Lower Silesian Orbital Atherectomy Registry (LOAR)

NCT06451146 — Recruiting, 500 participants, Miedziowe Centrum Zdrowia SA

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Evaluation of the Safety and Efficacy of Orbital Atherectomy (OA) for Calcified Lesions in Patients With Coronary Artery Disease: The Lower Silesian Orbital Atherectomy Registry (LOAR)

Registry	NCT06451146, acronym LOAR
Status	Recruiting
Study type	Observational
Enrollment	500 (Estimated)
Sponsor	Miedziowe Centrum Zdrowia SA (Other); collaborators: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
Conditions	Safety Issues, Efficacy, Self
Interventions	PCI Facilitated with Orbital Atherectomy Device (Procedure)
Dates	start 2022-05-01, primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2024-06-11, last updated 2024-08-21
Locations	2 sites in Poland

-Summary

The Lower Silesian Orbital Atherectomy Registry (LOAR), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of the Orbital Atherectomy Device due to the presence of calcified lesion in coronary arteries. Data will be collected in two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).

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+Detailed description

The study population consisted of all consecutive patients with severely calcified coronary lesions undergoing percutaneous coronary intervention (PCI) with the Orbital Atherectomy Device at two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland). All study patients had a clinical indication for PCI based on current European Society of Cardiology (ESC) revascularization guidelines, with local heart team support where appropriate.

The decision to perform OA-assisted PCI was left to the discretion of the operator, based on clinical and angiographic features with a concomitant assessment of calcification. Only patients with moderate or severe calcification were enrolled. Calcification severity was defined either by angiographic assessment or by intravascular assessment using intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT). All patients were thoroughly informed about all therapeutic options and PCI-related risks before giving written consent.

+Arms and interventions

Arm	Type	Interventions	Description
OA Intervention		Procedure: PCI Facilitated with Orbital Atherectomy Device	All consecutive patients with moderate/ severely calcified coronary lesions who underwent PCI facilitated by the Orbital Atherectomy The decision to perform orbital atherectomy was left to the operator's dissertation after the detection of a moderate/severely calcified lesion. Angiographic calcification was classified as moderate when it involved between 30% and 50% of the reference lesion diameter, and severe when it occupied over 50% of the reference diameter. When the initial assessment was based on IVUS finding lesion had to reach at least 2 points in the IVUS calcium score. There were no angiographic exclusion criteria regarding lesion anatomy such as the length, tortuosity, severity, or location. All procedural features(use additional lesion preparation technique; stent implantation parameters, periprocedural pharmacological therapy, use of intravascular imaging along with the left ventricular support device) were left to the discretion of the operator.

PCI Facilitated with Orbital Atherectomy Device (Procedure): Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device

+Outcome measures

Primary outcomes

The rate of patients who achieved The Clinical Success [Evaluation at discharge (assessed up to day 10)]: Clinical success was defined as effective stent deployment without significant stent under expansion and the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow at the end of the procedure.
Incidence of Treatment-Emergent Adverse Events [Evaluation at discharge (assessed up to day 10)]: The safety outcomes were defined as procedural complications(coronary perforation, slow- or no-reflow, new coronary thrombus, ventricular arrhythmias, vessel closure, and device failure).

Secondary outcomes

Major adverse cardiac and cerebrovascular events (MACCE) [Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)]: MACCE was defined as acute coronary syndrome, cerebrovascular events, major bleeding, need for repeated revascularization, or death.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* The presence of moderately to severely calcified lesions.

Exclusion Criteria:

* Lack of patient consent
* Target vessel perforation due to previous unsuccessful lesion preparation
* Pregnancy

+Locations (2)

Facility	City	Country	Status
Department of Cardiology, Provincial Specialized Hospital in Legnica	Legnica, Lower Silesian Voivodeship	Poland	Recruiting
Department of Cardiology, The Copper Health Centre (MCZ)	Lubin, Lower Silesian Voivodeship	Poland	Recruiting

+Publications

Results publication: Rola P, Kulczycki JJ, Barycki M, Wlodarczak S, Furtan L, Kedzierska M, Giniewicz K, Doroszko A, Lesiak M, Wlodarczak A. Comparison of Orbital Atherectomy and Rotational Atherectomy in Calcified Left Main Disease: Short-Term Outcomes. J Clin Med. 2023 Jun 13;12(12):4025. doi: 10.3390/jcm12124025. PMID 37373718
Results publication: Rola P, Furtan L, Wlodarczak S, Jastrzebski A, Barycki M, Kedzierska M, Szudrowicz M, Kulczycki JJ, Doroszko A, Lesiak M, Wlodarczak A. Orbital atherectomy for treatment of calcified coronary artery lesions. First experiences in Poland: Short-term outcomes of the Lower-Silesia Orbital Atherectomy Registry (LOAR). Kardiol Pol. 2023;81(2):174-176. doi: 10.33963/KP.a2023.0003. Epub 2023 Jan 3. No abstract available. PMID 36594531
Results publication: Rola P, Wlodarczak S, Barycki M, Furtan L, Jastrzebski A, Kedzierska M, Doroszko A, Lesiak M, Wlodarczak A. Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR). J Clin Med. 2023 Sep 8;12(18):5842. doi: 10.3390/jcm12185842. PMID 37762782
Results publication: Wlodarczak S, Rola P, Furtan L, Barycki M, Szudrowicz M, Kulczycki JJ, Doroszko A, Lesiak M, Wlodarczak A. Orbital-Tripsy - orbital atherectomy facilitated by Shockwave Intravascular Lithotripsy: Novel bailout strategy in percutaneous coronary intervention in heavily calcified coronary lesions. Kardiol Pol. 2023;81(3):296-297. doi: 10.33963/KP.a2023.0005. Epub 2022 Dec 27. No abstract available. PMID 36573605