Promus ELITE™ Stent System Indications, Safety and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE:

The Promus ELITE™ Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length.

CONTRAINDICATIONS:

Use of the Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System is contraindicated in patients with known hypersensitivity to:

  • 316L stainless steel or platinum
  • everolimus or structurally-related compounds
  • the polymers or their individual components (see Section 2.2.2, Primer Polymer and Drug Matrix Copolymer Carrier)

Coronary Artery Stenting is contraindicated for use in:

  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
  • Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy (see Section 6.2, Pre- and Post-Procedure Antiplatelet Regimen for more information).

WARNINGS:

  • To maintain sterility, the inner package should not be opened or damaged prior to use.
  • The use of this product carries the risks associated with coronary artery stenting, including stent thrombosis, vascular complications, and/or bleeding events.
  • This product should not be used in patients who are not likely to comply with recommended antiplatelet therapy.

General Precautions

  • Only physicians who have received adequate training should perform implantation of the stent.
  • Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be readily performed.
  • Subsequent stent blockage may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized stents is not well characterized.
  • Consideration should be given to the risks and benefits of use in patients with history of severe reaction to contrast agents.
  • Do not expose the delivery system to organic solvents such as alcohol or detergents.
  • Care should be taken to control the position of the guide catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
  • Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize. Stent thrombosis is frequently associated with myocardial infarction (MI) or death. In the clinical trials analyzed to date, differences in the incidence of stent thrombosis have not been associated with an increased risk of cardiac death, MI, or all-cause mortality. Additional data from longer-term follow-up of the PLATINUM clinical trials and analyses of stent thrombosis related to DES are expected and should be considered in making treatment decisions as data become available.
  • When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the NG PROMUS and PLATINUM pivotal clinical trials.
  • Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI or death.
  • Orally-administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglyceride levels.

Pre- and Post-Procedure Antiplatelet Regimen

The optimal duration of antiplatelet therapy, specifically P2Y12 inhibitor therapy, is unknown and DES thrombosis may still occur despite continued therapy. Provided herein are recent recommendations for post-procedural antiplatelet therapy from the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention (PCI); see Section 6.2.1, Oral Antiplatelet Therapy.

Oral Antiplatelet Therapy

Continuation of combination treatment with aspirin and a P2Y12 inhibitor after PCI appears to reduce major adverse cardiac events. On the basis of randomized clinical trial protocols, secondary prevention measures and expert consensus opinion, aspirin 81 mg daily should be given indefinitely after PCI. Likewise, a P2Y12 inhibitor should be given daily for at least 12 months in patients who are not at high risk of bleeding. Full guidelines are provided at the following website: https:// content.onlinejacc.org/cgi/content/full/j.jacc.2011.08.007v1. It is very important that the patient is compliant with the post-procedural antiplatelet recommendations. Premature discontinuation of prescribed antiplatelet medication could result in a higher risk of thrombosis, MI or death. Prior to PCI, if a surgical or dental procedure is anticipated that requires early discontinuation of antiplatelet therapy, the interventional cardiologist and patient should carefully consider whether a DES and its associated recommended antiplatelet therapy is the appropriate PCI choice. Following PCI, should a surgical or dental procedure be recommended that requires suspension of antiplatelet therapy, the risks and benefits of the procedure should be weighed against the possible risk associated with premature discontinuation of antiplatelet therapy. Generally, it is recommended to postpone elective surgery for one year and among those patients for whom surgery cannot be deferred, ASA should be considered during the perioperative period in high risk DES patients. Patients who require premature discontinuation of antiplatelet therapy secondary to significant active bleeding should be monitored carefully for cardiac events and, once stabilized, have their antiplatelet therapy restarted as soon as possible per the discretion of their treating physicians.

Longitudinal Stent Deformation

Longitudinal stent deformation is a recognized potential failure mode of thin strut coronary stents. Although a rare event, longitudinal stent deformation may result in adverse clinical events and/or the need for additional treatment including repeat dilatation of the implanted stent, placement of a second stent, and/or surgical intervention. Implantation techniques that may reduce the likelihood of procedure related complications, including stent deformation, are described in the appropriate sections of this DFU (see sections 14.3.4 Delivery Procedure, 14.3.5 Deployment Procedure, 14.3.6 Removal Procedure, and 14.4 Post-Deployment Dilatation of Stented Segment). Please see section 8 Overview of Clinical Studies for a description of the enhancements made to the Promus ELITE™ Coronary Stent System.

