PAD NETWORK AD INTERIM ANALYSIS

(1)

PAD NETWORK

AD INTERIM ANALYSIS

Update to 24

^th

November 2021 Study Principal Investigators

P . G E

(2)

B ^ACKGROUND I

(3)

B ^ACKGROUND II

(4)

B ^ACKGROUND III

 Despite the elevated cardiovascular risks, claims studies have shown that a large portion of LEAD patients undergoing LER do not receive a medical therapy that properly mirror guidelines recommendations.

In our country, the portion of LEAD patients who are prescribed a guideline

recommended medical therapy and take the medications as prescribed after LER

is unknown.

(5)

M ^ETHODS

Study design: Multicentered, prospective, non-interventional study.

 Study population: Patients undergoing Lower Extremity Revascularization (LER) in Campania will be eligible for inclusion in the study. Patients aged < 18 years old will be excluded.

Definitions:

Adherence to recommendations (Physician adherence): the process by which physician prescribe medications as recommended by guidelines.

Adherence to medications (Patient Adherence): is the process by which patients take their medication as prescribed.

 Data management: demographic, clinical, procedural and therapeutic data

relating to patients and from all the involved centers in an anonymized digital

platform (RedCap®).

(6)

E ^NDPOINTS

• Primary endpoint

Evaluate the Physician and Patients adherence for antithrombotic agents, lipid lowering agents, angiotensin‐converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) at 1 month, 6 months, 1 and 2 years follow up after LER

• Secondary endpoints

Efficacy: Achievement of recommended target of therapy (BP and LDL-c values).

Estimate predictors of Patient and Physician Adherence

Safety: Occurrence of Major Adverse Cardiovascular Events (MACE) and Major

Adverse Limb Events (MALE)

(7)

E XPECTED RESULTS

Define adherence to guidelines recommendations of prescribed therapy to LEAD patients who have undergone LER (Physician adherence).

 Define LEAD patients’ adherence to prescribed therapy (Patient Adherence)

 Design future strategies to improve physician and patient adherence to

guidelines recommended medical therapy in these clinical setting

(8)

I NVOLVED CENTERS

CARDIOLOGIA

CHIRURGIAVASCOLARE

RADIOLOGIAINTERVENTISTICA

AOU Federico II di Napoli– UOC Cardiologia, Emodinamica e UTIC Casa di Cura Montevergine di Mercogliano (AV) – Cardiologia AORN San Giuseppe Moscati di Avellino – UO Ch. Vascolare AO San Pio di Benevento – UO Ch. Vascolare

AORN dei Colli – Ospedale Monaldi di Napoli – UO Ch. Vascolare Casa di Cura Salus di Battipaglia (SA) – Ch. Vascolare

AOU Federico II di Napoli – UOSD Chirurgia Vascolare AORN Cardarelli di Napoli– UOC Radiologia vascolare

AORN Sant'Anna e San Sebastiano di Caserta – UOC Ch. Vascolare Ospedale Fatebenefratelli di Benevento – UOC Cardiologia

AORN Cardarelli di Napoli– UOC Ch. Vascolare Clinica Mediterranea di Napoli – UOC Ch. Vascolare Ospedale del Mare di Napoli – UOC Ch. Vascolare

Presidio Ospedaliero dei Pellegrini di Napoli– UO Ch. Vascolare Casa di Cura Villa dei Fiori di Acerra (NA) – Ch. Vascolare

Casa di Cura San Michele di Maddaloni (CE) - Cardiologia

OORR San Giovanni di Dio e Ruggi d’Aragona di Salerno– UO Ch. Vascolare AO San Luca di Vallo Della Lucania (SA) – UOC Ch. Vascolare

(9)

A PPROVATION AND ENROLLING STATUS

7

1 2 7

Approved and enrolling Approved not enrolling yet Submitted Not approved

◼ AOU Federico II di Napoli– UOC Cardiologia, Emodinamica e UTIC

◼ Casa di Cura Montevergine di Mercogliano (AV) – Cardiologia

◼ AORN San Giuseppe Moscati di Avellino – UO Ch. Vascolare

◼ AO San Pio di Benevento – UO Ch. Vascolare

◼ AORN dei Colli – Ospedale Monaldi di Napoli – UO Ch. Vascolare

◼ Casa di Cura Salus di Battipaglia (SA) – Ch. Vascolare

◼ AOU Federico II di Napoli – UOSD Chirurgia Vascolare

◼ AORN Cardarelli di Napoli– UOC Radiologia vascolare

◼ AORN Sant'Anna e San Sebastiano di Caserta – UOC Ch. Vascolare

◼ Ospedale Fatebenefratelli di Benevento – UOC Cardiologia

◼ AORN Cardarelli di Napoli– UOC Ch. Vascolare

◼ Clinica Mediterranea di Napoli – UOC Ch. Vascolare

◼ Ospedale del Mare di Napoli – UOC Ch. Vascolare

◼ Presidio Ospedaliero dei Pellegrini di Napoli– UO Ch. Vascolare

◼ Casa di Cura Villa dei Fiori di Acerra (NA) – Ch. Vascolare

◼ Casa di Cura San Michele di Maddaloni (CE) - Cardiologia

◼ OORR San Giovanni di Dio e Ruggi d’Aragona di Salerno– UO Ch. Vascolare

◼ AO San Luca di Vallo Della Lucania (SA) – UOC Ch. Vascolare

18

(10)

S TUDY POPULATION

31%

19%

25%

2%

8%

4%

8% 3%

AOU Federico II – UOC Cardiologia, Emodinamica e UTIC Casa di Cura Montevergine di Mercogliano (AV)

AORN San Giuseppe Moscati di Avellino – UO Ch. Vascolare AO San Pio di Benevento – UO Ch. Vascolare

AORN dei Colli – Ospedale Monaldi – UO Ch. Vascolare Casa di Cura Salus di Battipaglia (SA) – Ch. Vascolare AOU Federico II – UOSD Chirurgia Vascolare

AORN Cardarelli – UOC Radiologia vascolare

343 E NROLLED PATIENTS

(11)

D EMOGRAPHICS

Males, n (%) 260 (75,6) Dyslipidemia, n (%) 277 (80,8)

Age, years 67,81 ± 9,35 Chronic kidney disease, n (%) 78 (22,9)

Body mass index, kg/m

²

27,24 ± 4,00 Dialysis, n (%) 13 (3,8)

Smoker, n (%) 233 (68,1) Chronic obstructive lung disease, n (%) 69 (20,1)

Current smoker, n (%) 128 (55,0) History of atrial fibrillation/flutter, n (%) 37 (10,8)

Former smoker, n (%) 105 (45,0) Previous PCI, n (%) 115 (33,5)

Arterial hypertension, n (%) 294 (85,7) Previous CABG, n (%) 53 (15,5)

Diabetes mellitus, n (%) 179 (52,2) Prior stroke, n (%) 14 (4,1)

Insulin dependent, n (%) 106 (59,2) Previous peripheral revascularization, n (%) 137 (40,4)

(12)

C LINICAL PRESENTATION

N=186 54%

N=156 46%

◼ Fontaine IIb

◼ Fontaine > IIb

(13)

T ARGET LESION R EVASCULARIZATION

89%

11%

PTA Surgery

84%

11%

5% De novo

Restenosis

In-stent Restenosis 25%

65%

10% AortoIliac

FemoroPopliteal InfraPopliteal

n= 342

(14)

91%

9%

PTA Surgery

A DDITIONAL LESION R EVASCULARIZATION

82%

13%

5% De novo

Restenosis

In-stent Restenosis 18%

50%

32%

AortoIliac

FemoroPopliteal InfraPopliteal

n= 187

(15)

I ^N -H ^OSPITAL E ^VENTS

7,0%

2,9%

1,5%

5,2%

1,2%

9,6%

5,5%

0% 0,6%

2%

4%

6%

8%

Clinical failure Acute Limb Ischemia

Urgent Revascularization

Planned amputation

Urgent amputation

Acute Kidney Injury

Bleeding Death

(16)

M EDICAL THERAPY AT DISCHARGE

99,7%

72,6% 78,7%

58,8%

0%

20%

40%

60%

80%

100%

Antithrombotics ACEi/ARB Lipid lowering drugs Anti-thrombotics ACEi/ARB

Lipid lowering drugs

(17)

