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M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular.

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Presentation on theme: "M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular."— Presentation transcript:

1 M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular Diseases On behalf of the PEPCAD II Investigators The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease PEPCAD II-ISR

2 M.Unverdorben; ACC March Presenter Disclosure Information PEPCAD II 12-Month Follow-up The following relationships exist related to this presentation: M.UnverdorbenNothing to disclose B.SchellerConsulting and lecture fees from BBraun, co-patent owner of Sequent® Please

3 M.Unverdorben; ACC March Agenda  The PACCOCATH technology  PEPCAD II ISR 6-month angiographic and clinical follow-up  PEPCAD II ISR 12-month clinical follow-up  Descriptive statistics: Mean ± SD  Inferential statistics: Student’s t-test, Fisher’s exact test, Logrank test  Level of significance: p < 0.05 Statistics

4 M.Unverdorben; ACC March Scheller Heart 2007, 93: DES vs. DEB (PACCOCATH) Hwang, Circulation 2001; 104:  Instant and short term drug release from balloon  ~ µg Paclitaxel  No polymers  Stenting optional  Slow and continuous drug release from stent struts  ~ µg Paclitaxel Sirolimus  Polymers with associated reactions  Implies stent deployment DES DEB Creel, Circ Res 2000; 86: ex vivo perfusion of calf carotid arteries,transmural distribution

5 M.Unverdorben; ACC March The Matrix Coating PACCOCATH technology creates a unique matrix coating pure paclitaxelpaclitaxel + hydrophilic spacer withoutwith PACCOCATH technology  huge contact surface between lipophilic drug and the vessel wall  high bioavailability of paclitaxel at the target site for rapid drug absorption by the vessel wall  uniform/complete application of the drug after 1 st balloon expansion

6 M.Unverdorben; ACC March *SeQuent ® Please (B.Braun Vascular Systems, Berlin, Germany) is manufactured based on the PACCOCATH technology with 3µg paclitaxel/mm²; CE mark filed in the EU SeQuent ® (uncoated balloon) SeQuent ® Please* (coated balloon)

7 M.Unverdorben; ACC March Objective Safety and efficacy of the Sequent ® Please DEB in the treatment of ISR in native coronary arteries (reference Ø:  2.5mm,  3.5mm; lesion length: ≤22mm) for procedural success and preservation of vessel patency in comparison to the Taxus ® DES Study Design Prospective, randomized, multi-center, two-arm phase-II pilot study conducted in Germany

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

9 M.Unverdorben; ACC March Inclusion Criteria  Stable or unstable angina (no MI)  ISR in native coronary arteries Medication  ASS ≥ 100 mg daily  Clopidogrel 75 mg daily –3 months DEB –6 months DES

10 M.Unverdorben; ACC March Patients (ITT: N=131) DEB (N=66) DES (N=65) p  Age [years] 64.6± ±  Male 48 (72.7%) 50 (76.9%) 0.7  BMI [kg/m 2 ] 27.9 ± ±  Serum cholesterol [mg/dl] 172 ± ±  Serum LDL [mg/dl] 93 ± ±  Diabetes mellitus 22 (33.3%) 17 (26.2%) 0.4  Current/ex-smokers 44 (66.7%) 36 (55.4%) 0.3  Hypertension 53 (80.3%) 54 (83.1%) 0.8  Family history of CAD 21 (31.8%) 22 (33.8%) 0.9  Previous MI 37 (56.1%) 28 (43.1%) 0.2  PAVD 9 (13.6%) 7 (10.8%) 0.8  Serum crea [mg/dL] 1.1 ± ±

11 M.Unverdorben; ACC March Baseline Angiography (ITT: N=131) DEB (N=66)DES (N=65)p 1-vessel disease [%] vessel disease [%] vessel disease [%] Stenosis length [mm] 15.7   Mehran I31 (47.0%)25 (38.5%) Mehran II20 (30.3%)26 (40.0%)0.7 Mehran III14 (21.2%)12 (18.5%) Mehran IV 1 ( 1.5%)2 ( 3.1%) MLD pre PCI [mm] 0.74   Stenosis pre PCI [%] 74  973  MLD post PCI [mm] 2.30   0.41 < Stenosis post PCI [%] 20  1011  8<0.001

12 M.Unverdorben; ACC March Outcome (ITT: N=131) DEB (N=66)DES (N=65)p Follow-up: clinical [months] 6.2 ± Follow-up: clinical [N]64 (97.0%)65 (100%) 0.5 Follow-up: angiographic [N]57 (86.4%)59 (90.8%) 0.6 Late lumen loss [mm] 0.20 ± ± Binary restenosis in segment4/57 (7.0%)12/59(20.3%) 0.06 TLR 4/64 (6.3%) 10/65 (15.4%)0.1 Myocardial infarction 0/64 (0.0%) f 1/65 (1.5%)1 Death *2/64 (3.1%)**1/65 (1.5%)1 Total MACE (w/o noncardiac death) 5/64 (7.8%) 11/65 (16.9%)0.2 *1 each: non-cardiac & cardiac but not lesion related ** non-cardiac death f NSTEMI due to side branch occlusion

