Latvian Centre of Cardiology Real-lifeLatvian Centre of Cardiology Real-lifeRegistry on Bioresorbable Vascular

Scaffolds: A Single High Volume CentreScaffolds: A Single High Volume CentreExperience

Andrejs Erglis, MD, PhD, FESC, FACCLatvian Centre of Cardiology,

Experience

Pauls Stradins Clinical University Hospital

University of Latvia

Riga, LATVIARiga, LATVIA

Scaffold group % (n)

All death 2 (8/325)

The trial did not meet its co-primaryendpoints of superior vasomotor

reactivity and non inferior lateluminal loss for the Absorb

Cardiac death 1 (3/325)

Myocardial infarction 8 (27/325)

Target lesion 7 (24/325)

luminal loss for the Absorbbioresorbable scaffold with respect

to the metallic stent

Target lesionrevascularization

7 (24/325)

Target vesselrevascularization

10 (33/325)

A higher rate of device-orientedcomposite endpoint due to target

vessel myocardial infarction,including peri-procedural myocardialrevascularization

Scaffold thrombosis 3 (8/320)

Serruys P et al.Lancet 2016; 388: 2479–91

including peri-procedural myocardialinfarction, was observed in the

Absorb group

Riga single centre bioresorbable vascularscaffold registryscaffold registry

• First patient included November 2012

• Total amount of patients with bioresorbable scaffold: N=445

• Total Absorb scaffold (everolim useluting) patients: N=415

- Acute coronary syndrome: N=53- Acute coronary syndrome: N=53

- Stable angina: N=362

- LM bifurcation single centre study: N=50- LM bifurcation single centre study: N=50

• Total Magmaris scaffold (sirolim useluting) patients: N= 30

• 2 year clinical follow-up data for Absorb scaffolds : N=187 (96.2%)

Baseline demographics and clinical characteristics2 year follow-up Riga Absorb registry data

N=187 N (%)

MaleFemale

147 (78.6)40 (21.4)Female 40 (21.4)

Mean age (years) 56.74 ± 11.85

Arterial hypertension 151 (80.7)

Dyslipidemia 129 (69.0)

Diabetes mellitus 33 (17.6)

Smoking 29 (15.5)Smoking 29 (15.5)

Previous myocardial infarction 65 (34.8)

Previous PCI 77 (41.2)

Pervious CABG 5 (2.7)Pervious CABG 5 (2.7)

Previous cerebral infarction 10 (5.3)

Peripheral artery disease 8 (4.3)

Chronic heart failure 73 (39.0)

Chronic kidney disease 10 (5.3)

Clinical presentation2 year follow-up Riga Absorb registry data2 year follow-up Riga Absorb registry data

N=187 N (%)

Stable angina 148 (79.1)

Silent ischemia 4 (2.1)Silent ischemia 4 (2.1)

Unstable angina 11 (5.9)

Non-STEMI 6 (3.2)Non-STEMI 6 (3.2)

STEMI 18 (9.6)

Multi-vessel disease 115 (61.5)Multi-vessel disease 115 (61.5)

Lesion characteristics2 year follow-up Riga Absorb registry data2 year follow-up Riga Absorb registry data

N=187 N (%)

Target lesion vessel:• Left main (LM)• Left anterior descending (LAD)• Left circumflex (LCX)

2 (1.1)93 (49.7)27 (14.4)• Left circumflex (LCX)

• Right coronary artery (RCA)• First diagonal brunch (D1)• Marginal brunch (OM)

27 (14.4)47 (25.1)

6 (3.2)7 (3.8)• Marginal brunch (OM)

• Ramus intermedius (RIM)7 (3.8)4 (2.1)

Target lesion localization:• Ostial• Proximal

34 (18.2)123 (65.8)• Proximal

• Middle• Distal

123 (65.8)113 (60.4)24 (12.8)

True bifurcation lesion 28 (14.9)True bifurcation lesion 28 (14.9)

Procedural characteristics2 year follow-up Absorb registry data2 year follow-up Absorb registry data

N=187 N (%)

Radial approach 142 (75.9)

IVUS use 32 (17.1)

OCT use 31 (16.6)

GP-IIbIIIa inhibitors 112 (59.9)GP-IIbIIIa inhibitors 112 (59.9)

Pre-dilatation:• Regular balloon• Cutting balloon

173 (92.5)86 (50.3)87 (49.7)• Cutting balloon 87 (49.7)

Mean pre-dilatation balloon diameter (mm) 2.92 ± 0.48

Mean pre-dilatation balloon length (mm) 15.80 ± 8.66

Mean scaffold length (mm) 20.10 ± 6.48Mean scaffold length (mm) 20.10 ± 6.48

Mean scaffold diameter (mm) 3.17 ± 0.36

Post-dilatation 173 (92.5)

Post-dilatation balloon diameter (mm) 3.46 ± 0.41

Post-dilatation balloon maximal atmospheres 17.11 ± 3.34

Riga Absorb registry data2 year clinical follow up – all patients2 year clinical follow up – all patients

N (%)

Hospital death (n=187) 2 (1.1)Hospital death (n=187) 2 (1.1)

Hospital scaffold thrombosis (n=187) 1 (0.5)

Hospital myocardial infarction (n=187) 1 (0.5)

