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Situaciรณn actual de la intervenciรณn coronaria: Stents and BRS. Puntos clave para un implante correcto de BRS

Hector M. Garcia-Garcia MD, PhD MedStar Cardiovascular Research Network (MCRN) Invasive Imaging Core Laboratory July 31th, 2018

Washington, DC., USA

1


Is revascularization better than medical treatment in stable CAD patients? 100 trials in 93 553 patients 1. CABG reduces the risk of death, MI, and subsequent revascularisation compared with medical treatment. 2. Our results provide evidence for improved survival with new generation drug eluting stents but NO other percutaneous revascularisation technology compared with medical treatment.

BMJ 2014;348:g3859 doi: 10.1136/bmj.g3859 (Published 23 June 2014)


Innovacion en stents, puesta al dia en 2016: es uno mejor que otro?, cuando seleccionar uno en particular?


TAXUS Endeavor Xience V

nd st Durable Polymer DES: 2 Generation Durable Polymer DES: Durable Polymer DES: 1 ndGeneration HO

O O

O O O N O HO

O O

O

HO

O

O

A total of 147Driver trials Vision Liberté Polymer Stent including patients Polymer 126,526 Stent Polymer Stent Phosphorylcholine VDF + HFPderivative copolymer Polyolefin

Zotarolimus Everolimus Paclitaxel

Promus Cypher Resolute Element

Drug Drug Drug

HO

O O

O O O N O HO

O O

O

HO

O

O

Sirolimus Zotarolimus Everolimus

Hydrophilic Hydrophobic

PEVA+BioLinx +HFP PBMA blend VDF copolymer

BX Velocity(Ion) Driver Element

JACC: Card Intv Vol 9, Issue 12; 1203–1212


1. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. 2. CoCr-EES, PtCr-EES, and H-SES were associated

with significantly lower risk than BVS. 3. CoCr-EES and H-SES were superior to SES and BPBES

4. The risk of myocardial infarction was significantly lower with H-SES than with BVS. 5. No differences regarding mortality and comparably low risks of repeat revascularization.


Garcia-Garcia HM et al.. SOCIME textbook. 2016


Three approaches to improve early and late DES outcomes • Metallic DES with bioabsorbible polymers • Metallic DES, polymer free • Bioresorbable scaffolds


Abluminal Bioabsorbable Polymer Abluminal Bioabsorbable Synergy StentPolymer SYNERGY Stent (BSC)

Everolimus Drug PLGA Polymer

Drug & Polymer Coating

Abluminal (4μm)

SEM of coating (x5000)

Luminal

Platform

Polymer Coating

Drug

Platinum chromium • 74 μg (0.0029in)

PLGA • Abluminal • 4 µm thick • Undetectable in 4 mo

Everolimus • 100 μg/cm2 • Elutes in 3 months


EVOLVE II TLF at 1 and 2 years

EVOLVE II TLF at 1 and 2 years PROMUS Element Plus vs SYNERGY

1° Endpoint: 12 months ITT Pnoninferiority=0.0005

TLF (%)

16 12 8

6.7%

4

6.5%

2 years HR 1.10 [0.79, 1.52] P=0.57

9.4% 8.5% 1-2 years Xience 2.0% Synergy 2.7%

0 No. at risk PE+ SYNERGY

0

6

12

24 Months

838

790

772

538

846

807

794

553

ITT Population; Patients who did not receive a study stent were censored at 1 year; KM Event Rates; log-rank P values

ACC 2016 Kereiakes DJ et al. ACC 2016.


BioFreedom Drug Coated Stent

BioFreedom Drug Coated Stent (DCS) Selectively micro-structured surface holds drug in abluminal surface structures

Biolimus A9 is 10x more lipophilic than sirolimus1 100 80 60

%

40 20 0

12 mo in-stent LL ~0.17 mm (n=31)

Sirolimus Zotarolimus Everolimus Biolimus A9 ±2.8% (valid for all drugs test)

Potential Advantages: • Rapid drug transfer to vessel wall (98% within one month2) • Avoid possible polymer-related adverse effects • Safe to shorten DAPT? Tada et al. Circ Cardiovasc Interv 2010;3;174-183 2.

