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Current Absorb Implantation Mechanism – non-TGA approved device ♥  ABSORB EXTEND Trial – HREC Approval POWH/EHC 2010

Defined, relatively restrictive anatomical criteria n = 28

♥  “Real-world” Registry – TGA/HREC Approval 2012

Authorized Prescriber (3) Interventionalists Long lesions, younger patients Real-world patients and disease n = 219

Eastern Heart Clinic/Prince of Wales Hospital

BRS Utilization

Eastern Heart Clinic/Prince of Wales Hospital

BRS Utilization

Inclusion Criteria ♥  Younger patients < 65 ♥  Longer lesions (> 28mm) ♥  Mid LAD disease ♥  Reference vessel diameter suitable

for 2.5, 3.0 or 3.5 mm Absorb ♥  All patients eligible for PCI ♥  Life expectancy > 5 yrs

“Real-world” Registry�

Exclusion Criteria ♥  Instent restenosis ♥  Residual unexpanded lesion > 30% after

preparation ♥  Extreme calcification ♥  Extreme proximal tortuosity ♥  Inability to maintain DAPT for 12 mths ♥  Cardiogenic Shock ♥  Planned major surgery within 6 mths ♥  Participation in another trial ♥  No informed consent

Base-line Demographics - Dec 2010 - Aug 2014

Eastern Heart Clinic/Prince of Wales Hospital Real-World BRS Experience

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N 247 (263 procedures)

Age (yrs/range) 61 (18-83) Male (%) 74

DM (%) 18 Hypertension (%) 78

Prior MI (%) 17 Hyperlipidaemia (%) 83

CKD (%) 6 Prior PCI (%) 21 Prior CABG (%) 10

N 247 (263 procedures)

Procedural Details


��CTO (%) 6

Long lesions (%) 32

Bifurcations (%) 21

Moderate/severe calcification (%) 23

B2/C lesion complexity(%) 54

Bifurcations (%) 21

Clinical Outcomes


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100 % 30 d, 39% 12 mth, 12% 24 mth

Peri-procedural non-Q MI n (%) 6 (2.4)

Deaths n (%) 2 (0.8) Cardiac Deaths n (%) 1 (0.4)

TVR n (%) 6 (2.4)

TLR n (%) 3 (1.2)

MACE n (%) 15 (6.1) Scaffold thromboses – Definite/probable n (%) 1 (0.4)

Scaffold thromboses – Possible n (%) 1 (0.4)

MI (spontaneous) n (%) 1(0.4)

TVR n (%) 6 (2.4)

TLR n (%) 3 (1.2)

Cardiac Deaths n (%) 1 (0.4)

TVR (%) 6 (2 4)

MACE n (%) 15 (6.1) Scaffold thromboses – Definite/probable n (%) 1 (0.4)

S ff ld th b P ibl (%) 1 (0 4)

S ff ld th b D fi it / b bl (%) 1 (0 4)

CIT 2014, HLC (in press)�

Baseline characteristics �;<=

Age (yrs/range) 56 (43-80) Male (%) 84 DM (%) 19 Hypertension (%) 71 Prior MI (%) 15 Hyperlipidaemia (%) 95 CKD (%) 6 Prior PCI (%) 25 Prior CABG (%) 7

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Indications for PCI �;<=

Stable angina, n(%) 37 (71) Non-STE ACS, n (%) 15 (29) STEMI, n (%) 0

Eastern Heart Clinic/Prince of Wales Hospital Bifurcation Experience with BRS

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Lesion/vessel characteristics �� !��&��;<<

LM/LAD, LM/Cx n (%) 4 (7.3) LAD/Diag n (%) 28 (50.9)

LCx/OM n (%) 9 (16.4) RCA (PL/PDA) n (%) 14 (25.5)

True bifurcations (111/101/011) n (%)

29 (52.7)

100 n (%) 3 (5.5) 010 n (%) 5 (9.1) 110 n (%) 14 (25.5) Ostial SB only (001) n (%) 4 (7.3)

Type B/C n (%) 48 (87.3) Calcification (mod/heavy) n (%) 20 (36.4) CTO n (%) 10 (18.2)

