Mid-term results from real-world REPARA registry. Felipe Hernandez, on behalf of the REPARA investigators
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1 Mid-term results from real-world REPARA registry Felipe Hernandez, on behalf of the REPARA investigators
2 Potential conflicts of interest Speaker's name: Felipe Hernandez I have the following potential conflicts of interest to report: Consultant: BOSTON SCIENTIFIC, IZASA, ST. JUDE MEDICAL Institutional grant/research support: ABBOTT VASCULAR
3 REPARA (F. Hernandez) Objective: Evaluate the safety and efficacy of BVS usage in real world patients under well-controlled implementation criteria. Design: Prospective, Open-Label, Multi Center, Iberian registry in 1500 Pts, 60 Spanish sites Absorb Primary Endpoint Clinical follow-up 30dy 6mo 1yr Primary Endpoint: Secondary Endpoints: MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR Components: Death (Cardiovascular, Non-Cardiovascular), Myocardial Infarction (MI: QMI and NQMI, TV, ), Angina, DAPT rates and relationship to events
4 Enrollment complete September 18th 2448 patients
5 n=2448 Variables Age (years) 57.1±10.9 (20-89) Male (%) 80.8 High blood pressure (%) 52.9 Diabetes (%) 23.9 Dyslipidemia (%) 53.9 Tobacco use (%) 49.2 Prior MI (%) 13.4 Prior stroke (%) 2.9 Prior revascularization (PCI or CABG) (%) 15.0 Clinical indication (%) STEMI 32.4 non-stemi 26.7 unstable angina 15.4 stable angina / silent ischemia 21.4 others 3.3
6 n=2448 Variables Age (years) 57.1±10.9 (20-89) Male (%) 80.8 High blood pressure (%) 52.9 Diabetes (%) 23.9 Dyslipidemia (%) 53.9 Tobacco use (%) 49.2 Prior MI (%) 13.4 Prior stroke (%) 2.9 Prior revascularization (PCI or CABG) (%) 15.0 Clinical indication (%) STEMI 32.4 non-stemi % ACS unstable angina 15.4 stable angina / silent ischemia 21.4 others 3.3
7 Variables n=3370 Radial access (%) 84.4 Diseased vessels pr patient (n) 1.5 ± 0.7 Treated lesions (n) 3370 Treated lesions per patient (n) 1.38 ± 0.71 Vessel distribution (%) LAD 52.9 CX 20.6 RCA 26.5 Lesion type (%) A/B B2/C 41.6 Predilatation (%) 77.5 Lesion length (mm) 18.3 ± 9.4 Devices per patient (n) 1.6 ± 0.5 Implanted stents (n) 3950 Absorb (%) 83.0 DES (%) 15.5 BMS (%) 1.4 Device length (mm) 23.8 ± 13.1 Device size (mm) 3.0 ± 0.4 Postdilatation (%) 45.6 Postdilatation pressure (atm) 17.7 ± 5.1 Overlapping (%) 16.5 Bifurcations (%) 18.4 Moderate-severe tortuosity (%) 11.7 Moderate-severe calcification (%) 8.9 Intravascular imaging (%) IVUS OCT 8.6 Procedural success (%) 98.9
8 Variables n=3370 Radial access (%) 84.4 Diseased vessels pr patient (n) 1.5 ± 0.7 Treated lesions (n) 3370 Treated lesions per patient (n) 1.38 ± 0.71 Vessel distribution (%) LAD 52.9 CX 20.6 RCA 26.5 Lesion type (%) A/B B2/C 41.6 Predilatation (%) 77.5 Lesion length (mm) 18.3 ± 9.4 Devices per patient (n) 1.6 ± 0.5 Implanted stents (n) 3950 Absorb (%) 83.0 DES (%) 15.5 BMS (%) 1.4 Device length (mm) 23.8 ± 13.1 Device size (mm) 3.0 ± 0.4 Postdilatation (%) 45.6 Postdilatation pressure (atm) 17.7 ± 5.1 Overlapping (%) 16.5 Bifurcations (%) 18.4 Moderate-severe tortuosity (%) 11.7 Moderate-severe calcification (%) 8.9 Intravascular imaging (%) IVUS OCT 8.6 Procedural success (%) 98.9