1. Data on file at Biosensors Intl 2. Tada et al. Circ Cardiovasc Interv 2010;3;174-183


LEADERS FREE study LEADERS FREE Trial Design

Objective: To determine in patients at high bleeding risk, using one month DAPT, whether the BioFreedom DCS is as safe and more effective than a Gazelle BMS

Prospective, double-blind randomized (1:1) trial In 2466 high bleeding risk (HBR) PCI patients BioFreedom™ DCS

vs.

Gazelle™ BMS

DAPT mandated for 1 month only, followed by long-term SAPT • Primary efficacy endpoint: Clinically-driven TLR at 1 year (superiority) • Primary safety endpoint: Composite of cardiac death, MI, definite / probable stent thrombosis at 1 year (non-inferiority then superiority) Urban P et al. NEJM 2015:on-line


LEADERS FREE study: 1o. Leaders Free:EfficacyPrimary Efficacy Endpoint TLR Endpoint (Clinically-Driven TLR) 12

DCS (n=1221)

CD-TLR (%)

BMS (n=1211)

9.8%

9

6

5.1% 3

P < 0.001 0 0

90

180 Days

270

390

1221 1211

1167 1131

1130 1072

1098 1034

1053 984

Number at Risk DCS BMS

Urban P et al. NEJM 2015 Urban P et al. NEJM 2015:on-line


LEADERS FREE study: 1o. Endpoint LeadersCardiac Free: Primary Safety Endpoint SafetyDeath, MI and ST Cardiac death, MI or ST (%)

(Cardiac Death, MI, ST) 15

DCS (n=1221) BMS (n=1211)

12.9%

12

Number at Risk DCS BMS

9.4%

9 6

P=0.005

3 0 0

90

180 Days

270

390

1221 1211

1146 1115

1105 1066

1081 1037

1045 1000

Urban P et al. NEJM 2015 Urban P et al. NEJM 2015:on-line


BIOFLOW V

Comparison of Ultrathin SirolimusEluting Bioresorbable Polymer with Thin Everolimus-Eluting Durable Polymer Stents David E Kandzari, MD; Laura Mauri, MD, MSc; Jacques Koolen, MD, PhD; Joseph M Massaro, PhD; Gheorghe Doros, PhD; Hector M Garcia-Garcia, MD, PhD; Donald E Cutlip, MD; Ron Waksman MD, for the BIOFLOW V Investigators

Clinicaltrials.gov Identifier NCT02389946


Drug Eluting Stent Innovation Perspective •

Persistence of adverse events with both first generation and contemporary permanent polymer-based DES presents an opportunity for iterative improvement

Advancements include thinner struts, stent design modifications, improvement in polymer biocompatibility and most recently the development of bioresorbable polymers –

BP control drug release while allowing simultaneous (or subsequent) dissolution of the polymer material, eliminating the stimulus for chronic inflammation and hypothetically restoring the stent phenotype to an inert bare metal stent

Although previous comparative studies have reported statistical non-inferiority between bioresorbable and permanent polymer DES, no study to date has demonstrated a statistically meaningful difference in clinical outcomes


Orsiro Ultrathin Strut (BP SES) Stent System Stent material

L-605 Cobalt-Chromium

Strut thickness

60 µm*

Polymer material

Poly-L-lactic acid (PLLA)

Polymer type

Bioresorbable, asymmetric circumferential thickness; scission begins immediately with 24 month complete degradation

Passive coating

Amorphous silicon carbide

Antiproliferative drug

Sirolimus (1.4 µg/mm2), >80% eluted in first 90 days *For 2.25mm to 3.0mm diameter stents, 80 µm for >3.0 mm diameter stents


