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Presenter Disclosure Information DISCLOSURE INFORMATION: The following relationship exists related to this presentation: Coinventor of a patent application.

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Presentation on theme: "Presenter Disclosure Information DISCLOSURE INFORMATION: The following relationship exists related to this presentation: Coinventor of a patent application."— Presentation transcript:

1 Presenter Disclosure Information DISCLOSURE INFORMATION: The following relationship exists related to this presentation: Coinventor of a patent application for various methods of restenosis inhibition, including the technique employed in this trial, by Charité University Hospital, Berlin Bruno Scheller, MD UNLABELED/UNAPPROVED USES DISCLOSURE: PACCOCATH, Sequent Please and DEBlue in patients is investigational only

2 Bruno Scheller for the Paccocath ISR Study Group TCT Late Breaking Studies and First Report Investigations Wednesday, October , Main area PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg / Saar, Germany

3 Heart 2007, 93: Drug-Eluting Balloon (DEB) Drug-Eluting Stent Slow release Persistent drug exposure ~ µg dose Polymer Stent mandatory Drug-Eluting Balloon Immediate release Short-lasting exposure ~ µg dose No polymers Premounted stent optional

4 New Engl J Med 2006, 355: Uncoated balloonCoated balloon 0.74 ± 0.86 mm0.03 ± 0.48 mm 52 patients Primary endpoint (late lumen loss in-segment)

5 Paccocath ISR I New Engl J Med 2006, 355:

6 Two trials –separately randomized –double-blind, multicenter –identical protocol –108 patients in total Paccocath ISR I –52 patients Paccocath ISR II –56 patients Paccocath ISR I/II Efficacy and Safety of Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Homburg/Saar, Freiburg, Charité Mitte Berlin, Charité Virchow Berlin, Mannheim-Heidelberg

7 Main inclusion criteria –Clinically relevant coronary ISR –Diameter stenosis > 70 % –Lesion length < 30 mm –Vessel diameter 2.5 to 3.5 mm Repeated PTCA of coronary ISR –Coated balloon with 3 µg paclitaxel / mm² balloon surface –Uncoated balloon of the same type (BMT, Oberpfaffenhofen) Paccocath ISR I/II Primary endpoint –In-segment late lumen loss after 6 months –Independent, blinded angiographic core lab U. Dietz, Wiesbaden Secondary endpoints –Binary restenosis rate, MACE Statistics –p-values adjusted according to Fisher’s method of combining independent tests ASA + clopidogrel –4 weeks in both groups

8 Uncoated balloonDrug-coated balloonp n54 Age66.3 ± 9.8 years65.4 ± 10.3 years0.805 Male gender31 (57 %)42 (77 %)0.125 Diabetes mellitus Insulin-dependent 11 (20 %) 6 (11%) 9 (17 %) 3 (6 %) Hyperlipidema72 %78 %0.485 Smoking48 %43 %0.772 Hypertension82 % Unstable angina41 %37 %1.000 Single-vessel disease Two-vessel disease Three-vessel disease 13 (24 %) 19 (35 %) 22 (41 %) 9 (17 %) 24 (44 %) 21 (39 %) RCA CX LAD 17 (32 %) 12 (22 %) 25 (46 %) 18 (33 %) 13 (24 %) 23 (43 %) Paccocath ISR I/II – Patient Characteristics p-values adjusted according to Fisher’s method of combining independent tests

9 Paccocath ISR I/II - Lesions p-values adjusted according to Fisher’s method of combining independent tests

10 Uncoated balloonDrug-coated balloonp n54 Study balloon Diameter Length 3.0 ± 0.3 mm 24.3 ± 5.0 mm 3.0 ± 0.3 mm 24.1 ± 4.9 mm Mean pressure12.7 ± 2.7 atm12.5 ± 2.6 atm0.819 Balloon inflation time68.9 ± 37.7 sec77.2 ± 42.2 sec0.063 Paclitaxel residue on balloon post-angioplasty ± 4.1% (ISR I) Restenotic DES2 (4 %) Additional stents2 (4 %)3 (6 %)1.000 GP IIb/IIIa antagonists7 (13 %)5 (9 %)1.000 Paccocath ISR I/II - Intervention p-values adjusted according to Fisher’s method of combining independent tests

