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Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study
This is the first pivotal trial of the Passeo-18 Lux drug-coated balloon in Chinese patients.
•
One hundred fifty eight patients were followed for 12 months.
•
Treatment of femoropopliteal lesions using Passeo-18 Lux was safe and effective.
•
Target lesion revascularization rate was 1.4% and no major amputation occurred.
Background
The purpose of this trial was to assess the safety and effectiveness of a paclitaxel-coated balloon catheter in Chinese patients with de novo or nonstented restenotic femoropopliteal atherosclerotic lesions.
Methods
BIOLUX P-IV China is a prospective, independently adjudicated, multicenter, single-arm trial conducted in China. Patients with Rutherford class 2–4 were eligible, excluded were patients in which predilation resulted in severe (≥ grade D) flow-limiting dissection or residual stenosis > 70%. Follow-up assessments were conducted at 1, 6, and 12 months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12 months.
Results
We enrolled 158 patients with 158 lesions. Mean age was 67.6 ± 9.6 years, diabetes was present in 53.8% (n = 85), and previous peripheral intervention/surgeries in 17.1% (n = 27). Lesions were 4.1 ± 0.9 mm in diameter and 74 ± 50 mm long with a mean diameter stenosis of 91 ± 13%; 58.2% (n = 92) were occluded (core laboratory analysis). Device success was achieved in all patients. The rate of major adverse events was 0.6% (95% confidence interval: 0.0; 3.5) at 30 days, consisting of 1 target lesion revascularization. At 12 months, binary restenosis was present in 18.7% (n = 26) and target lesion revascularization was performed in 1.4% (n = 2, all clinically driven), resulting in a primary patency of 80.0% (95% confidence interval: 72.4, 85.8); no major target limb amputation occurred. Clinical improvement at 12 months, defined as improvement of at least 1 Rutherford class, was 95.3% (n = 130). The median walking distance per 6-minute walk test was 279 m at baseline and improved by 50 m at 30 days and by 60 m at 12 months; the visual analogue scale changed from 76.6 ± 15.6 at baseline to 80.0 ± 15.0 at 30 days and 78.6 ± 14.6 at 12 months.
Conclusions
Our results confirmed the clinical effectiveness and safety of a paclitaxel-coated peripheral balloon dilatation catheter for the treatment of de novo and nonstented restenotic lesion of the superficial femoral and proximal popliteal artery in Chinese patients (NCT02912715).
Introduction
Endovascular therapy for femoropopliteal revascularizations has become an established therapeutic strategy given the lower risk of procedural complications.
Initially treated with plain balloon angioplasty, drug-coated balloons (DCBs) have been developed to improve clinical outcomes through addition of highly lipophilic antiproliferative drugs.
2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European stroke organization (ESO)the task force for the diagnosis and treatment of peripheral arterial diseases of the European society of cardiology (ESC) and of the European society for vascular surgery (ESVS).
Another treatment option are conventional stents that have the advantage of scaffolding the vessel to restore blood flow but are associated with the drawbacks of permanent implants such as stent fractures that may occur with an incidence of up to 65% in femoropopliteal lesions, potentially leading to restenosis, thrombosis, pseudoaneurysm, or embolization.
DCBs have been successful in improving long-term patency compared to plain balloon angioplasty, leading to a Class IIb level A recommendation for their use in short (< 25 cm) femoropopliteal lesions.
2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European stroke organization (ESO)the task force for the diagnosis and treatment of peripheral arterial diseases of the European society of cardiology (ESC) and of the European society for vascular surgery (ESVS).
However, there is a current debate about a possible excessive risk of mortality after paclitaxel-coated device use when compared to the use of uncoated devices. A meta-analysis that included more than 4,000 patients found elevated mortality in patients with femoropopliteal artery disease.
Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials.
Another meta-analysis including 5-year outcomes, and a real-world safety analysis with data over 11 years past application in more than 60,000 patients did not reveal an increased mortality after use of paclitaxel-coated balloons though.
The Passeo-18 Lux paclitaxel-coated balloon is a DCB that showed superior outcomes compared to the uncoated Passeo-18 balloon (both BIOTRONIK AG, Buelach, Switzerland) in femoropopliteal lesions in a small randomized controlled trial.