Randomised Clinical Trials Involving Orsiro BP SES BIOFLOW II

BIOFLOW IV

BIOSCIENCE BIO-RESORT

Location

Europe

Europe, Japan

Switzerland

Netherlands

Design

Randomised 2:1 vs. Xience Prime

Randomised 2:1 vs. Xience Prime/Xpedition

Randomised (1:1 vs Xience Prime)

Randomised (1:1:1, Orsiro, Synergy, Resolute Integrity)

Primary Endpoint

LLL @ 9 Months

TVF @ 12 Months

TLF @ 12 Months

TVF @ 12 Months

Enrollment

452 (298 Orsiro, 154 Xience)

579 (387 Orsiro, 192 Xience)

2,119 (1,063 Orsiro, 1,056 Xience)

3,514 (1,172 Synergy, 1,169 Orsiro, 1,173 Resolute Integrity)

Inclusion

1 to 2 de novo lesions Separate arteries

1 to 2 de novo lesions Separate arteries

All-comers

All-comers

Follow-up

1, 6, 12 months and 2 to 5 year clinical 9 month clinical and angiographic (60 IVUS patients)

1, 6, 12 months and 2 to 5 year clinical

1, 6, 12 months and 2 to 5 year clinical

1 and 12 month and 2 to 5 year clinical


BIOFLOW V Primary and Secondary Endpoints

Primary Endpoint

Target Lesion Failure (TLF) at 12 months: cardiovascular death, target vessel-related myocardial infraction (MI), or ischaemiadriven TLR Noninferiority design, Event rate 7.0%, Delta 3.85%, Power 89%

Secondary Endpoints

Major Adverse Cardiac Events (MACE): all-cause death, MI, or ischaemia-driven TLR

Target Vessel Failure (TVF): cardiac death, target vessel-related MI, or ischaemia-driven TVR Individual components of composite endpoints at 30 days and 12 months Definite / probable stent thrombosis Device Success: achievement of <30% diameter stenosis of the target lesion within the study stent Procedure Success: final diameter stenosis <30% with the assigned stent and with no in-hospital MACE


Key Enrollment Criteria Inclusion Criteria • •

• • • • • •

Age ≥ 18 years IHD, stable or unstable angina, or silent ischaemia ≤ 3 de novo target lesions in ≤ 2 native target vessels (TV) RVD ≥ 2.25 mm and ≤ 4.0 mm LL ≤ 36 mm TIMI flow > 1 Eligible for DAPT therapy (aspirin + P2Y12) Provided informed consent

Exclusion Criteria •

• • • • • • • •

Doros et al. Am Heart J DOI: http://dx.doi.org/10.1016/j.ahj.2017.08.001

Recent (< 72 hours prior to procedure) STEMI or hemodynamically unstable NSTEMI/ ACS patients Chronic total occlusions, bypass grafts Bifurcations with side branch > 2.0 mm In-stent restenosis or active stent thrombosis LVEF < 30% Prior PCI within 30 days (non-TV) or within 9 months (TV) Planned staged PCI post-procedure Renal impairment > 2.5 mg/dL or 221 µmol/L or dialysis dependent Excessively tortuous/ angulated or severely calcified (operator visual assessment)


Patient Disposition 4,772 Patients screened 1,334 Patients enrolled

884 Allocated to BP SES 48 Did not complete a 12-month visit 24 Missed the 12-month visit 10 Withdrew consent 6 Were lost to follow-up 7 Died 1 Was exited for other reasons

833 Evaluable for primary endpoint 97.3% Follow-up

450 Allocated to DP EES 29 Did not complete a 12-month visit 14 Missed the 12-month visit 7 Withdrew consent 2 Were lost to follow-up 6 Died

427 Evaluable for primary endpoint 96.7% Follow-up


Clinical Characteristics

BP SES (N=884)

DP EES (N=450)

