Coronary Artery Disease

Abbott is a leader in percutaneous coronary intervention (PCI) therapies for patients with short dual anti-platelet therapy (DAPT) needs

Coronary Artery Disease

Abbott technologies enable physicians to approach each patient with sophisticated insights from imaging and physiology assessments to identify the presence or absence of ischemia, and interventional therapies with proven safety that have become the industry’s gold standard.

As a global leader in cardiology, Abbott is dedicated to supporting healthcare professionals no matter how simple or complex their coronary artery disease (CAD) cases may be. We’re striving toward the same goal: offering optimal therapies, ensuring patient safety and improving health.

Imaging

Optical coherence tomography (OCT) provides the intravascular imaging guidance that physicians increasingly turn to during PCI to guide decision-making. Abbott's OCT imaging system provides automated, accurate measurements to help guide stent selection, placement and deployment.1 OCT reduces ambiguities impacting vessel preparation, stent sizing and expansion to deliver optimal results.2 Discover the benefits of Abbott's OCT imaging today.

Imaging

Physiology

Physiological measurements such as fractional flow reserve (FFR) and resting full-cycle ratio (RFR) can be used to evaluate the functional significance of coronary stenosis.3,4 Beyond the visibility of angiography, index of microcirculatory resistance (IMR) and coronary flow reserve (CFR) can be used to diagnose coronary microvascular dysfunction.5,6 A comprehensive physiology assessment can improve PCI outcomes and patients' quality of life.5,7-8

Physiology

Dual Antiplatelet Therapy (DAPT)

The post-PCI decision about DAPT duration must be individualized for each patient. XIENCE™ Stents provide the only 28-day DAPT labeling option for patients at high bleeding risk.9 With the increasing number of complex cases, safety data on Abbott stents—for both short-term and long-term DAPT duration—can offer assurance to healthcare professionals focused on patient safety.10

DAPT

References

  1. Ultreon™ 1.0 Software Instructions for Use (IFU). Refer to IFU for additional information.
  2. Reyes, M. The next innovation in PCI is not a stent. The value of OCT. CathLab Digest. Oct 6, 2019. Volume 27, Issue 10.
  3. PressureWire™ X GuideWire Instructions for Use (IFU). Refer to IFU for additional information.
  4. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.
  5. Ford T, et al. CorMicA Trial. 2018; 72(23): 2841-55 with online appendix.
  6. Kunadian V, et al. EHJ & Eurointervention 2020: ehaa503. DOI:10.1093/eurheartj/ehaa503.
  7. Tonino PA, et al. Angiographics versus functional severity of coronary artery stenoses in the FAME study: Fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol 2010; 55:2816-21.
  8. De Bruyne B, et al. FFR Guided PCI versus Medical Therapy in Stable Coronary Disease, NEJM. 2012; 367 (11): 991-1001
  9. XIENCE Skypoint™ Instructions for Use (IFU). Refer to IFU for additional information.
  10. Zanchin C, et al. J Am Coll Cardiol Intv. 2019;12:1665-1675.

MAT-2205024 v1.0

Important Safety Information

OPTIS™ Next Imaging Systems and Software

Rx Only

Indications

The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS™ Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS™ Next Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.

Contraindications: Use of the Ultreon™ 1.0 Software is contraindicated where introduction of any catheter would constitute a threat to patient safety.
Contraindications include:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients diagnosed with coronary artery spasm
  • Patients disqualified for coronary artery bypass graft (CABG) surgery
  • Patients disqualified for percutaneous transluminal coronary angioplasty (PTCA)
  • Severe hemodynamic instability or shock
  • Total occlusion
  • Large thrombus
  • Acute renal failure
  • Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging.
  • PressureWire™ Guidewire is contraindicated for use in the cerebral vasculature.
  • The system has no patient alarm functions. Do not use for cardiac monitoring.

 

Complications: The risks involved in vascular imaging include those associated with all catheterization procedures. The following complications may occur as a consequence of intravascular imaging and may necessitate additional medical treatment including surgical intervention.