Subsequently, Passeo-18 Lux was tested in BIOLUX-P-III, a large international all-comers registry with initially 700 patients that was extended to 1,084 patients. In this registry, multivariate Cox regression analysis revealed that the paclitaxel dose was not a predictor for mortality.
To confirm the safety and effectiveness of the Passeo-18 Lux in de novo and nonstented restenotic lesion in femoropopliteal arteries in a Chinese patient population, the BIOLUX P-IV trial was initiated. Aside of assessing safety and effectiveness, BIOLUX P-IV assessed quality of life and walking impairment, relevant information that is rarely reported in studies using DCBs.
Materials and Methods
Study Design and Patient Population
BIOLUX P-IV China is a prospective, multicenter, nonrandomized clinical trial with follow-up investigations at 1, 6, and 12 months that includes ankle brachial index assessment, Rutherford classification, EQ5-D and Walking Impairment questionnaires, 6-Minute Walk test, and Doppler ultrasound. It aimed to assess the safety and effectiveness of the paclitaxel-coated Passeo-18 Lux balloon in de novo and nonstented restenotic femoropopliteal lesions.
Main inclusion criteria were lesion in the superficial femoral or proximal popliteal artery, Rutherford class (RC) 2–4, ≥ 70% diameter stenosis of the target lesion, lesion length ≤ 200 mm, and reference vessel diameter ≥ 2 mm and ≤ 7 mm by visual estimate. Main exclusion criteria were contralateral femoropopliteal disease requiring treatment during the index procedure, additional lesions in the target vessel requiring treatment during index procedure that do not meet the inclusion criteria, complete occlusion of the lesion > 100 mm, in-stent restenosis or bypass, severe calcification, or predilatation that results in a major flow-limiting dissection or residual stenosis > 70%. The full list of inclusion and exclusion criteria can be accessed at ClinicalTrials.gov NCT02912715.
The trial was conducted as per local regulations, the Declaration of Helsinki, ISO14155: 2011, ICH-GCP and applicable National Medical Products Administration regulations, and approved by the ethic committees of the participating centers. All patients provided an informed consent. Monitoring encompassed 100% source document verification, an independent core laboratory (Hangzhou Yingfang Biotechnology Co., Ltd Jing Hu) assessed the angiographic and duplex ultrasound images, and a clinical events committee adjudicated all major adverse events, target lesion revascularizations (TLRs), adverse device effects, and serious adverse events. Data management and statistical analysis were performed by the Medical Research and Biometrics Center, National Center for Cardiovascular Diseases.
The SafeGuard insertion aid is premounted on the balloon, protects the balloon coating from drug loss, and can be retracted and peeled away after insertion. Balloon diameters up to 4.0 mm are 4F compatible; diameters ≥ 5.0 mm are 5F compatible. The device gained CE-mark in January 2014 but was not approved for the Chinese market during trial enrollment.
Predilatation with a standard balloon was required. The Passeo-18 Lux ought to closely match the reference diameter of the target vessel and the balloon length should extend 0.5 to 1 cm beyond the ends reached by the predilatation balloon. The balloon should be inflated for at least 30 sec. In case of major (≥ grade D) dissection or residual stenosis of > 50%, prolonged (< 3 min) balloon inflation with a plain balloon ought to be performed and bail-out stenting if this proved to be unsuccessful. Dual antiplatelet therapy (using Clopidogrel 75 mg daily) was recommended for at least 1 month.
Study End Points
The primary outcome effectiveness end point was primary patency at 12 months postprocedure, defined as freedom from clinically driven target lesion revascularization (cd-TLR) and freedom from binary restenosis (either by peak systolic velocity ratio > 2.4 or > 50% stenosis by quantitative vascular angiography, assessed by an independent core laboratory). The primary safety end point was 30-day major adverse event rate (MAE, defined as composite of device and procedure mortality, major target limb amputation, and cd-TLR). Secondary outcomes were individual components of MAE, death, TLR, target vessel revascularization (TVR), clinically driven TVR, thrombosis at the target lesion site, sustained clinical improvement (defined as improvement of at least 1 Rutherford category compared to baseline), duplex-defined binary restenosis (PSVR > 2.4), Walking Impairment Questionnaire, 6-Minute-Walk-Test, EQ-5D questionnaire, device success (successfully delivery, balloon inflation, deflation, and retrieval of the study device without burst below the rated burst pressure), procedural success (residual stenosis of ≤ 50% (nonstented subjects) or ≤ 30% (stented subjects) by core laboratory assessment, and clinical success (procedure success without procedural complications such as death, major target limb amputation, thrombosis of the target lesion, or TVR).