64.5 ± 10.3

64.6 ± 10.7

Female

25.3%

27.1%

Hypertension

79.7%

80.5%

Hyperlipidemia

78.9%

82.4%

Diabetes mellitus

34.0%

37.0%

Prior MI

27.4%

25.9%

Prior PCI

36.8%

33.0%

Prior CABG

7.1%

5.2%

Current smoking

23.6%

22.7%

Stable angina

48.4%

47.4%

Acute coronary syndrome

51.4%

49.6%

Age, years

Clinical presentation


Angiographic/Procedural Results

BP SES (N=1,051 lesions)

DP EES (N=561 lesions)

Lesion length

13.3 ± 7.6

13.2 ± 7.7

Reference vessel diameter

2.6 ± 0.5

2.6 ± 0.6

No. target lesions/pt*

1.2 ± 0.4

1.3 ± 0.5

% diameter stenosis, pre

55.4 ± 13.3

55.9 ± 13.5

% diameter stenosis, post

7.1 ± 9.8

7.4 ± 9.8

47.7%

46.2%

No. stents/lesion*

1.07 ± 0.3

1.13 ± 0.4

Stent length/lesion

20.8 ± 9.1

21.8 ± 10.5

Overlapping stents*

9.4%

15.0%

Post-dilation performed

*P<0.05 for comparison


BIOFLOW V Primary Endpoint: 12 Month Target Lesion Failure Orsiro BP SES (n=884)

Xience DP EES (n=450)

P value

Target lesion failure

6.2%

9.6%

0.040

Cardiac death

0.1%

0.7%

0.115

Target vessel MI

4.7%

8.3%

0.016

Clinically-driven TLR All data represented as intention to treat

2.0%

2.4%

0.686


BIOFLOW V Conclusions • In an international, randomised trial, treatment with the ultrathin strut Orsiro BP SES was superior to the Xience DP EES regarding 12 month TLF and MI – Differences in MI observed early but persisted in landmark analysis • Revascularization with Orsiro BP SES was associated with favorably low TLR and stent thrombosis • Bayesian pooled analysis including patient level outcomes from BIOFLOW II and IV trials demonstrated unequivocal non-inferiority with mean TLF treatment difference of -2.6 % favoring Orsiro and posterior probability of superiority 96.9% • These results endorse the safety and efficacy of the ultrathin Orsiro BP SES in patients representative of those treated in clinical practice and advance a new standard for DES comparison


Published online, 26 August 2017


Garcia-Garcia HM et al.. SOCIME textbook. 2016

Bioresorbable Scaffolds


6 Months

24 Months

36 Months

42 Months

Onuma Y et al. Circulation 2013.


C

10-year FU of Igaki-Tamai stent at Thorax Centre D E Pre

E B

E

D

C A

B

A Arrow indicates a metallic marker

Eurointervention 2009

2009 1999


Histology: 10 years stented LAD with an Igaki-Tamai stent


DREAMS 2G (MAGMARIS) Sirolimus Eluting Mg Scaffold

Sirolimus + PLLA (BIOlute) 150µm

150µm

90-Day Faxitron, porcine explant

   

6-crown 2-link design 150µm strut thickness 150µm strut width Optimized scaffold design for  Higher bending flexibility  Higher acute radial force  Slower resorption rate: 95% at 12 months  Sirolimus drug elution & PLLA (ORSIRO BIOlute coating)  Tantalum radiopaque markers  Gained CE mark in June 2016


Study design OBJECTIVE  Assess the safety and clinical performance of the DREAMS 2G in de novo coronary artery lesions.

