclusions:This large individual meta-analysis of patients with femoropopliteal artery disease found that the use of PTXD does not have a negative effect on 5-year mortality.
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