Results from the Tack Optimized Balloon Angioplasty (TOBA)
study demonstrate the benefits of minimal metal implants for
dissection repair after angioplasty

J 2016

Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty

BOSIERS, Marc, Dierk SCHEINERT, Jeroen M. H. HENDRIKS, Christian WISSGOTT, Patrick PEETERS et. al.

Základní údaje

Originální název

Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty

Autoři

BOSIERS, Marc (56 Belgie), Dierk SCHEINERT (276 Německo), Jeroen M. H. HENDRIKS (56 Belgie), Christian WISSGOTT (276 Německo), Patrick PEETERS (56 Belgie), Thomas ZELLER (276 Německo), Marianne BRODMANN (40 Rakousko) a Robert STAFFA (203 Česká republika, garant, domácí)

Vydání

Journal of Vascular Surgery, New York, Mosby Inc. 2016, 0741-5214

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 3.536

Kód RIV

RIV/00216224:14110/16:00090354

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1016/j.jvs.2016.02.043

UT WoS

000378562900016

Klíčová slova anglicky

SUPERFICIAL FEMORAL-ARTERY; NITINOL STENT IMPLANTATION; CLINICAL IMPACT; ELUTING STENTS; RESTENOSIS; PACLITAXEL; TRIAL; LESIONS; DISEASE; THROMBOSIS

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 8. 2016 12:48, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

Objective: The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent fracture. Tack (Intact Vascular, Wayne, Pa) implants have minimal metal and low radial force and are specifically designed for dissection repair. This study evaluated Tack implants for treatment of dissections resulting from standard balloon PTA for femoral-popliteal arterial disease. Twelve-month outcomes after Tack treatment of post-PTA dissections are described. Methods: This prospective, single-arm study evaluated patients with ischemia (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard balloon angioplasty, and post-PTA dissections were treated with Tacks. The primary end points were core laboratory-adjudicated device technical success, defined as the ability of the Tack implants to resolve post-PTA dissection, and device safety, defined as the absence of new-onset major adverse events. Patients were followed up to 12 months after implantation. Results: Tacks were used in 130 patients with post-PTA dissections (74.0% >= grade C). Technical success was achieved in 128 (98.5%) patients with no major adverse events at 30 days. The 12-month patency was 76.4%, and freedom from target lesion revascularization was 89.5%. Significant improvement from baseline was observed in Rutherford clinical category (82.8% with grade <= 1) and ankle-brachial index (0.68 +/- 0.18 to 0.94 +/- 0.15; P<.0001). Conclusions: Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization. Tack treatment represents a new, minimal metal paradigm for dissection repair that can safely improve the clinical results associated with PTA.

Citovat

BOSIERS, Marc, Dierk SCHEINERT, Jeroen M. H. HENDRIKS, Christian WISSGOTT, Patrick PEETERS, Thomas ZELLER, Marianne BRODMANN a Robert STAFFA. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. Journal of Vascular Surgery. New York: Mosby Inc., 2016, roč. 64, č. 1, s. 109-116. ISSN 0741-5214. Dostupné z: https://dx.doi.org/10.1016/j.jvs.2016.02.043.

@article{1349552,
   author = {Bosiers, Marc and Scheinert, Dierk and Hendriks, Jeroen M. H. and Wissgott, Christian and Peeters, Patrick and Zeller, Thomas and Brodmann, Marianne and Staffa, Robert},
   article_location = {New York},
   article_number = {1},
   doi = {http://dx.doi.org/10.1016/j.jvs.2016.02.043},
   keywords = {SUPERFICIAL FEMORAL-ARTERY; NITINOL STENT IMPLANTATION; CLINICAL IMPACT; ELUTING STENTS; RESTENOSIS; PACLITAXEL; TRIAL; LESIONS; DISEASE; THROMBOSIS},
   language = {eng},
   issn = {0741-5214},
   journal = {Journal of Vascular Surgery},
   title = {Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty},
   volume = {64},
   year = {2016}
}

TY  - JOUR
ID  - 1349552
AU  - Bosiers, Marc - Scheinert, Dierk - Hendriks, Jeroen M. H. - Wissgott, Christian - Peeters, Patrick - Zeller, Thomas - Brodmann, Marianne - Staffa, Robert
PY  - 2016
TI  - Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty
JF  - Journal of Vascular Surgery
VL  - 64
IS  - 1
SP  - 109-116
EP  - 109-116
PB  - Mosby Inc.
SN  - 07415214
KW  - SUPERFICIAL FEMORAL-ARTERY
KW  - NITINOL STENT IMPLANTATION
KW  - CLINICAL IMPACT
KW  - ELUTING STENTS
KW  - RESTENOSIS
KW  - PACLITAXEL
KW  - TRIAL
KW  - LESIONS
KW  - DISEASE
KW  - THROMBOSIS
N2  - Objective: The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent fracture. Tack (Intact Vascular, Wayne, Pa) implants have minimal metal and low radial force and are specifically designed for dissection repair. This study evaluated Tack implants for treatment of dissections resulting from standard balloon PTA for femoral-popliteal arterial disease. Twelve-month outcomes after Tack treatment of post-PTA dissections are described. Methods: This prospective, single-arm study evaluated patients with ischemia (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard balloon angioplasty, and post-PTA dissections were treated with Tacks. The primary end points were core laboratory-adjudicated device technical success, defined as the ability of the Tack implants to resolve post-PTA dissection, and device safety, defined as the absence of new-onset major adverse events. Patients were followed up to 12 months after implantation. Results: Tacks were used in 130 patients with post-PTA dissections (74.0% >= grade C). Technical success was achieved in 128 (98.5%) patients with no major adverse events at 30 days. The 12-month patency was 76.4%, and freedom from target lesion revascularization was 89.5%. Significant improvement from baseline was observed in Rutherford clinical category (82.8% with grade <= 1) and ankle-brachial index (0.68 +/- 0.18 to 0.94 +/- 0.15; P<.0001). Conclusions: Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization. Tack treatment represents a new, minimal metal paradigm for dissection repair that can safely improve the clinical results associated with PTA.
ER  -

BOSIERS, Marc, Dierk SCHEINERT, Jeroen M. H. HENDRIKS, Christian WISSGOTT, Patrick PEETERS, Thomas ZELLER, Marianne BRODMANN a Robert STAFFA. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. \textit{Journal of Vascular Surgery}. New York: Mosby Inc., 2016, roč.~64, č.~1, s.~109-116. ISSN~0741-5214. Dostupné z: https://dx.doi.org/10.1016/j.jvs.2016.02.043.

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