rotarex®s for isr/occlusion: a french multicentre ... · with in-stent occlusion in iliac and...
TRANSCRIPT
Rotarex®S for ISR/occlusion: A French multicentre experience with
128 patients
Prof. Romaric LOFFROY, MD, PhD, FCIRSE
Chief, Department of Vascular & Interventional Radiology
Image-Guided Therapy Center
François-Mitterrand University Hospital
Dijon, France
Disclosure
Speaker name:
Romaric LOFFROY
I have the following potential conflicts of interest to report:
Consulting: Straub Medical, Guerbet, Medtronic, Cook
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
x
Background
• In-stent restenosis (ISR) after peripheral angioplasty constitutes a growingtherapeutic challenge
– Incidence of 15-42% at 1 year (up to 73%)
• Risk factors for ISR
– Patient specific: diabetes, female
– Lesion specific: location, vessel diameter, lesion length, plaque burden, statusof distal vessels (run-off)
• Unsatisfactory treatment outcomes, especially higher ISR and occlusion rates, in patients with peripheral artery disease (PAD) treated with baremetal stents (BMS) resulted in market release of other technologies
Shishehbor MH.
Endovascular treatment of femoropopliteal lesions: so many options, little consensus.
J Am Coll Cardiol 2015;66:2339
Surprisingly, however, when restenosis recurred in DEB treated patients, it was of
the occlusive pattern in almost all cases. A possible explanation of this phenomenon
is related to the fixed amount of drug available in the balloon, perhaps not enough
to control the malignant attitude of intimal hyperplasia in predisposed patients.
Debulking might potentially be of special interest
in these complicated cases.
ISR vs total occlusion
No standard treatment !!!
• Repeat PTA ?– Plain balloon
– Cutting balloon
– DCB
• Stent implantation again ??– BMS
– Covered stents
– DES
• Catheter based atherectomy ???– Laser
– Directional
– Rotational
Rationale for debulking & options
• Debulking treatment has been attempted to lessen restenotic tissue burdenand improve patency while reducing target lesion revascularization (TLR)
• The debulking of the restenotic stent may potentially improve DCB treatment effects by reducing the thickness of thrombus and hyperplastictissue and increasing drug dosage transit to the intima
Laser Directional+ Rotational
RotationalDirectionalOrbital
HawkOne JetStreamRotarex®S Phoenix
The RotarexⓇS device itself
Target vessel diameter: 3 - 5 mm → use 6F catheter !
Target vessel diameter: 5 - 8 mm → use 8F catheter !
Target vessel diameter: 7 - 12 mm → use 10F catheter !
Rotarex® 6F 110 cm (antegrade/crossover)
Rotarex® 8F 85 cm (antegrade) or 110 cm (crossover)
No published data for ISR/occlusion
- with more than 100 patients
- multicentric
Purpose
• To ascertain the safety and mid-term outcomes of Rotarex®Srotational atherectomy (Straub Medical AG, Wangs, Switzerland) with or without additional treatment(PTA/DCB/stenting) in patients with IS restenosis or occlusion in the iliac and/or infrainguinal arteries
• Endpoints: safety, technical success, patency rates, clinicalimprovement, limb salvage, survival
Materials
• French multicentre retrospective study
• 6 centers/128 patients
• January 2013 – November 2018
• All patients treated by in-stent debulking with Rotarex®S device, whatever further procedure
• Inclusion criteria– Acute, subacute or chronic ISR (>50%) or CTO
– Rutherford category 2 to 6 in the target limb
– Iliac and/or infrainguinal arteries
– Successful intraluminal guidewire crossing of target lesion
• Exclusion– BTK lesions
Definitions
• Technical success was defined as successful delivery and deployment of Rotarex catheter at the target lesion, whatever further treatment, with attainment of <30% diameter residual stenosis
• Clinical success was defined as
– Clinical improvement of at least one clinical category for patients with claudication (Rutherford 2)
– The resolution of ischemic rest pain and the healing of ischemic ulcers for patients with rest pain (Rutherford 3) or CLI (Rutherford 4-5-6)
• Target lesion revascularization (TLR) was defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Demographics
Table 1. Demographical characteristics of 128 patients of the study.
