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Abbott
Cardiovascular

Diamondback 360™ es el único sistema de aterectomía con una corona revestida de diamante que orbita 360 grados, diseñado para abordar el calcio severo.


El sistema de aterectomía orbital coronaria (OAS) del Diamondback 360™ utiliza un mecanismo de acción dual único, que combina lijado diferencial y fuerzas pulsátiles, permitiendo la modificación simultánea del calcio intimal y medial para la entrega, expansión y aposición ideales del stent en lesiones severamente calcificadas. Un solo dispositivo trata calcio excéntrico, concéntrico y nodular.1-6

Diamondback 360™ OAS tiene un Diseño Único con Mecanismo de Acción Dual

Un único dispositivo reduce el calcio de la intima y fractura el calcio de la media. El lijado diferencial y las fuerzas pulsátiles permiten la modificación simultánea tanto del calcio de la intima y de la media para la entrega, expansión y aposición óptimas del stent en lesiones severamente calcificadas1-4

 

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.

El Diamondback 360™ OAS ofrece la versatilidad necesaria para tratar casos desafiantes

Trate incluso las lesiones más severamente calcificadas, con configuración en menos de 2 minutos7,8 y tiempos de procedimiento predecibles.2

Facilita el Tratamiento Anterógrado y Retrógrado de:

  • Lesiones Largas y difusas
    Tratamiento exitoso de lesiones de hasta 60 mm de longitud en estudio real.9
  • Lesiones Severamente Estenóticas
    Cruce de más del 99% de las lesiones con menos del 2% de pre-dilatación en el estudio ORBIT II.1,10
  • Lesiones Nodulares
    Tratamiento eficaz de la calcificación nodular.5,6
  • Lesiones Ostiales
    Tratamiento seguro de lesiones ostiales.11-13

Perfil Bajo
Compatible con 6F para acceso femoral o radial.14
 

Varios Tamaños de Vasos
Una sola corona de 1,25 mm trata vasos de 2,5 mm a 4,0 mm14

El Diamondback 360™ OAS Ha Demostrado Ser Eficaz y Seguro en el Tratamiento de Lesiones Severamente Calcificadas.
Extensamente estudiado y con más de 100,000 pacientes tratados,15 la aterectomía orbital ha demostrado un desempeño eficaz y seguro en el tratamiento de lesiones severamente calcificadas.
Seguridad Comprobada

 
Éxito del Procedimiento

 
Baja Tasa de
Infarto de Miocardio con Onda Q

 

>2,200

<1%

97.7%

0.9%

Pacientes en 11
Estudios Robustos 5,9

 

Complicaciones Angiográficas
en Dos Estudios del Mundo Real9,16

Cruce e implantación del stent
en el estudio ORBIT II1

 

En el Estudio
ORBIT II a los 30 días1

 


Desempeño Clínico Sostenido

Los datos son para TLR en el estudio ORBIT II en la cohorte de pacientes OA+DES.

“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. Chambers, J., et al., JACC Cardiovasc Interv. 2014;7(5):510-518.
  2. Shlofmitz, E., et al., Expert Rev Med Devices. 2017;14(11):867-879.
  3. Yamamoto, M., et al., Catheter Cardiovasc Interv. 2019;93(7):1211-1218.
  4. Kini, A., et al., Catheter Cardiovasc Interv. 2015;86(6):1024-1032.
  5. Shlofmitz, E., et al., Interv Cardiol. 2019;14(3):169-173.
  6. Abellas-Sequeiros, M., et al., REC Interv Cardiol. 2022;4(2):163-164.
  7. Lee, MS, et al., J Invasive Cardiol. 2016;28(4):147-150.
  8. Moses, J., Cardiac Interventions Today. 2015;May/June:75. Link accessed November 20, 2023. https://citoday.com/articles/2015-may-june/vesselpreparation-with-orbital-atherectomy-for-treating-severe-coronary-calcium-for-stent-delivery.
  9. Vinardell J, et al. J Am Coll Cardiol. 2020;76(17 Suppl S):B71.
  10. Data on file at Abbott. In the ORBIT II study, the OAS was inserted and activated in 434 subjects, but in 2 cases, the OAS was unable to cross the lesion.
  11. Lee MS, et al. J Interv Cardiol. 2018;31(1):15-20.
  12. Chambers JW, et al. Catheter Cardiovasc Interv. 2022;100(4):553-559.
  13. Ghazzal A, et al. Cardiovasc Revasc Med. 2024;58:52-57.
  14. Diamondback 360™ Coronary Orbital Atherectomy Systems Instructions for Use (IFU). Please refer to IFU for additional information.
  15. Data on file at Abbott.
  16. Lee, MS, et al., J Interv Cardiol. 2016;29(4):357-362.

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