IN STENT RESTENOSIS IN THE DES ERA

EFTIHIA SBAROUNI, FESC, FACC

DES ISR

• 5-10% overall, 10-20%recurrent ISR

• Low rate but not benign

• Outcomes worse with DES ISR vs

BMS ISR

Differences BMS and DES restenosis

• Diffuse pattern more

common

• LL max by 6-8 months

• Endothelialization 3-6

months

• Neoatheroscalerosis

infrequent, late

• Focal pattern more

common

• LL up to 5 yrs

• Endothelialization up to 48

months

• Neoatheroscalerosis

frequent, early

Rittger H et al. JACC 2012;59:1377-82

DEB for ISR (1)

• 436 DES and 114 BMS

• Early angio (6-12 months, 89% lesions)

• Late angio (12-24 months, 88% lesions)

• Early:21.1% vs 13%, TLR:13.9% vs 7%

• Late:16.8% vs 2.5%, TLR 24.2% vs 8.7%

• No difference between 1st and 2nd

generation

Habara et al. JACC 2015;66:14-22.

DEB for ISR (2)

Early

<2.5mm

% diameter stenosis post-PCI

In-stent occlusion

Late

DES-ISR

Hemodialysis

% diameter stenosis at early angio

Habara et al. JACC 2015;66:14-22.

DEB

• Predilation

• Balloon length to cover 2mm at both

proximal and distal margins

• Inflation time for 60 seconds

• No post-dilation

Unanswered qs for DEB

• ? Better lesion preparation with

cutting balloon

• ? Limus more effective

– Superior antiproliferative with metal

stents

• Duration of DAPT

Cutting and scoring balloon

• Cutting

– Simple

– Avoids balloon slippage outside stent

– Deep incision

• Scoring

– More flexible and deliverable

• RESCUT: BMS ISR cutting vs BA similar results

Song H-J et al JACC 2012;59:1093-100

ISAR-DESIRE-2

JACC 2010;55:2710-6

ISAR-DESIRE-2

Torguson r et al AJC 2006;98:1340-4

Brachytherapy

• Brachyterapy superior to BA and ablation

• Issues – geographic miss,

– Edge restenosis

– delayed healing

• SISR,TAXUS V ISR: BMS ISR DES vs radiation. DES better

• Meta-analysis DES vs BT ISR: no difference in AMI, death, TLR

Rotablation

• Only BMS diffuse ISR

– ROSTER (small single center) BA vs

rota positive

– ARTIST (large multi-center) BA vs rota

negative

11 RCT’s for ISR

• BMS and DES

• Superiority DEB and DES vs POBA

• DEB vs DES

– Comparable efficacy (TLR)

– Trend for lower risk of AMI and all cause

mortality for DEB

Lee et al JACC cardiovasc interv 2015;8:382-94.

Network meta-analysis

• 27 trials, 5932 pts, 6-60 months f/up

• 17 BMS, 10 DES

• 2001-2014

• EES, PCB, SES, PES, VBT, BMS, BA, ROTA

• EES: restenosis, TLR

• PCB:2nd best (similar to SES, PES but without new layer)

Siontis et al; Lancet 2015:386:655-64

Kawamoto et al. JACC interv 2015

Kawamoto et al. JACC interv 2015

Kawamoto et al. JACC interv 2015

Kawamoto et al. JACC interv 2015

Conclusions

• DES ISR rare but more complex

• DES ISR DES or DEB

– Better than POBA

– Always IVUS

– DEB: less metal layers, less DAT, large side branch,

multiple times

– DES: better acute gain (large volume of hyperplastic

tissue), stent fracture, edge restenosis, suboptimal

result post DEB

Recurrent ISR DES

• 2008-2013

• 171 lesions

• 82 → 2nd gen DES, 68 → DCB

• Acute gain 2.09±0.53 mm vs 1.60±0.62 mm, p<0.001

• MACE 14% vs12.3% at 1 yr, ns

• MACE 28.8%43.5% at 2 yrs, ns

• Mostly TLR (ns)

• Lesion length, early recurrence (within 1 year) independent predictors

Kawamoto et al; JACC card interv 2015:

BMS ISR

• RIBS I

– BA VS BMS: no difference

• ISAR DESIRE

– SES VS PES VS BA : BA worse

• RIBS II

– SES VS BA :BA worse

BMS vs DES

Reduction of TLR but prolonged DAT

One month for BMS

Twelve months for DES

Useful for subsets with high risk of

restenosis

LMS, SVG, DM, ISR, bifurcation lesions,

small vessels, long lesions, multiple

lesions

DES STENTS

• 1ST generation

– SES not manufactured

– PES inferior (thrombosis, TLR)

• 2nd generation

– Everolimus

– Zotarolimus

- Better than 1st generation (safer, more

effective)

- Comparable efficacy and safety

ISR-general

• incidence

– BMS era ISR:20-40% of all PCI’s

– DES era ISR:3-20%

• Clinical presentation

– BMSUA 26-53%, AMI 5-20%

– DESUA 16-66%, AMI 1-20%

Cosgrave J et al JACC 2006;47:2399-404

Kandzari et al JACC interv 2011

Byrne et al JACC 2011

DES ISR

• Low rate but not benign

• Outcomes worse with DES ISR vs

BMS ISR

• Multiple mechanisms

– Stent underexpansion, stent fracture

– Residual uncovered atheroma

– Tissue hyperplasia (resistance to drug,

nonuniform drug deposition, or

hypersensitivity to stent)

ISAR DESIRE-2

• PES vs SES for SES ISR

– Similar results

– JACC 2010;55:2710-6.

Habara S JACC interv 2011;4:149-54

PEPCAD-DES

• PCB vs POBA for DES ISR

– PCB better

– JACC 2012 ; 59: 1377-82

ISAR-DESIRE 3

• PCB vs POBA vs PES for SES ISR

– DEB better than POBA

– DEB similar to PES

– LANCET 2013; 381:461-7.

Unanswered qs for DES

• Bioresorbable scaffolds

Cosgrave J et al Am H J 2007;153:354-9

Carg S et al CCI 2007;70:9-14

RIBS IV

• DEB vs EES for DES ISR

– EES better

– JACC 2015;66:23-33.

PCI

• POBA vs BMS

• Treatment of

abrupt closure

• Reduction of

restenosis

• BMS vs DES

• Reduction of

restenosis but

prolonged DAPT

BMS

• High bleeding risk

• Pending surgery

• Non-compliance

• Low restenosis risk in large vessels

Restenosis definition

• >50% diameter stenosis at the stent

or its edges (5mm adjacent to the

stent)

• 12% for DES if routine angiography

• Severity and pattern

Mehran et al Circulation 1999;100:1872-78

Cosgrave J et al 2006;47:2399-404

Costa et al AHJ 2007;153:447-9