What's New in Interventional Cardiology

Case Study

TAXUS® Express²® Coronary Stent System

 Pre-Procedure

A 70 year old female presented w/stable angina. She had been experiencing chest pain for the past three months while at rest. A former smoker, she had a history of coronary artery disease and hypertension. After consultation with her physician, an angiogram was performed and a lesion was identified in the mid-LAD with approximately 80% diameter stenosis.

 Procedure

The lesion was pre-dilated with a balloon. Following the pre-dilatation, a 3mm x 16mm TAXUS® Express²® Drug-Eluting Stent System was inserted successfully.

 Post-Procedure

At day 1,417, a subsequent angiogram was performed and the stented area of the vessel was patent with less than 30% residual stenosis.

Indications

The TAXUS Express² Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions ≤ 28 mm in length in native coronary arteries ≥ 2.5 to ≤ 3.75 mm in diameter.

Contraindications

Use of the TAXUS Express² Paclitaxel-Eluting Coronary Stent System is contraindicated in patients with:

  • Known hypersensitivity to paclitaxel or structurally related compounds.
  • Known hypersensitivity to the polymer or its individual components.

Coronary Artery Stenting is contraindicated for use in:

  • Patients who can not receive recommended anti-platelet therapy and/or anticoagulant therapy.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.

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 subacute thrombosis, vascular complications, and/or bleeding events.
  • Patients with known hypersensitivity to 316L stainless steel may suffer an allergic reaction to this implant.
  • This product should not be used in patients who are not likely to comply with recommended antiplatelet therapy.

Potential Adverse Effects

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:

Aneurysm, Arrhythmias, Bleeding complications, Death, Distal Emboli, Emergent CABG, Myocardial Infarction, Myocardial Ischemia, Occlusion, Stent Delivery Failures, Target Lesion Revascularization, Thrombosis, Vascular complications, Vessel Dissection.

Potential adverse events not captured above that may be unique to the paclitaxel drug coating:

Alopecia, Allergic reaction to the drug or the polymer, Anemia, Blood product transfusion, Gastrointestinal symptoms, Hematologic dyscrasia, Hepatic enzyme changes, Histologic changes in vessel wall, including inflammation, cellular damage or necrosis, Myalgia/Arthralgia, Peripheral neuropathy.

The safety and effectiveness of the TAXUS Express² Paclitaxel-Eluting Coronary Stent System have not been established in the cerebral, carotid, or peripheral vasculature or the following patient populations:

  • Patients with vessel thrombus at the lesion site.
  • Patients with coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm.
  • Patients with coronary artery lesions longer than 28 mm or requiring more than one TAXUS stent.
  • Patients with lesions located in the saphenous vein grafts, in the unprotected 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 multi-vessel disease.
Prior to use, please see the complete "Directions for Use" at www.stent.com for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

Cautions

Federal (USA) law restricts this device to sale by or on the order of a physician.

Trademark

TAXUS, PROMUS, Express and Express² are registered trademarks of Boston Scientific Corporation or its affiliates. Cypher is a trademark of Cordis Corporation. Endeavor is a trademark of Medtronic Vascular, Inc. Plavix is a trademark of Sanofi-Aventis. PROMUS Stent is a private-labeled XIENCE V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation. XIENCE is a trademark of Abbott Laboratories group of companies.