Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Official title

Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Overview

Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).

Detailed description

The risk profile of patients and their comorbidities have worsened and the observed lesions undergoing treatment are increasingly complex. This has promoted the development of new technologies for plaque modification, especially in the context of calcified lesions. These predispose to suboptimal results of the intervention due to an increased risk of malapposition and underexpansion of the stents, the main variables for restenosis and/or thrombosis of the stents. Thus, compared with non-calcified lesions, the increased amount of calcium in the coronary artery leads to a higher incidence of major adverse cardiac events (MACE).

Coronary bifurcation stenting remains complex and is associated with a high risk of stent thrombosis and restenosis even with contemporary techniques, and suboptimal outcomes are frequently observed due to side branch (SL) involvement that increases cardiovascular events.

Our hypothesis is that the use of orbital atherectomy (OA) for coronary revascularization in the presence of calcified bifurcation lesions is feasible and safe compared to the more common technique, favoring the subsequent performance of provisional stenting (PS).

Interventions

• Device Orbital Atherectomy System Treatment
  Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.
• Device Balloon System Treatment
  Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.

Primary outcome measures

• EFFICACY: Angiographic criteria success [Time frame: At the end of PCI (Percutaneous Coronary Intervention)]
• EFFICACY: OCT criteria: Stent expansion [Time frame: At the end of PCI]

Secondary outcome measures (8)

• SAFETY:Major adverse cardiac events (MACE) [Time frame: 12 months]
• SAFETY:Major adverse cardiac events (MACE) [Time frame: 6 months]
• SAFETY:Major adverse cardiac events (MACE) [Time frame: 30 days]
• SAFETY:Major adverse cardiac events (MACE) [Time frame: At the end of PCI]
• EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) in mm2 [Time frame: At the end of PCI]
• EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) [Time frame: At the end of PCI]
• EFFICACY: Other variables related to stent expansion. Mean stent expansion [Time frame: At the end of PCI]
• EFFICACY: Other variables related to stent expansion. Stent expansion using linear model [Time frame: At the end of PCI]

Eligibility criteria

Inclusion criteria

• Patients over 18 years of age and
• Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and
• Patients agree to participate in the study, by signing the Informed Consent.

Exclusion criteria

• Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
• Patients with contraindication for the use of Orbital Atherectomy:

• Patients in cardiogenic shock.
• Patients with Thrombotic lesions.
• Patients with Vascular graft disease.
• Patients with remain vessel disease.
• Patients with severe left ventricular dysfunction.
• Patients allergic to the components of the washing serum (glide).
• Patients with life expectancy less than one year.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 9 centers

• H. G.U. de ALICANTE DR. BALMIS — Alicante
• Hospital Del Mar — Barcelona
• H. de La Santa Creu I Sant Pau — Barcelona
• Hospital Universitario Reina Sofia — Córdoba
• Hospital Universitario La Paz — Fuencarral-El Pardo
• Hospital Universitario Lucus Augusti — Lugo
• Hospital Universitario La Luz — Madrid
• Hospital Universitari de Salamanca — Salamanca
• … and 1 more center

Publications

• Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5. PMID 23460596
• Burzotta F, Louvard Y, Lassen JF, Lefevre T, Finet G, Collet C, Legutko J, Lesiak M, Hikichi Y, Albiero R, Pan M, Chatzizisis YS, Hildick-Smith D, Ferenc M, Johnson TW, Chieffo A, Darremont O, Banning A, Serruys PW, Stankovic G. Percutaneous coronary intervention for bifurcation coronary lesions using optimised angiographic guidance: the 18th consensus document from the European Bifurcation Club. PMID 38752714
• den Dekker WK, Siskos AA, Wilschut JM, Nuis RJ, Scarparo P, Neleman T, Masdjedi K, Ligthart JMR, Diletti R, Daemen J, Van Mieghem NM. Initial experience with orbital atherectomy in a tertiary centre in the Netherlands. Neth Heart J. 2023 May;31(5):196-201. doi: 10.1007/s12471-022-01742-3. Epub 2022 Dec 12. PMID 36507948
• Donatelle M, Agasthi P, Parise H, Igyarto Z, Martinsen BJ, Leon MB, Beohar N. Coronary Orbital Atherectomy in Patients With Severe Aortic Stenosis. J Invasive Cardiol. 2022 Oct;34(10):E696-E700. doi: 10.25270/jic/22.00066. PMID 36200995
• Jurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345

Identifiers

NCT: NCT06736899 · EPIC44-OraBil

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