Coronary porcine studies of mechanical, morphometric, and physiological performance based on OCT /angiography of CD31-endothelial-mimetic coating stent, drug-eluting stent and bare metal stent

Background Patients at high bleeding risk (HBR, approximately 30% of the PCI population) continue to pose the challenge of achieving an optimal balance between ischemic and bleeding events. Safely reducing the duration or even the need for dual antiplatelet therapy (DAPT) has therefore emerged as a critical unmet need. A CD31 endothelial-mimetic coating, utilizing SP1072,—a 16-amino-acid peptide replicating a key motif in CD31 domain mediating trans-homophilic interactions essential for blood homeostasis—creates a biomimetic surface that potentially restores anti-thrombo-inflammatory signaling . Purpose Mechanical, morphometric and physiological performances of the SP1072-coated cobalt-chromium stent CD31 stent was compared with a contemporary everolimus-eluting stent and a bare metal stent (BMS, L605 cobalt chromium) in a healthy porcine coronary model, using both angiography and optical coherence tomography (OCT) post procedure and at 28 days. Methods Fifteen CD31-coated stents ,4 DES and 5BMS were implanted in the left anterior descending (LAD,n=9), left circumflex (LCX,n=6), and right coronary artery (RCA,n=9) of nine pigs. At implantation balloon artery ratio (BAR) as a surrogate for baro-trauma and acute mechanical recoil were computed from Quantitative coronary angiography (QCA). Post implantation and at 28 days. Quantitative Flow Ratio (QFR) and QCA (Diameter Stenosis, DS and Minimal Lumen Diameter, MLD) derived from angiography as well as Minimal Luminal Area (MLA)derived from OCT were analyzed at an independent Corelab ( CORRIB lab of the University of Galway ,Ireland ) Results At implantation, BAR averaged 1.16 (SD, 0.09) for BMS, 1.14 (0.06) for CD31, and 1.19 (0.08) for DES (ANOVA, p = 0.34). Acute recoil was similar amongst groups (BMS: 4.00 [4.33] %, CD31: 5.47[1.95] %) and DES: 6.03 [1.96] %, p = 0.48). At 28 days, minimal luminal area on OCT was comparable (BMS: 4.21 [0.60], CD31: 4.49 [1.33], DES: 4.78 [1.05], p=0.66). DS, MLD, QFR and the correlation between DS and QFR is presented are presented in figure 1. Conclusion In this study of healthy porcine coronary arteries, CD31-coated stents ,DES and BMS were exposed to similar baro-trauma and exhibited comparable acute recoil. At 28 days in this small exploratory pilot study the 3 stents showed comparable minimal luminal area with OCT,did not exhibit binary restenosis (DS>50%) or flow limitation below the threshold of QFR<0.80.These preliminary results mandated further experimentation in restenotic and atherosclerotic porcine model.