Prospective FIM enrolling 123 patients with de novo coronary artery stenosis

1 Month, Clinical FUP

PRIMARY ENDPOINT  In-segment late lumen (LLL) loss at 6-month

DESIGN

6 Month • Clinical FUP (mandatory) • Angiographic FUP (mandatory) • IVUS / OCT (Subgroup only) • Vasomotion (Subgroup only)

 Prospective, multi-center, first-in-man trial COORDINATING CLINICAL INVESTIGATOR  Prof. M. Haude, Lukaskrankenhaus, Neuss, Germany CORELAB

12 Month • Clinical FUP (mandatory) • Angiographic FUP (voluntary) • IVUS / OCT (voluntary) • Vasomotion (voluntary)

2 Year, Clinical FUP

 Cardialysis, Rotterdam, the Netherlands  Medstar, Washington DC, USA

3 Year • Clinical FUP • Angiographic FUP (voluntary) • IVUS / OCT (voluntary) • Vasomotion (voluntary)


Baseline patient and lesion characteristics N = 123

Baseline Characteristics Age (mean ± SD) Male Hypertension

N (%)

Lesion Location

N (%)

65.2±10.3

LAD

47 (38.2)

78 (63.4)

LCx

29 (23.6)

101 (82.1)

RCA

45 (36.6)

Hyperlipidemia

74 (60.2)

Smoking

67 (54.5)

Diabetes mellitus

36 (29.3)

Insulin dependent

11 (30.6)

Non-Insulin dependent

25 (69.4)

History of MI

29 (23.6)

Previous percutaneous Intervention

52 (42.3)

Intermediate branch

2 (1.6)

Lesion Characteristics

N (%)

Lesion length (mm ± SD)

12.6 ± 4.5

RVD (mm ± SD)

2.7 ± 0.40

AHA/ ACC Lesion Class B2/C

53 (43.4)

Calcification moderate/severe

13 (10.7)


Clinical data out to 36-month 6-month

12-month

24-month

36-month

N=120

%

N=118

%

N=120

%

N=117

%

4

3.3

4

3.4

7

5.9

8

6.8

2

1.7

2

1.7

4

3.3

5

4.3

Cardiac Death

11

0.8

11

0.8

21,2

1.7

21,2

1.7

Non-cardiac death

13

0.8

13

0.8

23,4

1.7

33,4,5

2.6

Target Vessel MI*

1

0.8

1

0.8

1

0.8

1

0.9

Clinically driven TLR

2

1.7

2

1.7

4

3.3

5

4.3

0

0.0

0

0

0

0.0

0

0.0

0

0.0

0

0.0

0

0.0

0

0.0

TLFâ&#x20AC; Death

CABG Scaffold Thrombosis definite or probable â&#x20AC; Composite

of TLF: cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG according to SCAI definition *peri-procedural MI according to SCAI definition All events have been adjudicated by a clinical event committee 1. Unwitnessed death 134 days post PCI of distal RCA, no autopsy available 2. Unwitnessed death 395 days post PCI of the mid RCA, no autopsy available 3. Patient died of cancer 4. Patient died of pulmonary infection leading to septic shock 5. Patient died of intracerebral hemorrhage


Serial comparison of in-segment LLL at 6- and 36-month N=47 100

6-month 36-month

Cumulative Frequency (%)

80

60 0.17 ± 0.25

0.43 ± 0.41

40

20 ∆ 0.26 ± 0.37 p-value <0.0001 0 -0.75

-0.25

0.25

0.75

In-Segment Late Lumen Loss (mm)

1.25

1.75

2.25


Serial comparison of in-segment LLL at 6-, 12- and 36-month N=25 100

6-month 12-month 36-month

Cumulative Frequency (%)

80

60

0.17 ± 0.20

0.35 ± 0.23

0.46 ± 0.25

40

20

0

-0.50

-0.25

0.00 0.25 0.50 0.75 In-Segment Late Lumen Loss (mm)

∆ 6- vs 12-month ∆ 6- vs 36-month ∆ 12- vs 36-month

Mean ± Std 0.18 ± 0.34 0.29 ± 0.29 0.11 ± 0.28

1.00

1.25

p-value 0.0156 <0.0001 0.0598

1.50


Serial OCT analysis post-procedure, 12- and 36-month N=12 12M-FU

POST -PCI

Post-procedure (N=12)

