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Abbott
Cardiovascular

Stent Supera™

Los resultados importan. La plataforma importa.

Casos de estudio del Stent Supera™

Estudio de caso 1: Arteria femoral superficial (AFS) larga y calcificada

Antecedentes del caso:

  • Varón de 67 años con claudicación de la extremidad inferior izquierda
  • Índice tobillo-brazo (ITB) de 0,75 a la izquierda




Caso e imágenes cortesía del Dr. Ehrin Armstrong.

Estudio de caso 2: AFS larga, calcificada y ocluida

Antecedentes del caso:

  • Varón de 72 años con antecedentes de diabetes, hipertensión, dislipidemia e infarto de miocardio previo tratado con intervencionismo coronario percutáneo (ICP)
  • Claudicación bilateral de Rutherford en estadio 3
  • Oclusión de la AFS izquierda con calcificación moderada a grave
  • Tratamiento previo en la AFS derecha: oclusión subtotal muy calcificada, requirió aterectomía orbital, angioplastia transluminal percutánea (ATP) y dos stents estándar de nitinol superpuestos

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Caso e imágenes cortesía del Dr. Sahil Parikh.

 

The XIENCE™ Stent is also recognized as being significantly more anti-thrombotic than other DES on the market. As shown in the study findings, XIENCE™ Stent reveals significantly less (p < 0.01) platelet adhesion—shown in red in the confocal microscopy images—than other DES, and platelet adhesion is an important factor in stent thrombosis.*8 These findings suggest that this stent choice “may be ideally suited for very short-term DAPT.”8

*Ex Vivo Swine Shunt Model.

XIENCE™ Stent is thromboresistant, showing significantly less (p < 0.01) platelet adhesion than Synergy,‡ Orsiro,‡ Ultimaster,‡ Onyx,‡ and BioFreedom‡ DES.

Diamondback 360™ OAS Gives You the Versatility to Treat Challenging Cases

Treat even the most severely calcified lesions, with under 2-minute setup7,8 and predictable procedure times.2

Facilitates antegrade and retrograde treatment of:

  • Long, Diffuse Lesions
    Successfully treated lesions up to 60 mm in length in real-world study.9
  • Heavily Stenosed Lesions
    Crossed >99% of lesions with <2% pre-dilatation in the ORBIT II study.1,10
  • Nodular Lesions
    Effectively treats nodular calcification.5,6
  • Ostial Lesions
    Safely treats ostial lesions.11-13

Low Profile
6F compatible for femoral or radial access.14
 

Multiple Vessel Sizes
A single 1.25 mm crown treats vessels 2.5 mm to 4.0mm14

Diamondback 360™ OAS Has Been Proven Effective and Safe in the Treatment of Severely Calcified Lesions.
Extensively studied, and with over 100,000 patients treated,15 orbital atherectomy has been demonstrated to perform effectively and safely in the treatment of severely calcified lesions.

 
Proven Safety

 
Procedural Success

 
Low Q-Wave MI Rate

 

>2,200

<1%

97.7%

0.9%

Patients Across 11
Robust Studies5,9

 

Component Angiographic
Complications in Two
Real-world Studies9,16

Crossing and Stent
Deployment in ORBIT II Study1

 

In the ORBIT II 
Study at 30 days1

 


Sustained Clinical Performance

Data are for ORBIT II TLR in the OA+DES patient cohort.

“Stopping DAPT at 3 months in selected patients after [XIENCE™ Stent] implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group.”

— Masahiro Natsuaki, MD, STOPDAPT Trial9

STOPDAPT 2 Trial Design and Randomization10

Exclusion criteria in STOPDAPT 2 included patients on oral anticoagulants, with a history of intracranial bleeding, and with major in-hospital complications such as MI, stroke or major bleeding

Short 1-Month DAPT

  • 0 to 1-month: Aspirin + P2Y12
  • After 1-month: Clopidogrel monotherapy
Exclusion criteria in STOPDAPT 2 included patients on oral anticoagulants, with a history of intracranial bleeding, and with major in-hospital complications such as MI, stroke or major bleeding