13 M.Unverdorben; ACC March As-Treated Randomization N=131 Sequent Please n=66 Taxus n=65 4 protocol violators Lesion too long (41.1mm) Multilesion PCI in metal jacket Significant flap after PCI Severe renal failure 1 crossing failure treat/w convent balloon 4 crossing failure treat/w Sequent Please 60 DES 2 with additional DES 66 DEB 56 DEB only 6 DEB + BMS 4 DEB (cross-over)

14 M.Unverdorben; ACC March Outcome (AsT: N=126) DEB (N=66)DES (N=60)P= Follow-up: clinical [months] 6.2 ± Follow-up: clinical [N] 64 (97.0%) 60 (100%)0.4 Follow-up: angiographic [N] 58 (87.9%) 54 (90.0%) 0.8 Late lumen loss [mm]0.19 ± ± Binary restenosis in segment2/58 (3.4%) 11/54 (20.4%) TLR2/64 (3.1%)10/60 (16.7%)0.02 Myocardial infarction0/64 (0.0%) f 1/60 (1.7%)1 Death*2/64 (3.1%) **1/60 (1.7%)1 Total MACE (w/o noncardiac death) 3/64 (4.7%) 11/60 (18.3%)0.02 f NSTEMI due to side branch occlusion *1 cardiac, not lesion related 2 non cardiac ** non-cardiac death

15 M.Unverdorben; ACC March Event Free Survival (ITT/As-Treated) *p=0.2 ITT *p=0.03 As-Treated Months post PCI *Logrank test

16 M.Unverdorben; ACC March Month Follow-up: As-Treated 60 DES 2 with additional DES 66 DEB 56 DEB only 6 DEB + BMS 4 DEB (cross-over) Unknown today 2/60 (3.3%) Lost to FU 1/60 (1.7%) Follow-up 12.3±0.8 months 57/60 (95.0%) Deaths 3/60 (5%) Unknown today 1/66 (1.5%) Lost to FU 0/60 (0%) Follow-up 12.3±0.7 months 59/60 (98.3%) Deaths 2/66 (3.0%)

17 M.Unverdorben; ACC March Month Event Free Survival (ITT/As-Treated) P*=0.09 ITT P*=0.01 As-Treated Months post PCI *Logrank test

18 M.Unverdorben; ACC March Events From 6 to 12 Months  DEB –2 Px with PCI in non-target vessel –1/66 (1.5%) Px with re-re PCI in target lesion  DES –2 Px with non-cardiac death –3/60 (5%) Px with re-re PCI in target lesion No new patient with MACE

19 M.Unverdorben; ACC March Summary PEPCAD II  In the treatment of ISR the paclitaxel- eluting balloon catheter Sequent ® Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate, –exhibited a significant reduction in 6-month late lumen loss and 6/12-month MACE when compared to the Taxus ® stent, and –was not associated with late thrombosis in  250 patient years.

20 M.Unverdorben; ACC March The PEPCAD II Investigators F.X. Kleber, Unfallkrankenhaus Berlin H. Heuer, N. Schulze-Waltrup; St. Johannes Hospital, Dortmund C. Vallbracht; Herz- und Kreislaufzentrum, Rotenburg an der Fulda B. Scheller; Universitätsklinikum des Saarlandes, Homburg/Saar C. Hengstenberg, Universitätsklinikum, Regensburg M. Leschke; Städtische Kliniken, Esslingen C. Hamm, M. Rau; Kerckhoff Klinik, Bad Nauheim G. Werner; Städtisches Klinikum, Darmstadt D. Antoni; Krankenhaus Bogenhausen, München W. Bocksch; Charité Virchow, Berlin H.Ackermann; Department for Biostatistics, University of Frankfurt/M M.Boxberger, B.Braun, Berlin R.Degenhardt, M.Unverdorben; Clinical Research Institute, Rotenburg an der Fulda

21 M.Unverdorben; ACC March The PEPCAD Program Paclitaxel-Eluting PTCA-Catheter in Coronary Artery Disease TitleDesignStatusPI PEPCAD I SVDSequent in ≤2.8mm, 120px, multi-center, GER 6mo-FU  12mo-FU  MU, CRI PEPCAD II ISR Sequent vs Taxus in ISR, 131px, multi-center, GER 6mo-FU  12mo-FU  MU, CRI PEPCAD IIISequent + pre-loaded Coroflex Blue vs Cypher, 600 px, Europe Q2/07 recruiting B.Scheller C.Hamm PEPCAD IV DMSequent vs Taxus in DM, 160px, multi-center, Thailand, Malaysia Q2/07 recruiting D.Rosli, MU, CRI PEPCAD V BIFSequent, 25px, dual- center, GER Q3/ 07 recruiting D.Mathey F.Kleber MU, CRI INDICORCoroflex Blue+Sequent, Real World, 100px IRBU.Kaul, MU,CRI

22 M.Unverdorben; ACC March This is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning. (Sir Winston S.Churchill)


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