12-month (N=12)

36-month (N=12)

Mean Lumen Area(mm2)

7.85±1.49

6.34±2.20

5.89±2.05

6.53±1.63

4.67±1.86

3.87±1.44

Minimum lumen

area, mm2 (*) p<0.05

36M-FU

Δ Post-Proc. vs. 12-month

∆Post-Proc. vs. 36-month

∆12- month vs 36-month

1.52*

1.97*

0.45

[0.88, 2.15]

[1.34, 2.60]

[-0.09, 0.99]

1.86*

2.66*

0.80*

[1.13, 2.59]

[1.79, 3.52]

[0.15, 1.44]


Serial IVUS analysis post-procedure, 12- and 36-month N=8 12M-FU

POST -PCI

36M-FU

Post-procedure (N=8)

12-month (N=8)

36-month (N=8)

Δ Post-Proc. vs. 12- month

∆Post-Proc. vs. 36-month

∆12- month vs 36-month

Vessel area, mm2

14.47±2.46

14.40±2.79

14.77±3.30

0.07 [-0.62, 0.76]

-0.30 [-1.38, 0.78]

-0.37 [-1.23, 0.49]

Lumen area, mm2

6.58±1.03

5.89±1.17

5.87±1.45

0.69* [0.29, 1.09]

0.71* [0.21, 1.20]

0.02 [-0.44, 0.48]

Plaque area, mm2

7.89±1.56

8.50±1.77

8.89±2.05

-0.62* [-1.05, -0.18]

-1.01* [-1.79, -0.23]

-0.39 [-0.92,0.14]

(*) p<0.05


Serial IVUS VH analysis post-procedure, 12- and 36-month N=8 POST -PCI

Fibrous

12M-FU

Fibrous Fatty

36M-FU

Necrotic core

Calcium

Post-procedure (N=8)

12-month (N=8)

36-month (N=8)

Δ Post-Proc. vs. 12-month

∆Post-Proc. vs. 36-month

∆12-month vs. 36-month

Fibrous, %

28.69±6.89

45.74±9.36

46.42±8.82

-17.1* [-22.9, -11.2]

-17.7* [-24.7, -10.8]

-0.67 [-3.34, 1.99]

Fibrous Fatty, %

2.53±1.51

6.01±2.60

8.21±3.48

-3.48* [-5.50, -1.47]

-5.69* [-8.46, -2.92]

-2.21* [-4.23, -0.18]

Necrotic core, %

29.78±2.10

28.21±2.35

26.43±3.18

1.57 [-0.85, 4.00]

3.35 [-0.16, 6.86]

1.78 [-0.49, 4.05]

Calcium, %

39.01±9.34

20.04±10.80

18.94±9.75

18.97* [13.18, 24.76]

20.06* [13.08, 27.05]

1.10 [-1.43, 3.63]

(*) p<0.05

na = Not Applicable


Comparative angiographic analysis of target vessel versus non-target vessel (without stenosis) Analyzed Vessel

Analyzed Segment

Correlation

Long Segment Prox. Edge

Target Vessel

Target Segment

Study Stent

Whole vessel analysis proximal part excluding the Target Segment Original Study Scaffolded Segment (In-Segment)

Dist. Edge

Long Segment

Remaining segments of the Target vessel

Equivalent to the Target Segment of Target Vessel

Target Segment Long Segment

A ’

Whole vessel analysis proximal part excluding the Target Segment

Long Segment

NonTarget Vessel

Whole vessel analysis distal part excluding the Target Segment

A ’

Remaining segments of the non-Target vessel

Whole vessel analysis distal part excluding the Target Segment

A ’

A ’


Comparative angiographic analysis of target vessel versus non-target vessel Normalized Late Lumen Loss (LLL/RVD) Segment Short

Segment Long

∆ Target vs Non-target (N=21) p-value

Target (N=25)

