Purpose: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease. Methods: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality. Results: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%–75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%). Conclusion: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.
Gerhard-HermanMDGornikHLBarrettCet al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e686–e725.
TASC Steering Committee, JaffMRWhiteCJet al. An update on methods for revascularization and expansion of the tasc lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Endovasc Ther. 2015;22:663–677.
4.
TenderaMAboyansVBartelinkM-Let al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. The Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–2906.
5.
Biondi-ZoccaiGGSangiorgiGLotrionteMet al. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009;16:251–260.
6.
SchmidtAUlrichMWinklerBet al. Angiographic patency and clinical outcome after balloon angioplasty for extensive infrapopliteal arterial disease. Catheter Cardiovasc Interv. 2010;76:1047–1054.
7.
RandonCJacobsBDe RyckFet al. Angioplasty or primary stenting for infrapopliteal lesions: results of a prospective randomized trial. Cardiovasc Intervent Radiol. 2010;33:260–269.
8.
Rocha-SinghKJJaffMJoyeJet al. Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: the XCELL trial. Catheter Cardiovasc Interv. 2012;80:1042–1051.
9.
BosiersMLioupisCDelooseKet al. Two-year outcome after Xpert stent implantation for treating below the knee lesions in critical limb ischemia. Vascular. 2009;17:1–8.
10.
BosiersMScheinertDPeetersPet al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012;55:390–398.
11.
RastanATepeGKrankenbergHet al. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011;32:2274–2281.
12.
ScheinertDKatsanosKZellerTet al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012;60:2290–2295.
13.
KatsanosKKitrouPSpiliopoulosSet al. Comparative effectiveness of plain balloon angioplasty, bare metal stents, drug-coated balloons, and drug-eluting stents for the treatment of infrapopliteal artery disease: systematic review and Bayesian network meta-analysis of randomized controlled trials. J Endovasc Ther. 2016;23:851–863.
14.
FusaroMCasseseSNdrepepaGet al. Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials. JACC Cardiovasc Interv. 2013;6:1284–1293.
15.
IqbalJOnumaYOrmistonJet al. Bioresorbable scaffolds: rationale, current status, challenges, and future. Eur Heart J. 2013;35:765–776.
16.
VarcoeRLSchoutenOThomasSDet al. Initial experience with the absorb bioresorbable vascular scaffold below the knee: six-month clinical and imaging outcomes. J Endovasc Ther. 2015;22:226–232.
17.
VarcoeRLSchoutenOThomasSDet al. Experience with the Absorb everolimus-eluting bioresorbable vascular scaffold in arteries below the knee: 12-month clinical and imaging outcomes. JACC Cardiovasc Interv. 2016;9:1721–1728.
18.
OtsukaFPachecoEPerkinsLEet al. Long-term safety of an everolimus-eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model. Circ Cardiovasc Interv. 2014;7:330–342.
19.
PerkinsLEKossuthM-BFoxJCet al. Paving the way to bioresorbable technology development: from the concept to pre-clinical evaluation. Catheter Cardiovasc Interv. 2016;88(S1):1–9.
20.
SerruysPWOnumaYOrmistonJAet al. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010;122:2301–2312.
21.
VarcoeRLThomasSDRapozaRJet al. Lessons learned regarding handling and deployment of the Absorb bioresorbable vascular scaffold in infrapopliteal arteries. J Endovasc Ther. 2017:24;337–341.
22.
CostopoulosCLatibANaganumaTet al. Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population. Catheter Cardiovasc Interv. 2015;85:E10–E15.
23.
PuricelSCuculiFWeissnerMet al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016;67:921–931.
24.
TamburinoCLatibAvan GeunsRJet al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. EuroIntervention. 2015;11:45–52.
25.
SerruysPWOnumaYGarcia-GarciaHMet al. Dynamics of vessel wall changes following the implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014;9:1271–1284.