9 Global population Immediate procedural success 98.9% MACE at 30 days n % Myocardial infarction (%) All deaths (%) Cardiac deaths (%) Device thrombosis (%) TLR (%)
10 Global population Immediate procedural success 98.9% MACE at 30 days n % Myocardial infarction (%) All deaths (%) Cardiac deaths (%) Device thrombosis (%) TLR (%)
11 Variables STEMI OTHERS p Radial access (%) Diseased vessels per patient (n) 1.74 ± ± Treated lesions (n) Treated lesions per patient (n) 1.45 ± ± Vessel distribution (%) LAD CX RCA Lesion type (%) A/B B2/C Predilatation (%) Lesion length (mm) 18.6 ± ± Devices per patient (n) 1.2 ± ± Implanted stents (n) Absorb (%) Metallic DES (%) Metallic BMS (%) Device length (mm) 23.8 ± ± Device size (mm) 3.0 ± ± Postdilatation (%) Postdilatation mean pressure (atm) 17.7 ± ± Overlapping Bifurcation (%) Moderate-severe tortuosity (%) Moderate-severe calcification (%) Intravascular imaging (%) IVUS OCT Procedural success (%)
12 Variables STEMI OTHERS p Radial access (%) Diseased vessels per patient (n) 1.74 ± ± Treated lesions (n) Treated lesions per patient (n) 1.45 ± ± Vessel distribution (%) LAD CX RCA Lesion type (%) A/B B2/C Predilatation (%) Lesion length (mm) 18.6 ± ± Devices per patient (n) 1.2 ± ± Implanted stents (n) Absorb (%) Metallic DES (%) Metallic BMS (%) Device length (mm) 23.8 ± ± Device size (mm) 3.0 ± ± Postdilatation (%) Postdilatation mean pressure (atm) 17.7 ± ± Overlapping Bifurcation (%) Moderate-severe tortuosity (%) Moderate-severe calcification (%) Intravascular imaging (%) IVUS OCT Procedural success (%)
13 STEMI patients MACE at 30 days STEMI OTHERS p N Myocardial infarction 14 (1.8) 22 (1.3) Total deaths 3 (0.4) 8 (0.5) Cardiac deaths 3 (0.4) 4 (0.2) Stent thrombosis 8 (1.0) 14 (0.8) TLR 6 (0.8) 14 (0.8) 0.999
14 Diabetics Variables No DM DM p Radial access (%) Diseased vessels pr patient (n) 1.4 ± ± 0.8 <0.001 Treated lesions (n) Treated lesions per patient (n) 1.34 ± ± Vessel distribution (%) LAD CX RCA Lesion type (%) A/B B2/C Predilatation (%) Lesion length (mm) 18.2 ± ± Devices per patient (n) 1.2 ± ± Implanted stents (n) Absorb (%) DES (%) BMS (%) <0.001 Device length (mm) 23.6 ± ± Device size (mm) 3.1 ± ± Postdilatation (%) Postdilatation pressure (atm) 17.5 ± ± Overlapping (%) Bifurcations (%) Moderate-severe tortuosity (%) Moderate-severe calcification (%) <0.001 Intravascular imaging (%) IVUS OCT Procedural success (%)
15 Diabetics Variables No DM DM p Radial access (%) Diseased vessels pr patient (n) 1.4 ± ± 0.8 <0.001 Treated lesions (n) Treated lesions per patient (n) 1.34 ± ± Vessel distribution (%) LAD CX RCA Lesion type (%) A/B B2/C Predilatation (%) Lesion length (mm) 18.2 ± ± Devices per patient (n) 1.2 ± ± Implanted stents (n) Absorb (%) DES (%) BMS (%) <0.001 Device length (mm) 23.6 ± ± Device size (mm) 3.1 ± ± Postdilatation (%) Postdilatation pressure (atm) 17.5 ± ± Overlapping (%) Bifurcations (%) Moderate-severe tortuosity (%) Moderate-severe calcification (%) <0.001 Intravascular imaging (%) IVUS OCT Procedural success (%)
16 Diabetics MACE at 30 days No DM DM p Myocardial infarction (%) 26 (1.4) 10 (1.7) All deaths (%) 7 (0.4) 4 (0.4) Cardiac deaths (%) 3 (0.2) 4 (0.7) Device thrombosis (%) 16 (0.9) 6 (1.0) TLR (%) 14 (0.8) 6 (1.0) 0.598
