Drug-Coated-Balloon:

how to use in daily practice?

Dinh Duc Huy, MD, FSCAI

Tam Duc Heart Hospital

Why Drug-Coated-Balloon (DCB)?

1. Less metallic-device concept

2. With highly lipophilic drugs, even short contact times

between the balloon surface and the vessel wall are

sufficient for effective drug delivery

3. No risk of stent thrombosis

4. No stent strut across side-branch ostia

5. Shorter DAPT duration

6. Potential of allowing vessel to function normally

European Heart Journal (2019) 40, 87–165

PANTERA LUX DEB Paclitaxel Releasing Balloon Catheter

SEQUENT PLEASE Drug-Coated-Balloon

My take for DCB in daily practice

1. In-Stent Restenosis

2. Small vessel PCI

Case 1: complex clinical presentation

• 67 year-old male

• Valve surgery + CABG several years ago

• PCI with DES to LCx 4 years ago (stable angina)

• Admitted due to CCS3-4 angina (March 2019)

• CAG

o LIMA graft to LAD patent

o Saphenous graft to RCA patent

o ISR of LCx DES

• Failed with OMT

Case 2: restenosis kept on coming back!

• 67 year-old female, CAD, HTN, DM2

• DM: Poor controlled, HbA1C >9%

• PCI

o BMS RCA, LAD (2009)

o EES LAD due to 1st time ISR (2012)

o SES LAD due to 2nd time ISR (2014)

• March 2016: LAD ISR (50%), FFR >0.8 (2016)

• September 2019: High risk unstable angina due to

severe LAD ISR (3 layers of metallic stent in LAD)

2018 ESC Guidelines on myocardial revascularization: ISR treatment

European Heart Journal (2019) 40, 87–165

2nd generation DES Drug-coated balloon

RIBS V study: DCB (PEB) versus DES (EES) for BMS ISR

JACC 2014;63:1378-86

Similar clinical outcomes at 12 months

ISAR-DESIRE 3: PEB as treatment option for patients with DES restenosis

Lancet 2013; 381: 461–67

• PEB = PES (Diameter Stenosis)

• PEB and PES > Balloon Angioplasty

3-year ISAR-DESIRE 3

• PEB = PES (TLR or Death/MI)

• PEB > BA (TLR); PEB= BA (Death/MI)

J Am Coll Cardiol Intv 2015;8:877–84

Paclitaxel releasing balloon vs. DES Orsiro in ISR (BMS/ DES)

Naber, EuroPCR 2016

17.9%

2.1%

6.3%

13.5%

0.7% 0.7%

18.6%

1.4%

8.6%

11.6%

1.5% 2.9%

0%

5%

10%

15%

20%

25%

TLF CD TV MI Cl-TLR CABG ST

Full cohort – clinical events at 18 months DCB

DES

17.0%

3.8%

5.9%

9.8%

0.0% 2.0%

20.0%

4.0%

8.0% 8.3%

4.2% 4.0%

0%

5%

10%

15%

20%

25%

TLF CD TV MI Cl-TLR CABG ST

BMS-ISR – clinical events at 18 months

DCB

DES

18.7%

1.1%

6.6%

15.7%

1.1% 0.0%

17.8%

0.0%

8.9%

13.3%

0.0% 2.3% 0%

5%

10%

15%

20%

25%

TLF CD TV MI Cl-TLR CABG ST

DES-ISR – clinical events at 18 months

DCB

DES

Clinical follow-up at 12 months & 18 months

TLF: Composite of cardiac death, target vessel MI, CABG and

clinically driven target lesion revascularization

Naber, EuroPCR 2016

Meta-analysis: DCB versus DES for ISR treatment Cai J-Z, et al. BMJ Open 2018

• DES: significant higher

acute luminal gain

• DES: significantly

reduced the risk of TLR

• No statistical differences for

-MACE

-MI, Cardiac death

J Am Coll Cardiol Intv 2019;12:558–66

• 50 patients with DES ISR

• Novel SCB (SeQuent SCB, 4 mg/mm2)

vs. clinically proven PCB (SeQuent

Please Neo, 3 mg/mm2)

• After 6 months, in-segment LLL

0.21±0.54 mm (PCB) versus

0.17±0.55 mm (SCB) (p= NS)

• Similar clinical events up to 12 months

New generation DCB is coming!

Imaging- guided algorithm for ISR

http://www.scai.org/QITTip/tips-tricks-management-of-in-stent-restenosis (February 2019)

Case 1: how to?

