SCAI consensus guidelines for device selection in femoral‐popliteal arterial interventions Article Swipe

The Society for Cardiovascular Angiography and Interventions (SCAI) has a history of prioritizing quality initiatives in the field of endovascular therapy (EVT) for peripheral artery disease (PAD). In 2017, SCAI updated the 2014 Appropriate Use Criteria (AUC) for EVT in the aorto-iliac, femoral-popliteal (FP), infra-popliteal and renal arterial circulations, promoting data-driven procedural decision making and understanding of relative risks and benefits of EVT in specific clinical and anatomic scenarios 1. In 2016, the updated AHA/ACC PAD Guidelines document provided contemporary recommendations for diagnosis and management of lower extremity PAD 2. However, these documents did not address the selection of specific devices when EVT is indicated. Device choices for EVT in the FP arterial bed remain challenging due to a wide spectrum of available endovascular device options and a paucity of comparative effectiveness data. The purpose of this first device-focused consensus document is to provide a review of comparative effectiveness data, including safety and efficacy of FP devices, and to provide clinicians with guidance and recommendations for device selection, when these devices are intended as the definitive or adjunctive therapy. This document provides recommendations applicable to devices used for EVT in FP disease. The goal is to guide clinical judgment with an emphasis on evidence-based and cost-effective utilization. This document is intended as a guide to improve decision making regarding EVT device selection for patients undergoing EVT. A balanced writing group was nominated and selected based on their EVT expertise, with consideration of relationships with industry and professional specialty or area of focus. The Writing Group Chairman and ≥50% of the members had no relevant relationships with industry (Table 1). The recommendations listed, whenever possible, were based on randomized controlled trials (RCTs) and meta-analyses, but also included registries, nonrandomized comparative studies, case series, cohort studies, and expert opinion. The writing committee chose the studies to highlight in this document; the final summary of the reviewed and most relevant clinical data is included in the Supporting Information Tables S1-S7. Abbott Vascular—advisory board Boston Scientific—advisory board Cardiovascular Systems—advisory board Cook—advisory board Gore—consultant Spectranetics—consultant, advisory board Non-Compensated Advisor: Abbott Vascular; Boston Scientific; Cordis, a Cardinal Health Company; Medtronic Compensated Advisor: Philips/Volcano; Micell; Vactronix; Venarum; American Orthotics and Prosthetics Association Equity Investment: PQ Bypass; Primacea; Gemini; eFemoral; Embolitech; Vascular Therapies; Sano V Abbott Vascular—advisory board Boston Scientific—advisory board Medtronic—advisory board Philips/Spectranetics—advisory board Abiomed—Speaker ACIST Medical—Grants/Research Support AstraZeneca—Speaker General Electric—Consultant Medtronic—Grants/Research Support Osprey Medical - Consultant Abbott Vascular—advisory board, consultant Atrium—grants/research support (national PI) Bard—grants/research support (national PI) Capture Vascular—advisory board, consultant Cardinal Health—advisory board, consultant Contego—advisory board, consultant Cook—advisory board Cruzar—advisory board, consultant, Ownership/Stock Owner/Shareholder Endospan—advisory board, consultant, Ownership/Stock Owner/Shareholder Eximo—advisory board, consultant, Ownership/Stock Owner/Shareholder Medtronic—advisory board, consultant Abbott - advisory board, consultant Boston Scientific - advisory board, consultant Phillips - advisory board, consultant ACIST Medical—Grants/Research Support Boston Scientific—Ownership/Stock Owner/Shareholder The Class (strength) of Recommendation (COR) represents the anticipated magnitude and certainty of comparative benefit for a group of devices (i.e., symptom improvement, patency, functional status, and/or quality of life) against the risks and cost of the device use based on the SCAI (modified ACC/AHA guideline recommendation) 3 classification (Table 2). The Level of Evidence (LOE) provides evidence supporting the effect of the devices on the basis of the type, quality, quantity, and consistency of data. The COR and LOE are determined independently; any COR may be paired with any LOE. Class I (Strong) Benefit ⋙ Risk (&Cost) Class IIa (Moderate) Benefit ≫ Risk (&Cost) Class IIb (Weak) Benefit ≥ Risk (&Cost) Class III: No Benefit (Moderate) Benefit = Risk (&Cost) Class III: Harm (Strong) Risk > Benefit (&Cost) The committee used a modified Delphi panel methodology, which employed an expert panel of clinicians who rated a series of anatomical scenarios with respect to COR/LOE. The panel participated in three rounds of voting, with communication among the panelists after the first anonymized round. Each panelist had equal weight in determining the final rating. Agreement among panelists was achieved when >80% of the recommendations ratings for the scenarios were concordant (Tables 2 and 3). IIB C-LD IIB C-EO IIA B-R IIA