Percutaneous Coronary Interventions (PCI) are widely used to treat complex patient populations. Post-PCI clinicians make decisions on the dual-antiplatelet therapy (DAPT) strategy.
Assessing Bleeding Risk vs. Ischemic Risk
The Academic Research Consortium (BARC) has standardized HBR definitions for patient undergoing PCI. The intention is to ensure the consistency and quality of data collection and reporting.
(Adapted from Lawton J, et al 2022)
* SIHD - Stable Ischemic Heart Disease. ACS - Acute Coronary Syndrome.
** Out of 5,769 patients in TWLIGHT STENT subanalysis, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES.
MAT-2108839 v1.0
INDICATIONS
Applies to XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems:
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:
WARNINGS
PRECAUTIONS
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:
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.
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
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Precautions
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