Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules, Orbital Atherectomy, Intravascular Lithotripsy, Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Chronic Coronary Syndrome, Acute Coronary Syndrome (ACS)
Conditions
Keywords
Coronary arterial disease, Coronary calcification, Coronary calcified nodules, Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Chronic Coronary Syndrome, Acute Coronary Syndrome (ACS), ORBIT-SHOCK, ORBIT SHOCK
Brief summary
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
DEVICEOrbital 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.
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.
DEVICEOptical 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 deployment.
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Sponsors
Abbott
Spanish Society of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Once the presence of a calcified nodular lesion is confirmed and the patient meets the inclusion criteria without any exclusion criteria, the patient will be randomized to one of the two treatment techniques being evaluated in the study (OA vs. IVL) in a 1:1 ratio. A stratified randomization will be implemented based on the type of calcified nodule (eruptive or non-eruptive) to ensure equal proportions of each type between the two treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥ 18 years. 2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization. 3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\*. 4. 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
1. Culprit lesions in acute coronary syndrome with ST elevation. 2. Left main disease. 3. In-stent restenosis lesions. 4. 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. 5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm. 6. Cardiogenic shock. 7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty. 8. Pregnancy. 9. Life expectancy of less than one year. 10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization. 11. Coronary artery disease with an indication for surgical revascularization. 12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography. 13. Inability to obtain informed consent. 14. Allergy to eggs or soy, contraindicating the use of OA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent expansion | At the end of percutaneous coronary intervention | Percentage of stent expansion at the CN site: measured with OCT, defined as the ratio between the minimum stent area at the CN site and the average of the distal and proximal reference areas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Strategy success | At the end of percutaneous coronary intervention | Defined as procedural success without the need for crossover to an alternative treatment. |
| Minimum stent area | At the end of percutaneous coronary intervention | Minimum stent area (MSA) |
| Minimum stent area at the CN site. | At the end of percutaneous coronary intervention | Minimum stent area at the CN site. |
| Significant stent malapposition at the CN site | At the end of percutaneous coronary intervention | Measured using OCT, defined as a stent strut detachment ≥ 0.4 mm from the underlying vessel wall, with a longitudinal extension ≥ 1 mm. |
| Degree of calcium nodule debulking | At the end of percutaneous coronary intervention | Reduction in calcium nodule size (mm²), measured after plaque modification and prior to stent implantation. |
| Procedural success | At the end of percutaneous coronary intervention | Achieving a stent expansion of ≥ 80% with TIMI III flow, in the absence of stent loss, coronary perforation, or intraprocedural death. |
| Degree of stent ellipticity at the CN site | At the end of percutaneous coronary intervention | Measured using OCT at the end of the procedure, calculated as the ratio of the maximum luminal diameter to the minimum luminal diameter of the stent at the CN site. |
| Residual luminal protrusion of the calcium nodule following stent implantation | At the end of percutaneous coronary intervention | Residual luminal protrusion of the calcium nodule following stent implantation, measured by OCT in mm2. |
| Target lesion failure (TLF) at 12 months | At 12 months | Composite of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to the target lesion. |
| Target lesion revascularization (TLR) at 12 months | At 12 months | Repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. |
| Major Adverse Cardiovascular Events (MACE) at 12 months | At 12 months | Defined as a composite of cardiovascular death, non-fatal target lesion myocardial infarction, unplanned target lesion revascularization or stent thrombosis. |
| Evidence of fracture at the CN site | At the end of percutaneous coronary intervention | Evidence of new disruption or discontinuity observed on OCT after plaque modification and prior to stent implantation. |
Countries
Spain
Contacts
Primary ContactÁngel Sánchez-Recalde, MD, PhD.
Backup ContactLuis Manuel Domínguez-Rodríguez, MD.
Outcome results
None listed