Mean ± standard deviation (SD) or number (%)
Age (range) (years) 66.7 ± 12.0 (39-94)
Gender
Men 88/128 (68.75)
Women 40/128 (31.25)
Comorbidities /Risks factors
Smoker 87/128 (67.97)
Arterial hypertension 80/128 (62.50)
Diabetes 40/128 (31.25)
Dyslipidemia 78/128 (60.94)
Coronary vascular disease 14/128 (10.94)
Chronic renal impairment 14/128 (10.94)
Cardiopathy 38/128 (29.69)
Values are means ± SD or numbers (%) of observations.
Loffroy et al. Quant Imaging Med Surg 2020
Initial Rutherford score
Table 3. Baseline Rutherford scores of patients at admission.
Rutherford score Patients, n (%)
2-362/128 (48.4)
444/128 (34.4)
5-622/128 (17.2)
Loffroy et al. Quant Imaging Med Surg 2020
The cohort included 51.6% CLI patients
Angiographic dataTable 2. Overall angiographic and procedural data on stented arteries.
Arterial levelIliac 31/128 (24.3)SFA 56/128 (43.8)
Popliteal 14/128 (10.9)
SFA + popliteal 27/128 (21.0)In-stent lesion length
<5 cm 32/128 (25.0)
5–10 cm 66/128 (51.6)
>10 cm 30/128 (23.4)
In-stent lesion typeStenosis 50/128 (39.1)
Occlusion 78/128 (60.9)Age of lesion
Acute (< 14 days) 48/128 (37.5)
Subacute (< 3 months) 55/128 (43.0)Chronic (> 3 months) 25/128 (19.5)
Operative details
Procedure time (min)
Rotarex time 5.10 ± 2.28
Total time 57.2 ± 32.0
Rotarex size
6-Fr 73/128 (57.0)
8-Fr 53/128 (41.4)
10-Fr 2/128 (1.6)
Approach
Ipsilateral 40/128 (31.2)
Controlateral 86/128 (67.2)
Brachial 2/128 (1.6)
Use of closure device
Yes 117/128 (91.4)
No 11/128 (8.60)
Procedural dataTable 2. Overall angiographic and procedural data on stented arteries.
Intraoperative additional procedure
None (Rotarex alone) 4/128 (3.1)
PTA 95/128 (74.2)
DEB 16/128 (12.5)
PTA + DEB 13/128 (10.2)
Stenting
Yes 85/128 (66.4)
Same location / Other location / Both 50/85 (58.8) / 30/85 (35.3) / 5/85 (5.9)
No 43/128 (33.6)
Post-interventional medication
Anticoagulant therapy
Preventive 96/128 (75)
Curative 32/128 (25)
Antiplatelet therapy
Single 51/128 (39.8)
Dual 77/128 (60.2)
Abbreviation: SFA, superficial femoral artery; PTA, percutaneous transluminal angioplasty; DEB, drug-eluting balloon.Continuous data are presented as means ± SD or numbers (%) of observations.
Technical/clinical success ratesTable 4. Procedure success and failure, n (%).
Procedural success
Technical success 124/128 (96.9)
Additional thrombolysis for outflow occlusion 6/128 (4.7)
Primary clinical success
At 1 month 121/128 (94.5) – 121/128 (94.5)
At 3 months 103/128 (80.5) – 103/116 (88.8)
At 6 months 80/128 (62.5) – 80/88 (90.9)
At 12 months 51/128 (39.8) – 51/55 (92.3)
Mean follow-up (range) (months) 7 (1-60)
Secondary clinical success at mean follow-up 117/128 (91.4)
Failure at mean follow-up
Rate of reintervention 32/128 (25.0)
Mean time from Rotarex treatment to reintervention ± SD (mo) 7.1 ± 8.2
Type of reintervention
Rotarex alone 13/32 (40.6)
Bypass 12/32 (37.5)
Amputation 8/32 (25)
Target lesion revascularization (TLR) 25/128 (19.5)
Type of amputation
Major amputation 4/32 (12.5)
Minor amputation 4/32 (12.5)
Rotarex or bypass + minor or major amputation 3/32 (9.3)
Limb salvage at mean follow-up 120/128 (93.7)
Loffroy et al. Quant Imaging Med Surg 2020
Complications at 1 month
Table 5. Complications within 30 days.