Statistical Analysis
Data management and biostatistical analysis were performed by Medical Research & Biometrics Center, National Center for Cardiovascular Diseases. Data are presented for the intention-to-treat population. Details of the sample size calculation are provided in the Supplementary Tables 1 and 2. In brief, the sample size was calculated based on the published results of the In.PACT SFA, LEVANT 2, PACIFIER, THUNDER, and FEMPAC trials.
Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial.
Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.
H0 was 12-month patency < 55%, considering a DCB patency of 70%, 80% power, unilateral significance level α = 0.025, an expected drop-out rate of 25%, and post-DCB stenting of 30%. A sample size of 158 patients was calculated to be required (83 patients + lost to follow-up + post-DCB stenting). This sample size is also adequate to evaluate the MAE-safety end point, assuming a 5% MAE-rate at 30 days at a confidence level of 95% confidence interval (CI) that the MAE incidence will be in the range of ± 3.4% from 5%.
Continuous variables are displayed as mean ± standard deviation and median with interquartile ranges as applicable. Categorical variables are presented as frequencies and percentages of the total. Adverse event rates refer to the respective time intervals (e.g., 365 ± 30 days). To test the study-specific objective performance goal of primary patency, the one-sample normal approximation for the binomial test is applied. Primary patency was calculated using Kaplan–Meier methods and standard errors were calculated using the Greenwood's formula. Clinical outcomes were calculated as frequencies, considering the patient numbers at follow-up (including died patients for determining mortality rates and excluding died patients for calculating complication rates). CIs were calculated as appropriate. All statistical analyses were carried out using SAS 9.4 (SAS Institute Inc. Cary, North Carolina).
Results
From November 2016 to July 2018, 204 patients were screened in 16 centers in China, thereof 158 were enrolled; no patient failed to receive DCB treatment. Thirty-day follow-up data are available for 155 patients and 12-month data for 145 patients (13 patients were lost to follow-up).
Patients were 67.6 ± 9.6 years in average and 76.6% were males. The analysis of the risk factors revealed 77.2% hypertension, 53.8% diabetes, and 43.0% previous peripheral artery disease. Furthermore, 21.5% of patients had cerebrovascular disease and 30.4% concomitant coronary artery disease (Table I).
Table IDemographic data and baseline characteristics
Outcomes
N = 158 patients
Age, years
67.6 ± 9.6
27.1–89.7
Male gender
121 (76.6%)
Body mass index
24.3 ± 3.3
15.0–32.1
Hypertension
122 (77.2%)
Hyperlipidemia
50 (31.6%)
Smoking habits
Used to smoke
24 (15.2%)
Currently smoking
67 (42.4%)
Diabetes mellitus
85 (53.8%)
Renal disease
11 (7.0%)
Cancer
11 (7.0%)
Cerebrovascular disease
34 (21.5%)
Coronary artery disease
48 (30.4%)
History of peripheral artery disease
68 (43.0%)
Previous peripheral interventions/surgeries
27 (17.1%)
N = 158 lesions (core laboratory analysis)
Reference diameter, mm, N = 151
4.1 ± 0.9
2.1–6.9
Target lesion length, mm
74 ± 50
5–200
Diameter stenosis, %
91 ± 13
40–100
Occlusion
92 (58.2%)
Data are displayed as mean ± standard deviation, Min–Max, or n (%).
As per the angiographic core laboratory analysis, the target lesion length was 74 ± 50 mm, occlusive lesions accounted for 58.2%, the average length of occlusive lesions was 24 ± 30 mm, and the diameter stenosis was 91 ± 13%. Postprocedure, the mean diameter stenosis improved to 27 ± 9%. Dissections occurred in 26.6% (n = 42), thereof n = 27 Grade B, n = 14 grade C, and n = 1 Grade D.
