11:35 Protect IV and PROTECT-Europe trial Giuseppe Tarantini (Padua) _____________________________________________ PARALLEL SESSION Cto & Chip Regitries & Trials Auditorium Zubin Mehta - Friday 11:00 - 12:00 Chairpersons: Paul Knaapen (Amsterdam - NL), Gennaro Sardella (Rome) Discussants: Björn Billmann (Wolfenbuettel - D), Laurent Drogul (Nice - F), Sergey Furkalo (Kiev - UA), Maciej Lesiak (Poznan - PL) ___________________________________________ 15th Experts Live CTO, EUROCTO Club meeting in partnership with the GISE CTO meeting. September 8th - 9th, 2023 Florence, Italy

1. Giuseppe Tarantini, MD, PhD, FESC
Professor and Director of Interventional
Cardiology
University of Padua – Italy
PROTECT IV and
PROTECT-EU TRIAL

2. PROTECT IV
Impella®-Supported PCI in
High-Risk Patients with
Complex Coronary Artery
Disease and Reduced Left
Ventricular Function:
The PROTECT IV Trial
A prospective multinational
registry on preventive left
ventricular support with
Impella in high-risk PCI
treated patients :
The PROTECT-Eu Registry
HRPCI + Impella > HRPCI - Impella
for D/CVA/LVAD-HT/MI/reHosp by 3-year
HRPCI + Impella effectiveness
for D/CVA/MI/repeat revasc at 3-months
PROTECT-EU

3. PROTECT IV STUDY GOVERNANCE
High-risk PCI & Impella: PROTECT IV and EU
PROTECT IV
STEERING & WRITING
COMMITEE
P.I.
G.
Tarantini
Co P.I.
A.
Chieffo
G. Esposito
G. Masiero
C. Aurigemma
J. Oreglia
C. Di Mario
T. Schmitz
E. Nicolini
H. Möllman
N. Werner
M. Seiffert
A. Marchese
D. Gregori

4. High-risk PCI & Impella: PROTECT IV and EU
PROTECT IV
PRIMARY EP: The composite of all-cause D, stroke, durable LVAD
implant or HT, MI or hospitalization for CV causes 1-3 yrs.
No
N=1252
PRIMARY EP: composite of all-cause D, CV accident, MI, repeat
revasc at 90-day (PROTECT III Registry like)
N=859

5. High-risk PCI & Impella: PROTECT IV and EU
PRIMARY EP: composite of all-cause D, CV accident, MI, repeat
revasc at 90-day (PROTECT III Registry like)
PROTECT IV
PRIMARY EP: The composite of all-cause D, stroke, durable LVAD
implant or HT, MI or hospitalization for CV causes 1-3 yrs
No
CURRENT STATUS
USA Europe TOTAL
Sites
(ACTIVE)
61 18 79
RCT
(CASES)
504 196 700
Registry
(CASES)
411 189 600
CURRENT STATUS
ITA GER TOTAL
Sites
(ACTIVE)
6 1 7
Sites
(1° wave)
12 15 27
Enrolled
cases
20 1 21

6. PROTECT IV STUDY GOVERNANCE
What is included P-Eu that is not in P-IV?
STEERING & WRITING
COMMITEE
PROTECT IV
Patient level
Angio level
Previous Ileo-femoral stents < 6 months
Severe PH or Mod/severe RVD
Surgery planned within 6 months
Previous PCI/CABG
Criteria of complexity
Very long lesion/Severe calcification/ULMD
or ULEQ/MVD+MV-PCI/CTO/Giant
thrombus/SVG/ Last patent conduit
At least
1 criteria
At least 2
criteria
OR
2 complex
lesions

7. PROTECT-EU Sites: FIRST WAVE (N=429)
Milano - San Donato Hospital Bedogoni + Testa
Milano - San Raffaele Hospital Montorfano + Chieffo
Roma - Policlinico Gemelli Hospital Trani + Aurigemma
Padova - Azienda Ospedaliera di Padova Tarantini
Napoli - Federico II Esposito
Milano- IRCCS Ospedale Galeazzi-Sant’Ambrogio Ielasi
Milano - Hospital Niguarda Oreglia
Roma - Policlinico Umberto I Sardella
Verona - Borgo Trento Ribichini
Ancona - Hospital Lancisi Piva + Nicolini
Roma- San Camillo Forlanini Musto
Vercelli - Sant'Andrea Ugo
Universitäres Herz- und Gefäßzentrum Hamburg, Universitätsklinikum
Hamburg-Eppendorf
PD Dr Moritz Seiffert
Segeberger Kliniken Dr. Martin Landt
Uniklinik Bonn Prof. Dr. Sebastian Zimmer
Kath. St Paulus Gesellschaft St Johannes Hospital Innere Medizin I Prof. Dr. Helge Möllmann
REGIOMED Kliniken GmbH Klinikum Coburg iI. Medizinische Klinik Dr. Steffen Schnupp
Klinikum Fürth Dr. Stylianos Pyxaras
KLW St. Paulus GmbH, St. Marienhospital Lünen Dr Ingo Wickenbrock
Klinikum Nürnberg Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Dr Fadil Ademaj
Heinrich Braun Klinikum Zwickau Klinik für Innere Medizin PD Dr Holger H. Sigusch
Asklepios Klinik Nord Prof. Dr Alexander Ghanem
Herzzentrum Lahr PD Dr Kambis Mashayekhi
Deutsches HZ München Dr Jens Wiebe
UK Schleswig Holstein Dr Abdelhakim Allali
Universitätsmedizin Mainz PD Maike Knorr
Kerckhoff Klinikum GmbH Bad Nauheim Dr Maren Weferling

8. PATIENT ENROLLED IN PADUA CENTRE ON 11° APRIL
LVEDP 30 mmHg
NSTEMI patient, surgical refusal

9. PATIENT ENROLLED IN PADUA CENTRE ON 11° APRIL
DEBULKING THERAPY + LM DK CRUSH

10. PATIENT ENROLLED IN PADUA CENTRE ON 11° APRIL
1-Year Follow-UP (last week)
NYHA I, CCS 0, FE 55%

11. @interventionalcardiologyteampadova
@giuseppetarantinimdphd
@G_Tarantini01
Thank You!