ASSESSMENT OF VASCULAR RESPONSE OF N-DEAVOUR® DRUG ELUTING STENT VS. XIENCE PRO™ DRUG ELUTING STENT AND MULTILINK VISION BARE METAL STENT IN THE PORCINE CORONARY ARTERY MODEL

Abstract

Objectives: The objectives of the study were to evaluate the vascular and tissue response of Pakistani manufactured novel drug eluting stent (called N-DEAVOUR^®) on a swine model and compare the results with XIENCE PRO™.

Methodology: A total of 10 animals were used for the study and assigned randomly to each time-point group. The test articles were administered percutaneously and each animal was implanted with one stent in each one of the coronary arteries (3 in total) LCA (left circumflex artery), LAD (left anterior descending coronary artery), and RCA (right coronary artery). Additionally, a second test stent was implanted in some animals (4 in total). QCA (Quantitative Coronary Angiography) technique was used for measurements of the vessel at the target site.  OCT (Optical Coherence Tomography) was performed only at follow up time-points which were 30, 90 and 180 days.

Results: At 30 DFU, parameters for N-DEAVOUR^® were comparable to those of both control (XIENCE PROTM and VISION) stents. At 90 days follow-up N-DEAVOUR^® showed no statistically significant difference in performance for values of lumen area, stent area, area stenosis, and neointimal area against XIENCE PRO™. With reference to stent area, at 90 DFU, N-DEAVOUR^® performed better than XIENCE PRO™ (p=0.0056). For neo-intimal area, area stenosis and lumen area, the differences between XIENCE PRO™ and N-DEAVOUR^® were non-significant (p=0.13; p=0.9; p=0.086) respectively. These results indicate the positive potential of N-DEAVOUR^® to be successfully implanted in clinical settings after necessary randomized clinical trials are executed.

Conclusion: This study proved that the drug eluting stent examined in the present study is both safe and feasible. This study supports that this stent can move forward for human trials.