P6443The five-year clinical and angiographic follow-up outcomes of intra-coronary transfusion of circulation-derived cd34+ cells for patients with end-cad unsuitable for coronary intervention-phase I trial

Abstract

Objective: This study investigated the clinical and angiographic long‐term out‐comes of intra‐coronary transfusion of circulation‐derived CD34+ cells for pa‐tients with end‐stage diffuse coronary artery disease (EnD‐CAD) unsuitable for coronary intervention. Design and setting: A single‐center prospective randomized double‐blinded phase I clinical trial. Thirty‐eight patients undergoing stem cell therapy were ran‐domly allocated into groups 1 (1.0 x 107 cells/each vessel; n=18) and 2 (3.0 x 107 cells/each vessel; n=20). Patients: Those with EnD‐CAD were unsuitable for percutaneous and surgical coronary revascularization. Interventions: Intracoronary delivery of circulation‐derived CD34+ cells Measurements and main results: Five‐year clinical, echocardiographic, and angiographic outcomes were compared between survivors and non‐survivors. By the end of 5‐year follow‐up, the survival rate and major‐adverse car‐dio/cerebrovascular event were 78.9% (30/38) and 36.8% (14/38), respectively. During follow‐up period, 31.6% (12/38) patients received coronary stenting for reason of sufficient target vessel size grown‐up after stem cell treatment. En‐dothelial function measured by flow‐mediated dilatation (FMD) was significantly reduced in the non‐survivors than the survivors (p=0.039). Wimasis image anal‐ysis of angiographic findings showed that the angiogenesis was significantly and progressively increased from baseline to 1 and 5 years (all p