Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France (Far XIENCE V®)

Study Population Description * Definition: For observational studies only, a description of the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).

Inclusion Criteria:

All patients enrolled in the study must :

• be at least 18;
• be covered by Social Security
• agree to be enrolled in the study (sign the informed consent after reading the information letter).

In addition, the Xience V endoprothesis implantation must be performed following the LPPR indications here under :

Treatment of coronary heart disease attributable to de novo lesions (reference vessel with a 2.5 to 3.5 mm) of native coronary arteries, solely in the following groups of patients :

• patients with diabetes ;
• lesions of small vessels (diameter < 3 mm);
• long lesions (longer than 15 mm) ;
• stenosis of proximal anterior intraventricular septum .

The use of the Xience V stent is limited to one per patient, except :

• in case of acute occlusive dissection where three stents, maximum, may be covered ;
• for the pluritroncular diabetic patient, in case a bypass is contra-indicated : a stent per artery, with a limit of three per patient, may be covered.

Exclusion Criteria:

• Pregnant women

• Patients with:

  • a non cardiac vital prognosis endangered during the year following the implantation ;
  • less than 72 hours myocardial infarction ;
  • lower left ventricular ejection fraction < 30 % ;
  • an allergy to the platelets antiaggregant treatment, to heparin, chrome cobalt alloy, or to the angiography contrast medium ;
  • a stenosis of the unprotected common trunk;
  • a lesion with calcifications that cannot be pre-dilated;
  • a thrombus that can be detected by angiography on the lesion to be treated ;
  • an intra-stent re-stenosis.

Are also excluded :

• patients having had an angioplasty with implantation of an endoprothesis on the same vessel;
• patients having had an angioplasty with implantation of an endoprothesis during the 6 previous months ;
• Patients unable to keep a treatment associating aspirin and thiénopyridines for at least 6 months;
• Patients residing abroad or who cannot be monitored according to the modalities of the study ;
• Patients unable to give on their own free will their informed consent ; On the other hand, in absence of clinical validation, the other sub-groups of at risk patients (notably bifurcation lesions and pluritroncular lesions) cannot be considered , taken alone, as indications for the use of Xience V.