C-EO IIA C-EO III H C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB B-R III NB C-EO IIA A I B-R I A IIB B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-R IIB C-EO IIA A I B-R I A IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB A III NB C-LD IIA A I B-R I A IIB B-R III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-R III NB C-LD IIA A I B-R I A IIB B-R III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-NR III NB C-EO IIA B-NR I B-NR I B-R IIA B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-NR IIB C-LD IIA C-LD I C-LD I C-LD IIB C-EO III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-NR III NB C-LD IIA C-LD I C-LD I C-LD IIB C-EO III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-NR III NB C-LD IIA C-EO I C-EO I C-LD IIA C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-R III NB C-EO IIA B-R I B-R I B-R IIB C-LD III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB B-R III NB C-EO IIA B-R I B-R I B-R IIB B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB B-NR III NB C-EO IIA C-LD I B-NR I B-NR IIA B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-R III NB C-LD III NB C-EO IIB C-LD I B-R IIB C-LD IIA B-R III NB C-EO III H C-EO III NB C-EO III NB B-R III NB C-LD III NB C-EO IIA C-LD I B-R IIB B-R IIA B-R III NB C-EO III H C-EO III NB C-EO III NB B-NR III NB C-EO III NB C-EO IIA C-LD I B-R IIA B-R IIA B-R III NB C-EO III H C-EO III NB C-EO The use of the adjunctive devices for lesion preparation, such as atherectomy or specialty balloons, is separately addressed in this document including recommendations for both dilatable and undilatable lesions (Table 4). Atherectomy may be chosen as the adjunctive device for lesion preparation, whereas DCB may be selected as the intended definitive treatment. IIB C-EO III NB C-EO IIB C-EO IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO IIB C-EO IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO 6. Diffuse SFA lesion III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIA C-EO IIB C-LD III NB C-EO IIA C-EO IIB C-EO IIA C-EO IIB C-LD III NB C-EO IIA C-EO IIB C-EO IIA C-EO IIB C-LD III NB C-EO IIA C-EO IIB C-EO IIB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO IIB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO IIB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIA B-R III NB C-EO III H C-EO III NB C-EO III NB C-EO IIA B-R III NB C-EO III H C-EO III NB C-EO III NB C-EO IIA B-R III NB C-EO III H C-EO III NB C-EO The cost of the devices (Table 5) was considered secondary to examining efficacy and safety data when determining COR/LOE, particularly for devices with limited comparative clinical data that could justify their additional cost. 8.75 (CPT® Code 37224) $5085 (APC 5192) 10.24 (CPT® Code 37226) $10,510 (APC 5193) 11.75 (CPT® Code 37225) $10,510 (APC 5193) There has been a lack of consistent definitions and nomenclature across clinical trials of devices, drugs or biologics for the treatment of PAD. In an effort to overcome this barrier, the Peripheral Academic Research Consortium (PARC) developed consensus definitions for clinically meaningful outcomes and endpoints 4. The current consensus document recommends adopting the PARC definitions for acute procedural and technical success of EVT, short- and long-term surrogate endpoints of procedural success (using imaging and physiologic measures), and functional/clinical outcome definitions 4. In patients with claudication, functional assessments using standardized validated treadmill protocols or 6-min hall walk testing should be used. In CLI patients, limb outcomes with respect to major and minor lower extremity amputation, wound healing, ischemic rest pain, and major adverse limb events (MALE) should be examined. In this document, when evaluating comparative effectiveness, clinical and functional outcomes (e.g., clinically driven TLR) were given greater emphasis than surrogate endpoints (e.g., DUS-derived restenosis), which in turn were weighted more heavily than procedural success endpoints. When available, cost effectiveness studies were also taken into consideration in the recommendations. Lower extremity PAD has classically been defined by the anatomic segments affected as aorto-iliac, femoral-popliteal (FP) segment, and below knee infra-popliteal (IP) or infrageniculate arteries. The FP segments represent the common femoral artery (CFA), profunda femoris artery (PFA), superficial femoral artery (SFA) and popliteal artery, the longest nonbranched vessel. In this document, we discuss devices specific to the above-knee FP segment, while separately addressing CFA disease. The CFA bifurcation lesions refer to lesions that involve the common femoral bifurcation and ostial SFA/PFA; however, the recommendations also apply to isolated CFA disease. The above-knee popliteal artery segment includes the P1 (from intercondylar fossa to proximal edge of patella) and P2 (from proximal part of patella to center of knee joint space) popliteal segments. In addition to anatomical location, the lesions are classified according to length, stenosis versus occlusion, degree of calcification, and whether they represent de novo or in-stent restenosis (ISR). The TASC