Indications, Safety, and Warnings
Resolute Onyx™ DES
The Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 mm. In addition, the Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System is indicated for treating de novo chronic total occlusions and non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique.
The Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System is contraindicated for use in:
- Patients with a known hypersensitivity or allergies to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, drugs such as zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative
- Patients with a known hypersensitivity to the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) or platinum-iridium alloy
- Patients with a known hypersensitivity to the BioLinx™ polymer or its individual components
Coronary artery stenting is contraindicated for use in:
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
- Please ensure that the inner package has not been opened or damaged as this would indicate the sterile barrier has been breached.
- The use of this product carries the same risks associated with coronary artery stent implantation procedures, which include subacute and late vessel thrombosis, vascular complications, and/or bleeding events.
- This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
- Only physicians who have received adequate training should perform implantation of the stent.
- Subsequent stent restenosis or occlusion may require repeat catheter-based treatments (including balloon dilatation) of the arterial segment containing the stent. The long-term outcome following repeat catheter-based treatments of previously implanted stents is not well characterized.
- The risks and benefits of the stent implantation should be assessed for patients with a history of severe reaction to contrast agents.
- Do not expose or wipe the product with organic solvents such as alcohol.
- The use of a drug-eluting stent (DES) outside of the labeled indications, including use in patients with more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
- Care should be taken to control the position of the guide catheter tip during stent delivery, stent deployment, and balloon withdrawal. Before withdrawing the stent delivery system, confirm complete balloon deflation using fluoroscopy to avoid arterial damage caused by guiding catheter movement into the vessel.
- Stent thrombosis is a low-frequency event that is frequently associated with myocardial infarction (MI) or death. Data from the RESOLUTE clinical trials have been prospectively evaluated and adjudicated using the definition developed by the Academic Research Consortium (ARC).
The safety and effectiveness of the Resolute Onyx™ stent have not yet been established in the following patient populations:
- Patients with target lesions that were treated with prior brachytherapy or the use of brachytherapy to treat in-stent restenosis of a Resolute Onyx™ stent
- Women who are pregnant or lactating
- Men intending to father children
- Pediatric patients below the age of 18 years
- Patients with coronary artery reference vessel diameters of <2.0 mm or >5.0 mm
- Patients with evidence of an acute ST-elevation MI within 72 hours of intended stent implantation
- Patients with vessel thrombus at the lesion site
- Patients with lesions located in a saphenous vein graft, in the left main coronary artery, or ostial lesions
- Patients with diffuse disease or poor flow distal to identified lesions
- Patients with three-vessel disease
The safety and effectiveness of the Resolute Onyx™ stent have not been established in the cerebral, carotid, or peripheral vasculature. Additionally, the safety and effectiveness of using atherectomy devices with Resolute Onyx™ stent have not been established. The effect of potential drug interactions on the safety or effectiveness of the Resolute Onyx™ stent has not been investigated. Potential interactions of the Resolute Onyx™ stent with other drug-eluting or coated stents have not been evaluated and should be avoided whenever possible.
Clinical studies of the Resolute™ stent did not suggest any significant differences in safety and effectiveness for male and female patients and did not include sufficient numbers of patients to assess for differences in safety and effectiveness due to ethnicity.
Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgment, assessment of the benefit/risk ratio, and patient preference. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of stent thrombosis, MI, or death. Before PCI, if premature discontinuation of antiplatelet therapy is anticipated, physicians should carefully evaluate with the patient whether a DES and its associated recommended DAPT regimen is the appropriate PCI choice.
Following PCI, if elective noncardiac surgery requiring suspension of antiplatelet therapy is considered, the risks and benefits of the procedure should be weighed against the possible risk associated with interruption of antiplatelet therapy. Patients who require premature DAPT discontinuation should be carefully monitored for cardiac events. At the discretion of the patient’s treating physician(s), the antiplatelet therapy should be restarted as soon as possible.
Instructions for stenting of bifurcation lesions
The provisional technique of bifurcation stenting recommends a single stent placement in the Main Vessel (MV), finalized with proximal optimization technique (POT). POT includes performing post-dilatation to achieve full apposition of the stent proximal to the bifurcation and reduce the risk of side branch (SB) compromise. If inadequate results are found in the SB such as: threatened SB closure, TIMI flow <3, dissection type B or worse, or residual stenosis >80%, the provisional bifurcation stenting technique recommends placing a second stent in the SB as a bailout. As per cardiology societal recommendations, two-stent techniques following single stent provisional bifurcation stenting including T, TAP, and Culotte stenting may be utilized as needed. However, the RESOLUTE ONYX PAS Bifurcation Cohort did not evaluate the safety and effectiveness of two-stent bifurcation techniques, including planned (upfront) two-stent bifurcation techniques (such as DK-crush). Additionally, two-stent bifurcation techniques may introduce additional forces and/or failure modes to the stents, and the performance of the Resolute Onyx stent has not been evaluated under these conditions in nonclinical testing.
Potential adverse events
Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. These risks (in alphabetical order) may include but are not limited to:
- Abrupt vessel closure
- Access site pain, hematoma, or hemorrhage
- Allergic reaction (to contrast, antiplatelet therapy, stent material, or drug and polymer coating)
- Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF)
- Arrhythmias, including ventricular fibrillation
- Balloon rupture
- Cardiac tamponade
- Coronary artery occlusion, perforation, rupture, or dissection
- Coronary artery spasm
- Embolism (air, tissue, device, or thrombus)
- Emergency surgery: peripheral vascular or coronary bypass
- Failure to deliver the stent
- Hemorrhage requiring transfusion
- Incomplete stent apposition
- Infection or fever
- Peripheral ischemia/peripheral nerve injury
- Renal failure
- Restenosis of the stented artery
- Shock/pulmonary edema
- Stable or unstable angina
- Stent deformation, collapse, or fracture
- Stent migration or embolization
- Stent misplacement
- Stroke/transient ischemic attack
- Thrombosis (acute, subacute, or late)
Adverse events related to zotarolimus
Patients’ exposure to zotarolimus is directly related to the total amount of stent length implanted. The actual side effects/complications that may be associated with the use of zotarolimus are not fully known. The adverse events that have been associated with the intravenous injection of zotarolimus in humans include but are not limited to:
- Dry skin
- Injection site reaction
- Pain (abdominal, arthralgia, injection site)
The potential adverse reactions in nursing infants from zotarolimus have not been determined. The pharmacokinetic and safety profiles of zotarolimus in infants are not known.
Adverse events related to BioLinx™ polymer
Although the type of risks of the BioLinx™ polymer coating are expected to be no different than those of other stent coatings, the potential for these risks are currently unknown as the coating has limited previous use in humans. These risks may include but are not limited to the following:
- Allergic reaction
- Focal inflammation at the site of stent implantation
- Restenosis of the stented artery
Please reference appropriate product Instructions for Use for more information regarding indications, contraindications, warnings, precautions, and potential adverse events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
For further information, please call and/or consult Medtronic at the toll-free numbers or websites listed.