Safety and performance of the resorbable magnesium ...

Safety and performance of the resorbable magnesium scaffold,

Magmaris in a real world setting - First cohort subjects at 12-month follow-up

of the BIOSOLVE-IV registry

Michael Lee, MDQueen Elizabeth Hospital

Hong Kong SAROn behalf of the BIOSOLVE-IV investigators

Potential conflicts of interest

Michael Lee

Speaker's name : Michael Lee

☑ I do not have the potential conflicts of interest to declare.

Magmaris (DREAMS 2G)

Michael Lee

• 6-crown 2-link design

• 150 µm strut thickness

• 150 µm 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

Sirolimus + PLLA (BIOlute)

90-Day Faxitron, porcine explant

150 µm

150 µm

Registry Design

Design

• Prospective, multi-center (up to 120 sites in up to 30

countries), real world setting registry

Primary Endpoint

• Target Lesion Failure (TLF) at 12 months

Secondary Endpoints (at 6 months, 1-5 years)

• TLF*

• Clinically Driven TLR and TVR

• Cardiac Death

• Target Vessel MI

• Procedure and Device Success

• Scaffold thrombosis at 12 months (powered for

superiority of Magmaris compared to Absorb)

Coordinating Clinical Investigators

• S. Verheye, MD, Belgium – Europe

• M. Lee, MD, Hong Kong – Asia Pacific

2054 patients with

de novo coronary artery stenosis

6-month Clinical FUP






*TLF: composite of target vessel myocardial

infarction, clinically driven TLR, cardiac death

and emergent CABG

Michael Lee

Enrollment & Registry Organization

• Data being presented for Cohort 1 (1075 subjects)

• Subjects were enrolled according to the consensus letter1, 4Ps and Instruction for Use (IFU)

• NSTEMI subjects included in BIOSOLVE-IV

• 4P Strategy

• Independent Clinical Events Committee: Adjudication of all ADE, SADE, USADE and endpoint related SAE

• Independent Core laboratory imaging analysis of endpoint related events

• 25 % source data verification

Patient & lesion selection

Proper scaffold sizing

Pre-dilatation for lesion

preparation

Post-dilatation

Michael Lee

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

Baseline Patient & Lesion Characteristics

Baseline Characteristics N (%)

Age (mean ± SD) 61.3 ± 10.5

Male 806 (75.0)

Hypertension 724 (67.3)

Hyperlipidemia 713 (66.3)

Smoking history 654 (61.1)

Diabetes mellitus 228 (21.2)

Insulin dependent 45 (19.7)

Non-Insulin dependent 183 (80.3)

History of MI 219 (20.4)

Previous percutaneous Intervention

287 (26.7)

NSTEMI 206 (19.2)

Lesion Location N (%)

LAD 561 (50.0)

LCX 213 (19.0)

RCA 333 (29.7)

Ramus intermedius 14 (1.2)

Lesion Characteristics* N (%)

Lesion length (mm ± SD) 14.9 ± 4.2

RVD (mm ± SD) 3.2 ± 0.3

AHA / ACC Lesion Class B2 / C 170 (15.2)

Calcification moderate / severe 82 (7.3)

Bifurcation lesions 57 (5.1)

Michael Lee

*Lesion characteristics are estimated by investigator

Target Lesion Failure out to 12 Months

Device success: 97.3% & Procedure success: 98.9%

• 1 Composite of cardiac death, target vessel myocardial infarction (TV-MI), clinically driven target lesion revascularization (CD-TLR) and emergent CABG. Peri-procedural MI according to SCAI definition and spontaneous MI according to the Extended Historical definition.

• All events have been adjudicated by an independent clinical event committee

0 30 180 365

Time to Event [days]

0

5

10

15

20

25

100

4.3% [95% CI: 3.2;5.7]

TLF

[%]1

Michael Lee

0.5% [95% CI: 0.2;1.1]

Secondary endpoints out to 12 Months

Michael Lee

0 30 180 365Time to Event [days]

0

5

10

15

20

25

100

Targ

et v

esse

l MI[

%]

0 30 180 365


0

5

10

15

20

25

100

Car

dia

cD

eath

[%

]

0 30 180 365Time to Event [days]

0

5

10

15

20

25

100

Clin

ical

ly d

rive

n T

LR [

%]

1.1% [95% CI: 0.6;2.0]

3.9% [95% CI: 2.9;5.3]

0.2% [95% CI: 0.0;0.7]

4 out of 5 scaffold thrombosis cases had early

antiplatelet or anticoagulant interruption

after procedure

0 30 180 365


0

5

10

15

20

25

100

Scaf

fold

th

rom

bo

sis

[%]

(def

init

e/p

rob

able

)1

Conclusions

BIOSOLVE-IV confirms low TLF rates (4.3% at 12-month) from

previous trials also in a real world setting with 115 centers in 25 countries

Excellent device success (97.3%) and procedure success (98.9%)

Very good safety profile of the scaffold up to 12-month

• 0.2% cardiac death

• 0.5% scaffold thrombosis

• 0.1% scaffold thrombosis rate excluding cases with early antiplatelet or anticoagulant interruption

Michael Lee

PCRonline.com

Safety and performance of the resorbable magnesium ...

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