• 67 year-old male, CCS3-4 angina

• Valve surgery + CABG several years ago

• DES ISR of LCx @ bifurcation with big OM

• If DES was considered for the 2nd intervention:

o May need 2-stent technique

o Too much metallic material (2 DES for LCx, 1

DES for OM)

o Complex antithrombotic therapy

• DCB seemed to be a good potion

• 2 DCBs angioplasty did good angiographic results

Case 2: 2.5 SE balloon- 3.0 NC balloon- 3.0/40 mm DCB with good result

PCI to treat small vessel disease (≤2.75 mm in diameter)

• Challenging lesions

• Higher risk of retenosis & TLR

• Higher MACE rates

• DES is beneficial in randomised trials

• DCB?

o Can be as good as DES

o (benefits seen in a small study - BELLO)

• Prospective, multicenter, randomized trial

• 182 patients with lesions in SV (RD < 2.8 mm)

• Paclitaxel DEB and provisional BMS (n=90) vs. PES (n=92)

• PE: non-inferiority of angiographic in-stent (in-balloon)

Late Loss (with Δ= 0.25 mm)

• SE: angiographic restenosis, TLR, & MACE (death, MI, TVR)

at 6 months (similar in between 2 groups)

0.08±0.38 mm vs. 0.29±0.44 mm

difference -0.21; 95% CI: -0.34 to -0.09

P noninferiority <0.001; P superiority =0.001

J Am Coll Cardiol 2012;60:2473–80

In-stent (in-balloon) late loss was

significantly less with DEB vs. PES

A Propensity Score Matched Comparative Study Between PCB and EES

for the Treatment of Small Coronary Vessels

Catheterization and Cardiovascular Interventions 90:380–386 (2017)

Similar clinical outcomes in between paclitaxel-DCB & 2nd-EES in small vessel

• multicentre, open-label, randomised

non-inferiority trial (n= 758)

• DCB versus 2nd-generation DES

after successful pre-dilatation (1:1)

• PE: non-inferiority of DCB versus

DES regarding MACE (death/MI/TVR)

Jeger RV. Lancet. 2018; 392: 849-856

BASKET-SMALL 2: MACE (12 months)

HR 0.97, 95% CI 0.58 to 1.64; p=0.9180

DCB – 7.5% DES – 7.3%

Jeger RV. Lancet. 2018; 392: 849-856

BASKET-SMALL 2: Single Components of MACE (12 Months)

3.1 vs. 1.3%; HR 2.33,

95% CI 0.82 to 6.61; p=0.1131

1.6 vs. 3.5%; HR 0.46,

95% CI 0.17 to 1.20; p=0.1123

3.4 vs. 4.5%; HR 0.75,

95% CI 0.36 to 1.55; p=0.4375

Cardiac Death

Non-fatal Myocardial Infarction

Target-vessel Revascularization

Jeger RV. Lancet. 2018; 392: 849-856

BASKET-SMALL 2: Major Bleeding BARC ≥3 (12 Months)

1.1 vs. 2.4%; HR 0.45, 95% CI 0.14 to 1.46; p=0.1834

Jeger RV. Lancet. 2018; 392: 849-856

BASKET-SMALL 2: Conclusions

• First large RCT testing the efficacy and safety of a paclitaxel-iopromide-coated DCB vs. 2nd -generation

DES in a large all-comer population regarding clinical endpoints

• DCB are non-inferior to DES in lesions of small native coronary arteries (MACE up to 12 months)

• Small native coronary artery disease may safely be treated with DCB after successful predilatation

• No permanent material is implanted in the coronary artery potentially translating in a reduced

number of very late adverse events (long-term follow-up is needed)

Jeger RV. Lancet. 2018; 392: 849-856

J INVASIVE CARDIOL 2018;30(7):256-261. Epub 2018 April

Alfonso F., Scheller B. EuroIntervention 2017;13:680-695

LCx PCI with both DCB & DES

RCA ISR

Summary 1. DCB is an attractive concept of treating lesions & leaving nothing

behind. Lesion preparation is key!

2. DCB to treat ISR: proven, Class I-A recommendation by ESC 2018

3. DCB to treat de novo coronary lesion of small vessel: shown to be as

good as DES; no caging of artery to preserve vessel function

(constrict and dilate)

4.Sirolimus-coated balloon has had very first promising result. Wait

for more data!

Thank you!