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LAD/Diag n (%) 28 (50.9)

True bifurcations (111/101/011) n (%)

29 (52.7)

Ostial SB only (001) n (%) 4 (7.3)

Type B/C n (%) 48 (87 3)Calcification (mod/heavy) n (%) 20 (36.4) CTO n (%) 10 (18 2)


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RCA CTO – 51 yo male, SAP �

POW/EHC Absorb Registry - Case # 153

RCA CTO – 51 yo male, SAP Bifurcation dRCA

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3.0 x 28 mm Absorb� 3.5 mm NC balloon�

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Set-up

Bifurcation Circumflex Disease - Staged 53 yo male, recent RCA DES (STEMI – PPCI) + staged Absorb BRS x 3 LAD

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2.5 mm balloon

Bifurcation Circumflex PCI – 53 yo male

Post-predilatation


2.5 x 12 mm Absorb



3.0 x 18 mm Absorb

Two scaffold strategy – Shunt/modified T

2.0 mm balloon


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Sequential kiss


OCT post-Sequential kiss

Final kissing balloons – 2.5 mm NC balloons x 2 Minimal overlap Low pressure 8atm


Final Result (OCT guided)




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LAD/D1 (011) Bifurcation – 57 yo male, SAP DK Crush

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3.0 x 28 mm Absorb�2.5/2.5 mm NC balloons�

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Procedural Characteristics n= 55 Bifurcations

Pre-dilatation (%) 100 Rotablator/scoring balloon (%) 6 Multi-vessel BVS (%) 35 Total scaffolds (n) 87 Scaffolds/patient (n/range) 1.7 (1-3) OCT (%) 27 NC balloon post-dilatation (%) 100 Concomitant DES (%) 20

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Procedural Characteristics n= 55 Bifurcations

MAIN VESSEL BVS number (n) 1.6 BVS diameter (mm) 2.91 Total BVS length (mm) 37.3

SIDE BRANCH BVS number (n) 0.15 BVS diameter (mm) 2.68

Total BVS length (mm) 15

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Procedural Results �;<=��!��,�;<<��

Procedural success (%) 100

Device success (%) 100

Failure to deliver (MV or SB) (%) 0

Final kissing balloon inflation (%) 89

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Death (n) 0 0

Myocardial infarction

0 0

QMI (n)

0 0

Non-QMI (n) 2* 0

TLR/TVR (n)

0 0

Scaffold dislodgement (n)

0 0

Scaffold Thrombosis (n) 0 0

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Cardiac Death (n) 0

Myocardial infarction 1

TLR/TVR n, (%) 1(1.9)

MACE n, (%) 2(3.8)

Scaffold Thrombosis (n) 0

CVA (n) 0

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Australian Real-World BRS Experience in Bifurcations

Conclusions

♥  Treatment of bifurcations with Absorb BRS is technically feasible

♥  Excellent device and procedural success in a variety of bifurcations (provisional and systematic two stent strategies)

♥  Very high safety and efficacy both in-hospital and in follow-up in “real-

world” bifurcations associated with long lesions, chronic total occlusions, calcification, and multi-vessel disease

Australian Real-World BRS Experience in Bifurcations Lessons Learnt

♥  Meticulous technique (sizing, preparation, post-dilatation)

♥  Prolonged DAPT

♥  Liberal OCT use

♥  Bench modeling and trial results required

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Procedural Details (1)


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Pre-dilatation (%) 100

Scaffold overlap (%) 32

Multi-vessel BVS (%) 15

Total scaffolds (%) 421

Scaffolds/patient (n/range) 1.7 (1-5)

OCT/IVUS use (%) 13

Rotablator/scoring balloon (%) 5

NC balloon post-dilatation (%) 99



��Bivalirudin (%) 19

Unfractionated heparin (%) 81

Aspirin (%) 100

Clopidogrel (%) 64

Prasugrel (%) 35

Ticagrelor (%) 1

$ 0 ! , / $ , - bifurc.net · ckd (%) 6 prior pci (%) 21 prior cabg (%) 10 n 247 (263 procedures)...

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