A ^NTI - THROMBOTICS AT D ^ISCHARGE

80,2%

17,8%

10,8% 1,4%

7%

0%

10%

20%

30%

40%

50%

60%

70%

80%

DAPT SAPT DPI AC alone

◼ with SAPT

◼ with DAPT

(18)

L IPID LOWERING DRUGS AT D ^ISCHARGE

57,4%

42,6%

14,9%

5,2% 1,9% 0,8% 0,8% 0%

0%

20%

40%

60%

High intensity statin

Mid-Low intensity statin

High int. Statin Ezetimibe

MLi Statin Ezetimibe

PCSK9i Statin Ezetimibe

PCSK9i Statin

PCSK9i Ezetimibe

PCSK9i alone

(19)

S TUDY POPULATION

50%

25%

18%

7%

AOU Federico II – UOC Cardiologia, Emodinamica e UTIC

Casa di Cura Montevergine di Mercogliano (AV)- UTIC -Emodinamica AORN San Giuseppe Moscati di Avellino – UO Ch. Vascolare

Casa di Cura Salus di Battipaglia (SA) – Ch. Vascolare

1 MONTH FOLLOW UP

191

(20)

S TUDY POPULATION

67%

22%

11%

AOU Federico II – UOC Cardiologia, Emodinamica e UTIC Casa di Cura Montevergine di Mercogliano (AV) -UTIC- Emodinamica

AORN San Giuseppe Moscati di Avellino – UO Ch. Vascolare

6 MONTHS FOLLOW UP

104

(21)

A DHERENCE TO M ^EDICAL T ^HERAPY

99,7%

72,6% 78,7%

58,8%

99,5%

70,7%

86,4%

62,8%

98,5%

76,0%

91,3%

71,2%

0%

20%

40%

60%

80%

100%

Anti-thrombotics ACEi/ARB Lipid lowering drugs Anti-thrombotics

ACEi/ARB Lipid Lowering drugs

Discharge (n=343) 1 month (n=191) 6 months (n=104)

(22)

L IPIDS TREND DURING F ^{OLLOW UP}

20 40 60 80 100 120 140 160

Discharge 1 month 6 months

mg/dl

Total Cholesterol LDL Cholesterol HDL Cholesterol Triglycerides

(23)

LDL ^DURING F ^{OLLOW UP}

18%

32%

47%

0%

10%

20%

30%

40%

50%

Discharge 1 month 6 months

LDL-C < 55 mg/dL (14 mmol/L)

 PAD

(24)

P ^ATIENT S ATISFACTION SURVEY

1 1,5 2 2,5 3 3,5 4 4,5 5

Quanto il nuovo modello di gestione assistenziale integrata e multidisciplinare per i pazienti sottoposti a rivascolarizzazione contribuisce all'ottimizzazione del percorso di cura del paziente?

Quanto questo servizio è utile nell'offrire informazioni relative alla prevenzione cardiovascolare secondaria?

Quanto questo servizio la aiuta ad essere più aderente alla terapia e alle indicazioni ricevute dal Suo Medico?

Come valuta complessivamente la sua esperienza del Servizio?

Come valuta complessivamente la qualità del Servizio offerto?

(25)

P ^HYSICIAN S ATISFACTION SURVEY

1 1,5 2 2,5 3 3,5 4 4,5 5

Come valuta complessivamente l'efficacia del nuovo modello di presa in carico dei pazienti con AOP?

Quanto l'implementazione della rete integrata Hub & Spoke contribuisce alla riduzione delle liste d'attesa e al miglioramento del referral nelle strutture regionali coinvolte?

Quanto ritiene che la rete integrata Hub & Spoke sia efficace nel garantire l'adozione di un approccio di assistenza standardizzato?

Che impatto ha l'implementazione della rete integrata Hub & Spoke nel miglioramento del percorso di presa in carico e del referral dei pazienti con AOP?

Che impatto ha questo Servizio nel suo percorso di cura, dopo la dimissione ospedaliera?