11 Angiographic measurements at treatment Paccocath ISR I/II Uncoated balloonDrug-coated balloonp n54 Left ventricular function60.3 ± 13.9 %60.8 ± 14.5 %0.862 Lesion length18.6 ± 8.3 mm18.3 ± 9.7 mm0.845 Reference diameter2.94 ± 0.37 mm2.94 ± 0.35 mm0.731 Minimal lumen diameter initial0.70 ± 0.35 mm0.63 ± 0.29 mm0.015 Minimal lumen diameter post angioplasty 2.34 ± 0.44 mm2.43 ± 0.47 mm0.955 p-values adjusted according to Fisher’s method of combining independent tests

12 Angiographic measurements at follow-up angiography Paccocath ISR I/II Uncoated balloonDrug-coated balloonp n54 Follow-up angiography49 (91 %)47 (87 %)0.944 Minimal lumen diameter In-stent In-segment 1.53 ± 0.81 mm 1.50 ± 0.79 mm 2.30 ± 0.62 mm 2.23 ± 0.57 mm Late lumen loss In-stent In-segment 0.81 ± 0.79 mm 0.80 ± 0.79 mm 0.14 ± 0.46 mm 0.11 ± 0.44 mm Binary restenosis rate In-stent In-segment 24 (49 %) 25 (51 %) 3 (6 %) p-values adjusted according to Fisher’s method of combining independent tests

13 24 month Clinical follow-up Paccocath ISR I/II Uncoated balloonDrug-coated balloonp n54 TLR20 (37 %)3 (6 %)0.001 Myocardial infarction5 (9 %) 1 (2 %) Death3 (6 %) 2 (4 %) Stroke3 (6 %) 2 (4 %) MACE25 (46 %) 6 (11 %) Intention-to-treat analysis; p-values adjusted according to Fisher’s method of combining independent tests

14 Paccocath ISR I/II - MACE TLR, MI, acute/subacute closure, stroke, or death Mantel-Cox log-rank test; p-values adjusted according to Fisher’s method of combining independent tests

15 Paccocath ISR I vs. II ISR IISR IIp n5256 Age 63.6 ± 10.8 years68.0 ± 8.9 years Female patients15 (29 %) 20 (36 %) Diabetes mellitus10 (19 %) 18 (32 %) Lesion length 18.0 ± 7.0 mm18.8 ± 10.5 mm0.669 Binary Restenosis in-segment 10 (43 %) vs. 1 (5 %) ∆ 38 % 15 (56 %) vs. 2 (7 %) ∆ 49 % ISR I ISR II TLR 24 months 6 (23 %) vs. 0 ∆ 23 % 14 (50 %) vs. 3 (11 %) ∆ 39 % ISR I ISR II MACE 24 months 9 (35 %) vs. 1 (4 %) ∆ 31 % 16 (57 %) vs. 5 (18 %) ∆ 39 % ISR I ISR II 0.003

16 Paccocath ISR I vs. II Late lumen loss in-segment

17 First in man trial with a paclitaxel-coated balloon Angiographic and clinical efficacy up to 24 months Safety 24 months no late thrombosis clopidogrel only for one month No coating-related adverse events Inhibition of restenosis by drug-coated balloons does not require stent implantation and sustained drug release at the site of injury. Conclusions

18 DEB - clinical applications Treatment of ISR Paccocath ISR I/II PEPCAD II Small vessels PEPCD I Bifurcation lesions PEPCAD V DEB with pre-mounted stent PEPCAD III Peripheral artery disease THUNDER PACCOCATH FEM Pediatric cardiology

19 Study centers Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar (M. Böhm, B. Cremers, M. Kindermann, U. Laufs, T. Müller, B. Scheller, J. Schmidt, S. Siaplaouras; N. Hollinger, B. Werner) Innere Medizin III, Medizinische Universitätsklinik, Freiburg i. Br. (Christoph Hehrlein; A. Becherer) Kardiologie, Campus Virchow-Klinikum, Charité, Berlin (Wolfgang Bocksch, J. Waigand) Kardiologie, Campus Mitte, Charité, Berlin (Wolfgang Rutsch; S. Schroeckh) I. Medizinische Klinik, Universitätsklinikum, Mannheim-Heidelberg (Dariush Haghi, K. Haase, T. Süsselbeck) Angiographic Core Lab Deutsche Klinik für Diagnostik, Wiesbaden (Ulrich Dietz, K. Wilhelmi; Quantitative Coronary Angiography) Pharmaceutical Development Ulrich Speck; Charité, Berlin Devices and Sponsoring Bavaria Medizin Technologie, Oberpfaffenhofen Bayer-Schering Pharma AG, Berlin Paccocath ISR Study Group


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