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Wolfgang Bocksch,M.D.,PhD. Director Cardiac Catheterization Laboratories Charité-Campus Virchow Klinikum, Berlin, German

Advanced Angioplasty 2008 London 23.1.-25.1.2008. Sequent Paclitaxel-Elutng Balloon Scientific Program. Wolfgang Bocksch,M.D.,PhD. Director Cardiac Catheterization Laboratories Charité-Campus Virchow Klinikum, Berlin, Germany. Advisory board Boston Scientific B.Braun Vascular Systems.

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Wolfgang Bocksch,M.D.,PhD. Director Cardiac Catheterization Laboratories Charité-Campus Virchow Klinikum, Berlin, German

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  1. Advanced Angioplasty 2008 London 23.1.-25.1.2008 Sequent Paclitaxel-Elutng Balloon Scientific Program Wolfgang Bocksch,M.D.,PhD. Director Cardiac Catheterization Laboratories Charité-Campus Virchow Klinikum, Berlin, Germany

  2. Advisory board Boston Scientific B.Braun Vascular Systems My Conflict of Interests

  3. Drug eluting balloon (DEB) Coating technology • Coating of conventional angioplasty balloon catheters (Sequent) • Controlled dose, homogeneity of coating, non-toxic agents • Procedure EEE • Ethyl acetate as solvent • 2 µg Paclitaxel / mm² balloon surface (EEER) • Procedure Ac • Aceton as solvent + iopromide as additive • Low dose: 1.3 µg Paclitaxel / mm² (AcL) • Medium dose: 2.5 - 3 µg Paclitaxel / mm² (AcR[regular]) • High dose: 4 – 5.5 µg Paclitaxel / mm² (AcH)

  4. DEB- porcine restenosis study • coronary stent implantation LAD + CX with study balloon: • uncoated control, EEER, AcL, AcR; 28 days follow-up, n=40 8 ns control, n=12 EEER, n=9 AcL, n=10 AcR, n=9 7 6 p=0.001 p=0.001 5 4 3 2 1 0 vessel area [mm²] luminal area [mm²] neointimal area [mm²] Scheller et al. Circulation 2004;110:810 - 4

  5. Paccocath ISR I study FIM (n=52) • Comparison DEB vs. conventional PTCA catheter • Safety and efficacy of paclitaxel coated balloon (Sequent-DEB) in BMS-ISR • Randomized, double-blind multicenter trial • Coronary BMS-ISR (80% diffuse and 20 focal, < 30mm) • Repeated PTCA of BMS-ISR vs. using the Sequent DEB • 3 µg paclitaxel / mm² balloon surface or a non-coated balloon of the same type (control group) • 6-week-clopidogrel only Scheller et al. NEJM 2006:335:2113-24

  6. Paccocath ISR I study • Main inclusion criteria • Clinically relevant coronary BMS-ISR • Diameter stenosis of at least 70 % • < 30 mm length • Vessel diameter of 2.5 to 3.5 mm • Primary endpoint • Late lumen loss after 6 months • independent, blinded Core lab • Secondary endpoints • Binary restenosis rate 6 m. • MACE (TLR, myocardial infarction, death) 12 m. Scheller et al. NEJM 2006:335:2113-24

  7. Paccocath ISR I study QCA / primary endpoint: In-segment analysis Scheller et al. NEJM 2006:335:2113-24

  8. Paccocath ISR I study MACE – longest available follow-up TLR, MI, acute/subacute closure, stroke, or death November 1, 2006; Mantel-Cox log-rank test; p-values adjusted according to Fisher’s method of combining independent tests

  9. Drug-eluting Balloon 2 questions • Is the Sequent-DEB equally effective or superior to DES for the treatment of BMS-ISR ?? • Is the DEB also effective in native coronary atheroma

  10. PEPCAD II trial “The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat BMS-In-Stent Restenoses: A Comparison to the Paclitaxel-Eluting Taxus™ Stent –

  11. PEPCAD II – Objective / Study Design • Objective The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloonin the treatment of BMS-In-stent restenoses in native coronary arteries with reference diameters between  2.5 mm and  3.5 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency in comparison to the Paclitaxel-eluting Taxus™ stent. • Study Design This study is a prospective, randomized, multi-center, two-armed phase-II study.

