Author + information
- Received October 13, 2018
- Revision received November 1, 2018
- Accepted November 2, 2018
- Published online February 11, 2019.
- Yvonne Bausback, MDa,
- Tim Wittig, MDa,
- Andrej Schmidt, MDa,
- Thomas Zeller, MDb,
- Marc Bosiers, MDc,
- Patrick Peeters, MDd,
- Steffen Brucks, MDe,
- Aaron E. Lottes, PhDf,
- Dierk Scheinert, MDa and
- Sabine Steiner, MDa,∗ (, )@UniLeipzig
- aDivision of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
- bDepartment of Angiology, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany
- cDepartment of Vascular Surgery, AZ St.-Blasius, Dendermonde, Belgium
- dDepartment of Cardiovascular Surgery, Imelda Hospital, Bonheiden, Belgium
- eAngiologikum Hamburg, Hamburg, Germany
- fCook Research Incorporated, West Lafayette, Indiana
- ↵∗Address for correspondence:
Dr. Sabine Steiner, Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Liebigstraße 20, 04103 Leipzig, Germany.
Background Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing.
Objectives The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months.
Methods Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes.
Results More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months.
Conclusions Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441)
- drug-coated balloons
- drug-eluting stents
- peripheral vascular disease
- superficial femoral artery disease
The superficial femoral artery (SFA) is commonly affected by symptomatic peripheral arterial disease (PAD). Endovascular treatment with balloon angioplasty only is limited by high restenosis rates and has been proven inferior to modern stent- and drug-coated balloon (DCB)-based approaches in several randomized clinical trials (1–4). Drug-eluting technologies have been developed to improve patency rates by inhibiting neointimal hyperplasia and smooth muscle cell proliferation. For drug-eluting stents (DES), scientific evidence is available for the self-expandable nitinol Zilver PTX stent (Cook Medical, Bloomington, Indiana), which has a 3 μg/mm2 polymer-free coating of paclitaxel on its outer surface. In a large randomized controlled trial of 474 de novo or restenotic native femoropopliteal lesions, 12-month patency rates of 83% to 90% were superior compared with angioplasty and bailout implantation of bare-metal stents (BMS), with a sustained clinical benefit ≤5 years (4,5). Prospective registry data also support this DES for treating long, more complex SFA lesions (6,7).
As an alternative treatment option without the need of a permanent implant, except in those cases where bailout stent implantation is required, several DCBs coated with paclitaxel dosages ranging from 2.0 to 3.5 μg/mm2 were successfully tested in clinical trials and exhibited promising primary patency rates up to 89% after 1 year (2,3,8–10). In the rather short, less complex SFA lesions included in these studies, bailout stenting rates after DCB were low, ranging from 2.5% to 15.0%. In a registry studying DCB for longer lesions with a high proportion of total occlusions and in-stent restenosis, the bailout stenting rate was 23%; patency rates were still favorable after 1 year (79%) but dropped to 54% at 2 years, suggesting only a delay of the restenotic process (11).
So far, comparative effectiveness of DES versus DCB has not been tested within a clinical trial. The REAL PTX (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery) study was designed to provide a preliminary evaluation of effectiveness and safety of the self-expandable nitinol stent platform DES versus a commercially available DCB in patients with symptomatic femoropopliteal lesions.
Study design and patient population
The REAL PTX study was a prospective randomized controlled trial including 150 patients with symptomatic femoropopliteal arterial disease (Rutherford category 2 to 5) who underwent endovascular intervention in five participating vascular centers located in Germany and Belgium. Recruiting centers and principal investigators are listed in the Online Appendix.
Key inclusion criteria included de novo or restenotic femoropopliteal lesions not exceeding the medial femoral epicondyle, a lesion length ≤30 cm, and at least 1 patent tibial runoff vessel. Exclusion criteria included the presence of thrombus, lesion pre-treatment with adjunctive devices, and prior stent placement in the target lesion. Detailed inclusion and exclusion criteria are listed in Table 1.
The study protocol was approved by each site’s local ethics committee and patients provided written informed consent before enrollment. A clinical trial registration was performed prospectively.
Pre-procedure data collection included assessment of the patient’s medical history as it related to PAD, documentation of Rutherford category, and completion of the Walking Impairment Questionnaire (WIQ) (12).
