A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients TReated with Endothelial Progenitor Cell CapTuring Stents for De Novo Coronary Artery Disease PERfECT Stent Study Jochen Wöhrle University of Ulm Ulm, Germany TCT 2010 – First Report Investigation

Background Treatment of coronary stenosis with drug eluting stents reduce –the restenosis rate and the need for repeat revascularization, but –about 1/3 of restenoses occur proximal or distal to the stent, and –there is a continuous risk for late stent thrombosis (incomplete endothelialization, inflammatory response due to coating). With a paclitaxel coated balloon the administration of the antiproliferative drug is homogenous to the vessel wall without peaks at stent struts (no further need for coating of stent struts). Endothelial progenitor cell capturing (EPC) stents with human anti- CD34 antibodies on the surface facilitate rapid endothelialization of the stent struts. EPC stents were associated with low rates of stent thrombosis, even in complex lesions.

120 patients enrolled and randomized 120 patients enrolled and randomized Stratified according to Presence of diabetes mellitus Stratified according to Presence of diabetes mellitus Paclitaxel coated balloon plus EPC stent N=62 Paclitaxel coated balloon plus EPC stent N=62 EPC stent alone N=58 EPC stent alone N=58 6 months angiographic follow-up 95.2 % (N=59/62) 6 months angiographic follow-up 95.2 % (N=59/62) 6 months angiographic follow-up 96.6 % (N=56/58) 6 months angiographic follow-up 96.6 % (N=56/58) 6 months clinical follow-up 100 % (N=62/62) 6 months clinical follow-up 100 % (N=62/62) 6 months clinical follow-up 100 % (N=58/58) 6 months clinical follow-up 100 % (N=58/58) Age > 18 years Lesion in native coronary artery De-novo stenosis Indication for PCI Reference diameter mm Lesion length ≤ 25 mm

P = 0.01P < 0.001P = 0.20P < Late Loss at 6 Months EPC StentPaclitaxel Coated Balloon and EPC Stent Late Loss (mm) primary endpoint

P = 0.009P = Binary Angiographic Restenosis at 6 Months Binary Restenosis (%) EPC StentPaclitaxel Coated Balloon and EPC Stent N=3 N=12N=13

Paclitaxel Coated Balloon plus EPC Stent EPC Stent alone P Value Target lesion revascularization 3 (4.8 %)9 (15.5 %)0.05 Myocardial infarction Non-target vessel1 (1.6 %)1 (1.7 %)0.96 Target vessel0 (0 %) -- Death0 (0%)1 (1.7 %)0.30 MACE*3 (4.8 %)10 (17.2 %)0.03 Definite / probable stent thrombosis 0 (0 %) -- Clinical Outcomes at 6 Months * TLR, myocardial infarction not attributable to non-target vessel, cardiac death

Conclusions In this prospective, randomized, single-blind, multicenter study the combined treatment strategy with paclitaxel coated balloon and EPC stent implantation compared with EPC stent implantation alone for treatment of de-novo coronary artery disease showed: –A significantly lower late loss (primary endpoint) –A significantly lower binary restenosis rate, percent diameter stenosis and a significantly larger minimal lumen diameter at follow-up –A significantly lower combined clinical endpoint –No definite / probable stent thrombosis