Non-target (N=21)

Resorption time Δ Baseline. vs. 12 month [mm]

0.123 ± 0.094

0.019 ± 0.128

0.096 ± 0.194

Post Resorption time ∆ 12- vs 36-month [mm]

0.049 ± 0.113

0.023 ± 0.093

0.015 ± 0.142

Target (N=24)

Non-Target (N=22)

∆ Target vs Non-target (N=21)

0.051

0.058 ± 0.090

0.019 ± 0.102

0.023 ± 0.103

0.384

0.627

-0.017 ± 0.082

0.015 ± 0.099

-0.019 ± 0.102

0.395

p-value

 Similar RVD and length of the selected target and non-target vessels  Increase in LLL in the target vessel occurs within the first 12-month with a strong trend (p=0.051) towards a higher increase in the target versus the non-target vessel

 No change in normalized LLL between 12-month versus 36-month in the target versus the nontarget vessel


Safety and performance of the resorbable magnesium scaffold, Magmaris in a real world setting - First 200 subjects at 12-month followup of the BIOSOLVE-IV registry

On behalf of the BIOSOLVE-IV Investigators


Registry design Design  Prospective, multi-center, real world setting, registry.

1065 patients with de novo coronary artery stenosis

Primary Endpoint

 Target Lesion Failure (TLF) at 12 months Secondary Endpoints (at 6 months, 1-5 years)

6-month Clinical FUP

12-month Clinical FUP

 TLF  Clinically Driven TLR and TVR  Cardiac Death

24-month Clinical FUP

 Target Vessel MI  Scaffold Thrombosis

36-month Clinical FUP

 Procedure and Device Success 48-month Clinical FUP Coordinating Clinical Investigators

 S. Verheye, MD, Belgium - Europe  M. Lee, MD, Hong Kong – Asia Pacific TLF: composite of target vessel myocardial infarction, clinically driven TLR, cardiac death and CABG

60-month Clinical FUP


Countries and sites Country

Site #

Country

Site #

Germany

32

Hungary

2

Australia

5

Portugal

2

Austria The Netherlands Belgium

5

Singapore

2

5

South Africa

2

4

South Korea

2

France

4

Taiwan

2

Switzerland

4

Israel

1

Italy

3

Latvia

1

Hong Kong

3

Malaysia

1

New Zealand

3

Poland

1

Spain

3

Sweden

1

Denmark

2

90 sites in 23 countries


Enrolment

Inclusion Criteria* Subjects were enrolled according to the consensus letter1, 4Ps and Instruction for Use (IFU) requirements of Magmaris

NSTEMI subjects included in BIOSOLVE-IV

1. Fajadet et al., EuroIntervention 2016;12:828-833.


4P Strategy: Patient / lesion selection, Proper sizing, Pre-dilatation, Post-dilatation

Patient and lesion selection

Proper scaffold sizing

Pre-dilatation for lesion preparation

Post-dilatation


Patient Flow 200 subjects

N= 2 devices not implanted N= 1 missed visit

6-month follow-up (98.5%) 197 subjects

N= 2 devices not implanted N= 4 missed visit

12-month follow up (97.0%) 193 subjects 1 death1 . 1:

Non-cardiac death (cancer)


Baseline and Lesion Characteristics Baseline Characteristics Age (mean ± SD) Male Hypertension Hyperlipidemia Smoking Diabetes mellitus Insulin dependent Non-insulin dependent History of MI Previous percutaneous Intervention NSTEMI

N (%) 62.3±11.1 154 (77.0) 126 (63.0) 128 (64.0) 123 (61.5) 43 (21.5) 6 (14.0) 37 (86.0) 35 (17.5) 48 (24.0) 29 (14.5)

Lesion Location LAD LCx RCA Lesion Characteristics* Lesion Length (mm ± SD) RVD (mm ± SD) AHA/ ACC Lesion Class B2/C Calcification Moderate