After successful lesion crossing, but before lesion preparation (e.g., pre-dilatation), patients were randomly assigned 1:1 to primary stent implantation with the drug-eluting self-expandable nitinol Zilver PTX platform stent (Cook Medical) or balloon angioplasty with a DCB (In.Pact Admiral or In.Pact Pacific, Medtronic Vascular, Santa Clara, California; or Lutonix, C.R. Bard, Murray Hill, New Jersey) using a web-based randomization system (Institute for Medical Informatics, Statistics and Documentation, University of Graz, Austria). Lesions were stratified by length into 3 categories (lesion length ≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm), with approximately 50 patients in each stratum. Pre-dilatation was at the operator’s discretion, but was to be performed in accordance with the instructions for use of the device.
DES and DCB were intended to fully cover the target lesion and were placed at least 1 cm below the origin of the SFA and above the medial femoral epicondyle, with a maximum lesion length of 30 cm. DES post-dilation was at the operator’s discretion to achieve a residual stenosis <30%. For DCB, all reasonable measures were used at the operator’s discretion to diminish the need for provisional stenting, including prolonged (>2 min) balloon inflation(s) and use of vasodilators and/or thrombolytic agents. Provisional stenting with a BMS was performed at the operator’s discretion in case of residual stenosis of >50% or major flow-limiting dissection, and this decision was not adjudicated by the core laboratory. Calcification was assessed by the core laboratory using an angiographic calcium grading system based on circumference and length of calcium (mild <180°, <one-half total lesion length; moderate <180°, ≥one-half total lesion length; moderately severe ≥180°, <one-half total lesion length; and severe ≥180°, ≥one-half total lesion length). Clinical assessment and duplex ultrasound of the treated vessel were performed before discharge.
All patients received 5,000 IE of heparin intravenously before endovascular treatment. Antiplatelet therapy in both groups consisted of aspirin and clopidogrel starting at least 24 h before the intervention (or a procedural loading dose of clopidogrel 300 mg orally). Clopidogrel was continued for ≤60 days, and aspirin indefinitely.
Patients returned for pre-planned in-house visits at 6, 12, 24, and 36 months for assessment of medical conditions, Rutherford category, WIQ, medications, and patency as evaluated by duplex ultrasound. Although study completion was initially planned for 24 months, study extension to 36 months was implemented and approved by local ethics committees after all patients completed the 12-month visit.
The primary endpoint was primary patency through 12 months analyzed by Kaplan-Meier (KM) estimate and defined as absence of clinically driven target lesion revascularization (CD-TLR) or binary restenosis. Binary restenosis was defined as a peak systolic velocity ratio >2.4 as evaluated by duplex ultrasound core laboratory analysis. CD-TLR was defined as a reintervention performed for ≥50% diameter stenosis (confirmed by angiography) within ±5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of PAD following the initial procedure.
Protocol pre-specified secondary endpoints included CD-TLR, target limb major amputation, all-cause mortality, and changes in ankle-brachial index, Rutherford classification, and WIQ scores. The pre-specified combined safety endpoint comprised the combination of death within 30 days of index procedure, CD-TLR, or major target limb amputation within 12 months.
The study was overseen by independent monitoring services in Belgium (Flanders Medical Research Program, Hamme-Zogge, Belgium) and Germany (Vascuscience, Leipzig, Germany). Angiographic and duplex ultrasound images were independently analyzed by a core laboratory (CoreLab Bad Krozingen, Bad Krozingen, Germany).
The study was designed as a pilot trial to provide a preliminary evaluation of DES compared with DCB and was aiming for 150 randomized patients within 3 lesion-length strata of approximately 50 patients each. Accounting for a 15% dropout rate, the sample size was powered to detect a difference in primary patency of 20% between the 2 groups from 1 through 12 months. Outcomes were analyzed using the intent-to-treat population. Continuous data are reported as mean ± SD, and categorical data are reported as number (percentage). Comparisons were performed using independent t-test, Wilcoxon signed rank test, chi-square test, or Fisher exact test, as appropriate. Time-to-event outcomes for the primary endpoint of primary patency and the secondary endpoint of CD-TLR were evaluated by KM analysis and log-rank test. For KM estimates, the study end was harmonized to 1,155 days for all events censored ≥1,095 days. The difference of 1- and 3-year outcome rates as estimated by the KM method were calculated. The Com-Nougue approach was used to estimate 95% confidence intervals (CIs) for 1- and 3-year differences (13). Because there were no significant deviations from the proportional hazards assumption, multivariate Cox regression analysis was conducted including the following covariates: sex (female vs. male), age (continuous), diabetes (yes vs. no), smoking status (current or previous vs. never), study arm (DCB vs. DES), calcification (none/mild vs. moderate/moderately severe/severe), lesion type (de novo vs. restenotic), lesion length (continuous), reference vessel diameter (continuous), occlusion (yes vs. no), core lab–adjudicated residual stenosis ≥30% (yes vs. no), and below-the-knee (BTK) runoff (patent BTK vessels 0 to 1 vs. 2 to 3). In addition, treatment by covariate interactions was analyzed. Statistical analysis was performed using SAS 9.4 (SAS Institute, Cary, North Carolina).
Patient and procedural characteristics
Between March 2012 and May 2014, 150 patients (75 in the DES group and 75 in the DCB group) were enrolled at 5 study sites in Europe (Figure 1). The treatment groups were well matched with respect to baseline demographics and lesion characteristics (Table 2). The majority of patients had claudication, with only 13% in Rutherford category 4 or 5. More than 50% of lesions were total occlusions, with increasing proportions according to lesion-length strata (DCB group 16%, 52%, and 92% in the short-length, middle-length, and long-length strata, respectively; DES group 28%, 50%, and 77% in the short-length, middle-length, and long-length strata, respectively). About one-half of the lesions exhibited moderately severe or severe calcification; the difference in calcification approached significance, with more severely calcified lesions in the DES group (p = 0.09).
In the DCB arm, the most commonly used study devices were the In.Pact Admiral/In.Pact Pacific DCB (77.3%) and the Lutonix DCB (21.3%). As a consequence of the 2 diverse interventional approaches, several procedural data differed significantly between DCB and DES (Table 3). Although most lesions were pre-dilated in both groups, a larger balloon diameter was chosen in the DES group. As expected, the maximum study device nominal diameter was larger in the DES group due to the typical oversizing differences between self-expanding nitinol stents and angioplasty balloons. Post-dilation was performed more frequently in the DES group; data regarding pre- or post-dilation duration, inflation pressure, or the need for repeat dilation were not available. In the DCB group, bailout stenting was performed in 19 cases (25.3%), mostly in middle- and long-length lesions (8 cases [32.0%] in each stratum). In most cases (15 of 19; 79%), bailout stenting was required in cases of chronic total occlusion (CTO) treatment; of the 40 CTOs in the DCB group, 15 (37.5%) were treated with provisional stenting. Core laboratory–adjudicated dissections were significantly higher in the DCB group. Although in total, only 3 cases of residual stenosis ≥30% were identified by visual estimation at the study sites, core lab–adjudicated analysis found a significantly higher proportion of cases of residual stenosis ≥30% in the DCB group compared with DES group (42.7% vs. 16.0%; p < 0.001), corresponding to a higher mean residual stenosis post-procedure in the DCB group. Intraprocedural complications comprised 5 ipsilateral embolic events (4 in the DCB group, 1 in the DES group) and 1 target vessel perforation (in the DCB group); all complications were resolved successfully by the operators.
Effectiveness, safety, and clinical benefit
The primary endpoint of primary patency through 12 months per KM estimate was almost identical in both groups (79.9% DCB, 79.3% DES; rate difference 0.6%; 95% CI: −13% to 14.2%; p = 0.96). Patency decreased over time, with the curves separating beyond 1 year, yielding a patency rate of 56.7% in the DES arm and only 42.4% in the DCB arm after 3 years (rate difference −14.3%; 95% CI: −34.4% to 2.2%; p = 0.17) (Central Illustration, Figure 2). In a subgroup analysis separating DCB patients with and without bailout stenting, similar results to the overall analysis were seen (Online Figure 1), with comparable results at 1 year and a signal for separating curves beyond that time point favoring DES. In the subgroup DCB plus bailout stenting, patency rates were 73.7% at 1 year and 33.8% at 3 years.
