XIENCE™ Stent, With Proven DAPT Options, Helps Optimize Treatment For Your Patients2
XIENCE™ Stent is the gold standard for DES with proven safety across a wide range of patients.3 Now with a HBR indication and 1-month and 3-month labeling, XIENCE™ Stent can help optimize treatment for an even broader range of patients.2
XIENCE™ Stent design has protective attributes of its fluoropolymer coating. XIENCE™ Stent clearly shows significantly less platelet adhesion vs. Synergy‡ and Resolute Onyx‡. (p<0.05).10
Aspirin Only Monotherapy10
Unlike Resolute Onyx‡, XIENCE™ Stent can point to both 1-month and 3-month DAPT labeling in HBR patients. XIENCE™ Stent is significantly more thromboresistant than other DES.10
P2Y12 Inhibitor Only Monotherapy10
“Device-versus-device studies can investigate whether specific stent platforms may provide important clinical benefits in combination with specific antiplatelet therapy regimens.11”
STOPDAPT Studies: 1-Month DAPT and 3-Month DAPT in All-Comers Population5,12
STOPDAPT12 and STOPDAPT 25 were prospective trials of the XIENCE™ Stent that studied DAPT cessation at 3 months and 1 month, respectively.
STOPDAPT 2 Trial: 1-Month DAPT Superior to 12-Month DAPT5
The STOPDAPT 2 trial revealed that 1-month DAPT demonstrated superior safety over 12-month DAPT for the primary endpoint of net adverse cardiovascular events (NACE). NACE included cardiovascular death, myocardial infarction (MI), definite ST, stroke, or thrombolysis in MI (TIMI) major/minor bleeding. All of the 3,009 patients in this randomized, controlled trial were treated with XIENCE™ Stent.
XIENCE™ Stent, With Proven DAPT Options, Helps Optimize Treatment for Your Patients2,5,12,13,14
“It was noteworthy that no definite or probable stent thrombosis occurred in [XIENCE™ Stent] patients enrolled in STOPDAPT.”
—Masahiro Natsuaki, MD, STOPDAPT Trial112
STOPDAPT Study: XIENCE™ Stent with 3-Month DAPT12
STOPDAPT was the first prospective trial to study DAPT cessation at 3 months after stent implantation. Among other 1-year outcomes, XIENCE™ Stent showed stent thrombosis was 0.0%.
STOPDAPT Study – XIENCE™ Stent with 3-Month DAPT12
XIENCE 28 and XIENCE 90 Publication: 3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation15
*Shortest as compared to all commercially available competitor DES products in the U.S. Reference: Competitor product IFUs. In HBR patients, in whom ischemic and bleeding risks must be weighed, DAPT discontinuation after 3 months or 1 month (as short as 28 days) post-PCI with XIENCE™, did not show any increase in ischemic risks. Source: XIENCE Skypoint™ Stent – Instructions for Use (IFU). Refer to IFU for additional information.
XIENCE Skypoint™ Stent – Instructions for Use (IFU). Refer to IFU for additional information; Synergy‡ – Instructions for Use; Resolute Onyx‡ – Instructions for Use; Orsiro‡ – Instructions for Use; Promus Premier‡ – Instructions for Use. Shortest DAPT labeling as compared to all commercially available competitor DES products in the U.S. Reference: Competitor product IFUs. In HBR patients, in whom ischemic and bleeding risks must be weighed, DAPT discontinuation after 3-months or 1-month (as short as 28 days) post-PCI with XIENCE™, did not show any increase in ischemic risks.
XIENCE Skypoint™ Stent – Instructions for Use (IFU). Refer to IFU for additional information.
Zanchin C, et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675. Serruys P, et al. N Engl J Med. 2010;363:136-146. Shiomi H, et al. JACC Cardiovasc Interv. 2019;12:637-647. Kufner S, et al. Circulation. 2019:139(3):325-333. Palmerini T, et al. Lancet. 2013;379:1393-1402. Bangalore S, et al. Circulation. 2012;125:2873-2891. Bangalore S, et al. Circ Cardiovasc Interv. 2013;6(6):378-390. Pilgrim T, et al. Lancet. 2014;384:2111-2122. Pilgrim T, et al. Lancet. 2018;392:737-746. Data on file at Abbott.
Généreux P, et al. Circ Cardiovasc Interv. 2015;8(5):e00136. Natsuaki M, et al. Cardiovasc Interv Ther. 2016;31:196-209. Watanabe H, et al. JAMA. 2019;321(24):2414-2427. Hahn J, et al. ACC 2019 – SMART CHOICE. Valgimigli M, et al. Circulation. 2012;125:2015-2026. Gilard M, et al. J Am Coll Cardiol. 2015;65:777-786. Hong SJ, et al. JACC Cardiovasc Interv. 2016;9:1438-1446. Gwon HC, et al. ACC 2011 – EXCELLENT. Mehran R, et al. JACC Cardiovasc Interv. 2021;14:1870-1883.
Watanabe H, et al. JAMA. 2019;321(24):2414-2427.
Valgimigli M, et al. J Am Coll Cardiol. 2021;78:2060-2072.
Synergy‡ – Instructions for Use.
Resolute Onyx‡ – Instructions for Use.
Finn A. TCT 2021 – Stent design for short-term DAPT in HBR patients: what is required?
Sato Y, et al. Int J Cardiol. 2021;338:42-49. Pre-clinical experiments completed by CVPath – data on file at Abbott.
Capodanno D, et al. J Am Coll Cardiol. 2020;76:1468-1483.
Natsuaki M, et al. Cardiovasc Interv Ther. 2016;31:196-209.
Watanabe H, et al. ESC 2021 – STOPDAPT-2 ACS.
Hahn J, et al. ACC 2019 – SMART CHOICE.
Mehran, R et al., 3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation, JACC Cardiovascular Interventions, 2021, 14 (17): 1870-1883
INDICATIONS
Applies to XIENCE Skypoint™, 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.
In addition, XIENCE Skypoint™ Stent System is indicated with reference vessel diameters of ≥ 2.25 mm to ≤ 5.25 mm.
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 or lesion lengths > 32 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 Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems in single and in overlapped configurations up to 71 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
Infections (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
Applies only to XIENCE Sierra™ and XIENCE Alpine™ 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.
MAT-2100879 v5.0
DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?
CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.
Precautions
Please be sure to read it.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
Are you a healthcare professional?
Test
yes
Precautions
Please be sure to read it.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
Are you a healthcare professional?
Test
[prod, crx3, samplecontent, publish, crx3tar]
test
DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?
CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.