[4 years' experience with a balloon-expandable endoprosthesis. Experimental and clinical application]

During a 4-year period of clinical application of the balloon-expandable Palmaz stent, a randomized trial comparing stent implantation and traditional balloon angioplasty of iliac arteries in arterial occlusive disease was started. The first long-term results, recorded after 2 years, indicate statistically significant differences in the complication rate (after stenting 2/62 and after angioplasty 5/69) and patency (greater than or equal to 70% of original lumen size upon stent implantation or balloon inflation: 95% after stenting and 72% after angioplasty). Clinical improvement after 2 years was 89% after stenting and 70% after angioplasty. Parallel to the clinical trials, experimental canine artery stenting was performed to evaluate differences in the long-term patency of stents exposed to restricted flow. Significant differences in neointimal healing were found between normally perfused stents and stents with artificially reduced flow: during the total observation period of 6 months the neointimal height was up to 200% higher in flow-restricted stents, while the histological composition of the neointima was the same as with normally perfused stents.