Several significant predictors of restenosis were identified in Cox regression analysis, including presence of a total occlusion (hazard ratio [HR]: 2.1; 95% CI: 1.2 to 3.8), diabetes (HR: 1.9; 95% CI: 1.1 to 3.3), poor BTK runoff (HR: 2.0; 95% CI: 1.2 to 3.3), and lesion length (HR: 1.03; 95% CI: 1.0 to 1.1 per cm). Interaction analysis identified a signal for a different treatment effect (DCB vs. DES) in stenotic versus occluded vessels with a p value for interaction of 0.09; DES demonstrated significantly improved patency compared with DCB in stenotic lesions (log rank p = 0.04), whereas patency was similar in CTOs (Figures 3A and 3B). Further, in a post hoc patency analysis, short lesions <10 cm were compared with a combined group of middle and long lesions >10 cm (Figures 4A and 4B). In short lesions ≤10 cm, KM curves were almost overlapping in the first 2 years with good patency results through 36 months (63.8% DCB, 76.5% DES; rate difference −12.7%; 95% CI: −42.9% to 17.5%; p = 0.45). In longer lesions, >10 cm, restenotic events accrued over time in both groups, but with a numerically lower patency rate in the DCB arm at 3 years (32.3% DCB, 45.2% DES; rate difference −12.9%; 95% CI: −40.5% to 1.7%; p = 0.19).
Freedom from CD-TLR at 12 months was high in both groups (DCB 92.5%, DES 90.0%; rate difference 2.5%; 95% CI: −7.1% to 12.1%; p = 0.34) but dropped to around 70% at 3 years (DCB 71.3%, DES 68.9%; rate difference 2.4%; 95% CI: −14.8% to 19.6%; p = 0.74) (Figure 5).
The combined safety outcome of death within 30 days, CD-TLR, and major target limb amputation within 12 months after the index procedure occurred in 8% of patients in the DCB group and 7% in the DES group (p = 0.77). Overall, 11 patients (7.3%) died, 8 (10.7%) in the DCB group and 3 (4.0%) in the DES group (p = 0.12). Although more deaths occurred in the DCB group, no safety signals were identified by the clinical events committee, and the observed 3-year mortality rate in the DCB group is within the expected range. No death was considered device-related, and 1 death in the DCB group at 1-day post-procedure was classified as procedure-related in a patient with pre-existing chronic lung disease and acute respiratory failure. No other death was considered device-related or occurred within 30 days after the procedure (causes of death and time points are shown in Online Table 1). One major target limb amputation was performed in the DES group 24 months after the procedure. KM analysis of major adverse events and all-cause mortality is given in Table 4.
Regarding clinical outcomes, ankle-brachial index measurements, Rutherford classification, and WIQ scores showed significant improvements after 12, 24, and 36 months in both the DCB and DES groups (all p values <0.05 compared with baseline) without between group differences (Table 5).
In randomized trials comparing DCB or DES with conventional balloon angioplasty with provisional BMS implantation, both drug-eluting technologies showed promising short-term (12-month) patency rates in femoropopliteal lesions with moderate complexity, that is, short- and middle-length lesions (2–5,8–10). In the absence of a head-to-head clinical trial, a retrospective propensity score–matched single-center study found comparable 12-month patency and TLR results for DCB and DES in long femoropopliteal lesions ≥10 cm (14). Our study extends the existing evidence by adding a direct comparison of DCB and DES in a cohort comprising 3 different lesion-length strata with a high proportion of CTOs and extending the follow-up duration through 3 years. In contrast to prior DCB studies, only lesion crossing, but not successful pre-dilation, was a prerequisite for study inclusion, and no limitation was set to the degree of vessel calcification. As a consequence of the more complex and longer lesions, the bailout stenting rate of 25% overall and 32% in longer lesions (>10 cm) in the DCB group was higher than in prior randomized controlled trials; the 12% bailout stent rate in short lesions (≤10 cm) is within the range of prior studies in the field. Although DCB is often considered a treatment that does not involve a permanent implant, our study found that provisional stent implantation remains necessary following DCB treatment in a substantial number of cases with complex lesions.
