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Registro de pacientes con Dispositivo
Biorreabsorbible en la práctica
clínica habitual
Felipe Hernández Hernández, en representación de los
investigadores de REPARA
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
Primary Endpoint: 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
Secondary
Endpoints:
Components: Death (Cardiovascular, Non-Cardiovascular), Myocardial
Infarction (MI: QMI and NQMI, TV,…), Angina, DAPT rates and
relationship to events
Clinical follow-up
30dy 6mo 1yr
Primary Endpoint
Absorb
18 septiembre 2015: final inclusión pacientes
2448 patients
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/B1 58.4
 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 (%) 11.1
- IVUS 2.5
- OCT 8.6
Procedural success (%) 98.9
MACE at 30 days n %
 Myocardial infarction (%) 36 1.5
 All deaths (%) 11 0.4
 Cardiac deaths (%) 7 0.3
 Device thrombosis (%) 22 0.9
 TLR (%) 20 0.8
Global population
Immediate procedural success 98.9%
Publicaciones
Comunicaciones orales presentadas en
ESC 2015
SEC 2015
TCT 2015
EuroPCR 2016
Manuscrito en preparación (resultados inmediatos y a
30 días)
Análisis específico de subgrupos: STEMI, DM,
bifurcaciones, overlapping

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REPARA. Registro de paciEntes con dispositivo biorreabsorbible en la Práctica clínica habitual

  • 1. Registro de pacientes con Dispositivo Biorreabsorbible en la práctica clínica habitual Felipe Hernández Hernández, en representación de los investigadores de REPARA
  • 2. 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 Primary Endpoint: 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 Secondary Endpoints: Components: Death (Cardiovascular, Non-Cardiovascular), Myocardial Infarction (MI: QMI and NQMI, TV,…), Angina, DAPT rates and relationship to events Clinical follow-up 30dy 6mo 1yr Primary Endpoint Absorb 18 septiembre 2015: final inclusión pacientes 2448 patients
  • 3. 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/B1 58.4  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 (%) 11.1 - IVUS 2.5 - OCT 8.6 Procedural success (%) 98.9
  • 4. MACE at 30 days n %  Myocardial infarction (%) 36 1.5  All deaths (%) 11 0.4  Cardiac deaths (%) 7 0.3  Device thrombosis (%) 22 0.9  TLR (%) 20 0.8 Global population Immediate procedural success 98.9%
  • 5. Publicaciones Comunicaciones orales presentadas en ESC 2015 SEC 2015 TCT 2015 EuroPCR 2016 Manuscrito en preparación (resultados inmediatos y a 30 días) Análisis específico de subgrupos: STEMI, DM, bifurcaciones, overlapping