Vai trò của stent tự tiêu trong điều trị bệnh lý nhiều thân mạch vành

Stents Vs Meds Absorb A Absorb B Absorb Extend Absorb II Absorb III/IV 60 months BVS Expand... Acute gain was reduced on QCA ABSORB: 1.15mm vs.. Reduced acute gain Operator’s behavio

BRS in Multivessel CAD

Faisal Latif, MD FACC FSCAI, Ramesh Daggubati, MD FACC FSCAI

Associate Chief of Cardiology Director of Interventional Cardiology Winthrop University Hospital

Mineola, NY USA

BVS ready for clinical use?

Stents Vs Meds

Absorb A Absorb B Absorb Extend Absorb II Absorb III/IV

60 months

BVS Expand

#Fact 1 Despite a larger profile (ABSORB: 1.4mm, vs Xience 1.1mm), device success was 99.2% in B1/B2 lesions (98.3%)

In registries (e.g ABSORB Expand), the device success was 98.2% in complex lesions

Propensity Matched Comparison of

#Fact 2 Acute gain was reduced on QCA (ABSORB:

1.15mm vs Xience: 1.46mm) and Q-IVUS (ABSORB:

#Comment:

• Guidance on angiography for sizing and expansion

• Angiography underestimate the luminal dimension

• Intravascular imaging for sizing and expansion might have implication for FDA labeling

Reduced acute gain

Operator’s behavior

• Limited expansion of device

• Fear of scaffold disruption

• Use of a smaller postdilatation balloon at a lower pressure

43.4% of patients had two or more diseased vessels

Per Patient Analysis

LAD 51.3%

LCX 19.6%

LMCA 0.4%

8

One Year Clinical Outcomes

Note: Clinical outcome data from those 1702 patients who complete 1 year follow-up

DoCE: device-oriented composite endpoint; PoCE: patient-oriented composite endpoint; DMR: all death, all MI, all

1.4% (24)

0.4% (7) 1.0% (17)

Multivariate Logistic Regression

Predictor Analysis for TLF

#Fact 2 Acute gain was reduced on QCA (ABSORB:

1.15mm vs Xience: 1.46mm) and Q-IVUS (ABSORB:

#Fact 3 The definite scaffold/stent thrombosis rate was 0.6% (1 acute and 1 subsacute) in the ABSORB arm vs 0% in the Xience arm

In the ABSORB Extend registry (Ishibashi et al EIJ 2014)

Non-Hierarchical % (n)

6 Months * 12 Months * (N=450) (N=450) Scaffold Thrombosis (ARC Def/Prob) 0.7 (3) 0.9 (4)

BVS overlap

BVS

BVS

• 2 cases related to interruption of/ or

resistance

to DAPT

• 1 related to overlap

• 1 unknown cause

2 subacute (day 6 and 29), 2 late(day 75 and 239)

#Fact 3 The definite scaffold/stent thrombosis rate was 0.6% (1 acute and 1 subsacute) in the ABSORB arm vs 0% in the Xience arm

• Underexpansion - Yes

• Overlap - Yes

• Possible scaffold disruption -?

• Malapposition –?

• Alternance of high and low

shear stress on protruding

RCA, patient 1023

RCA, Patient ID 100353-006

Mechanism of neointimal formation: Low ESS behind the strut will lead to neointimal formation which will smooth luminal surface

150

89

Post Proc

1Y

18M

Dilemma: The vessel size is >4.0mm, while the

device size is 3.0mm…The operator is aware of

ISA, but considering the expansion limit of 3.5mm,

the operator cannot correct malapposition by

• Stenosis in the OM branch treated with a 3.0X18 mm ABSORB BVS

• After Postdilatation with a compliant 3.5-mm balloon at 16 atm (expected diameter, >3.96 mm), OCT shows appearances consistent with strut breakage

Acute Disruption

1M later

In one patient out of 101 patients (ABSORB B study)

Overexpansion of a 3.0 mm ABSORB…

Ormiston et al Circ interv 2012

Capodanno et al Ghost EU registry, EuroIntervention 2014, ahead of print

Def/Prob ST Ghost-EU registry

1.189 patients treated with the Absorb scaffold

1.4%

N

ST in SAP, N (%)

ACS,

N

ST in ACS, N (%)

STEMI,

N

ST in STEMI,

N (%)

Kraak et al., AMC Single Centre

Abizaid et al, ABSORB EXTEND

Onuma et al., ABSORB A (JACC

Serruys et al., ABSORB II

Ielasi et al., RAI registry (EIJ in

Weighted average

including the

GHOST-EU registry

Average F/U: 10.3 Months 4309 0.16% 0.60% 0.76% 1.22% 1797 0.94% 973 2.16% 491 1.22%

Table 1 The rate of ST in individual populations *

* ST= scaffold thrombosis, SAP= stable/silent angina pectoris, ACS=acute coronary syndrome, STEMI=ST-segment elevation myocardial infarction

When excluding the Ghost EU,

In 3120 patients with a mean follow-up of 10.6 Months,

• Acute ST: 0.06%

• Subacute ST : 0.48%

• Total ST: 0.89%

• SAP 0.68%, ACS 1.71%, STEMI 0.67%

When including the Ghost EU,

In 4309 patients with a mean follow-up of 10.3 Months,

#Fact 4 Cardiac biomarker rise < 48 hours after the

index procedure and per-protocol peri-procedural MI did not differ between the two arms

Postprocedural CKMB rise

in the ABSORB II

#Fact 4 Cardiac biomarker rise < 48 hours after the

index procedure and per-protocol peri-procedural MI did not differ between the two arms

(N=335 pts) (N=166 pts) EES p value

Side branch occlusion after device implantation 2.7% 0.6% 0.18

coronary dissection after pre dilatation (NHLBI D or E) 0.3% 0% 1

Incidence of anatomic complications assessed by angiography in patients with

periprocedural MI

#Fact 4 Cardiac biomarker rise < 48 hours after the

index procedure and per-protocol peri-procedural MI did not differ between the two arms

When the cardiac biomarker rise was subcategorized

universal definition and the SCAI definition, PMI rates were:

• 5·2% vs 2·5% (CKMB >5x ULN)

• 32·0% vs 26·9% (troponin >5x ULN, 3 rd Universal)

• 0·6% vs 0·6% (CKMB >10x ULN, SCAI)

• 4·6 % vs 1·9 % (troponin >70x ULN, SCAI)

These results strongly emphasize the arbitrary

character of any definition of PMI

ABSORB 1-Year Meta-analysis

ABSORB II, ABSORB III, ABSORB Japan, ABSORB China

Meta-analysis summary

BVS (N=2164)

CoCr-EES (N=1225)

RR [95% CI]

Fixed effect P Value I 2

P het

NA = not applicable - cannot test for heterogeneity because no events were present in one cell in 3

of the 4 trials; het = heterogeneity

Baseline Angio

68 mm BVS: 28/3.0, 28/3.5, 12/3.5

Index Procedure 1y FU

Individualize the therapy

• BRS in multivessel disease is possible

• No RCT of BRS in MVD

• Registries show that there is small

periprocedural MI in MVD stenting with

BRS

We need data !!!