N (%) 110 (51.4) 42 (19.6) 62 (29.0) N (%) 14.5 ± 4.2 3.3 ± 0.3

37 (17.3) 14 (6.5)

*: Lesion characteristics are eyeball estimate of investigators - No core laboratory analysis


Clinical results 6-month* N=198 % TLF1 Cardiac Death Target Vessel MI2 CD-TLR CABG Scaffold Thrombosis Definite or probable

12-month* N=198 %

5

2.5

9

4.6

0 1

0.0 0.5

0 1

0.0 0.5

5 0

2.5 0.0

9 0

4.6 0.0

13

0.5

13

0.5

1. Composite of cardiac death, target vessel myocardial infarction (TV-MI), clinically driven target lesion revascularization (CD-TLR) and CABG. 2. One patient with an MI experienced a TLR as well. For TLF rate calculation time to first event is taken into consideration. 2. Peri-procedural MI according to the SCAI definition and spontaneous MI according to the Extended Historical definition 3. DAPT interruption after the procedure. Same patient had a scaffold thrombosis and target vessel MI. *: Kaplan-Meier failure estimate analysis / All events have been adjudicated by a clinical event committee


Case explanation Scaffold thrombosis and TV-MI NSTEMI - 18.Dec.2016

Index procedure - 22.Dec.2016 Heavily calcified RCA treatment with Magmaris

Planned MIDCAB - 27.Dec.2016 â&#x20AC;¢ DAPT Interruption

Scaffold thrombosis & TV-MI 01.Jan.2017 Target vessel MI, N=1, 0.5% Scaffold thrombosis, N=1, 0.5% Staged PCI of Cx - 10.Jan.2017 Treatment with DES


Clinical results at 12-month FU BIOSOLVE-II&III1 6-month N=181 % TLF2

BIOSOLVE-IV 6-month N=198 %

BIOSOLVE-II&III1 12-month N=180 %

BIOSOLVE-IV 12-month N=198 %

6

3.3

5

2.5

6

3.3

9

4.6

Cardiac Death

2

1.1

0

0.0

2

1.1

0

0.0

Target Vessel MI3

1

0.6

1

0.5

1

0.6

1

0.5

CD-TLR

3

1.7

5

2.5

3

1.7

9

4.6

CABG

0

0.0

0

0.0

0

0.0

0

0.0

0

0.0

14

0.5

0

0.0

14

0.5

Scaffold Thrombosis Definite or probable

1. Combined results of BIOSOLVE-II and BIOSOLVE-III, TCT2017 2. Composite of cardiac and unknown death, target vessel myocardial infarction (TV-MI), clinically driven target lesion revascularization (CD-TLR) and CABG 3. Peri-procedural MI according to the SCAI definition and spontaneous MI according to the Extended Historical definition 4. DAPT interruption after the procedure


BIOSOLVE-IV extended

Up to 2065 subjects with de novo coronary artery stenosis 6-month Clinical FUP

BIOSOLVE-IV will be extended to include up to 2â&#x20AC;&#x2122;065 patients, to further confirm Magmaris safety and efficacy

12-month Clinical FUP 24-month Clinical FUP

36-month Clinical FUP 48-month Clinical FUP 60-month Clinical FUP


Conclusion •

TLF rates at 6-month (2.5%) and 12-month (4.6%)  confirm TLF rates of BIOSOLVE-II and -III studies  are comparable to various 2nd generation drugeluting stents

Excellent safety profile of the scaffold up to 12-month  no cardiac death  1 patient had target vessel myocardial infarction and scaffold thrombosis (DAPT interruption)


Conclusion 

DES newer generations reduced mortality in patients with stable angina

Thin struts DES appeared to reduce even further TLF compared to best in class 2nd gen DES BRS concept is promisory and long term outcomes are comparable to DES so far.

Profile for solacisocime18

garcia-garcia-modulo1-proeducar  

garcia-garcia-modulo1-proeducar  

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