Intrahospital and late outcomes in a unique centre of treatment with different kinds of drug eluting stents, in patients with "Off Label" coronary angioplasty indication

Introduction

In coronary angioplasty with “On Label” indication, Drug Eluting stents (Cypher, Taxus y Endeavor) have proved to reduce dramatically, the major events at the expense of a significant reduction of revascularization of the target lesion. These indications are arguable, and its role is not exactly known yet, in the “Off Label” indication, even less known when other different kinds of platforms and drugs are used, as it happens in our real life.

Objectives

To analyze intrahospital results, and in the later follow-up, of a population of patients with “Off. Label” coronary lesions, treated with different kinds of drug eluting stents.

Material and methods

255 consecutive patients were retrospectively analyzed (from 31-5-03 to 28-02-07), average age: 64 (37-89), male: 192 (75,3%)

Demographics

• Hipertension: 116 (45.5%)
• Diabetic: 59 (23.1%)
• Dislypemia: 97 (38%)
• Smokers 82 (32.2%)
• Previous MI: 74 (29%)
• Previous ACTP: 48 (18,8)
• Previous cardiac surgery: 15 (5.9%)

Clinical indication

• Stable angina: 15 (5,9%)
• Unastable angina: 239 (93.7%)

Anatomy indication

• Ostial lesions: 19 (7.5%)
• Total oclusion: 25 (9.8%)
• Bifurcation lesions: 11 (4.3%)
• Restenosis of bare metal stents: 42 (16.5%)
• Restenosis of drug eluting stents: 26 (10.2%)

Vessel treated

• Left main: 11 (4.3%)
• LAD: 151 (59.2%)
• Circunflex: 54 (21.2%)
• Rigth coronary: 60 (23.5%)
• Diagonal: 10 (3.9%)
• Marginal: 3 (1,2%)

Lesion type: 302 lesions

• Type A: 1 (0.3%)
• Type B1: 5 (1.6%)
• Type B2: 55 (18.2%)
• Type C: 241 (79%)
  

Anatomy indication

• Ostial lesions: 19 (7.5%)
• Total oclusion: 25 (9.8%)
• Bifurcation lesions: 11 (4.3%)
• Restenosis of bare metal stents: 42 (16.5%)
• Restenosis of drug eluting stents: 26 (10.2%)
  
  
• Vessel diameter: 2.25 A 4.0 mm (mean 2.9 mm)
• Lesion length : 10-48mm (mean 25 mm)

Number of vessels treated

• one: 221 (86.7)
• two: 31 (12.2%)
• three: 4 (1,6%)

Stent Type: 330 stents

• APOLLO: 6 (1.8%)
• AXXION: 3 (0.9%)
• COSTAR: 25 (7.5%)
• ENDEAVOR: 96 (29%)
• FIREBIRD: 29 (8.7%)
• CYPHER: 52 (15.7%)
• TAXUS: 118 (35.7%)
• XIENCE: 1 (0.3%)

Tecnic implantation

• Balon predilatation in 250 patients (98%).
• Direct stent in 5 patients (2%)
• Post dilatation in 2 patients (0.8%)
  
  
• Stents diameter: 2,25 A 4.0 mm (mean 2,9 mm)
• Stents length: 12 A 33 mm (mean 27,6 mm)

Results

Success of the procedure: 254 patients (99,6%), myocardial infarction (MI): 1 (0,4%), follow-up: 255 patients/259 patients (98,5%), average: 19 months (6-45 months), general death: 6 (2,35%), cardiac death: 1 (0,4%), revascularization of the treated lesion: 30 (11,8%), survival free of cardiac death and infarct: 99,3%, survival free of major events (MI, death, revascularization of responsible lesion): 87,5%, late thrombosis: 3 (1,2%), definite: 2, probable: 1.

Conclusions

Coronary angioplasty, with the implantation of different kinds of drug eluting stents was effective in reducing the rate of revascularization of the responsible lesion, in patients with high restenosis risk, without significant increase of death or myocardial infarct.