Use of Multiple Stents

The use of multiple DES will expose the patient to larger amounts of drug and polymer.

Brachytherapy

The safety and effectiveness of the Promus ELITE stent in patients with prior brachytherapy of the target lesion have not been established.

Use in Conjunction with Other Procedures

The safety and effectiveness of using mechanical atherectomy devices (directional atherectomy catheters or rotational atherectomy catheters) or laser angioplasty catheters in conjunction with Promus ELITE stent implantation have not been established.

Pediatric Use

The safety and effectiveness of the Promus ELITE stent in pediatric patients have not been established.

Lesion/Vessel Characteristics

The safety and effectiveness of the Promus ELITE Stent have not been established in the cerebral, carotid, or peripheral vasculature or in the following patient populations:

  • Patients with vessel thrombus at the lesion site.
  • Patients with coronary artery reference vessel diameters <2.25 or >4.00 mm.
  • Patients with coronary artery lesions longer than 34 mm or requiring more than one Promus ELITE Stent.
  • Patients with lesions located in the saphenous vein grafts, in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
  • Patients with diffuse disease or poor flow distal to the identified lesions.
  • Patients with tortuous vessels (>60 degrees) in the region of the obstruction or proximal to the lesion.
  • Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
  • Patients with in-stent restenosis.
  • Patients with moderate or severe calcification in the lesion or a chronic total occlusion.
  • Patients with 3 vessel disease.

Drug Interactions

Several drugs are known to affect everolimus metabolism, and other drug interactions may also occur.

Magnetic Resonance Imaging (MRI) Safety Information:

Non-clinical testing has demonstrated that the Promus ELITE Stent is MR Conditional for single and overlapped conditions up to 74 mm. A patient with this device can be safely scanned in a Magnetic Resonance system meeting the following conditions:

  • Static magnetic field of 3.0 and 1.5 Tesla only
  • Maximum spatial gradient magnetic field of 2200 gauss/cm (22 T/m)
  • Maximum Magnetic Resonance system reported, whole body averaged specific absorption rate (SAR) of <2 W/kg (Normal Operating Mode) Under the scan conditions defined above, the Promus ELITE Stent is expected to produce a maximum temperature rise of 2.6ºC after 15 minutes of continuous scanning

MR Conditional Stent Handling (also see Section 14, Operational Instructions)

  • The premounted Promus ELITE Stent and its delivery system are designed for use as a unit.
  • Use only the appropriate balloon inflation media (see Section 14.3.3, Balloon Preparation). Do not use air or any gas medium to inflate the balloon.

Stent Placement Preparation

  • An unexpanded stent should be introduced into the coronary arteries one time only. An unexpanded stent should not be subsequently moved in and out through the distal end of the guide catheter as stent or coating damage or stent dislodgment from the balloon may occur.

Stent Placement

  • Do not expand the stent if it is not properly positioned in the vessel (see Section 6.15, Stent Delivery System Removal).
  • Balloon pressures should be monitored during inflation. Do not exceed rated burst pressure as indicated on product label (see Section 14.5, In Vitro Information, Table 14.1, Typical Promus ELITE™ Stent System Compliance).
  • Placement of the stent has the potential to compromise side branch patency (see Section 14.4, Post-Deployment Dilatation of Stented Segments).
  • Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion, and may cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilation, placement of additional stents, or other).
  • When treating multiple lesions, the distal lesion should generally be stented first, followed by stenting of the more proximal lesion(s).

Stent Delivery System Removal

  • If unusual resistance is felt at any time during lesion access before stent implantation, the stent delivery system and the guide catheter should be removed as a single unit.
  • Do not attempt to pull an unexpanded stent back into the guide catheter, as stent or coating damage or stent dislodgment from the balloon may occur.
  • Stent retrieval methods (use of additional wires, snares and/ or forceps) may result in additional trauma to the vascular site.