This pilot study was only powered to assess patency through 12 months. There was a trend for improved outcomes with the DES beyond 1 year; however, the difference between the 2 treatment strategies was not significant. Although patency rates were excellent in short lesions and reasonable in long lesions at 12 months in both groups, results after 3 years were more sobering, especially in long lesions, with 3-year DCB patency of 25.8% and DES patency of 45.2%.
In the DCB group, the observed patency rate of 63.8% in the short lesion-length stratum after 3 years is in line with the recently published 3-year results from the IN.PACT SFA study (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery), in which a primary patency rate of 70% in the DCB arm in relatively short lesions with a mean lesion length of 9 cm was reported (15). Analyzing longer lesions (>10 cm) in our study, we observed a markedly higher reobstruction rate, with 43.7% patency at 24 months and 25.8% patency at 36 months in the DCB group. This loss of patency over time is consistent with our own, previously published results from a retrospective registry of DCB in longer lesions (mean lesion length 24 cm), where patency rates were still promising after 1 year (79%) but dropped to 54% at 2 years, indicating only a delay, rather than a prevention, of the restenotic process (11).
In the DES group, our results in short lesions (3-year primary patency 77%) are comparable with the randomized Zilver PTX trial (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery), where primary DES implantation (average lesion length 6.5 cm) showed a sustained benefit, with primary patency rates of 84%, 76%, and 72%, at 1, 2, and 3 years, respectively (4,5,16). Focusing on longer lesions >10 cm in our study, slightly more than one-half of these exhibited restenosis in the DES arm after 36 months.
A number of prior registries have presented results with the self-expandable nitinol stent in longer lesions. A 1-year Japanese post-marketing surveillance study found a primary patency rate of 86% for 907 femoropopliteal lesions with a mean length of 14.7 cm (7). Another Japanese registry (ZEPHYR [Zilver PTX for the Femoral Artery and Proximal Popliteal Artery]; mean lesion length 17 cm) reported a restenosis rate of 37% after 12 months in 831 femoropopliteal lesions (17); however, the definition for restenosis in the ZEPHYR study included any reintervention of the study limb, thereby reflecting a limb-level assessment rather than a specific evaluation of the study lesion, resulting in a substantially higher reported restenosis rate. A global Zilver PTX study with 900 lesions and a mean lesion length of 10 cm exhibited 1-year patency of 86% (18), similar to the Japanese results; a de novo long-lesion subgroup of this study for lesions >15 cm (mean 23 cm) demonstrated 78% patency at 1 year (6). Of note, the aforementioned studies all included patients treated for in-stent restenosis, a challenging patient group that is excluded from most studies, including the present study.
Although KM curves of primary patency for the 2 treatment strategies were almost superimposable in the first 12 months after the procedure, results between 1 and 3 years suggest a different pattern, with a continuing increase of restenotic events in the DCB group and a flattening of the curve in the DES group. DCB treatment inhibits early restenosis, but events after 1 year could reflect progression of the disease or failure of the transient drug transfer to provide durable outcomes, especially in long lesions with extensive atherosclerotic burden. Because after 1 year the drug coating on the self-expandable nitinol DES is no longer present (19), one might speculate that the addition of mechanical scaffolding from the stent could potentially have an impact on the atherosclerotic progression. In a prior propensity score–matched analysis of DCB and BMS, similar trends were observed because restenosis seemed to achieve a plateau over time for the BMS group compared with continued restenosis in the DCB group within the observed time interval ≤3 years (20). However, in our study, the addition of a BMS to DCB did not appear to inhibit the continued restenosis over time, with similar results to DCB alone, although the sample size was limited.
Both DCB and DES treatment strategies were especially challenged in long and totally occluded lesions, with high numbers of patency failures. As expected, lesion length and presence of total occlusion were significant predictors of restenosis in regression analysis. Because this study was designed to compare 2 drug-eluting technologies for femoropopliteal interventions, additional devices for vessel preparation beyond standard balloon angioplasty were not used. We observed a relatively high percentage of residual stenosis after DCB treatment (on average 26%) despite provisional stenting in every fourth intervention. This rate is similar to other clinical trials comparing DCB to standard angioplasty (2,3,8–10), but could be more relevant in complex lesions when longer vessel segments are treated. In the DES group, a relatively high number of early patency failures within the first year were observed in the long-lesion stratum, and a role of heavy calcification in these early failures cannot be excluded because there was a trend to more severe calcification in the DES group. The optional use of mechanical debulking or scoring balloons could have the potential to improve outcomes in complex lesions that do not respond to standard vessel preparation, but in the absence of supporting data, the impact of vessel preparation on patency has to be evaluated within clinical trials.