classification has previously placed FP lesions into 4 categories according to lesion length and whether disease is stenotic or occlusive 5. However, in this document and relevant to existing data for devices in RCTs, we have defined lesion length as focal (<10 cm), intermediate (10–20 cm), and diffuse (>20 cm), which is consistent with the AUC document 1. Given that definitions for degree of calcification varied between trials, we have provided recommendations for a general category of moderate-severely calcified lesions (≥180° degree of calcification involving both sides of vessel at same location). The lesion is considered undilatable if it could not be fully expanded during a balloon predilation. In stent restenosis (ISR) is defined as a stenosis or occlusion within a previously placed stent, regardless of whether the original stent was bare metal, drug eluting, or a covered stent. When EVT is considered, there are technical considerations such as choice of access site, the use of embolic protection and the use of re-entry devices. In this document, the choice of access site is left to the discretion of the operator. In some chronic total occlusions (CTOs), antegrade crossing results in subintimal wire passage and the need for re-entry into the true lumen. A number of re-entry devices and techniques have been described 6. Occasionally during FP treatment, an embolic protection device (EPD) may be appropriate, and several are commercially available. The utilization of re-entry or EPDs is beyond the scope of this document. Surgical endarterectomy has historically been the treatment of choice for CFA disease 7, 8. However, recent reports of EVT (DCB, atherectomy, stenting) 9, 10 and a randomized trial of stenting versus surgery 11 have demonstrated high technical success, improved safety and comparable patency for EVT compared to open surgery for CFA lesions. Data derived from a large pooled analysis (n = 1,014) from the Vascular Quality Initiative, demonstrate low procedural morbidity with CFA EVT (77% cases were PTA) 12. The TECCO (The Endovascular Versus Open Repair of the Common Femoral Artery) trial randomized 117 patients with de novo disease to CFA endarterectomy or stent placement 11. Of note, in the stenting group, 1/3 were treated with balloon-expandable stents, particularly in lesions that involved the common femoral bifurcation. There were more early complications in the surgical group (26% vs. 12.5%, P = 0.05) and longer duration of hospitalization with surgery (6.3 vs. 3.2 days, P < 0.0001); however, at 2 years there were no significant differences in freedom from TLR, patency or the sustained clinical improvement between the 2 groups. Based on the single randomized trial and expert consensus, recommendations for EVT in CFA disease are listed in Table 3. PTA therapy includes the use of conventional uncoated balloons. An "uncoated PTA-first" strategy that reserves stent placement for "bail-out" has historically been the common initial treatment approach. However, this approach is no longer the standard of care given the overwhelming evidence from RCTs in favor of DCB and DES therapy over stand-alone PTA with uncoated balloons. Uncoated PTA still remains an important adjunctive treatment modality for lesion preparation in primary stenting or DCB drug delivery and in conjunction with atherectomy devices. Based on comparative data for PTA with uncoated balloons versus other devices (see future sections), recommendations for stand-alone uncoated PTA as the intended definitive therapy in FP disease have been derived (Table 3). Recent meta-analyses of RCTs comparing treatment modalities in FP disease demonstrated that PTA with uncoated balloons alone was inferior to bare metal stents, covered stents, DCB, and DES with respect to technical success, restenosis and TLR rates 13, 14. For relatively short lesions (<5 cm), registry data suggested the primary patency rates approached 90% at 1 year, 80% at 2 years, and ∼70% at 3 years 15. Comparative data from multiple RCTs of bare metal stents failed to demonstrate a benefit of stents over uncoated balloons PTA alone in lesions of <10 cm lengths 16, 17. However, as lesion length increases (i.e., lesions >10 cm), data suggest superiority of bare metal stents over PTA with uncoated balloons alone 18, 19. Increasing amounts of FP lesion calcification increase the risk of PTA failure. Among 394 patients undergoing EVT for FP disease uncoated balloon PTA alone was successful in only ∼20% of cases, largely confined to noncalcified lesions 20. In lesions with more severe calcification, the uncoated balloon PTA-only success rate was low, 8.3%. These data highlight the limitations of uncoated balloon PTA alone in severely calcified lesions. Late patency rates following uncoated balloon PTA in CTOs at 12–36 months remain disappointing, with rates after a subintimal PTA approach declining from ∼70–80% at 6 months to ∼40–50% at 36 months 21, 22. Restenosis rates with uncoated balloon PTA alone, particularly for long segments of ISR or occluded stents, have also been disappointing with restenosis and TLR rates approaching 50% 23, 24. Uncoated balloon PTA has demonstrated inferior outcomes when compared to