Challenges of in-stent Restenosis. The Balloon Approach

Transcription

1 Challenges of in-stent Restenosis The Balloon Approach Bruno Scheller Klinische und Experimentelle Interventionelle Kardiologie, Universität des Saarlandes, Campus Homburg Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes Homburg / Saar, Germany

2 Disclosure Statement of Financial Interest Affiliation/Financial Relationship Company Grant/Research Support Speaker Honoraria Major Stock Shareholder/Equity Intellectual Property Rights B.Braun B.Braun, Medtronic InnoRa GmbH (a small company doing research in restenosis prevention) Named as coinventor of a patent application submitted by Charite university hospital, Berlin, Germany

3 Drug Eluting Stents Hwang, Circulation 2001; 104: Joner, J Am Coll Cardiol 2006; 48:

4 Drug Coated Balloon Drug Eluting Stent Slow release Persistent exposure ~ µg dose Polymer Stent mandatory Drug Coated Balloon Immediate release Short-lasting exposure ~ µg dose No polymers Premounted stent optional Scheller, Circulation 2004; 110: Scheller, Heart 2007, 93:

5 Prototype Drug Coated Balloon non-coated Paccocath coated

6 Kastrati, JAMA 2005; 293:

7 Primary endpoint (late lumen loss in-segment) Uncoated balloon PACCOCATH 0.74 ± 0.86 mm 0.03 ± 0.48 mm Paccocath prototype New Engl J Med 2006, 355:

8 PACCOCATH ISR I / II Clin Res Cardiol 2008; 97:

9 PACCOCATH ISR I / II long-term Uncoated Balloon Drug Coated Balloon n p Follow-up 5.2 ± 1.5 yrs 5.6 ± 0.9 yrs Death 8 (14.8 %) 5 (9.3 %) MI 8 (14.8 %) 5 (9.3 %) TLR 21 (38.9 %) 5 (9.3 %) Stent thrombosis Stroke 5 (9.3 %) 5 (9.3 %) MACE 32 (59.3 %) 15 (27.8 %) EuroPCR 2011

10 PACCOCATH ISR I / II long-term EuroPCR 2011

11 PACCOCATH ISR I/II Follow-up 5.5 years ISR DEB (PACCOCATH) After DEB (PACCOCATH) 2 years later 4 years later 5.5 years later

12 SeQuent TM Please vs. Taxus TM Circulation 2009; 119:

13 100% 90% 80% 70% Cumulative Frequency 60% 50% 40% 30% 20% Drug-coated balloon pre MLD Drug-eluting stent pre MLD Drug-coated balloon post MLD Drug-eluting stent post MLD 10% Drug-coated balloon follow-up MLD Drug-eluting stent follow-up MLD 0% Observed minimal lumen diameter [mm] SeQuent TM Please vs. Taxus TM Circulation 2009; 119:

14 PEPCAD II ISR as treated 4 patients cross-over from Taxus to SeQuent Please B Freedom from stent thrombosis, target lesion revascularization, myocardial infarction, and death No. at risk Drug-coated balloon Drug-eluting stent SeQuent TM Please vs. Taxus TM Circulation 2009; 119:

15 ESC/EACTS Guidelines 2010 Eur Heart J Aug 29

16 J Am Coll Cardiol 2010; 55:

17 SeQuent TM Please vs. POBA JACC: Cardiovascular Interventions, 2011; 4:

18 SeQuent TM Please vs. POBA JACC: Cardiovascular Interventions, 2011; 4:

19 Drug Coated Balloon Treatment of DES-ISR Ongoing trials PEPCAD DES o ISR of Cypher TM - and Taxus TM -DES o SeQuent TM Please DCB vs. uncoated balloon o n=110 o PI: H. Rittger, Coburg, Germany o results TCT 2011 o ClinicalTrials.gov NCT ISAR DESIRE 3 o ISR of Limus -DES o Taxus TM -DES vs. SeQuent TM Please DCB vs. uncoated balloon o n=375 o PI: J. Mehilli, Munich, Germany o results TCT 2012 o ClinicalTrials.gov NCT

20 Compassionate Use ( Heilversuch ) #1 - RCA SeQuent Please 12 / / 07 SeQuent Please uncoated balloon

21 EuroIntervention 2011; 7: K125-8

22 EuroIntervention 2011; 7: K106-11

23 Drug Coated Balloon Treatment of ISR Treatment of ISR o DES with repeated restenosis of ~ 20% in BMS-ISR and DES-ISR o DCB with repeated restenosis of < 10% in BMS-ISR and DES-ISR o DCB avoids a second stent, reduction of dual antiplatelet therapy BMS-ISR o 3 RCT with Paccocath TM / SeQuent TM Please o Class IIa recommendation (ESC 2010) o o o Drug-eluting balloons should be considered for the treatment of in-stent restenosis after prior BMS. Recommendation is only valid for specific devices with proven efficacy/safety profile, according to the respective lesion characteristics of the studies. 4 weeks dual antiplatelet therapy (vs months) DES-ISR o o 1 RCT with SeQuent TM Please additional 4 weeks dual antiplatelet therapy (vs. additional 6-12 months) DCB may become the new standard treatment for BMS- and DES-ISR.