Currently, clinical trials in the field of endovascular peripheral interventions focus on patency rates for specific devices. However, a combination of various devices will probably be needed to optimally address complex SFA lesions with the goal of improving long-term outcomes. Therefore, well-powered pragmatic clinical trials with long-term follow-up comparing multiple endovascular strategies rather than single devices and encouraging the appropriate use of various technologies should be performed to better reflect clinical reality, delineate optimal treatment approaches, and support clear recommendations in future practice guidelines for the treatment of complex SFA lesions.
The number of patients available for assessment of the primary endpoint was limited by a relatively high loss rate of approximately 20% at 1 year for both groups. In addition, because this was a pilot trial not powered to detect differences beyond 1 year or differences within lesion length strata, our results can only be seen as hypothesis generating providing a starting point for further trials in the field. The study was not designed to test equivalence, or noninferiority, between the 2 treatment options, and the width of the 95% confidence intervals leaves open the possibility of a substantial benefit for either group that must be further refined in future trials. Interpretation of long-term results in this study is limited by the relatively small study size of 150 patients and the fact that study extension to 36 months was implemented while the clinical trial was already underway, yielding a limited number of patients with full follow-up at 3 years. Another limitation is the use of various types of DCBs coated with different paclitaxel dosages, because potential differences in efficacy have been previously suggested (21). Although the studied devices have been successfully tested in randomized trials against standard angioplasty (2,3), no head-to-head comparison has been performed to date, and the sample size in our study is too small to rule out potential differences. Further, in line with most studies, we focused on patency as a primary outcome, whereas functional outcomes may be more relevant to patients. Because only 20 critical limb ischemia patients were included, we cannot separate results according to clinical status.
Overall, results for DCB and DES were similar at 12 months in this pilot study, whereas at longer time points a trend in favor of the DES was observed; larger long-term studies are necessary to more thoroughly assess relative outcomes for these technologies and identify patients that may benefit most from 1 therapy or the other.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: In patients with complex femoropopliteal artery atherosclerotic lesions ≤30 cm in length, 12-month patency rates of neatly 80% can be achieved with either drug-eluting stents or drug-coated balloon devices. Outcomes of percutaneous revascularization of totally occluded femoropopliteal lesions are limited by relatively high restenosis rates ≤3 years, requiring frequent clinical surveillance after intervention.
TRANSLATIONAL OUTLOOK: Larger trials should investigate whether drug-eluting device technologies employed after optimal vessel preparation improve long-term clinical outcomes in patients with long lesions in this arterial segment.
The authors thank Randi Hooten for editorial assistance.
REAL PTX was supported by funding from Cook Medical. Dr. Bausback has been a consultant for C.R. Bard and Medtronic. Dr. Schmidt has been a consultant for and/or received speakers honorarium from Abbott, Boston Scientific, C.R. Bard, Cook, Cordis, Intactvascular, Medtronic, Reflow, and Upstream Peripheral. Dr. Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, and Shockwave; has been a consultant for Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, B. Braun, Shockwave, Bayer, and Vesper Medical; and has received research funding from 480 Biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Veryan, Shockwave, Med Alliance, Intact Vascular, and B. Braun; and holds common stock in Veryan and QT Medical. Dr. Lottes is an employee of Cook Research Incorporated. Dr. Scheinert has been a consultant or advisory board member for Abbott, Bayer, Biotronik, Boston Scientific, Cardionovum, Cook Medical, Cordis, C.R. Bard, Gardia Medical/Allium, Medtronic/Covidien, Philips, TriReme Medical, Trivascular, and Upstream Peripheral Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Abbreviations and Acronyms
- bare-metal stent(s)
- clinically driven target lesion revascularization
- confidence interval
- chronic total occlusion
- drug-coated balloon
- drug-eluting stent(s)
- hazard ratio
- peripheral arterial disease
- superficial femoral artery
- Walking Impairment Questionnaire
- Received October 13, 2018.
- Revision received November 1, 2018.
- Accepted November 2, 2018.
- 2019 The Authors
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