Clopidogrelresistance

Hospital myocardial infarction (n=187) 1 (0.5)

All reason death (n=178) 8 (4.3)All reason death (n=178)• Cancer• Cardiovascular• Unknown

8 (4.3)3 (1.6)2 (1.1)3 (1.6)Unknown 3 (1.6)

Myocardial infarction (n=178) 3 (1.7)

Cerebral infarction (n=178) 3 (1.7)

Major Bleeding (n=178) 2 (1.1)Major Bleeding (n=178) 2 (1.1)

Scaffold thrombosis (n=178) 1 (0.5)

Riga Absorb registry data2 year clinical follow up – all patients2 year clinical follow up – all patients

N (%)N (%)

In-scaffold restenosis (angio. detected)(n=82)

5 (6.1)(n=82)

Restenosis type:• Focal

Diffuse1 (1.2)4 (4.9)• Diffuse 4 (4.9)

Treated in-scaffold restenosis (n=82) 4 (4.9)

Target lesion revascularization (n=178) 7 (4.0)Target lesion revascularization (n=178) 7 (4.0)

Target vessel revascularization (n=178) 15 (8.6)

Repeat elective PCI (n=178) 51 (27.3)Repeat elective PCI (n=178)• Repeat PCI in target lesion

51 (27.3)7 (4.0)

Riga Absorb registry data2 year clinical follow up separate in patient groups2 year clinical follow up separate in patient groups

Stable angina%(n)

Acute patients%(n)

Hospital death 0.6 (1/158) 3.4 (1/29)Hospital death 0.6 (1/158) 3.4 (1/29)

Hospital scaffold thrombosis 0.6 (1/158) 0

Hospital myocardial infarction 0.6 (1/158) 0Hospital myocardial infarction 0.6 (1/158) 0

All reason death 3.8 (6/157) 0All reason death• Cancer• Cardiovascular• Unknown

3.8 (6/157)1.9 (3/157)1.3 (2/157)1.9 (3/157)

0000

Myocardial infarction 0.6 (1/157) 7.1 (2/28)

Cerebral infarction 1.9 (3/157) 0

Major Bleeding 1.3 (2/157) 0Major Bleeding 1.3 (2/157) 0

Scaffold thrombosis 0.6 (1/157) 0

Riga Absorb registry dataRiga Absorb registry data2 year clinical follow up separate in patient groups

Stable angina%(n)

Acute patients%(n)

In-scaffold restenosis 6.9 (5/72) 0In-scaffold restenosis

Restenosis type:• Focal

6.9 (5/72)

1.4 (1/72)

0

0• Focal• Diffuse

1.4 (1/72)5.5 (4/72)

00

Treated in-scaffold restenosis 5.6 (4/72)

Target lesion revascularization 4.5 (7/157) 0Target lesion revascularization 4.5 (7/157) 0

Target vessel revascularization 7.6 (12/157) 10.7 (3/28)

Repeat PCI 21.6 (41/157) 35.7 (10/28)Repeat PCI• Repeat PCI in target lesion

21.6 (41/157)4.5 (7/157)

35.7 (10/28)0

Hospital scaffold thrombosis case(2013 (N o80 inregistry))(2013 (N o80 inregistry))

LAD ostial lesion 75%• Male 57year old• Stable angina class II• Staged for elective PCI

LAD ostial lesion 75%

• Staged for elective PCILAD 27.08.2013.

• Radial approach 6F,• Predilat. with cutting balloon 3.25x10mm• Absorb 3.0x18 mm• Absorb 3.0x18 mm• NC – 3.5x12 mm

Hospital scaffold thrombosis case(2013 (N o80 inregistry))(2013 (N o80 inregistry))

Final angio.

Last angio. image 28. 08.2013

Positive clopidogrelresistance test by VASP!!!

Early scaffold thrombosis case(2012 (N o4 inregistry))(2012 (N o4 inregistry))

LAD/D1 bif.lesion > 75%

Male 65 year oldStable angina class II-III PCI – RCAwith BMS 09.11.2012.with BMS 09.11.2012.Dyslipidaemia,hypertension,Previous PCI – RCA with BMSStaged for elective PCI LAD/D111.12.2012.11.12.2012.

• Radial approach 6F,• Predilat. LAD and D1 with cutting balloon 2.75x15mm• LAD 3 Synergy stents• LAD 3 Synergy stents• D1 – Absorb 2.5x28 mm• NC – 3.5x15 mm LAD and 2.5x15mm D1

Early scaffold thrombosis case(2012 (N o4 inregistry))

D1

IVUS before scaffoldafter 4bar CBafter 4bar CB

OCT middle part of scaffoldFinal angio.

Early scaffold thrombosis case(2012 (N o4 inregistry))(2012 (N o4 inregistry))

Scaffold thrombosis day 5Scaffold thrombosis day 5

• NC balloon 2.5x8 mm – 17 bar• GPIIbIIIa infusion 48 hours

• TIMI III after 3 month angio. control

• Bioresorbable scaffolds are future in vessel• Bioresorbable scaffolds are future in vesselrestoration therapy

• Scaffold implantation should be done using• Scaffold implantation should be done usingimaging guidance and control (followingmeasurements)measurements)

• Operator skills and experience are veryimportant to achieve good long term resultimportant to achieve good long term result

• Long term DAPT should be considered

03.March.2017