PCI with DEB only for Bifurcation Lesions

Transcription

1 PCI with DEB only for Bifurcation Lesions Franz X. Kleber MD, FESC, Berlin, DE Disclosure: Consulting B.Braun

2 Why did we adapt an all stent approach in bifurcations? - because it is safe - because it leads to better results than POBA - because it is convenient - because acute results are satisfying Does this justify to stent almost all patients? - PTCA is also safe on the background of DAPT - Better results with stents are achieved in a subset of patients only - Convenience of Stenting for Physicians is counteracted by inconvenience for the patient by long-term DAPT and other rare late and very late complications - Satisfaction might come with good long term results

3 Good Reasons for Stenting - Recoil: Acceptable is any amount that does not affect flow: the bigger is only the better if late loss is high - Dissection: Therapeutic Dissection is a Benefit - Fear of Acute Closure?

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5 Dissection and Restenosis

6 Dissection and Late Loss

7 Dissection and Clinical Outcome

8 Copyright F. X. Kleber, Berlin

9 World Wide Registry (13 %, no specific report so far) Small Vessel Registry (23 %, no specific report so far) Australian Jepsen report 2013 mainly ISR Debiut Study (MB stenting SB provisional stenting, Paclitaxel without matrix/excipient) PEPCAD V (MB stenting SB provisional stenting)(dcb only in-segment LLL 0.04mm) Babilon (randomized DEB/BMS vs DES) Sgueglia 2011(MB stenting, kissings DEBs) Herrador 2013 (MB DES SB DCB & provisional stenting) Kenneth Chin 2013 (DES MB, DCB SB) Biolux-I (DES MB, DCB SB) Schulz 2013 (DEB only) PEPCAD BIF (randomized DEB only) 9 Wöhrle Jacc 2012;60:1733 Zeymer Eurointervention 2013 Stella Cath Cardiovasc Interv 2012 Mathey Eurointervention 2011 Jepsen DIT March 2013 Herrador J Interv Card 2013;26:454 Sgueglia Card Rev Med 2011;12:280 Chin TCT 2013 Worthley TCTm2013 Schulz/Kleber CRC 2014 in press Babilon Eurointervention 2014 Pepcad Bif Kleber submitted 2014

10 Former Concept: DES MB, DEB SB Tabelle 1 Herrador Chin POBA DEB p DES MB DEB SB n = TLR 2.9 (2/29) 5.6 (4/69) MACE MI (non Q) 0 (0/69) 1.4 (1/69) TLR S Thrombosis 0 (0/69) 0 (0/69) SB stenosis Death 0 (0/69) 0 (0/69) SB LLL MACE % Herrador JA, et al.j Interv Cardiol Oct; 26(5): doi: /joic Kenneth Chin TCT 2013 with permission

11 New Concept: DEBOnly MB and SB pts lesions Total 47 DCB only ISR 4 DCB + Stent 5 ACS 46 % MVD 67 % Medina 1-x-x 36 % 2 branches affected 49 % SB/distal MB only 51 % Registry: Antonia Schulz et al

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13 New Concept: DEBOnly MB and SB pts lesions Total 47 DCB only ISR 4 DCB + Stent 5 ACS 46 % MVD 67 % Medina 1-x-x 36 % 2 branches affected 49 % SB/distal MB only 51 % MACE (TLR) 7.7 % all TLR ostial LAD/CX lesions Registry: Antonia Schulz et al

14 Drug eluting balloons as stand alone procedure for coronary bifurcational lesions - a randomized multicenter study Franz X. Kleber 1, MD; Harald Rittger 2, MD; Josef Ludwig 2, MD; Antonia Schulz 3 ; Detlef G. Mathey 4, MD; Michael Boxberger 5, MD; Ralf Degenhardt 6, MD; Bruno Scheller 7, MD; Ruth H. Strasser 8, MD 1 Cardio Centrum Berlin, Academic Teaching Institution Charité University Medicine Berlin, DE 2 Universitätsklinikum Erlangen, DE 3 Charité University Medicine Berlin, DE 4 Universitäres Herz- und Gefäßzentrum Hamburg, DE 5 Medical Scientific Affairs B.Braun Melsungen AG, DE 6 Center for Cardiovascular Diseases, Rothenburg a.d. Fulda, DE 7 Universitätsklinikum des Saarlandes, Homburg/Saar, DE 8 Technische Universität Dresden, Herzzentrum Dresden, DE

15 Drug eluting balloons as stand alone procedure for coronary bifurcational lesions - a randomized multicenter study Inclusion Criteria: Bifurcation lesions to be included had to be within 5 mm of the branching point, had to have a side branch vessel diameter at the take off of over 2 mm and to be Medina type 0,0,1/ 0,1,0 or 0,1,1. Procedure: Careful and vigorous predilatation with a balloon to artery ratio of 0.8 to 1 Randomization if residual stenosis 30 %, dissection < B, TIMI FLow III to either DEB 2-3 mm longer than predilatation length or no further intervention

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17 New Concept: DEBOnly MB and SB Minimal luminal diameters (MLD) frequency distribution at diagnostic angio pre PCI (dotted lines), at end of PCI (final result, dashed lines)) and at follow up (solid lines) in the POBA (green) and DEB (blue) treated groups Tabelle 1 DEB POBA p pts(lesions) 32(34) 32(35) acute gain (mm) 1,38 1,33 ns f.up MLD (mm) 1,78 1,39 0,015 LLL in segment 0,08 0,47 0,006 binary restenosis % 5,9 25,7 0,045 Kleber et al TCT 2014

18 DES in LAD AHA 7 and DCB in LAD-D1 bifurcation

19 ISR in DES in LAD 7 and DCB good result in LAD-D1 bifurcation

20 D-1 ostial stenosis - 4 months follow up

21 RH female 67 yrs 1062 und OM stenosis acute result Reprinted from EuroIntervention 2011, 7 K, F.X.Kleber, B.Scheller, P.W.Serruys (Edit), Cover Page, Copyright (2011), with permission from Europa Digital & Publishing

22 RH female 67 yrs 1062 und OM stenosis Acute & 4 months result Reprinted from EuroIntervention 2011, 7 K, F.X.Kleber, B.Scheller, P.W.Serruys (Edit), Cover Page, Copyright (2011), with permission from Europa Digital & Publishing

23 directly after DEBOnly PCI before The aim is not the optimal lumen but the absence of a relevant (re)stenosis. As you can rely on absence of relevant restenosis or even expect further luminal enlargement you can leave results which you would never have left before. Data Base and fxk Berlin. at 4 months follow up

24 Berlin-Homburg Registry of 56 Consecutive Patients (58 lesions) Franz X. Kleber and Bruno Scheller and coworkers, CRC 2014 in press

25 T. Poerner Octopus I/II study DGK Mannheim 2014

26 Conclusions DEB only strategy is effective in Medina 0-X-X bifurcations DEB only strategy is possible in the majority of such lesions Stenting might be avoidable in many patients without an increase in restenosis and MACE rate The DEB only approach should be investigated in larger series of patients