DCB and laser atherectomy in ISR lesions 23, 25, 26. Based on comparative clinical data, DCB or DES as the definitive device therapy for most lesions in the FP segment, with or without adjunctive PTA, would be preferred (Table 6). Specialty balloons (i.e., the Angiosculpt scoring balloon [Royal Philips, Amsterdam, The Netherlands], the peripheral cutting balloon [Boston Scientific, Inc., Marlborough, MA], the Chocolate PTA balloon [TriReme Medical, LLC, Pleasanton, CA], and the VascuTrak [Bard Peripheral Vascular, Inc., Tempe, AZ]) emerged to address the limitations of conventional uncoated balloon PTA - the ability to treat severely calcified and undilatable lesions. In general, specialty balloon studies are small, observational and the main comparator (when is conventional stand-alone PTA Information Table There are no between specialty balloons or (e.g., of the devices have demonstrated their but have a cost (Table 4). In clinical specialty balloons are used as the intended definitive therapy but as the lesion preparation devices. Based on limited data consensus recommendations for stand-alone specialty balloons utilization as the intended definitive therapy (Table as as the adjunctive therapy (Table in FP disease have been were developed to address the (e.g., acute and long-term (e.g., limitations of PTA, a between PTA, lesion length and restenosis has been demonstrated RCTs in FP stenosis or occlusion failed to demonstrate in in primary patency or in with versus following RCTs demonstrated an benefit of including the 18, (The Versus with in Femoral and the versus In The SFA and/or Artery) studies, of which patients with length FP disease Information Table These studies were pooled in a 2014 of 11 RCTs, patients with or CLI and TASC A or lesions these trials demonstrated patency by and and patency by with primary versus However, at months patency by and were between primary versus A number of recent studies have stents for treatment of FP including in longer significant calcification, of but not ISR lesions these studies have not included any comparative devices, that limited the relative effectiveness or comparative safety of the devices be Information Table Comparative RCTs of to DES and DCB are to their relative (Table The Medical, DES is a stent, which was developed for treatment of the FP segment to provide both a stent and drug to The randomized trial patients with and SFA or proximal popliteal disease to DES or PTA the primary DES group had primary patency than the primary PTA group Among patients who a secondary for failed PTA, DES use was also with primary patency compared to of this demonstrated sustained freedom from vs. There was also a improved freedom from among patients treated with a DES strategy versus single studies with endpoints have the outcomes of in the single a and the registry Information Table The single was a registry of patients with PAD treated with The primary patency was and the freedom from TLR was The TASC lesion of this registry included lesions with a lesion length of primary patency was and freedom from TLR, with a stent rate of only In the of ISR primary patency was at 1 and freedom from TLR was (Table three have been in and RCTs, and have been for the treatment of FP Vascular, and Philips, Amsterdam, The with from 2 to and in with and and Information Table A analysis of DCB trials that there may not be a effect and that the treatment of DCB devices may on their including drug and to clinical trials between the are to their relative to data have suggested DCB to be cost in the FP segment Among the current options for FP DCB recommendations based on the LOE from several (Table The for the of 1 and 2 RCTs the DCB with a of of 2 with a and and The initial 1 trial patients randomized to DCB versus PTA, but TLR differences were not significant at = and procedural were and the 2 trial the use of the DCB in FP in patients A rate of primary patency by was at months with DCB versus PTA vs. P = A large number of patients treated with the DCB were from primary safety events vs. P = including low rates of and embolic secondary efficacy endpoints compared between PTA and DCB were in treated with A pooled analysis of patients of the and from the SFA versus for the of Femoral and Artery) trial that primary patency at months was improved in the DCB versus uncoated PTA, and at months vs. PTA, vs. P < vs. P < DCB use was to uncoated PTA in of clinically driven TLR at which also at months vs. PTA, vs. P < vs. P < The DCB to for use in de novo and FP lesions was the DCB from the trial series The DCB a of 2 and is with a The and in the and of the and Among patients of the primary patency vs. P < and clinically driven TLR vs. P = were in the DCB versus uncoated PTA at months among patients of the restenosis rates vs. P = and clinically driven TLR were lower vs. P = in the DCB group at months The use of DCB alone in FP long lesions and CTOs has been in several The Versus for Restenosis of Femoral Artery) trial randomized patients with SFA ISR to DCB versus PTA lesion length DCB was with a significant of TLR in to uncoated PTA vs. P = In the a registry of the DCB in patients, the clinical cohort included with long lesions