Author + information
- Adam Mazurek1,
- Mariusz Trystuła2,
- Jacek Jąkała3,
- Andrzej Brzychczy4,
- Anna Borratyńska5,
- Agata Leśniak-Sobelga6,
- Małgorzata Urbańczyk7,
- R. Paweł Banyś7,
- Wojciech Zajdel8,
- Klaudia Proniewska3,
- Lukasz Partyka9,
- Krzysztof Zmudka8,
- Piotr Podolec10 and
- Piotr Musialek10
- 1Department of Cardiac and Vascular Diseases, John Paul II ND Hospital, Krakow, Poland
- 2Dept. Vascular Surgery, John Paul II Hospital, Krakow, Poland
- 3Krakow Cardiovascular Research Institute, Krakow, Poland
- 4Dept. Vascular Surgery, John Paul II Hospital, krakow, Poland
- 5Neurology Outpatient Dept., John Paul II Hospital, Krakow, Poland
- 6Department od Cardiac and Vascular Diseases, John Paul II ND Hospital, krakow, Poland
- 7Dept. Radiology, John Paul II Hospital, Krakow, Poland
- 8Clinical Dept. of Interventional Cardiology, John Paul II Hospital, Krakow, Poland
- 9KCRI, Krakow, Poland
- 10Department od Cardiac and Vascular Diseases, John Paul II ND Hospital, Krakow, Poland
Using conventional carotid stents, highly calcific carotid stenosis (HCCS) is considered a classic contraindication to carotid artery stenting (CAS). All-comer PARADIGM (Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system) study evaluates feasibility, safety, and outcome of CAS using routinely a novel dual-layer embolic prevention stent (MN-EPS, InspireMD) in 101 consecutive, unselected patients (106 lesions) with symptomatic or increased-stroke risk asymptomatic carotid stenosis. The study has no exclusion criteria other than lack of NeuroVascular Team (NVT) agreement on revascularization indication and endovascular route feasibility. Liberal post-dialations are allowed to minimise residual stenosis. Aim: The present analysis evaluated clinical safety of HCCS management using the study device, and compared HCCS procedural and angiographic data with those for non-HCCS lesions.
Independent CoreLab analysis, inclusive of angiographic calcium scores, identified 17 HCCS and 91 non-HCCS. The HCCS patients were older (70.3±7.4 vs 68.7±7.5, p=0.44). 1 HCCS lesion (5.9% HCCS) was treated with CEA. Neuroprotection device (NPD) was used in all CAS with distal NPD more frequent in HCCS (10/16 (62.5%) vs 47/90 (52.2%), p<0.005). In HCCS higher postidilatation pressures were used (21.4±3.3 vs 19.5±3.5atm, p=0.049).
Baseline angiographic diameter stenosis (DS) was similar in HCCS vs. non-HCCS (80.4±9.5% vs 83.5±9.8%, p=0.24); however residual DS was significantly higher in HCCS (12.2± 10.9% vs 4.6±4.5, p=0.005, CopreLab evaluation). Procedural success (including <30% residual DS) was achieved in 15/16 (93.75%) vs. 90/90 (100%) lesions (p<0.005). In one HCCS patient no postdilatation optimisation was performed due to severe bradycardia-asystole; residual DS was 46%DS. While baseline peak systolic velocities (PSV) were similar (3.6±1.4 vs 3.7±1.2 m/s, p=0.81), their value after 30 days was significantly higher in HCCS (0.9±0.3 vs 0.6±0.3m/s, p=0.006). Endovascular HCCS management was clinically safe and was agiographically free of contrast extravasation. By 30 days there were no adverse events.
In the all-comer PARADIGM study population, HCCS endovascular management using the CGuard MN-EPS was feasible and it was safe. However, residual DS and post-procedural PSV were higher as compared to the non-HCCS lesions. Adequate technique including proper lesion preparation and post-dilatation is required in endovascular management of HCCS.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention