Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

Official title

Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.

Overview

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.

Detailed description

Coronary calcification in the form of calcified nodules (CN) is systematically associated with worse outcomes due to the difficulty in adequately dilation of the lesion and the inability to properly fracture the calcium nodule before stent implantation.

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting CNs, identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).

Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).

Primary endpoint: Compare both techniques in terms of achieving adequate stent expansion, measured by OCT.

Secondary endpoints: Evaluate procedural and strategy success rates, assess their impact on calcium nodule modification, and monitor the incidence of adverse clinical events at 12 months.

Patients will be monitored for 12 months after the procedure to assess the incidence of adverse events during follow-up.

Interventions

• Device Orbital atherectomy
  The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
• Device Intravascular lithotripsy
  The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
• Device Optical Coherence Tomography (OCT)
  Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure. These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deploymen
• Device Percutaneous coronary intervention with stent implantation
  All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.

Primary outcome measures

• Stent expansion [Time frame: At the end of percutaneous coronary intervention]

Secondary outcome measures (12)

• Procedural success [Time frame: At the end of percutaneous coronary intervention]
• Strategy success [Time frame: At the end of percutaneous coronary intervention]
• Minimum stent area [Time frame: At the end of percutaneous coronary intervention]
• Minimum stent area at the CN site. [Time frame: At the end of percutaneous coronary intervention]
• Significant stent malapposition at the CN site [Time frame: At the end of percutaneous coronary intervention]
• Degree of calcium nodule debulking [Time frame: At the end of percutaneous coronary intervention]
• Evidence of fracture at the CN site [Time frame: At the end of percutaneous coronary intervention]
• Degree of stent ellipticity at the CN site [Time frame: At the end of percutaneous coronary intervention]
• Residual luminal protrusion of the calcium nodule following stent implantation [Time frame: At the end of percutaneous coronary intervention]
• Target lesion failure (TLF) at 12 months [Time frame: At 12 months]
• Target lesion revascularization (TLR) at 12 months [Time frame: At 12 months]
• Major Adverse Cardiovascular Events (MACE) at 12 months [Time frame: At 12 months]

Eligibility criteria

Inclusion criteria

• Patients aged ≥ 18 years.
• Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
• Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\*.
• Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. \* Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.

Exclusion criteria

• Culprit lesions in acute coronary syndrome with ST elevation.
• Left main disease.
• In-stent restenosis lesions.
• Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.
• Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
• Cardiogenic shock.
• Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
• Pregnancy.
• Life expectancy of less than one year.
• Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
• Coronary artery disease with an indication for surgical revascularization.
• Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
• Inability to obtain informed consent.
• Allergy to eggs or soy, contraindicating the use of OA.

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 · 6 centers

• Hospital Universitario General de Alicante — Alicante
• Hospital Universitario Lucus Augusti — Lugo
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario de Salamanca — Salamanca
• Hospital Clínico Universitario de Valladolid — Valladolid
• Hospital Universitario Reina Sofía de Córdoba — Córdoba

Publications

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 1 PMID 21670242
• Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A PMID 28183511
• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available. PMID 30165617
• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-22 PMID 29897428
• Maehara A, Ben-Yehuda O, Ali Z, Wijns W, Bezerra HG, Shite J, Genereux P, Nichols M, Jenkins P, Witzenbichler B, Mintz GS, Stone GW. Comparison of Stent Expansion Guided by Optical Coherence Tomography Versus Intravascular Ultrasound: The ILUMIEN II Study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Interv PMID 26585621
• Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the mana PMID 39210710
• Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, PMID 37634149
• Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Dogan O, McGreevy RJ, McNutt RW, Nie H, Buccola J, West NEJ, Stone GW; ILUMIEN IV Investigators. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476. doi: 10.105 PMID 37634188

Identifiers

NCT: NCT06736665 · ORBIT-SHOCK

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