cm (n = de novo ISR lesions (n = and cm (n = patency at months was and clinically driven TLR at months was and These data the of the DCB in ISR lesions. of DCB in ISR the in Peripheral for a registry comparing DCB (n = versus (n = for FP ISR in patients with CLI 1 year, both restenosis and clinically driven TLR were for DCB However, at 3 years, TLR rates were in DCB and PTA the trial was a small, evaluating DCB (n = versus uncoated PTA (n = in patients with SFA ISR and CLI from TLR was in the DCB cohort at months vs. P < long-term results are not available. The use of covered stents is for treatment of FP disease. These stent covered with expanded and a stent to the are not for ostial lesions involving a major or in the of Based on current efficacy data and risks of device consensus recommendations for covered stents in FP disease have been derived Information Tables In the randomized with versus bare stent in the treatment of long lesions in superficial femoral artery occlusive primary patency rates at months versus vs. P = in FP lesions In long covered had a patency at months vs. P = had greater primary patency compared to however, without a significant on TLR rate In the at 3 years, primary patency rates were not between patients treated with the and who vs. In the with in the of Femoral primary patency at months was which was not affected by device vs. 6 vs. or lesion length cm vs. were in a with primary patency not affected by lesion length in lesions versus in cm P = The trial randomized patients with FP ISR to PTA or PTA with placement months the primary patency rate was with PTA stenting) versus with stent In a were treated for ISR length TASC with of of restenosis of in acute limb more following covered compared to covered stent of and edge restenosis have been as the to stent The regarding stent and acute limb as the for covered stents have in limited utilization of these devices as definitive therapy for most de novo FP lesions (Table the by or of has been used in the FP segment, the lack of comparative outcomes data to justify the additional cost of these devices. atherectomy devices have been developed over the including and devices Information Table There are no RCTs comparing atherectomy to stents or should be that these devices are (Table and are used as a stand-alone definitive but as the adjunctive therapy for lesion this document provides recommendations for atherectomy devices intended as the definitive therapy (Table and recommendations for devices to be used for lesion preparation (Table data regarding adjunctive use of atherectomy devices, particularly in ostial and popliteal are The of in the treatment of de novo FP disease was in the single of of the for the of This registry a primary patency of in with no between and The use of was with a low use of stents However, was with a risk of and risk of arterial However, without comparative evidence to support the use of this device as a definitive treatment strategy in FP it is to justify the use of based on cost. the trial of of the for the of the use of DCB or DCB alone in patients with lesions between and The trial no between the with respect to for DCB vs. for DCB and patency as by for DCB vs. for DCB and atherectomy devices lack comparative evidence to support their use as a definitive studies of and a number of recent trials of in FP disease Information Table have been The single comparative trial the trial to Benefit of in by to Atherectomy in randomized patients to PTA or PTA alone In this freedom from TLR or restenosis was not at months with PTA vs. with There is no comparative evidence to support the use of the atherectomy devices as a definitive treatment The of the Atherectomy Scientific, Inc., Marlborough, included patients at <10 cm in the FP and cm in the with stenosis were These lesions were rated to have to high in adverse events in of driven TLR at 6 months in and at months in restenosis as by in of lesions. by of therapy was first used in an occluded SFA in The randomized Peripheral compared the laser to PTA and failed to demonstrate any patency for the device in long SFA occlusions The for of Restenosis trial randomized patients with FP ISR to PTA versus PTA months of the PTA in lesions of cm were TLR, but was by significant to be to support the use of this in ISR lesions. trial (n = compared DCB to DCB alone in CLI patients with occlusion of the FP segment secondary to The patency rates at months were in the DCB group versus DCB alone 26. A number of adjunctive other than specialty balloons such as and have been in FP which data or failed to demonstrate significant over available PTA and/or stents with respect to procedural success or future restenosis such as for calcified undilatable FP disease are The SCAI writing committee a review and analysis of the evidence and developed recommendations for FP EVT. These recommendations are a first to provide clinicians with relevant anatomical scenarios to guide device selection based on and quality of evidence for comparative effectiveness, and expert opinion. in the Supporting Information may be in the supporting for this Tables The is not for the or of any supporting by the than should be to the for the