Post-Procedure

  • Care must be exercised when crossing a newly deployed stent with any wire, catheter or ancillary device to avoid disrupting the stent placement, apposition, geometry, and/or coating.

POTENTIAL ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to:

  • Abrupt stent closure
  • Acute myocardial infarction
  • Allergic reaction to anti-coagulant and/or antiplatelet therapy, contrast medium, or stent materials
  • Angina
  • Arrhythmias, including ventricular fibrillation and ventricular tachycardia
  • Arteriovenous fistula
  • Bleeding
  • Cardiac tamponade
  • Cardiogenic shock/pulmonary edema
  • Coronary aneurysm
  • Death
  • Dissection
  • Emboli, distal (air, tissue or thrombotic material or material from device(s) used in the procedure)
  • Heart failure
  • Hematoma
  • Hemorrhage, which may require transfusion
  • Hypotension/hypertension
  • Infection, local or systemic
  • Ischemia, myocardial
  • Pain, access site
  • Perforation or rupture of coronary artery
  • Pericardial effusion
  • Pseudoaneurysm, femoral
  • Renal insufficiency or failure
  • Respiratory failure
  • Restenosis of stented segment
  • Stent embolization or migration
  • Stent deformation, collapse, or fracture
  • Stent thrombosis/occlusion
  • Stroke/cerebrovascular accident/transient ischemic attack
  • Total occlusion of coronary artery
  • Vessel spasm
  • Vessel trauma requiring surgical repair or reintervention

Zortress™, the oral formulation of everolimus developed by Novartis Pharmaceuticals Corporation, has been evaluated in clinical trials and is approved in the United States for the prevention of organ rejection in adult kidney transplant recipients at the dose of 1.5 mg/day. Outside the U.S., Zortress is sold under the brand name, Certican™, in more than 70 countries. Everolimus is also approved in the United States under the name of Afinitor™ for patients with advanced renal cell carcinoma (cancer), after failure of treatment with sunitinib or sorafenib, at doses of 5 to 20 mg/day when taken by mouth. The following list includes the known risks of everolimus at the oral doses listed above. The amount of drug that circulates in the bloodstream following implantation of a Promus ELITE™ Stent is several folds lower than that obtained with oral doses (1.5 mg to 20 mg/day, see Section 7.2, Pharmacokinetics).

  • Abdominal pain (including upper abdominal pain)
  • Anemia
  • Angioedema
  • Anorexia
  • Asthenia
  • Constipation
  • Cough
  • Delayed wound healing/fluid accumulation
  • Diarrhea
  • Dyslipidemia (including hyperlipidemia and hypercholesterolemia)
  • Dysgeusia
  • Dyspepsia
  • Dyspnea
  • Dysuria
  • Dry skin
  • Edema (peripheral)
  • Epistaxis
  • Fatigue
  • Headache
  • Hematuria
  • Hyperglycemia (may include new onset of diabetes)
  • Hyperkalemia
  • Hyperlipidemia
  • Hypertension
  • Hypokalemia
  • Hypomagnesemia
  • Hypophosphatemia
  • Increased serum creatinine

  • Infections and serious infections: bacterial, viral, fungal, and protozoal infections (may include herpes virus infection, polyoma virus infection which may be associated with BK virus associated nephropathy, and/or other opportunistic infections)
  • Insomnia
  • Interaction with strong inhibitors and inducers of CYP3A4
  • Leukopenia
  • Lymphoma and other malignancies (including skin cancer)
  • Male infertility (azospermia and/or oligospermia)
  • Mucosal inflammation (including oral ulceration and oral mucositis)
  • Nausea
  • Neutropenia
  • Non-infectious pneumonitis
  • Pain; extremity, incision site and procedural, back, chest, musculoskeletal
  • Proteinuria
  • Pruritus
  • Pyrexia
  • Rash
  • Stomatitis
  • Thrombocytopenia
  • Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS)
  • Tremor
  • Upper respiratory tract infection
  • Urinary tract infection
  • Vomiting

Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.

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