  • Abnormal heart rhythm or arrhythmias
  • Acute myocardial infarction
  • Allergic reaction to the contrast media or drug administered for the procedure
  • Arterial dissection, injury, or perforation
  • Bleeding
  • Catheter access site reactions: sterile inflammation or granuloma
  • Coronary artery spasm
  • Death
  • Embolism
  • Myocardial ischemia
  • Renal insufficiency or failure from contrast media use
  • Repeat revascularization
  • Thrombus formation, abrupt closure, or total occlusion
  • Tissue necrosis
  • Unstable angina
  • Hypotension
     

Warnings:

  • Refer to the contrast media Instructions for Use for general warnings and precautions relating to use of contrast media.
  • The heart rate and mean pressure values shown on the OPTIS™ Next Imaging System are for reference only and are not intended to be used as the primary display.
  • The system may place the point of index value at the wrong location due to pressure artifacts, for example: abnormal heartbeats, artifacts in AO (Pa) caused by flushing of guiding catheter, or valve opening / closing. The physician should always confirm that the point selected by the system is a valid point for the calculation of index value.
  • Inside the catheterization laboratory, only port-powered USB drives may be connected to the USB port. Connecting externally powered devices to the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment. Do not use the OPTIS™ Next Imaging System if there is reason to believe the system’s security has been compromised or if the system was unaccounted for during a period of time (i.e., misappropriated, modified, or tampered with).
     

Precautions:

  • Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
  • Monitor the OCT image for indications of Dragonfly™ Imaging Catheter optical failure. If optical failure is suspected, remove the Dragonfly™ Imaging Catheter from the patient, press “Unload” on the drive motor and optical controller (DOC), detach the catheter, and replace it with a new one.
  • If the pullback triggers before contrast is injected, repeat the pullback.
  • For optimal imaging, only use 100% contrast media.

MAT-2104193 v3.0

Ultreon™ 1.1 Software for Ultiri™ Measurement System

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Indications:

The Ultreon™ 1.1 Software for Ultiri™ Measurement System is intended to be used only with compatible Ultiri™ Measurement Systems.

The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment, to determine if therapeutic intervention is indicated.

Contraindications:

There are no known contraindications for the Ultreon™ 1.1 Software for Ultiri™ Measurement System.

Warnings:

  • Inside the catheterization laboratory, only port-powered USB drives may be connected to the USB port. Connecting externally powered devices to the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
  • The system may place the point of index value at the wrong location due to pressure artifacts, for example: abnormal heartbeats, artifacts in AO (Pa) caused by flushing of guiding catheter, or valve opening / closing. The physician should always confirm that the point selected by the system is a valid point for the calculation of index value.
  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Do not use this device for any conditions contraindicated for use of compatible guide wires.
  • The heart rate and mean pressure values shown on the Ultiri™ Measurement System are for reference only and are not intended to be used as the primary display.
  • Do not use the Ultiri™ Measurement System if it has been dropped, or in any other way exposed to mechanical or electrical damage, or if liquids are suspected to have penetrated the casing or the power supply unit. This can cause the user to be exposed to electric shock or loss of system function. Contact Abbott Technical Service for further instructions.
  • Do not sterilize the Ultiri™ Measurement System or any of its parts. Do not use this system or any of its parts if it has been sterilized.
  • The PressureWire™ X Guidewire is sterilized by ethylene oxide and is intended for one-time use only. Nonpyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize. Any attempt to reuse or re-sterilize the PressureWire™ X Guidewire may compromise the structural integrity of this device. Adverse effects of using a non-sterile or re-sterilized guide wire may include, but are not limited to: local and / or systemic infection, mechanical damage, inaccurate results.
  • Do not use the PressureWire™ X Guidewire if there are any signs of damage.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment. Do not use the Ultiri™ Measurement System if there is reason to believe system security has been compromised or if the system was unaccounted for during a period of time (i.e., misappropriated, modified, or tampered with).
  • The system has no patient alarm functions. Do not use for cardiac monitoring.

