[Direct coronary stent implantation without predilatation--a new therapeutic approach with a special balloon catheter design].
Stent implantation serves as the gold standard for proximal lesions of the coronary arteries with a diameter between 2.75-3.5 mm. Our new concept aims at a reduced procedure duration and fluoro-time as well as a decreased ischemic period during stent implantation. A new therapeutic concept of a direct stent implantation without predilatation was tested using a specially developed balloon catheter on which various 14-16 mm long "slotted-tube" stents are mounted between two conical, radiopaque markers. In 105 consecutive patients, who were scheduled for angioplasty, this method of direct stent implantation was performed. Six of the procedures were performed for acute myocardial infarction and 8 in so-called high-risk procedures. The direct stent implantation was successful in 88%. In 6%, predilatation of the lesion site was necessary before stent placement. In the remaining 6%, a stent could not be successfully implanted despite the availability of various other systems. Comparison of the direct stent implantation with conventional stent placement with predilatation revealed that 1) The fluoro-time for direct stent implantation, compared to the conventional method, was 8.4 +/- 4.9 min vs. 13.7 +/- 8.0 min; p < 0.05, respectively. Furthermore, there were less balloons used per lesion for direct stent implantation (1.4 +/- 0.4) compared to the conventional method (1.7 +/- 0.7), but there was not a significant difference. 2) If we compare those patients with successful direct stent implantation with those with the unsuccessful procedures, the latter group had a higher percent of angiographically visible calcification at the site of the lesion (80% vs. 18%; p < 0.01). In addition, these patients had an increased average age (72 +/- 7 vs. 61 +/- 11 yrs; p < 0.01). The success rate of direct stent implantation did not depend on lesion diameter stenosis before PTCA. Stent dislocation was observed in 3.8% of the procedures, and a single case of stent embolism was seen. In conclusion, the direct stent implantation offers the advantages of a shortened fluoro-time, the use of fewer balloons, and has the potential of less ischemic stress compared to the conventional method of stent implantation with predilatation, if old patients with calcified lesions are excluded. This should be proved on a large scale in future studies also considering a learning curve with regard to the new method. Whether this new approach also reduces the restenosis rate, warrants further studies.
Hoffmann
M
M
Klinik für Innere Medizin III, Kardiologie, Angiologie, Internistische Intensivtherapie Friedrich-Schiller-Universität Jena.
Werner
G S
GS
Ferrari
M
M
Richartz
B M
BM
Figulla
H R
HR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents