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Abbott
Cardiovascular

La aterectomía orbital es un enfoque de primera línea para la preparación ideal del vaso en casos complejos de angioplastia con calcio severo.


El calcio coronario tiende a ser subestimado. El calcio considerado leve o moderado por la angiografía puede realmente ser severo si se utilizan exámenes de imagen avanzados, como el ultrasonido intravascular (IVUS) o la tomografía de coherencia óptica (OCT).1,2 El calcio arterial moderado a severo está presente en el 30-40% de los pacientes sometidos a una ICP.2,3


Desafíos asociados con el calcio4

  • Propenso a disección durante la angioplastia con balón o pre-dilatación
  • Difícil de dilatar completamente el balón
  • Puede impedir la entrega del stent
  • Puede impedir la expansión y aposición adecuadas del stent

El Diamondback 360™ OAS ha demostrado ser eficaz y seguro en el tratamiento de lesiones severamente calcificadas, estudiado en más de 2,200 pacientes en 11 estudios robustos.5,6

Estudio Clínico ORBIT II7

El estudio principal ORBIT II fue un estudio prospectivo y multicéntrico realizado en EE. UU. que evaluó a pacientes con lesiones coronarias gravemente calcificadas tratados con el Sistema de Aterectomía Orbital Coronaria Diamondback 360™ (OAS) Corona Clásica antes de la implantación del stent.

 

Principales Conclusiones

  • El ORBIT II alcanzó los objetivos primarios de seguridad y eficacia por un margen significativo7
  • El ORBIT II demostró resultados duraderos a largo plazo con una baja tasa de revascularización de la lesión objetivo (TLR) de 3,4% en 1 año y 6,6% en 3 años en los subconjuntos de stents farmacológicos (N=389/443)8

 

Diseño del estudio7

  • 443 pacientes con lesiones severamente calcificadas fueron inscritos en 49 centros en EE. UU
  • Diseñado para evaluar la seguridad y eficacia de la corona Diamondback 360™ Coronary OAS Classic
  • Resultado primario de seguridad: Eventos cardíacos adversos mayores (MACE) en 30 días
  • Resultado primario de eficacia: Éxito del procedimiento definido como éxito en la facilitación de la entrega del stent con estenosis residual de <50% y sin la ocurrencia de MACE intrahospitalario


POBLACIÓN DE PACIENTES7

  N=443
Historial de diabetes 36.1%
Historial de CABG 14.7%
Historial de dislipidemia 91.9%
Historial de hipertensión 91.6%
Fumador (fumador o exfumador) 66.1%

RESULTADO DEL ESTUDIO7

Éxito del procedimiento 88.9%
Entrega exitosa del stent 97.7%
Menos del 50% de estenosis residual 98.6%
Libertad de MACE intrahospitalario 90.2%


*Éxito del procedimiento definido como éxito en la facilitación de la entrega del stent con estenosis residual <50% y sin la ocurrencia de MACE durante la hospitalización.

Resultados de 30 días9


Resultados a 1 año9




 

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. Mintz GS. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging. 2015;8(4):461-471.
  2. Mintz GS, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91(7):1959-1965.
  3. Genereux P, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014;63(18):1845-1854.
  4. Shlofmitz E, et al. Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices. Expert Rev Med Devices. 2017;14(11):867-879.
  5. Shlofmitz, E., et al., Lesion Preparation with Orbital Atherectomy. Interv Cardiol. 2019;14(3):169-173. .
  6. Beohar, N., Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Lesions. A Tertiary Center Experience, Presented at TCT Connect 2020.
  7. Chambers JW, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518.
  8. Data on file at Abbott.
  9. Lee M, et al. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017;18(4):261-264.

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