BIOFLOW-III an all comers registry with a Sirolimus Eluting Stent: Presentation of 1-Year TLF Data in patients with complex lesions

Transcription

1 BIOFLOW-III an all comers registry with a Sirolimus Eluting Stent: Presentation of 1-Year TLF Data in patients with complex lesions Johannes Waltenberger, MD, F.E.S.C. Uniklinik Münster Münster, Germany

2 Potential conflicts of interest Speaker's name: Johannes L Waltenberger I have the following potential conflicts of interest to report: Honorarium: BIOTRONIK

3 Orsiro Hybrid DES with Bioabsorbable Polymer The underlying PRO-Kinetic Energy Stent with thin strut (60μm) design The hybrid structure: Passive component encapsulates the stent Active component contains bioabsorbable PLLA and sirolimus

4 Study Design 1,356 All Comers patients enrolled between Aug 2011 March 2012 Orsiro 6-month clinical follow-up International, prospective, non-randomized, multicenter, open-label design Primary Endpoint Target Lesion Failure* (TLF) at 12-month follow-up * Composite of cardiac death, target vessel Q-wave or non-q wave MI, Emergent CABG, clinically driven TLR 12-month clinical follow-up 36-month clinical follow-up 60-month clinical follow-up Secondary Endpoints TLF at 6, 36 and 60 months TVR at 6, 12, 36 and 60 months TLR at 6, 12, 36 and 60 months Stent Thrombosis at 6, 12, 36 and 60 months Device & procedural Success Coordinating Investigator: Johannes Waltenberger University Hospital Muenster, Germany Source: Waltenberger J. CRT, Washington DC, USA. Oral presentation, February ClinicalTrials.gov Identifier: NCT

5 Patient and Lesion Characteristics Patient Characteristics N = 1,356 Age in years (mean ± SD) 66.1 ± 10.7 Male % (N) 71.6% (971) Hypertension 75.9% (1,029) Hypercholesterolemia 60.1% (815) Smoking 54.6% (741) Diabetes mellitus 29.6% (402) Insulin dependent 34.1% (137) Non-Insulin dependent 65.9% (265) History of MI 27.7% (376) Stable angina 47.3% (641) Previous PCI 39.6% (537) Lesion Characteristics N = 1,738 B2/C type lesions 52.1% (905) Bifurcations 16.2% (282) Moderate calcification 23.6% (411) Severe calcification 7.0% (122) RVD (mm) 3.0 ± 0.4 Lesion length (mm) 15.8 ± 9.1 Diameter stenosis (%) 86.3 ± 11.1 Source: Waltenberger et al. EuroIntervention 2015; 10-online publish-ahead-of-print March

6 TLF Primary & Major Secondary Endpoint Results TLF at 12 Months All Subjects 10% 8% 6% 4% 5.1% 2% 0% Time to Event (days) Major Secondary Endpoints: Device and Procedural Success Devices N = 1,738 Device success 98.8% Procedures N = 1,356 Procedure success 98.2% Source: Waltenberger et at. EuroIntervention 2015; 10-online publish-ahead-of-print March

7 Single & Multivessel Disease (SVD/MVD) Subgroup Analysis Patient Characteristics SVD N = 1050 MVD N = 305 Age in years (mean ± SD) 65.5 ± ± Hypertension 75.3% (791) 77.7% (237) Hypercholesteremia 59.1% (621) 63.3% (193) Diabetes 29.0% (305) 31.8% (97) Non-Insulin dependent 31.8% (97) 41.2% (40) Insulin dependent 68.2% (208) 58.8% (57) Previous MI 27.7% (291) 27.9% (85) Renal disease 11.9% (125) 11.1% (34) CHF 11.0% (116) 10.5% (32) Previous TIA 5.5% (58) 5.2% (16)

8 Single & Multivessel Disease (SVD/MVD) Subgroup Analysis Lesion and Stent Characteristics SVD N = 1050 MVD N = 305 B2/C type lesions 50.2% (528) 54.8% (377) Mean stent length (mm) 18.2 ± ± 5.9 Mean stent diameter (mm) 3.0 ± ± 0.4 Number of Vessels Treated in MVD Group