 

Precautions:

  • Before beginning a physiology procedure, review “Performing a Physiology Procedure” for additional warnings and cautions.
  • To connect to the correct Wi-Box™ AO Transmitter, you must select the room where the system is being used. The first time you connect to a room, you must enter the room’s information into the system. Refer to the “Wi-Box™ AO Transmitter” section.
  • The choice of excessively high number of heartbeats may result in insensitive pressure averaging (noticeable when there is a short hyperemic plateau for FFR). The choice of excessively low number of heartbeats may result in pressure averaging, which are overly sensitive to arrhythmia and pressure disturbances. An insensitive or overly sensitive mean average of pressure may result in an incorrect index value reading.
  • The system may place the cursors at the incorrect location (value) due to artifacts in Pa or Pd pressure. The physician should confirm that the point selected by the system is a valid point for the selected index.
  • If the cursor position has been saved, the index value is changed accordingly.
  • Patients with potential microvascular dysfunction and borderline index values should be interpreted with caution, and management strategies should be guided not only by pressure measurement, but also by possible supplementary clinical risk stratification and other tests.
  • If the PressureWire™ X Guidewire is turned off or loses power at any point after equalization, you must remove it from the patient and re-zero it in its plastic hoop in heparinized saline before continuing. Refer to the PressureWire™ X Guidewire Instructions for Use for more information on troubleshooting the PressureWire™ X Guidewire.
  • If the equalization offset value is greater than or equal to 30, or less than or equal to -30, the system displays an alert icon in the Equalization measurement box. If the system displays this alert icon, try the following to reduce the EQ value:
    • Confirm the AO transducer is positioned at the same height as the patient's heart, and re-zero and reequalize.
    If the alert remains, remove the PressureWire™ X Guidewire from the patient and re-zero it in its plastic hoop in heparinized saline.
  • To prevent incorrect measurement of the aortic pressure by the guiding catheter, causing an incorrect index value calculation:
    • Flush any contrast remnants from the guide catheter with heparinized saline.
    • The insertion tool must be pulled back out of the hemostatic valve.
    • The hemostatic valve must be closed during pressure measurement.
  • The Ultiri™ Measurement System should only be connected to a secure intranet. Direct connection to the Internet may interfere with correct operation and / or result in inappropriate access to patient information, and voids system warranties.
  • Do not leave the system unattended when logged in as Site Administrator.
  • It is recommended to utilize the latest secure protocol that is compatible with the DICOM server (e.g., TLS1.3). If unencrypted DICOM connections are utilized, there is a risk for compromise of information.
  • If there are network security concerns for domain user authentication (i.e., via NTLMv2), non-domain (i.e., local) user authentication can be used.
  • Do not turn on more than one PressureWire™ X Guidewire while the system is Searching / Connecting.
  • After use, the PressureWire™ X Guidewire may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • If you have zoomed in on a section of the recording, portions of the waveform are not displayed (the recording extends off screen). The physician should always review the entire unzoomed recording before selecting the point for the calculation of the index value.
  • When closing the recording, the current cursor position and corresponding index value is saved. When the recording is re-opened, the cursor appears at the saved position. The cursor may then be moved, and the displayed Pa and Pd pressures and index value change to reflect the new cursor position.
  • Deleted files cannot be restored. After files have been deleted, they can only be imported back to your system from your archived copies.
  • Restoring factory default settings resets ALL user-entered configuration values except the date and time. This button should be used only under the direction of qualified service personnel.
  • Do not use images that have been exported to JPEG or Compressed AVI formats for clinical decision making. These formats use compression methods that may degrade the image quality.

 

Potential Adverse Events:

Potential complications which may be encountered during all catheterization procedures include, but are not limited to:

  • Angina
  • Arrhythmia
  • Bleeding
  • Coronary vascular injury
  • Death
  • Drug reactions to vasodilators (e.g., Adenosine or nitroglycerine) used to induce hyperemia during FFR determination such as bronchospasm, dyspnea, bradycardia, coronary artery spasm
  • Hypotension
  • Infection
  • Ischemia
  • Potential allergic reactions to drugs administered for the procedure
  • Stenosis

MAT-2208957 v2.0

Coroventis CoroFlow Cardiovascular System

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Indications: CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.

CoroFlow is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.

Contraindications: The system has no patient alarm functions. Do not use for cardiac/vital signs monitoring.

Warnings:

  • If CoroFlow is used together with 3rd party infusion catheters for assessment of Absolute Flow and Resistance, ensure that the maximum infusion rate per manufacturers instruction is not exceeded or vessel injury may occur.
  • Do not use the CoroFlow measurement system if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).
  • Do not leave the CoroFlow measurement system unattended when logged in as a PC Administrator
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), the PC on to which CoroFlow is installed must be configured according to the Installation Instructions in this manual. Failure to configure the PC correctly may result in increased risk for unauthorized release of protected health information. Windows settings include:
    • Activation and configuration of restricted user Access
    • Activation of Windows Firewall and blocking of network connections
    • Activation of Windows Bitlocker drive encryption
    • Activation of Windows Secure Boot
    • Activation of Windows Anti-Virus scanning
    • Activation of Windows update
  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
  • Use of accessories, transducers and cables other than those specified or provided by Coroventis could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of CoroFlow, including cables specified by Coroventis. Otherwise, degradation of the performance of this equipment could result.