17 Bifurcations Variables No bifurcation Bifurcation P Radial access (%) Diseased vessels pr patient (n) 1.6 ± ± 0.9 <0.001 Treated lesions (n) Treated lesions per patient (n) 1.3 ± ±1.0 <0.001 Vessel distribution (%) LAD CX RCA <0.001 Lesion type (%) A/B B2/C Predilatation (%) Lesion length (mm) 18.1 ± ± Devices per patient (n) 1.2 ± ± Implanted stents (n) Absorb (%) DES (%) BMS (%) <0.001 Device length (mm) 23.5 ± ± Device size (mm) 3.0 ± ± Postdilatation (%) Postdilatation pressure (atm) 17.2 ± ± Overlapping (%) Moderate-severe tortuosity (%) Moderate-severe calcification (%) Intravascular imaging (%) IVUS OCT Procedural success (%)
18 Bifurcations Variables No bifurcation Bifurcation P Radial access (%) Diseased vessels pr patient (n) 1.6 ± ± 0.9 <0.001 Treated lesions (n) Treated lesions per patient (n) 1.3 ± ±1.0 <0.001 Vessel distribution (%) LAD CX RCA <0.001 Lesion type (%) A/B B2/C Predilatation (%) Lesion length (mm) 18.1 ± ± Devices per patient (n) 1.2 ± ± Implanted stents (n) Absorb (%) DES (%) BMS (%) <0.001 Device length (mm) 23.5 ± ± Device size (mm) 3.0 ± ± Postdilatation (%) Postdilatation pressure (atm) 17.2 ± ± Overlapping (%) Moderate-severe tortuosity (%) Moderate-severe calcification (%) Intravascular imaging (%) IVUS OCT Procedural success (%)
19 Bifurcations MACE at 30 days No bifurcation Bifurcation p Myocardial infarction (%) 25 (1.2) 11 (2.9) All deaths (%) 7 (0.3) 4 (1.0) Cardiac deaths (%) 4 (0.2) 3 (0.8) Device thrombosis (%) 15 (0.7) 7 (1.8) TLR (%) 15 (0.7) 5 (1.3) 0.225
20 Overlapping Variables No Overlapping Overlapping p Radial access (%) Diseased vessels pr patient (n) 1.6 ± ± 0.8 <0.001 Treated lesions (n) Treated lesions per patient (n) 1.4 ± ±1.0 <0.001 Vessel distribution (%) LAD <0.001 CX RCA Lesion type (%) A/B <0.001 B2/C Predilatation (%) <0.001 Lesion length (mm) 16.6 ± ± 15.5 <0.001 Devices per patient (n) 1.0 ± ± 0.8 <0.001 Implanted stents (n) Absorb (%) DES (%) BMS (%) Device length (mm) 20.4 ± ± 20.4 <0.001 Device size (mm) 2.9 ± ± Postdilatation (%) <0.001 Postdilatation pressure (atm) 17.4 ± ± Bifurcation (%) Moderate-severe tortuosity (%) <0.001 Moderate-severe calcification (%) <0.001 Intravascular imaging (%) <0.001 IVUS <0.001 OCT <0.001 Procedural success (%)
21 Overlapping Variables No Overlapping p Overlapping Radial access (%) Diseased vessels pr patient (n) 1.6 ± ± 0.8 <0.001 Treated lesions (n) Treated lesions per patient (n) 1.4 ± ±1.0 <0.001 Vessel distribution (%) LAD <0.001 CX RCA Lesion type (%) A/B <0.001 B2/C Predilatation (%) <0.001 Lesion length (mm) 16.6 ± ± 15.5 <0.001 Devices per patient (n) 1.0 ± ± 0.8 <0.001 Implanted stents (n) Absorb (%) DES (%) BMS (%) Device length (mm) 20.4 ± ± 20.4 <0.001 Device size (mm) 2.9 ± ± Postdilatation (%) <0.001 Postdilatation pressure (atm) 17.4 ± ± Bifurcation (%) Moderate-severe tortuosity <0.001 (%) Moderate-severe calcification <0.001 (%) Intravascular imaging (%) <0.001 IVUS <0.001 OCT <0.001 Procedural success (%)
22 Overlapping MACE at 30 days No Overlapping p Overlapping Myocardial infarction (%) 23 (1.1) 13 (3.2) All deaths (%) 7 (0.3) 4 (1.0) Cardiac deaths (%) 3 (0.1) 4 (1.0) Device thrombosis (%) 12 (0.6) 10 (2.4) TLR (%) 12 (0.6) 8 (1.9) 0.011
23 DAPT at discharge Treatment % ASA + Clopidogrel 52.0 ASA + Prasugrel 16.3 ASA + Ticagrelor 31.7