Major (requiring hospitalization and/or reintervention) N %
Perforation 3/128 2.3
Dissection 3/128 2.3
Device defect 1/128 0.78
Thrombosis 2/128 1.6
Embolization 7/128 5.5
Bleeding 6/128 4.7
False aneurysm 5/128 3.9
Infection 3/128 2.4
MAE
Death 1/128 0.78
Myocardial infarction 2/128 1.6
Stroke 0/128 0
Major amputation 1/128 0.78
Renal failure 2/128 1.6
Major adverse events at follow-up
Table 6. Major adverse events (MAE) at mean follow-up.
MAE Events (%)
Death 18/128 14.06
Myocardial infarction 9/128 7.0
Stroke 2/128 1.6
Renal failure 3/128 2.3
Loffroy et al. Quant Imaging Med Surg 2020
None was device related
Patency rate at mean follow-up0
.00
0.2
50
.50
0.7
51
.00
0 20 40 60analysis time
Kaplan-Meier survival estimate
From 6 months and up to 60 months, 90% of patients had patent stent
Freedom from-reintervention rate0
.00
0.2
50
.50
0.7
51
.00
0 20 40 60analysis time
Kaplan-Meier survival estimate
50% of patients did not need any reintervention at 41.5 months
Survival0
.00
0.2
50
.50
0.7
51
.00
0 20 40 60analysis time
Kaplan-Meier survival estimate
68% of patients were alive at 60 months
Predictors of success ?
• Reintervention = 32/125 (25%)
– 10/77 (13.0%)
• Double antiplatelet therapy
– 22/29 (43.1%)
• Single antiplatelet therapy
Reintervention rate was lower in patients under dual antiplatelet therapy vs single antiplatelet therapy (p<0.05)
No impact of lesion type (length, degree, age) on patency/reintervention/survival rates (p>0.05)
Mr D./61 yo/Acute symptoms/IS thrombosis
Rotarex 6-Fr + PTA + Viabahn
Additional posterior tibial artery PTA
Lysis avoided, no distal embolization
Ms G./59 yo/Subacute symptoms after stenting/Extensive iliac artery thrombosis
Rotarex 8-Fr + PTA
No further stenting
Mr Z./69 yo/Chronic IS occlusion/Limping patient
Rotarex 6-Fr + PTA + DCB
Combined debulking & DCB technology
Limitations
• Non randomized retrospective study
• Modestly sized sample
• Heterogeneous population– Different target vessels
• Iliac vs SFA vs PA vs combined
– Different stent-graft occlusions
• Restenosis vs acute thrombosis vs chronic thrombosis vs combined
– Different techniques
• Debulking alone vs debulking + PTA vs debulking + DEB vs combined
• The results need to be confirmed in a larger study or randomized controlled trial with longer follow-up
Conclusion
• This study showed that RotarexⓇS rotational debulking±PTA/DCB angioplasty is safe, quick and effective in patients with in-stent occlusion in iliac and infrainguinal arteries
• It may produce satisfactory outcomes in terms of primarypatency rate
• This is the largest and only multicenter study that has analyzed the outcomes of such a hybrid intervention in the treatment of in-stent occlusion
• Its results justify further research in the application of thistherapy to determine cost/benefit
Rotarex®S for ISR/occlusion: A French multicentre experience with
128 patients
Prof. Romaric LOFFROY, MD, PhD, FCIRSE
Chief, Department of Vascular & Interventional Radiology
Image-Guided Therapy Center
François-Mitterrand University Hospital
Dijon, France