 

Precautions:

  • The PC and CoroHub shall not be placed within the patient environment (1.5 m from patient).
  • For operation of other devices used in conjunction with CoroFlow consult the IFU for each of these devices for details on indication, handling and safety information.
  • It is recommended to ensure local routines for data backup of stored recordings. CoroFlow does not create backup of stored data.
  • Always check minimum performance requirement on PC to ensure compatibility with CoroFlow.
  • It is recommended to install CoroFlow on a PC with backup battery to avoid interruption in case of power failure.
  • Always manually review and confirm valid cursor positions and detected heart beats.
  • Ensure that Pa and Pd pressure waveforms are aligned in phase and offset after equalization, or indices can be mis-calculated.
  • Confirm that the correct Wi-Box is selected by manually matching the Wi-Box ID number with the Wi-Box in the lab.
  • Changing parameter settings outside of default values may affect measurement performance, only for research purposes.
  • Only to be used by healthcare professionals
  • Using a network location to store data may cause previously unidentified risks if the network malfunctions
  • The assembly of medical electrical systems and modifications during the actual service life require evaluation to the requirements according to IEC 60601-1 standard series.
  • CoroHub does not have any serviceable parts and require no field maintenance. No modification or tampering with CoroHub is permitted.
  • CoroHub shall not be immersed in liquid.
  • CoroHub shall not be used if it has been subject to damage
  • Direct connection to a non-secure network, like the internet, may interfere with correct operation and/or result in inappropriate access to patient information. Furthermore, it should be noted that reconfiguring a used network may lead to inability to import patient as well as export examination data, ultimately leading to a risk of loss of patient and examination data. To avoid this problem Coroventis recommends verifying network settings in the system setup after each change.

MAT-2007904 v3.0

XIENCE Skypoint™, XIENCE Sierra™, XIENCE Alpine™ (XIENCE™ Family) Everolimus Eluting Coronary Stent Systems

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Indications

Applies to XIENCE Skypoint™ Stent Systems:

  • Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions ≤ 44 mm in length with reference vessel diameters of ≥ 2.25 mm to ≤ 5.25 mm and for high bleeding risk patients with coronary arteries lesions ≤ 32 mm in length with a reference vessel diameter of ≥ 2.25 mm and ≤ 5.25 mm.
  • Treating de novo chronic total coronary occlusions.

Applies to XIENCE Sierra™ and XIENCE Alpine™ Stent Systems:

  • Indicated for improving coronary artery luminal diameter in patients, including those at high risk for bleeding and those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm.
  • Treating de novo chronic total coronary occlusions.
     

Contraindications

The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are contraindicated for use in:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
  • Patients with hypersensitivity or contraindication to everolimus or structurally-related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, methacrylic polymer, fluoropolymer), or with contrast hypersensitivity.
     

Warnings

  • Each stent and the delivery system are for single use only. Do not reuse, reprocess, or resterilize. Note the product “Use by” date on the package. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and / or delivery system and / or lead to device failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and / or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device and / or delivery system may lead to injury, illness, or death of the patient.
  • It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon.
  • Antiplatelet therapy should be administered post-procedure.
  • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
  • Judicious selection of patients is necessary, since the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.
  • The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. The distal and intermediate portions of the device, the tip, and tapers of the balloon are coated with HYDROCOAT™ Hydrophilic Coating.

Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
 

Precautions

  • Implantation of the stent should be performed only by the physicians who have received appropriate training.
  • Stent placement should be performed at centers where emergency coronary artery bypass graft surgery (CABG) can be readily performed.
  • When the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of clinical trials. Compared to use within the specified indications for use, the use of the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems in patients and lesions outside of the labeled indications, including more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
  • The extent of the patient’s exposure to drug and polymer is directly related to the number of stents implanted. See Instructions for Use for current data on multiple stent implantation.
  • Safety and effectiveness of the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems have not been established for subject populations with the following clinical settings:
    • Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis.
    • Conjunctive use of the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems with either mechanical atherectomy devices or laser angioplasty catheters.
    • Women who are pregnant or lactating, men intending to father children, pediatric.
    • Unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm, for XIENCE Skypoint™ < 2.25 mm or > 5.25 mm, or lesion lengths >44 mm, lesions located in saphenous vein grafts, lesions located in unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.
  • Formal drug interaction studies have not been performed with the XIENCE Skypoint™, XIENCE Sierra™ or XIENCE Alpine™ Stent Systems because of limited exposure to everolimus eluted from XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems.
    • Everolimus, the active ingredient in the stents, is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
    • Oral everolimus use in renal transplant and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglyceride levels, which in some cases required treatment.
    • Nonclinical testing has demonstrated that the XIENCE Sierra™ and XIENCE Alpine™ Stent Systems in single and in overlapped configurations up to 71 mm, for XIENCE Skypoint™ 91 mm in length, are MR Conditional. See Instructions for Use for detailed scanning conditions

Potential Adverse Events

Adverse events that may be associated with PCI treatment procedures and the use of a stent in native coronary arteries include, but are not limited to, the following:

  • Allergic reaction or hypersensitivity to latex, contrast agent anesthesia, device materials, and drug reactions to everolimus, anticoagulation, or antiplatelet drugs
  • Vascular access complications which may require transfusion or vessel repair, including: Catheter site reactions, Bleeding, Arteriovenous fistula; pseudoaneurysm, aneurysm, dissection, perforation/rupture, Embolism, Peripheral nerve injury, Peripheral ischemia
  • Coronary artery complications which may require additional intervention, including: Total occlusion or abrupt closure, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection. Perforation/rupture, Tissue prolapse/plaque shift, Embolism, Coronary or stent thrombosis, Stenosis or restenosis
  • Pericardial complications which may require additional intervention, including: Cardiac tamponade, Pericardial effusion, Pericarditis.
  • Cardiac arrhythmias
  • Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction (including acute), coronary artery spasm, and unstable or stable angina pectoris)
  • Stroke/Cerebrovascular Accident (CVA) and Transient Ischemic Attack (TIA)
  • System organ failures: Cardio-respiratory arrest, Cardiac failure, Cardiopulmonary failure, Renal Insufficiency/failure, Shock
  • Bleeding
  • Blood cell disorders
  • Hypotension and/or hypertension
  • Infection
  • Nausea and vomiting
  • Palpitations
  • Dizziness
  • Syncope
  • Chest Pain
  • Fever
  • Pain
  • Death


The risks described below include the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings and precaution sections of the everolimus labels / SmPCs and / or observed at incidences ≥ 10% in clinical trials with oral everolimus for different indications. Please refer to the drug SmPCs and labels for more detailed information and less frequent adverse events.

  • Abdominal pain
  • Anemia
  • Angioedema
  • Arterial Thrombotic Events
  • Bleeding and coagulopathy
  • Constipation
  • Cough
  • Diabetes mellitus
  • Diarrhea
  • Dyspnea
  • Embryo-fetal toxicity
  • Erythema
  • Erythroderma
  • Headache
  • Hepatic artery thrombosis
  • Hepatic disorders
  • Hypersensitivity to everolimus active substance, or to other rapamycin derivates
  • Hypertension
  • Infection (bacterial, fungal, viral or protozoan infections, including infections with opportunistic pathogens). Polyoma virus-associated nephropathy (PVAN), JC virus-associated progressive multiple leukoencephalopathy (PML), fatal infections and sepsis have been reported in patients treated with oral everolimus
  • Kidney arterial and venous thrombosis
  • Laboratory test alterations
  • Lymphoma and skin cancer
  • Male infertility
  • Menstrual irregularities
  • Nausea
  • Nephrotoxicity
  • Non-infectious pneumonitis
  • Oral ulcerations
  • Pain
  • Pancreatitis
  • Pericardial effusion
  • Peripheral edema
  • Pleural effusion
  • Pneumonia
  • Pyrexia
  • Rash
  • Renal Failure
  • Upper respiratory tract infection
  • Urinary tract infection
  • Venous thromboembolism
  • Vomiting
  • Wound healing complications

There may be other potential adverse events that are unforeseen at this time.

MAT-2100879 v7.0