NakataniSIshibashiYSotomiYet al. Bioresorption and vessel wall integration of a fully bioresorbable polymeric everolimus-eluting scaffold: optical coherence tomography, intravascular ultrasound, and histological study in a porcine model with 4-year follow-up. JACC Cardiovasc Interv. 2016;9:838–851.
28.
GogasBDSandeepkBenhamJet al. TCT-828 Very late vasomotor responses and gene expression profiles of porcine coronary arteries at 4 years after deployment of the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic Xience V stent. J Am Coll Cardiol. 2016;68:B334–B335.
29.
FeiringAJKrahnMNelsonLet al. Preventing leg amputations in critical limb ischemia with below-the-knee drug-eluting stents: the PaRADISE (PReventing Amputations using Drug eluting StEnts) trial. J Am Coll Cardiol. 2010;55:1580–1589.
30.
RastanABrechtelKKrankenbergHet al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012;60:587–591.
31.
SiablisDKarnabatidisDKatsanosKet al. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol. 2009;20:1141–1150.
32.
SpreenMIMartensJMHansenBEet al. Percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia (PADI) trial. Circ Cardiovasc Interv. 2016;9:e002376.
33.
SpreenMIMartensJMKnippenbergBet al. Long-term follow-up of the PADI trial: percutaneous transluminal angioplasty versus drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Am Heart Assoc. 2017;6:e004877.
34.
WernerMSchmidtAFreyerMet al. Sirolimus-eluting stents for the treatment of infrapopliteal arteries in chronic limb ischemia: long-term clinical and angiographic follow-up. J Endovasc Ther. 2012;19:12–19.
35.
KarnabatidisDSpiliopoulosSDiamantopoulosAet al. Primary everolimus-eluting stenting versus balloon angioplasty with bailout bare metal stenting of long infrapopliteal lesions for treatment of critical limb ischemia. J Endovasc Ther. 2011;18:1–12.
36.
StoneGWGaoRKimuraTet al. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016;387:1277–1289.
37.
KimuraTKozumaKTanabeKet al. A randomized trial evaluating everolimus-eluting Absorb bioresorbablescaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015;36:3332–3342.
38.
KereiakesDJEllisSGMetzgerCet al. 3-year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: the ABSORB III trial. J Am Coll Cardiol. 2017;70:2852–2862.
39.
WykrzykowskaJJKraakRPHofmaSHet al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med. 2017;376:2319–2328.
40.
AliZASerruysPWKimuraTet al. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet. 2017;390:760–772.
41.
ToyotaTMorimotoTShiomiHet al. Very late scaffold thrombosis of bioresorbable vascular scaffold: systematic review and a meta-analysis. JACC Cardiovasc Interv. 2017;10:27–37.
42.
SotomiYOnumaYColletCet al. Bioresorbable scaffold: the emerging reality and future directions. Circ Res. 2017;120:1341–1352.
43.
SorrentinoSGiustinoGMehranRet al. Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents. J Am Coll Cardiol. 2017;69:3055–3066.
44.
CapodannoDGoriTNefHet al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015;10:1144–1153.
45.
StoneGWAbizaidAOnumaYet al. Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials. J Am Coll Cardiol. 2017;70:2863–2874.
46.
OnumaYSotomiYShiomiHet al. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016;12:1090–1101.
47.
TanakaALatibAKawamotoHet al. Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy. EuroIntervention. 2017;12:1730–1737.
48.
TenekeciogluEPoonEColletCet al. The nidus for possible thrombus formation: insight from the microenvironment of bioresorbable vascular scaffold. JACC Cardiovasc Interv. 2016;9:2167.
49.
MustaphaJADiaz-SandovalLJSaabF.Infrapopliteal calcification patterns in critical limb ischemia: diagnostic, pathologic and therapeutic implications in the search for the endovascular holy grail. J Cardiovasc Surg (Torino). 2017;58:383–401.
50.
DruekeTB.Arterial intima and media calcification: distinct entities with different pathogenesis or all the same?Clin J Am Soc Nephrol. 2008;3:1583–1584.
