M.Unverdorben; TCT Problem The treatment of stenoses of small coronary arteries (SVD) and of restenoses after stent deployment (ISR) still show unsatisfactory long-term results even after drug-eluting stent deployment Likely Solution Using a drug-eluting balloon catheter (B.Braun Melsungen AG, Germany)

M.Unverdorben; TCT Paccocath Hwang, Circulation 2001; 104: DES Scheller, Heart 2007; 2007;93: Paclitaxel-eluting stent (DES) vs. Paclitaxel-eluting balloon (DEB) Paclitaxel-eluting balloon (DEB)

M.Unverdorben; TCT 2007 The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease PEPCAD I-SVD PEPCAD II-ISR Martin Unverdorben Clinical Research Institute, Center for Cardiovascular Diseases Rotenburg an der Fulda, Germany On behalf of the PEPCAD Investigators

M.Unverdorben; TCT Primary Variable  6-month late lumen loss Secondary Variables  Procedural success (≤30% stenosis)  6-month binary restenosis rate  6-month MACE  MACE at 1 and 3 years

M.Unverdorben; TCT Outcome Comparison DEB ITT N=120 DEB Only N=82 Taxus*BMS* Follow-up [mo]6.7± ±1.999 Late loss [mm] 0.3± ±   0.63 Restenosis (segment) 15.5%5.5%31.2%49.4% Total MACE13.7%6.1%18.9%26.9% TLR12%4.9%10.4%21.5% Myocardial infarction 0.8%1.2%5.7%2.2% Cardiac death0% 1.9%1.1% *Stone, G JAMA 2005;294:

M.Unverdorben; TCT Summary PEPCAD I  The paclitaxel-eluting balloon catheter Sequent Please  (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in de-novo lesions –exhibited low late lumen loss after 6 months in SVD –patients treated w/o additional stenting demonstrated a restenosis rate of 5.5%

M.Unverdorben; TCT PEPCAD II Randomized Comparison to Taxus in ISR

M.Unverdorben; TCT Primary Variable  6-month late lumen loss Secondary Variables  Procedural success (≤30% stenosis)  6-month binary restenosis rate  6-month MACE  MACE at 1 and 3 years

M.Unverdorben; TCT As-Treated Groups Enrolled 131 Subj. Conventional balloon 1 Subj. Violator from DES

M.Unverdorben; TCT Outcome (N=126) DEB (N=66) 1 DES (N=60) 1 P= Follow-up [months]6.2 ± Follow-up: clinical62 (93.9%) 59 (98.3%)0.4 Follow-up: angiographic54 (81.8%) 53 (83.3%) 0.5 Late lumen loss [mm]0.19 ± ± Binary restenosis in segment2/54 (3.7%) 11/53 (20.8%) 0.02 Total MACE 3/62 (4.8%) 13/59 (22.0%)0.007 TLR 2/62 (3.2%) 11/59 (18.6%)0.008 Myocardial infarction 0/62 (0.0%) 1/59 (1.7%) 2 1 Death 1/62 (1.6%) 3 1/59 (1.6%) protocol violators excluded 2 NSTEMI side branch occlusion 4 non-cardiac death 3 cardiac, not lesion related

M.Unverdorben; TCT Event Free Survival (ITT/As Treated) p=0.07 ITT p=0.007 As Treated Months post PCI

M.Unverdorben; TCT Summary PEPCAD II  The paclitaxel-eluting balloon catheter Sequent Please  (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in ISR –exhibited low late lumen loss after 6 months in ISR –was superior to the paclitaxel-eluting Taxus  stent in ISR after 6 months –has not been associated with late thrombosis in  200 patient years in SVD and ISR

M.Unverdorben; TCT Additional Handouts

M.Unverdorben; TCT Abbreviations and Terms Abbreviation /Term Explanation BMSBare metal stent without any active coating DEBDrug-eluting balloon catheter that delivers (antiproliferative) drugs into the vessel wall DESDrug-eluting stent that delivers (antiproliferative) drugs into the vessel wall Follow-upObservation period of a patient following a procedure In-segmentThe 5mm of a vessel on either side of a deployed stent ISRRenarrowing/reocclusion of a stent Late lumen lossRenarrowing of a stenosis after PCI [mm] MACEMajor adverse cardiac event; usually incl. heart attack, repeat angioplasty (or bypass) of the stenosis, death PCIPercutaneous coronary intervention; treating coronary artery stenoses with catheters, incl. balloons, stents, drugs & others

M.Unverdorben; TCT Abbreviations and Terms Abbreviation/ Term Explanation RestenosisRenarrowing of the target lesion after PCI of at least 50% Stenosis Narrowing of the coronary artery [%]; considered as relevant when reaching 70% or more of the vessel diameter Stent Mesh-like devices to scaffold arteries, which are deployed using balloon catheters. Stents may (drug-eluting) or may not (bare metal) deliver drugs to the vessel wall. SVD Small vessel disease. Coronary artery with diamters  3.0mm ThrombosisRenarrowing/reocclusion of a vessel mainly by platelets TLTarget lesion; lesion that has been treated TLR Target lesion revascularization; lesion that has become narrow again (usually ≥ 70%) and needs „rework“ by PCI or bypass

M.Unverdorben; TCT Contact Information Martin Unverdorben MD, PhD, Associate Professor of Medicine  (EST) 