12-Month DAPT

  • 0 to 1-month: Aspirin + P2Y12
  • 1 to 12-month: Aspirin + Clopidogrel
  • 12 to 60-month: Aspirin monotherapy
Key inclusion criteria
  1. Successful PCI using CoCr everolimus-eluting stent: XIENCE™
  2. Eligible for DAPT (aspirin/P2Y12 receptor blocker) for 1 year
Key exclusion criteria
  1. Patients who need oral anticoagulants
  2. History of intracranial bleeding
  3. Major in-hospital complications (MI/stroke/major bleeding)

STOPDAPT Study: XIENCE™ Stent with 3-Month DAPT Is Feasible9

STOPDAPT9 was the first prospective trial to study DAPT cessation at 3 months after implantation. Among other 1-year outcomes, the XIENCE™ Stent rate of stent thrombosis was 0.0%.

STOPDAPT Study Demonstrates Feasibility of XIENCE™ Stent with 3-Month DAPT9

XIENCE™ Stent 1-year data, when using 3-month DAPT, shows 0.0% definite or probable stent thrombosis

Learn more about STOPDAPT 2

“It was noteworthy that no definite or probable stent thrombosis occurred in [XIENCE™ Stent] patients enrolled in STOPDAPT.”

— Masahiro Natsuaki, MD, STOPDAPT Trial9

STOPDAPT-3 Trial Design and Randomization11

Key inclusion criteria
  1. PCI with planned exclusive use of CoCr-EES (XIENCE)
  2. ACS presentation or ARC-HBR
  3. Eligible for DAPT (Aspirin/P2Y12inhibitor) for 1 month

Study design and Randomization

Group 1:

0 to 1-month: Aspirin + P2Y12 (Prasugrel)

After 1-month: Clopidogrel monotherapy

Group 2:

0 to 1-month: P2Y12 (Prasugrel)

After 1-month: Clopidogrel monotherapy

STOPDAPT-3 Trial 11 was designed to explore 0-month DAPT* (SAPT˄ using only P2Y12 inhibitor) for ACS and HBR patients.

Though the results are comparable for both bleeding and ischemic events for DAPT and SAPT arms, the study did not meet its endpoint and concluded to use DAPT for 1 month after PCI.

Major bleeding
CV Death, MI, Definte ST, Ischemic Stroke
XIENCE Stent Efficacy

XIENCE™ Stent remains the ONLY DES with the shortest DAPT indication, as short as 28 days.12

Referencias

  1. Data on file at Abbott.
  2. Competitors tested include Astron Pulsar-18, Complete SE, EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Data on file at Abbott.
  3. Flexibility is defined as kink resistance.  Competitors tested include Astron Pulsar-18, Complete SE,  EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Data on file at Abbott.
  4. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
  5. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
  6. Chan YC. et al., J Vasc Surg. 2015 Nov;62(5):1201-9.
  7. Dumantepe M. Vasc Endovascular Surg. 2017 Jul;51(5):240-246.
  8. George JC. et al., J Vasc Interv Radiol. 2014 Jun;25(6):954-61.
  9. Goltz JP. et al., J Endovasc Ther. 2012 Jun;19(3):450-6.
  10. León LR Jr. et al., J Vasc Surg. 2013 Apr;57(4):1014-22.
  11. Montero-Baker M. et al., J Vasc Surg. 2016 Oct;64(4):1002-8.
  12. Myint M. et al., J Endovasc Ther. 2016 Jun;23(3):433-41.
  13. Palena LM. et al., J Endovasc Ther. 2018 Oct;25(5):588-591.
  14. Scheinert D. et al., JACC Cardiovasc Interv. 2013 Jan;6(1):65-71.
  15. Scheinert D. et al., J Endovasc Ther. 2011 Dec;18(6):745-52.
  16. Steiner S. et al., J Endovasc Ther. 2016 Apr;23(2):347-55.
  17. Werner M. et al., EuroIntervention. 2014 Nov;10(7):861-8.
  18. San Norberto EM. et al., Ann Vasc Surg. 2017 May;41:186-195.
  19. Teymen B. et al., Vascular. 2018 Feb;26(1):54-61.
  20. Bhatt H. et al., Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):512-515.
  21. Arena F. et al., J Vasc Med Surg. 2013:1;116.
  22. Chen Y. et al., J Vasc Surg 2014;59:384-91.

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