Table II lists the index procedure characteristics. Only 1 lesion per patient was treated. A total of 222 Passeo-18 Lux DCB were used, including 62.7% of patients treated with 1 balloon, 34.2% treated with 2 balloons, and 3.2% with 3 balloons. Bail-out stenting was performed in 5.1% (n = 8, 6 for dissection and 2 for residual stenosis). Rutherford classification at baseline and follow-up is displayed in Figure 1. Mean RC improved by 1.7 ± 0.9 at 6 months and by 1.8 ± 0.9 at 12 months. Improvement of at least 1 RC in patients without TLR (primary clinical improvement) was 89.7% (131/146) at 6 months and 93.5% (130/139) at 12 months. Secondary improvement, including patients with TLR, was 90.4% (132/146) at 6 months and 95.0% (132/139) at 12 months.
Including 2 patients who received bailout-stenting for post-treatment diameter stenoses of 41.8% and 41.6% and 1 patient had a post-treatment diameter stenosis of 57.4%.
Including 2 patients who received bailout-stenting for post-treatment diameter stenoses of 41.8% and 41.6% and 1 patient had a post-treatment diameter stenosis of 57.4%.
155 (98.1%)
Data are displayed as mean ± standard deviation, Min–Max, or n (%).
a Including 2 patients who received bailout-stenting for post-treatment diameter stenoses of 41.8% and 41.6% and 1 patient had a post-treatment diameter stenosis of 57.4%.
Fig. 1Rutherford class at baseline and follow-up data were available for 157 patients at baseline, 155 patients at 30 days, 146 at 6 months, and 139 at 12 months. Mean Rutherford class improved from 2.73 ± 0.67 at baseline to 0.94 ± 0.78 at 30 days, 1.02 ± 0.87 at 6 months, and 0.91 ± 0.75 at 12 months.
The walking impairment questionnaire (WIQ) score improved by 26.8 ± 34.9 at 30 days (N = 154), by 21.6 ± 32.8 at 6 months (N = 145) and by 26.6 ± 32.6 at 12 months (N = 139). Thereby the walking distance average score increased by 31.7 ± 34.7 at 30 days (N = 152), 26.4 ± 35.4 at 6 months (N = 145), and 26.7 ± 37.3 at 12 months (N = 139). Per 6-minute walking test, the average walking distance was 262 ± 96 m at baseline (N = 153, median 279 m, Q1–Q3: 211–330); it improved by 72 ± 102 m at 30 days (N = 147, median 50 m, Q1–Q3: 15–121), by 59 ± 92 m at 6 months (N = 140, median 58 m, Q1–Q3: 6–125), and by 63 ± 98 m at 12 months (N = 136, median 60 m, Q1–Q3: 2–122) (Supplemental Fig. 1). Notably, patients with missing WIQ values at 12 months had lower 6-month values than those who had 12-month follow-up WIQ performed (Supplemental Table 3).
The EQ5D quality-of-life questionnaire consists of 5 question and 1 visual analogue scale ranging from 0 (worst health 1 can imagine) to 100 (best health 1 can imagine). The visual analogue scale changed from 76.6 ± 15.6 at baseline (N = 157) to 80.0 ± 15.0 at 30 days (N = 153, change of 3.4 ± 17.7), to 76.2 ± 17.3 at 6 months (N = 146, change of −0.42 ± 18.48), and to 78.6 ± 14.6 at 12 months (N = 145, change of 1.7 ± 20.4). Further details are provided in Supplementary Tables 3 and 4.
The primary patency at 12 months was 80.0% (95% CI: 72.4; 85.8) (Fig. 2), standard error 0.338, thereby 1.4% (n = 2) of patients had TLR and 18.7% (n = 26) binary restenosis. Primary patency at 30 days and 6 months was both 99.4%.
Fig. 2Kaplan-Meier analysis of the primary end point–primary patency at 12 months.
The primary safety end point, MAE at 30 days, was 0.6% (95% CI: 0.0; 3.5), consisting of 1 thrombosis with subsequent TLR. The patient suffered from severe pain 4 days postprocedure and the Doppler ultrasound showed a low echo reflex; a thrombolysis was successfully performed. The second TLR occurred on day 185. There was no additional TVR (Table III).
Table IIIClinical outcomes
Outcomes
30 days
6 months
12 months
All-cause mortality
N = 155
N = 148
N = 144
0 (0%)
2 (1.4%)
5 (3.5%)
Target lesion revascularization
N = 155
N = 146
N = 140
1 (0.6%)
2 (1.4%)
2 (1.4%)
Clinically driven target lesion revascularization
N = 155
N = 146
N = 140
1 (0.6%)
2 (1.4%)
2 (1.4%)
Target vessel revascularization
N = 155
N = 146
N = 140
1 (0.6%)
2 (1.4%)
2 (1.4%)
Clinically driven target vessel revascularization
N = 155
N = 146
N = 140
1 (0.6%)
2 (1.4%)
2 (1.4%)
Target limb major amputation
N = 155
N = 146
N = 140
0 (0%)
0 (0%)
0 (0%)
Thrombosis at target lesion
N = 155
N = 146
N = 140
1 (0.6%)
1 (0.7%)
1 (0.7%)
Data are displayed n (%). Data up to 37 days are considered for the 30-day interval, up to 210 days for the 6-month interval, and up to 395 days for the 12-month interval.
Five patients died during the cause of the study, 2 of cancer on postoperative day (POD) 279 and 319 (thereof 1 was pre-existing), 1 of aortic rupture on POD 40 (the patient had a medical history of thoracic and abdominal aortic stent implantation due to penetrating ulcers of the abdominal aorta which led to a massive bleeding 5 weeks after the index procedure), 1 of respiratory disease in combination of heart failure after revascularization of a nontarget lesion on POD 85, and 1 of hemorrhagic stroke on POD 271. All deaths were adjudicated as not being related to the device or procedure.
Discussion
The BIOLUX P-IV trial confirmed the safe and effective use of the Passeo-18 Lux DCB in Chinese patients with femoropopliteal lesions with similar outcomes to international DCB trials in this indication.
BIOLUX P-IV reflects a common patient population in clinical trials. Similar to the IN.PACT SFA China trial,
only RC 2–4 was permitted, whereas ACO-ART I China enrolled 16% of patients with RC 5. This may impact outcomes as higher RC may result in higher TLR rates, as assessed in the In.Pact Global substudy, that reported 12-month TLR rates of 6.6% for RC 2 and 3 patients and 13.7% for RC 4 and 5 patients, P = 0.007.
Outcomes after drug-coated balloon treatment of femoropopliteal lesions in patients with critical limb ischemia: a post hoc analysis from the IN.PACT global study.
This may also explain the lower TLR rates in our series as compared to outcomes in femoropopliteal lesions of BIOLUX P-III (12-month TLR rate of 1.4% vs. 6.1%), as BIOLUX P-III had less restrictive inclusion and exclusion criteria and also included patients in RC 5 and 6.
yet this may be related to the fact that the overall BIOLUX P-III population encompassed infrainguinal lesions including below-the-knee lesions. Another possible explanation for the lower TLR rate might be that Chinese patients may have a higher tolerability of ischemic symptoms and that most patients would not accept a procedure until the ankle brachial index is < 0.5, as speculated by other authors.
Drug-coated balloon angioplasty compared with uncoated balloons in the treatment of 200 Chinese patients with severe femoropopliteal lesions: 24-month results of AcoArt I.
This would also explain that despite the difference in TLR, the primary patency at 12 months was similar between BIOLUX P-IV and BIOLUX P-IIII (80.0% vs. 80.2% in the imaging cohort from the BIOLUX P-III femoropopliteal lesions subgroup analysis
The Aco-Art China had a higher TLR rate (7.2%) but similar primary patency (84.1%) but had lesions nearly twice as long (147 mm in average) and 16% RC 5 patients compared to BIOLUX P-IV and IN.PACT SFA. Another difference among the trials is the rate of provisional stenting that was 19% for Aco-Art China versus 4.2% for IN.PACT SFA China and 5.1% in our series.