  12. PEPCAD II trial “The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat BMS-In-Stent Restenoses: A Comparison to the Paclitaxel-Eluting Taxus™ Stent – • Primary Endpoint • 6-month late lumen loss • Secondary Endpoint • Procedural success (≤30%) • 6-month binary restenosis rate • 6-month MACE • MACE at 1 and 3 years

  13. PEPCAD II trial • “The Paclitaxel-Eluting PTCA-Balloon Catheter in • Coronary Artery Disease to Treat BMS-In-Stent Restenoses: • A Comparison to the Paclitaxel-Eluting Taxus™ Stent – Inclusion Criteria • Stable or unstable angina (no MI) • BMS-ISR in native coronary arteries Medication • ASS ≥ 100 mg daily • Clopidogrel 75 mg daily 3 months DEB 6 months DES

  14. PEPCAD II trial 2 NSTEMI side branch occlusion 4 non-cardiac death 1protocol violators excluded 3cardiac, not lesion related

  15. PEPCAD IISummary The paclitaxel-eluting balloon catheter Sequent Please … • was safe and associated with a high procedural success rate in BMS-ISR, • exhibited low late lumen loss after 6 months in BMS-ISR, • was superior to the paclitaxel-eluting Taxus  stent in BMS-ISR after 6 months, and in TLR • has not been associated with late thrombosis in 200 patient years in BMS-ISR. even though dual antiplatelet therapy was given only for 3 months

  16. Is the DEB equally effective in native CAD ?? ISRNative plaque Concentric eccentric Homogenous heterogenoeus No Lipid lipid-rich Extracellular matrix Inflammation

  17. PEPCAD I trial“The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease”

  18. PEPCAD I – Objective / Study Design • Objective The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70% and < 100 %) stenoses in native coronary arteries with reference diameters from  2.25 mm to  2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency. • Study Design This study is a prospective, non-randomized, multi-center, one-arm phase-II pilot study

  19. PEPCAD I trial“The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease” • Primary Endpoint • 6-month late lumen loss • Secondary Endpoint • Procedural success • 6-month binary restenosis rate • 6-month MACE • MACE at 1 and 3 years

  20. PEPCAD I trial“The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease” • Inclusion Criteria • Stable or unstable angina (no MI) • De-novo lesion in native coronary arteries • Medication • ASS ≥ 100 mg daily • Clopidogrel 75 mg daily • 1 month DEB only • 3 months DEB with additional non-DES stent

  21. PEPCAD I Patient Flow Chart Enrolled 120 Subj. Violation 2/120 (1.7%) Muscle bridge Lesion 50%, no PCI DEB 114/118 (96.6%) Crossing failure 4/118 (3.4%) DEB only 82/114 (71.9%) DEB + BMS 32/114 (28.1%) Conventional balloon 2/4(50%) Drugs 2/4 (50%)

  22. PEPCAD I Outcome *NSTEMI due to occlusion of non-target vessel

  23. PEPCAD III trial “Paclitaxel-Eluting PTCA-Balloon in Combination with the Coroflex Blue Stent vsthe Sirolimus Coated Cypher Stent in the Treatment of Advanced Coronary Artery Disease” The patient recruitment of 600 patients started in July 2007.

  24. PEPCAD III – Objective / Study Design • Objective The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting Coroflex DEBlue stent system in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting Cypher stent. • Study Design This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Europe.

  25. Drug-eluting balloon clinical program (B.Braun) January, 2006 PEPCAD I SeQuent Please for small vessels, 6-month-angiographic follow-up GERMAN MULTICENTER TRIAL PEPCAD II SeQuent Please for the treatment of in-stent restenosis randomized with TAXUS paclitaxel eluting stent, 6-month-angiographic follow-up GERMAN MULTICENTER TRIAL PEPCAD III Coroflex® DEBlue for complex lesions randomized with Cypher Select, 9-month-angiographic follow-up EUROPEAN MULTICENTER TRIAL PEPCAD IV SeQuent® Please with subsequent Coroflex® Blue implantation for diabeticsrandomized with Taxus, 9-month-angiographic follow-up ASIAN MULTICENTER TRIAL PEPCAD VBifurcationpilot study, Coroflex® Blue in main vessel and SeQuent® Please for sidebranch, 9-month follow-up German MULTICENTER TRIAL PEPCAD VI CTOpilot study, SeQuent® Please for chronical total occlusions, 6-month follow-up German MULTICENTER TRIAL

  26. DEB Sequent PleaseSummary The paclitaxel-eluting balloon catheter Sequent Please … • is so far the most potent and easiest device to treat focal/diffuse BMS-ISR, • avoids 6-12 month clopidogrel/Ticlopidine therapy • is a promising device for the treatment of native atheroma especially in small vessels • The role of DEB in complex disease as bifurcations, CTOs, SVGs has to be determined in further studies

  27. Drug-Eluting Stents sustained drug release essential Hwang, Circulation 2001; 104: 600-5 DES 28 days Scheller, Z Kardiol 2005; 94: 445-452

  28. PEPCAD ISummary The paclitaxel-eluting balloon catheter Sequent Please … • was safe and associated with a high procedural success rate in de-novo lesions in small vessels, • exhibited low late lumen loss after 6 months , and • patients treated per protocol (w/o additional stenting) demonstrated a restenosis rate of 5.5 %.

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