Beyond ISR Treatment Viewpoint of a European CONSENSUS Group

Transkript

1 Beyond ISR Treatment Viewpoint of a European CONSENSUS Group Franz X. Kleber MD FESC Professor of Medicine Charité University Medicine Berlin TCT AP Seoul April 24, 2013

2 Drug Coated Balloons for treatment of coronary artery disease updated recommendations from a Consensus Group Franz X. Kleber 1, Harald Rittger 2, Klaus Bonaventura 3, Uwe Zeymer 4, Jochen Wöhrle 5, Raban Jeger 6, Benny Levenson 7, Sven Möbius-Winkler 8, Leonhard Bruch 9, Dieter Fischer 10, Christian Hengstenberg 11, Tudor Pörner 12, Detlef Mathey 13, Bruno Scheller 14 1 Charité, University Medicine, Berlin, Germany 2 Medizinische Klinik 2, Universitätsklinikum Erlangen, Germany 3 Klinik für Kardiologie und Angiologie, Ernst von Bergmann Klinikum, Potsdam, Germany 4 Medizinische Klinik B, Klinikum Ludwigshafen, Germany 5 Klinik für Innere Medizin II, Universitätsklinikum Ulm, Germany 6 Kardiologie, Universitätsspital Basel, Switzerland 7 Kardiologische Gemeinschaftspraxis Charlottenburg, Berlin, Germany 8 Klinik für Kardiologie, Weißenfels, Germany 9 Klinik für Innere Medizin, Unfallkrankenhaus, Berlin, Germany 10 Department für Kardiologie und Angiologie, Universitätsklinikum Münster, Germany 11 Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Germany 12 Klinik für Innere Medizin I, Universitätsklinikum Jena, Germany 13 Universitäres Herz- und Gefäßzentrum, Hamburg, Germany 14 Klinische und Experimentelle Interventionelle Kardiologie, Klinik für Innere Medizin III, Universitätsklinkum des Saarlandes, Homburg/Saar, Germany

3 Intracoronary Iopromide Paclitaxel control 100 µmol/l 200 µmol/l 3 J Am Coll Cardiol 2003; 42:

4 DCB Treatment of ISR Scientific Evidence - Data Base - Paccocath ISR I - Paccocath ISR II - Paccocath long term follow up - PEPCAD II - Habara - PEPCAD DES - ISAR-DESIRE III Scheller NEJM 2006 Scheller CRC 2008 Scheller JACC Interv 2012 Unverdorben Circulation 2009 Habara JACC Interv 2011 Rittger JACC 2012 Byrne Lancet 2012

5 PEPCAD DES average delta 0.6mm 5 Rittger J Am Coll Cardiol. 2012;59(15):1377

6 TLR in DCB World Wide Registry 1 % Late Lumen Loss in Bello for DCB only 0.03 mm 6 Wöhrle JACC 2012 Latib JACC 2012

7 Coronary Balloon Overstretch Model in Pigs, intrapericardial Paclitaxel Influence on Intimal Area, External Elastic Membrane Area and Vessel Size Hou Circulation 2000:102:

8 RH female 67 yrs 1062 und OM stenosis acute result 8

9 RH female 67 yrs 1062 und OM stenosis Acute & 4 months result 9

10 Cumula1ve%Frequency%of%Mean%Lumen%Gain%in%mm%(N=58%pa1ents)% at%followbup% 1# 0,8# 0,6# 0,4# late lumen loss in 29 % late lumen gain in 69 % late lumen loss > 0.2 mm in 5 % late lumen gain > 0.2 mm in 33 % 0,2# Mean%lumen%gain%% in%mm% 0#!0,2# 0# 10# 20# 30# 40# 50# 60# 70#!0,4#!0,6#!0,8#!1# Number%of%pa1ents% 10 Kleber et al submitted 2013

11 11 Kleber et al submitted 2013

12 Restenosis (188 days n = 557) defined as an increase of 30 % in stenosis grade from end of procedure to follow up Restenosis rate 29.6 % Negative Remodeling 57.6 % Holmes Am J Cardiol 1984;53:77 C

13 13

14 NSTEMI 50 yrs Female ACS Angina at rest baseline and acute result 14

15 NSTEMI 50 yrs Female ACS Angina at rest acute and 4 months result 15

16 General principle of DCBonly, combination with BVS Lesion Preparation predilatation conventional semi-compliant balloon, inflation pressure > nominal, balloon-to-vessel ratio Options in complex lesions non-compliant high-pressure balloons, cutting balloon, scoring balloon, rotablation additional intravascular imaging (IVUS, OCT), functional measurements (FFR) Acceptable angiographic result No dissection or type A, B TIMI III, residual stenosis < 30 % Dissection type C-F TIMI < III Residual stenosis > 30 % DCB balloon-to-vessel ratio , nomimal pressure, > 30 seconds Permanent or temporary scaffolding BMS, DES, Spot-BMS + DCB, or BVS Figure 5 FXKleber for the DCB Consensus Group submitted

17 Positive Remodeling seems to be one of the mechanisms active after DCB Angioplasty This might represent a new paradigm in interventional therapy of vascular disease 17

18 While looking at PTCA restenosis and developing stents to overcome this we exaggerated neointimal proliferation and forgot about vessel remodeling DCB and BAVS give us the opportunity to rethink what we do 18