Long-term clinical data of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold

in the treatment of subjects with de novo lesions in native coronary arteries - BIOSOLVE-II

Michael Haude, MD, Rheinland Klinikum, Neuss Lukaskrankenhaus, Germany

On behalf of the BIOSOLVE-II Investigators

Potential conflicts of interest

MichaelHaude

Speaker's name: Michael Haude

☑ I have the following potential conflicts of interest to declare:

Receipt of grants / research support: BiotronikReceipt of honoraria or consultation fees: Biotronik, Cardiac Dimensions, Orbus Neich, Philips

Why this study?

Objective:

To assess the long-term safety and clinical performance of the DREAMS 2G in de novo coronary artery lesions up to 5-year clinical follow up.

MichaelHaude

Magmaris (DREAMS 2G)

• 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

MichaelHaude

How was the study executed?

MichaelHaude

Study design:

DESIGN Prospective, multi-center, first-in-man trial

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

SECONDARY ENDPOINTS (at 1-6 months, 1-5 years) TLF rate * Scaffold thrombosis rate Procedure and device success

COORDINATING CLINICAL INVESTIGATOR Prof. M. Haude, Lukaskrankenhaus, Neuss, DE

INVESTIGATIONAL SITES 13 sites in Europe, Brazil and Singapore

CORELAB Cardialysis, The Netherlands and Medstar, USA

* Composite of cardiac death, target-vessel MI, clinically-driven TLR and CABG.** The study was extended to 5 years after completion of the 3-year FUP, all patients had to be newly consented.

How was the study executed?

MichaelHaude

Inclusion and exclusion criteria:

Inclusion Criteria *

Maximum of two single de novo lesions in two separate coronary arteries

Target RVD by visual estimation:2.2-3.7 mm (after NITRO)

Target lesion length by visual estimation: ≤ 21 mm

Target lesion stenosis by visual estimation: ≥ 50% - < 100%

Exclusion Criteria *

Evidence of myocardial infarction within 72 hours prior to index procedure

LVEF < 30%

Thrombus in the target vessel (by QCA)

Severe calcification

Patients with three-vessel disease

Previous CABG in the target vessel

Additional coronary lesion in the same vessel

Totally occluded coronary artery (TIMI flow 0)

Target lesion involves a side branch (vessel diameter > 2.0 mm), a bifurcation or is located 5 mm next to a bifurcation

Ostial lesions

Unsuccessful pre-dilatation* list truncated.

What are the essential results?

MichaelHaude

* The study was extended to 5 years after completion of the 3-year FUP, all patients had to be newly consented.All events have been adjudicated by an independent clinical event committee.

Patient Flow

What are the essential results?

MichaelHaude

Baseline and Lesion Characteristics (N = 123)

Baseline Characteristics N (%)

Age (mean ± SD) 65.2 ± 10.3

Male 78 (63.4)

Hypertension 101 (82.1)

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)

Lesion Location N (%)

LAD 47 (38.2)

LCx 29 (23.6)

RCA 45 (36.6)

Intermediate Branch 2 (1.6)

Lesion Characteristics N (%)

Lesion Length (mm ± SD) 12.6 ± 4.5

RVD (mm ± SD) 2.7 ± 0.4

AHA/ACC Lesion Class B2/C 53 (43.4)

Calcification Moderate/Severe 13 (10.7)

What are the essential results?

MichaelHaude

Target Lesion Failure rate out to 5-year FUP

* Composite of cardiac death, target-vessel MI, clinically-driven TLR and 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 and results are presented as Kaplan-Meier statistics.

8.0% [95% CI: 4.2;14.9]

0 365 730 1095 1825

Time to Event [days]

0%

10%

20%

30%

TLF

rate

[%

] *

What are the essential results?

MichaelHaude

* 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 and results are presented as Kaplan-Meier statistics.

0 365 730 1095 1825

Time to Event [days]

0%

10%

20%

30%

Clin

ical

ly-d

rive

n T

LR [

%]

5.6% [95% CI: 2.5;12.2]

0 365 730 1095 1825

Time to Event [days]

0%

10%

20%

30%

Targ

et-v

esse

lMI[

%]

*

2.1% [95% CI: 0.5;8.6]

0 365 730 1095 1825

Time to Event [days]

0%

10%

20%

30%

Car

dia

cd

eath

[%]

1.7% [95% CI: 0.4;6.5]

Secondary clinical endpoints out to 5-year FUP

0 365 730 1095 1825

Time to Event [days]

0%

10%

20%

30%

Scaf

fold

th

rom

bo

sis

[%]

(def

init

e/p

rob

able

)

0.0% [95% CI: 0.0;0.0]

The essentials to remember

Summary and conclusion:

Why: To assess long-term safety and clinical performance of the DREAMS 2G in de novo coronary artery lesions up to 5-year clinical follow up.

What: DREAMS 2G (MAGMARIS), Sirolimus Eluting Magnesium Scaffold, CE mark in June 2016

How: Prospective, first-in-men trial enrolling 123 patients with a maximum of 2 single de novo coronary artery lesions from 13 sites in Europe, Brazil and Singapore

Results: BIOSOLVE-II demonstrates an excellent safety profile up to 5-year clinical FUP

Low TLF rate (8.0%) and clinically-driven TLR rate (5.6%)

Favorable safety results with only 1.7% cardiac deaths and 2.1% target-vessel MIs

No definite or probable scaffold thrombosis

Importance: These are the first long-term results on safety and clinical performance of Magmaris comparable to 2nd generation drug eluting stents, which will support future generations.

MichaelHaude

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