IN-STENT RESTENOSIS. K.Boerlage-van Dijk CarVasZ 2014

Transcription

1 IN-STENT RESTENOSIS K.Boerlage-van Dijk CarVasZ 2014

2 Definition ISR Angiographic: recurrent diameter stenosis >50% at the stent segment or edges (5-mm segments adjacent to stent) Mehran system morphological classification BMS- ISR (need for repeat revascularization) I Focal (19%) II Diffuse (35%) III Proliferative (50%) IV Occlusion (98%)

3 Mehran R. et al. Circulation 1999

4 Underlying substrate Underexpansion Stent misplacement or stents not fully covering underlying lesion Stent fractures In DES: drug resistance or local hypersensitivity reactions

5 Pathological images Courtesy of Dr. M. Joner, CVPath Inc. Gaithersburg, Maryland

6 Pathology neoatherosclerosis BMS vs DES Incidence greater in DES (31%) than BMS (16%) Median stent duration shorter in DES (420 days) than in BMS (2160 days) Unstable lesions (thin-cap fibroatheromas or plaque rupture) more frequent in BMS (7.4%) than DES (3.1%) Nakazawa G. et al. JACC 2011

7 Clinical presentation Asymptomatic Stable clinical presentation Unstable symptoms Elevation of cardiac markers

8 Incidence and treatment ISR High incidence of in-stent restenosis after PCI with BMS Reduction incidence ISR after PCI with DES, but restenosis still occurs Treatment by angioplasty with conventional balloons, BMS, cutting balloons, rotablation and brachtherapy unsatisfactory results ISR commonly treated by DES

9 Disadvantages DES Delayed healing Chronic inflammatory reaction (polymeric matrix) Late and very late stent thrombosis Inhomogeneous drug delivery In ISR double layer of stents

10 Drug Eluting Balloon 3ug/mm 2 paclitaxel Uniform and complete release target drug dose after first balloon expansion Used for ISR, small vessel disease and side branches in bifurcations

11 Drug eluting balloon Delivering biologically active drug No permanent foreign body Uniform drug release No inflammation from polymer Prevention of thrombosis Reduced time period for anti-platelet therapy

12 DES Equal Drug Distribution with DEB Hwang, Circulation 2001; 104: SeQuent Please

13 PACCOCATH ISR I and II A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis PI: Bruno Scheller Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg / Saar, Germany

14 PACCOCATH ISR I and II A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis PI: Bruno Scheller Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg / Saar, Germany

15 PACCOCATH ISR I/II Results QCA / primary endpoint: In-segment analysis at 6 months Control DEB p Lesion length 18.2 ± 7.9 mm 17.9 ± 6.1 mm Reference diameter 3.03 ± 0.37 mm 2.93 ± 0.47 mm Minimal lumen diameter initial 0.69 ± 0.39 mm 0.72 ± 0.35 mm Minimal lumen diameter post PTCA 2.52 ± 0.47 mm 2.44 ± 0.55 mm Minimal lumen diameter 6 months 1.71 ± 0.91 mm 2.30 ± 0.74 mm Late lumen loss (in segment) 0.82 ± 0.86 mm 0.13 ± 0.51 mm Binary restenosis rate 40.9 % 8.7 % 0.017

16 Late lumen loss - ISR I vs. ISR II Uncoated balloon Drug-coated balloon p < 0.01 p < 0.01 [mm] p < 0.01 p < late loss in-stent ISR I late loss insegment ISR I late loss in-stent ISR II late loss insegment ISR II November 1, 2006

17 PEPCAD II Trial The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses: A Comparison to the Paclitaxel-Eluting Taxus Stent - A Pilot Study PI: Martin Unverdorben

18 Results: 6 Months FU (As Treated) PEPCAD II SeQuent Please N=66 Taxus N=60 p-value Follow-up [mo] 6.2± ± Follow-up: clinical 62 (93.9%) 59 (98.3%) 0.40 Late loss [mm] 0.19± ± Restenosis (segment) 2/54 (3.7%) 11/53 (20.8%) 0.02 TLR 2/62 (3.2%) 11/59 (18.6%) >0.01 Myocardial infarction 0/62 (0.0%) 1/59 (1.7%) 1.00 Death 1/62 (1.6%) 1/59 (1.6%) 1.00 Total MACE 3/62 (4.8%) 13/59 (22.0%) >0.01

19 PEPCAD II Freedom from stent thrombosis, target lesion revascularization, myocardial infarction, and death B No. at risk Drug-coated balloon Drug-eluting stent

20 ISAR-DESIRE 3 ISAR-DESIRE 3 DEB, PES, BA in patients with restenosis after implantation of a DES: a randomised, open label trial Byrne R.A. et al. Lancet 2013;

21 Primary Endpoint Diameter Stenosis at Follow-up Angiography

22 Secondary Endpoint Binary Restenosis Target Lesion Revascularization

23 ISAR-DESIRE 3 RIBS V A randomized comparison of DEB vs EES in patients with BMS ISR Alfonso F. et al. JACC 2014;

24

25

26 ISAR-DESIRE 3 The SEDUCE OCT study of healing characteristics of DEB vs EES for ISR randomised clinical trial Adriaenssens T. et al. EuroIntervention 2014;

27 Conclusion DEB leaves fewer stent struts uncovered at 9 month FU EES lower percentage of diameter stenosis at 9 month FU DEB slightly better safety profile This did not translate into differences in clinical outcome. The use of both DEB and EES valuable treatment options for ISR.

28 DARE trial Multicenter, randomized study 270 Patients with ISR in BMS or DES SeQuent Please VS Xience Prime Primary Endpoint: Minimal lumen diameter at 6 months

29 OLVG VUmc AMC Isala ASZ UMCN Amphia

30 Conclusion Both DEB and DES superior to BA in ISR Both DEB and DES safe in ISR

31 Thank you for your attention