Transcript slides
Future Directions and Development of DCB Systems Bruno Scheller Klinische und Experimentelle Interventionelle Kardiologie, Universität des Saarlandes, Campus Homburg Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes Homburg / Saar, Germany Speaker’s name: Bruno Scheller X I have the following potential conflicts of interest to report: X Research contracts (B.Braun, MDT Invatec, AngioScore) Consulting Employment in industry X Stockholder of a healthcare company (InnoRa GmbH) Owner of a healthcare company X Other(s): coinventor in several patent applications I do not have any potential conflict of interest J Am Coll Cardiol Intv 2012;5:1001–12 Drug Coated Balloons – Future Innovation Coating and balloon technology o Crystalline vs. amorphous coating o Balloon surface o Dedicated balloon platforms for different vascular territories and indications o Nanotechnology DCB and dissections o Scoring balloon o DCA + DCB o DCB + bioabsorbable stents Alternative drugs Clinical evidence o RCT in different indications and for different types of DCB o No class effect o ‘DEBonly’ concept DCB - Mode of action Scheller, Heart 2007; 93: 539-41. Scheller, Circulation 2004; 110: 810-4. Speck, Circ Cardiovasc Interv 2012; 5: 392-400 Crystalline vs. amorphous paclitaxel on DCB Slide adapted from Juan Granada 2013 Cosmetic improvements at the expense of efficacy? Alexander Rübben, from the Internet Not all DCB are created equal “When presenting our first preclinical data on DCB about 10 years ago, people said it would never work in humans. Today, the greatest threat to this technology is bad clinical science. As mentioned in the ESC/EACTS guidelines for coronary revascularization, one cannot assume a class effect for DCB. Therefore, clinical evidence includes adequately powered RCTs in different indications for each type of DCB.” Cremers, Clin Res Cardiol 2009; 98: 325–330. SCAAR, Bondesson, EuroIntervention 2012; 8: 444-9. Scheller, Cardiovasc Revasc Med. 2012; 13: 257-9 Submitted Drug Coated AngioSculpt • AngioSculpt (coated) AngioSculpt (bare) May be able to deliver drug more effectively with a scoring element • Better acute luminal results with AngioSculpt compared to POBA • Lower rate of dissection with AngioSculpt compared to POBA • No slippage or “geographic miss” with AngioSculpt • May be able to avoid adjunctive stenting All of the above may allow a drug-coated AngioSculpt to provide “stand alone” therapy for a wide range of coronary and peripheral arterial lesions with a significantly lower restenosis rate than POBA or allow the use of BMS rather than DES In-Stent Restenosis (ISR) o Non-slip (avoid “geographic miss”) o Less tissue “recoil” o More optimal re-expansion of original stent, improved initial lumen gain Cardiovascular Revascularization Medicine 13 (2012) 219–223 Werner, LINC 2012 EuroIntervention 2011; 7: K17-22 Control (n=56) ns 8 ZES (n=14) ns ZCB (n=14) ns * # + # 6 : ns vs. Control (p>0.05) : p<0.05 vs. Control : p<0.005 vs. Control : p<0.05 vs. ZES ns * # 4 ns 2 0 *+ vessel area (mm²) luminal area (mm²) neointimal area (mm²) inflammation score (-) Clin Res Cardiol. 2012. Circ Cardiovasc Interv. 2011; 4: 447-55 DCB + BMS ! geographical mismatch ! partikels between stent struts and vessel wall => (spot-)stent, DCB postdilatation Clin Res Cardiol 2010; 99: 165–174. EuroIntervention 2011; 7: K57-60. Hamm AHA 2009. Heart 2011; 97: 1338-42 DCB only DCB are not a replacement for DES. New platform for local drug delivery without the need for stent implantation. Predilatation o Preparation of the lesion, identification of risk for dissections o Final size (de-novo) or 0.5 mm smaller (ISR) o Acceptable result, not stent-like Provisional BMS o Spot-stenting for dissections type C-F o Balloon-Artery ratio 0.8-1.0 o Nominal pressure, 30 seconds DCB EuroIntervention 2011; 7: K125-8 Coronary de-novo - DCBonly J Am Coll Cardiol 2012; 60: 2473-80. J Am Coll Cardiol. 2012; 60: 1733-8. DCBonly BIF - 54 year old male, unstable angina initial Final result Predilatation, Carina shift 6 months SQP 3.0/15 SQP 3.0/20 New age of vascular therapy: Leaving nothing behind New technologies to avoid permanent implants in vascular therapies DCB Bioabsorbable Stents Coronary > 4,300 (paclitaxel iopromide) > 440* (Absorb + AMS) Peripheral > 800 > 70 Coronary > 3,500 (paclitaxel iopromide) > 1,000 Peripheral > 4,500 (paclitaxel urea) ? published ongoing Clinical Evidence: # of pts in RCT and large registries. *no RCT, simple lesions TCT 2012. EuroIntervention 2011; 7: K7. Submitted for publication.