9 12-month TLF Results Multivessel Disease (MVD) Subgroup Analysis 20% MVD SVD 10% 0% 6.7% P= % month Secondary Endpoints SVD N = 1050 MVD N = 305 Cardiac Death 1.3% 1.7% MI 2.1% 2.7% TLR 2.8% 3.7% Device Success 98.3% 99.6% Procedural Success 98.4% 97.7%

10 Acute MI Subgroup Analysis Patient Characteristics Acute MI N = 442 Others N = 914 Age (mean yrs ± SD yrs) 64.9 ± ± 11 < Hypertension 66.3% (293) 80.5% (736) < Hypercholesteremia 50.2% (222) 64.9% (593) < Diabetes 25.8% (114) 31.5% (288) Non-Insulin dependent 61.4% (70) 67.7% (195) Insulin dependent 38.6% (44) 32.3% (93) Lesion and Stent Characteristics Acute MI N = 551 Others N = 1,187 B2/C type lesions 57.6% (318) 49.5% (587) Mean stent length (mm) 18 ± 6 18 ± Mean stent diameter (mm) 3.0 ± ± % 12-month TLF Results 8% 6% 4% 2% Log-rank test: p= % Acute MI No Time to Event (days) Device and procedural success Acute MI Others Device success 98.4% 99.0% Procedure success Yes 97.3% 98.7% 7.2% 4.0% Source: Waltenberger. Presentation CRT, USA 2015.

11 STEMI Subgroup Analysis Patient Characteristics STEMI N = 144 NSTEMI N = 293 All others N = 437 Age in years (mean ± SD) 61.5 ± ± ± 10.2 < Hypertension 57.6% (83) 71.0% (208) 80.3% (738) < Hypercholesteremia 45.8% (66) 52.6% (154) 64.7% (595) < Diabetes 23.6% (34) 27.0% (79) 31.4% (289) Non-Insulin dependent 64.7% (22) 60.8% (48) 67.5% (195) Insulin dependent 35.3% (12) 39.2% (31) 32.5% (94) Previous MI 11.1% (16) 23.9% (70) 31.6% (200) < Renal disease 5.6% (8) 15.0% (44) 11.6% (107) CHF 7.6% (11) 7.5% (22) 12.5% (115) Previous TIA 5.6% (8) 7.8% (23) 4.7% (43)

12 STEMI Subgroup Analysis Lesion and Stent Characteristics STEMI N = 144 NSTEMI N = 293 All others N = 919 B2/C type lesions 66.3% (110) 54.0% (204) 49.5% (591) Mean stent length (mm) 18.6 ± ± ± Mean stent diameter (mm) 3.1 ± ± ± TIMI Flow

13 12-month TLF Results STEMI Subgroup Analysis All others STEMI NSTEMI STEMI NSTEMI = % 5.0% 4.0% 12-month Secondary Endpoints STEMI N=144 NSTEMI N=293 All others N = 437 Cardiac Death 2.1% 3.1% 0.7% MI 2.1% 5.6% 1.9% TLR 2.2% 3.6% 2.9% Device Success 95.8% 99.5% 99.0% Procedural Success 96.5% 97.6% 98.7%

14 TLF/MACE Rates in STEMI cohorts BIOFLOW-III N=144 12m Orsiro BIOSCIENCE N=211 12m Xience Cypher BioMatrix Nobori BMS BIOSCIENCE N=196 12m LEADERS N=140 9m SORT-OUT V N=225 12m LEADERS N=135 9m COMFORTABLE AMI N=575 12m SORT-OUT V N=225 12m COMFORTABLE AMI N=582 12m Source: Pilgrim et al. Lancet Windecker et al. Lancet Christiansen et al. Lancet Raeber et al. JAMA

15 Conclusions In this all-comers setting a low TLF rate of 5.1% was observed within the first 12 months, which implies safety and effectiveness of the Orsiro Hybrid Stent The results observed in this real world population demonstrate a low TLF rate comparable to other state of the art DES at 12 months. The low TLF rate is not only observed in the overall cohort, but also in patients with STEMI and multi-vessel disease as seen in this post-hoc analysis In comparison with other published trials in patients with STEMI, the Orsiro Hybrid Stent shows a low TLF rate.