24 DAPT at discharge Treatment % ASA + Clopidogrel 52.0 ASA + Prasugrel 16.3 ASA + Ticagrelor 31.7 Treatment No bifurcation Bifurcation p Clopidogrel Prasugrel Ticagrelor Treatment No STEMI STEMI p Clopidogrel Prasugrel <0.001 Ticagrelor No significant differences in DM and overlapping groups
25 Device thrombosis data Variables No thrombosis N =2418 Device thrombosis N=22 Radial access (%) Vessel distribution (%) LAD CX RCA Lesion type (%) A/B B2/C p Predilatation (%) Lesion length (mm) 18.3 ± ±17.4 <0.001 Devices per patient (n) 1.18 ± ± Device length (mm) 23.8 ± ± Device size (mm) 3.0 ± ± Postdilatation (%) Postdilatation pressure (atm) 17.5 ± ± Overlapping (%) Bifurcations (%) <0.001 Moderate-severe tortuosity (%) Moderate-severe calcification (%) Intravascular imaging (%) IVUS OCT Procedural success (%)
26 Device thrombosis data Variables No thrombosis N =2418 Device thrombosis N=22 Radial access (%) Vessel distribution (%) LAD CX RCA Lesion type (%) A/B B2/C p Predilatation (%) Lesion length (mm) 18.3 ± ±17.4 <0.001 Devices per patient (n) 1.18 ± ± Device length (mm) 23.8 ± ± Device size (mm) 3.0 ± ± Postdilatation (%) Postdilatation pressure (atm) 17.5 ± ± Overlapping (%) Bifurcations (%) <0.001 Moderate-severe tortuosity (%) Moderate-severe calcification (%) Intravascular imaging (%) IVUS OCT Procedural success (%)
27 Early device thrombosis in overlapping 0.6% vs 2.4%, p=0.002 Time (days)
28 Early device thrombosis in bifurcations 0.7% vs 1.8%, p=0.036 Time (days)
29 6 month follow-up MACE at 6 months (n=2100) n % Myocardial infarction Total deaths Cardiac deaths Device thrombosis TLR All revascularizations
30 MACE at 6 months STEMI OTHERS p Myocardial infarction (%) 21 (2.7) 30 (1.8) All deaths (%) 6 (0.8) 13 (0.8) Cardiac deaths (%) 5 (0.6) 9 (0.5) Device thrombosis (%) 14 (1.8) 20 (1.2) TLR (%) 12 (1.5) 22 (1.3) All revascularizations (%) 24 (3.0) 43 (2.6) MACE at 6 months No DM DM p Myocardial infarction (%) 36 (1.9) 15 (2.6) All deaths (%) 10 (0.5) 9 (1.5) Cardiac deaths (%) 6 (0.3) 8 (1.4) Device thrombosis (%) 24 (1.3) 10 (1.7) TLR (%) 25 (1.3) 9 (1.5) All revascularizations (%) 50 (2.7) 17 (2.9) 0.780
31 MACE at 6 months No Overlapping Overlapping p Myocardial infarction (%) 34 (1.7) 17 (4.1) All deaths (%) 13 (0.6) 6 (1.5) Cardiac deaths (%) 8 (0.4) 6 (1.5) Device thrombosis (%) 22 (1.1) 12 (2.9) TLR (%) 23 (1.1) 11 (2.7) All revascularizations (%) 45 (2.2) 22 (5.4) <0.001 MACE at 6 months No bifurcation Bifurcation p Myocardial infarction (%) ) 13 (3.4) All deaths (%) 14 (0.7) 5 (1.3) Cardiac deaths (%) 9 (0.4) 5 (1.3) Device thrombosis (%) 25 (1.2) 9 (2.3) TLR (%) 26 (1.3) 8 (2.1) All revascularizations (%) 54 (2.6) 13 (3.4) 0.391
32 Conclusions Bioresorbable coronary devices in unselected patients are safe and effective, with a very high procedural success Lesion pre and postdilatation were lower than in most of other registries and trials Device thrombosis was 0.9% at 30 days and 1.4% at 6 months Overlapping devices and bifurcation lesions show an increase in early complications, especially device thrombosis No significant differences were observed in high risk subgroups like diabetics or STEMI patients
33 Thank you for your attention
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