Drug-coated balloon angioplasty compared with uncoated balloons in the treatment of 200 Chinese patients with severe femoropopliteal lesions: 24-month results of AcoArt I.
The difference in outcomes thereby is likely related to the differences in baseline characteristics. Notably, in the femoropopliteal subgroup of BIOLUX P-III,
the rate of provisional stenting was 20.2%, thus 4 times higher than in our series. This may be due to difference in RC, with RC 5 and 6 patients enrolled in BIOLUX P-III or due to the difference in protocol recommendations but more likely reflect a tendency to avoid provisional stenting if possible. Our outcomes suggest that this is a feasible approach.
Aside of the better TLR and lower provisional stenting rates, outcomes of DCB-treated Chinese patients are similar to those of international series.
Drug-coated balloon angioplasty compared with uncoated balloons in the treatment of 200 Chinese patients with severe femoropopliteal lesions: 24-month results of AcoArt I.
Major target limb amputation at 12 months was 0% in BIOLUX P-IV China versus 1.7% in the femoropopliteal BIOLUX P-III subgroup and all-cause mortality was 3.5% vs. 5.9%, respectively.
Notably, only 2 patients died of cancer, thereof 1 on day 12 was pre-existing.
Related to performance outcomes, there was a substantial clinical improvement with 93.5% of patients having improved by at least 1 RC. In contrast, quality of life increased only slightly but the patient population was not severely impacted in their daily life to start with, so there was not much room for improvement. Rather, an improvement in pain and walking capacity was observed, a similar pattern as seen in IN.PACT SFA China.
This trial has several limitations. It is not randomized and therefore comparison to other series is hampered. Thirteen patients were lost to follow-up and RC was only available in 88% of patients at follow-up. This circumstance might have biased outcomes and might be responsible for the drop in 6-month quality of life and walking scores that increased again at 12 months. In particular, patients with missing 12-month assessments had lower WIQ scores than those with 12-month assessment, potentially reflecting the fact that patients who did worse did not attend the 12-month follow-up. Data related to lesions treated outside the target vessel were not collected. Follow-up has only been scheduled for 12 months. In the light of the current discussion on potential paclitaxel-associated mortality, data beyond 12 months would have been interesting. However, BIOLUX P-III was extended to 5 years and further data can be expected from this series.
Paclitaxel-coated balloon angioplasty for the treatment of infrainguinal arteries: 24-month outcomes in the full cohort of BIOLUX P-III global registry.
In conclusion, the safety and efficacy of the Passeo-18 Lux paclitaxel-coated balloon catheter in treating superficial femoral and proximal popliteal artery lesions in Chinese patients have been confirmed. Low complication rates and high effectiveness were observed, comparable to outcomes of international series and Chinese trials performed with other types of drug-coated balloons, resulting in the decision to apply for market authorization in China.
We thank Beatrix Doerr, medical writer, for her help in preparing the manuscript, reimbursed by Biotronik.
2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European stroke organization (ESO)the task force for the diagnosis and treatment of peripheral arterial diseases of the European society of cardiology (ESC) and of the European society for vascular surgery (ESVS).
Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials.
Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial.
Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.
Outcomes after drug-coated balloon treatment of femoropopliteal lesions in patients with critical limb ischemia: a post hoc analysis from the IN.PACT global study.
Drug-coated balloon angioplasty compared with uncoated balloons in the treatment of 200 Chinese patients with severe femoropopliteal lesions: 24-month results of AcoArt I.
Paclitaxel-coated balloon angioplasty for the treatment of infrainguinal arteries: 24-month outcomes in the full cohort of BIOLUX P-III global registry.
Funding: This study was funded by Biotronik (Beijing) Medical Device Limited. The sponsor was involved in the design of the study and in the collection and analysis of data. The sponsor reimbursed the medical writer but was not involved in the final decision to submit the article for publication.
Data sharing: The data that support the findings of this study are available from Biotronik but restrictions apply to the availability of these data, which were used under license for the present study and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Biotronik.
Declaration of interest: The authors declare that they have no competing interests.
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