Clinical and angiographic assessment of immediate and long-term (up to 12 months) results of using the "Axxion" drug-eluting stent in patients with coronary atherosclerosis

The dissertation is devoted to the clinical and angiographic assessment of the immediate and long-term (up to 12 months) results of using the drug-eluting "Axxion" stent in patients with coronary atherosclerosis. The study was conducted at the Russian Cardiology Research and Production Complex and compares the efficacy of the novel "Axxion" stent with antiproliferative coating (paclitaxel and heparin) and the "Cypher" stent in the treatment of more than 400 patients with coronary artery disease who underwent stenting between 2004 and 2006. The work analyzes the immediate angiographic and in-hospital outcomes as well as the long-term clinical results of implantation of both stent types in homogeneous groups of patients with native coronary lesions.

Since the late 1970s, percutaneous coronary interventions (PCI) have been used in clinical practice. Earlier studies have demonstrated the high efficacy of PCI in the treatment of stenotic lesions of the coronary arteries in patients with coronary artery disease [10]. PCI have surpassed the frequency of coronary artery bypass grafting (CABG) due to lower cost, minimal invasiveness, absence of general anesthesia, and the lack of need for cardiopulmonary bypass [222]. Throughout almost all of Europe and America, the ratio of CABG to PCI procedures is 1:2 [7, 10, 70]. In developed countries, the number of PCI procedures continues to grow.

Intracoronary stents were first used in 1986 by J. Puel and U. Sigwart. In invasive cardiology, dozens of new stent models and types have appeared for the treatment of coronary atherosclerosis and are currently used. Some clinics preferred self-expanding stents (Wallstent), others — wire stents, and still others — tubular mesh stents. The manufacturing technology was continually improved, the design was modified, and low-profile stents (Cordis, Medtronic, Guidant, etc.) were introduced and found wide application in the clinical practice of invasive cardiology; in addition to bare-metal stents, drug-eluting stents also emerged.

Great hopes are placed on the new improved Axxion stents with antiproliferative coating (Paclitaxel & Heparin-eluting stent), which have been used in recent years for the treatment of coronary atherosclerosis. The first studies on the efficacy of stents with antiproliferative coatings in coronary atherosclerosis have appeared. Nevertheless, there are still few studies providing a real comparative assessment of their efficacy in patients with coronary artery disease.

The aim of the study was a comparative assessment of the efficacy of Axxion stents with antiproliferative coating versus their predecessor, the Cypher stent, for the treatment of coronary atherosclerosis.

Objectives of the study

1. To assess the immediate angiographic and in-hospital outcomes of implantation of Axxion stents with antiproliferative coating.

2. To analyze the long-term (up to 12 months) clinical outcomes of implantation of Axxion stents with antiproliferative coating.

3. To assess the immediate angiographic, in-hospital, and long-term outcomes of implantation of Cypher stents with antiproliferative coating.

4. To conduct a comparative assessment of the efficacy of Axxion and Cypher stents.

Scientific novelty

For the first time in real clinical practice in our country, a single-center comparison of the early and long-term outcomes of implantation of Axxion stents with antiproliferative coating versus their predecessor, the Cypher stent, was carried out in more than 400 patients with coronary artery disease who underwent stenting between 2004 and 2006. In relatively homogeneous groups of patients with coronary artery disease and native coronary lesions, the advantages of Cypher stents with antiproliferative coating were demonstrated and persisted throughout the entire follow-up period.

Practical significance

It has been shown that implantation of the Axxion stent coated with paclitaxel (Paclitaxel & Heparin-eluting stent) is a justified and sufficiently safe procedure for any group of patients with coronary artery disease, whether or not they present with thrombosis of the coronary bed, and that it is not significantly inferior to the current reference standard — the Cypher stent.