(26)

PAD NETWORK AD INTERIM ANALYSIS

PAD NETWORK

AD INTERIM ANALYSIS

Update to 24

November 2021 Study Principal Investigators

P . G E

B ACKGROUND I

B ACKGROUND II

B ACKGROUND III

 Despite the elevated cardiovascular risks, claims studies have shown that a large portion of LEAD patients undergoing LER do not receive a medical therapy that properly mirror guidelines recommendations.

In our country, the portion of LEAD patients who are prescribed a guideline

recommended medical therapy and take the medications as prescribed after LER

is unknown.

M ETHODS

Study design: Multicentered, prospective, non-interventional study.

 Study population: Patients undergoing Lower Extremity Revascularization (LER) in Campania will be eligible for inclusion in the study. Patients aged < 18 years old will be excluded.

Definitions:

Adherence to recommendations (Physician adherence): the process by which physician prescribe medications as recommended by guidelines.

Adherence to medications (Patient Adherence): is the process by which patients take their medication as prescribed.

 Data management: demographic, clinical, procedural and therapeutic data

relating to patients and from all the involved centers in an anonymized digital

platform (RedCap®).

E NDPOINTS

• Primary endpoint

Evaluate the Physician and Patients adherence for antithrombotic agents, lipid lowering agents, angiotensin‐converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) at 1 month, 6 months, 1 and 2 years follow up after LER

• Secondary endpoints

Efficacy: Achievement of recommended target of therapy (BP and LDL-c values).

Estimate predictors of Patient and Physician Adherence

Safety: Occurrence of Major Adverse Cardiovascular Events (MACE) and Major

Adverse Limb Events (MALE)

E XPECTED RESULTS

Define adherence to guidelines recommendations of prescribed therapy to LEAD patients who have undergone LER (Physician adherence).

 Define LEAD patients’ adherence to prescribed therapy (Patient Adherence)

 Design future strategies to improve physician and patient adherence to

guidelines recommended medical therapy in these clinical setting

I NVOLVED CENTERS

A PPROVATION AND ENROLLING STATUS

18

S TUDY POPULATION

343

E NROLLED PATIENTS

D EMOGRAPHICS

Males, n (%) 260 (75,6) Dyslipidemia, n (%) 277 (80,8)

Age, years 67,81 ± 9,35 Chronic kidney disease, n (%) 78 (22,9)

Body mass index, kg/m

27,24 ± 4,00 Dialysis, n (%) 13 (3,8)

Smoker, n (%) 233 (68,1) Chronic obstructive lung disease, n (%) 69 (20,1)

Current smoker, n (%) 128 (55,0) History of atrial fibrillation/flutter, n (%) 37 (10,8)

Former smoker, n (%) 105 (45,0) Previous PCI, n (%) 115 (33,5)

Arterial hypertension, n (%) 294 (85,7) Previous CABG, n (%) 53 (15,5)

Diabetes mellitus, n (%) 179 (52,2) Prior stroke, n (%) 14 (4,1)

Insulin dependent, n (%) 106 (59,2) Previous peripheral revascularization, n (%) 137 (40,4)

C LINICAL PRESENTATION

N=186 54%

N=156 46%

◼ Fontaine IIb

◼ Fontaine > IIb

T ARGET LESION R EVASCULARIZATION

89%

11%

PTA Surgery

84%

11%

5% De novo

Restenosis

In-stent Restenosis 25%

65%

10% AortoIliac

FemoroPopliteal InfraPopliteal

n= 342

91%

9%

PTA Surgery

A DDITIONAL LESION R EVASCULARIZATION

82%

13%

5% De novo

Restenosis

In-stent Restenosis 18%

50%

B ^ACKGROUND I

B ^ACKGROUND II

B ^ACKGROUND III

M ^ETHODS

E ^NDPOINTS

I ^N -H ^OSPITAL E ^VENTS

A ^NTI - THROMBOTICS AT D ^ISCHARGE

L IPID LOWERING DRUGS AT D ^ISCHARGE

A DHERENCE TO M ^EDICAL T ^HERAPY

L IPIDS TREND DURING F ^{OLLOW UP}

LDL ^DURING F ^{OLLOW UP}

P ^ATIENT S ATISFACTION SURVEY

P ^HYSICIAN S ATISFACTION SURVEY