DEB experience in Gachon Universtiy Gil Hospital (in ISR) Soon Yong Suh MD., PhD. Heart Center Gachon University Gil Hospital Seoul, Korea.

DEB experience in Gachon Universtiy Gil Hospital (in ISR) Soon Yong Suh MD., PhD. Heart Center Gachon University Gil Hospital Seoul, Korea.

In-stent restenosis (ISR) Remains important issue even in the drug eluting stent(des) era. Drug eluting balloon(deb) have emerged as potential alternative to treatment of ISR.

Why Drug Eluting Balloon (DEB) Disadvantages & Risk factors of DES DES are not convincing for complex cases; Instent restenosis (ISR), bifurcation, small vessel disease Risk of restenosis at stent margin Crossability of DES is inferior to BMS Risk of late stent thrombosis (ST) Antiplatelet therapy required for at least 12 months due to delayed healing

Why Drug Eluting Balloon (DEB) Advantages of Drug Eluting Balloon (DEB) Homogeneous drug distribution For ISR; Customized target lesion drug delivery Polymer-free ; prevention of late thrombosis Excellent Crossability Faster healing (no stent implantation) Antiplatelet therapy for only 1~3 months required

DEB in BMS ISR PACCOCATH ISR I PACCOCATH ISR II PEPCAD II Long term follow up of PACCOCATH ISR I,II

PACCOCATH ISR I

PACCOCATH ISR II PACCOCATH ISR I / II Clin Res Cardiol 2008; 97: 779-81

The PEPCAD (Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease) II

Long term follow up of PACCOCATH ISR I,II J Am Coll Cardiol Intv 2012;5:323 30

DEB in DES ISR DEB in SES ISR PEPCAD-DES

DEB in SES ISR J Am Coll Cardiol Intv 2011;4:149 54

PEPCAD-DES Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. J Am Coll Cardiol. 2012;59:1377-82

CASE 1 57/M, chest pain PHx UA, DM, HTN 2002 PCI with BMS in proximal LAD 2006 PCI with DES in mid RCA, distal LAD

Coronary angio RCA; Cypher 3.5x33mm plad ; S7 3.5x 24mm dlad ; Cypher 2.75x23mm

predilation Trek 3.0x15mm, 10atm Trek 3.0x15mm, 14atm

Target drug delivery DEB 3.0x26mm, 10atm DEB 3.5x20mm, 8atm

Final Angio Linear dissection without flow limitation

Case 2 M/57, Chest pain 2005. 6 distal LCX; Taxus 3.0x32mm, proximal LCX; Cypher 3.5x18mm (OVERLAPPED) 2007. 4 PCI mid LAD; Cypher 3.5x28mm Proximal LCX (ISR) ; Cypher 3.5X13mm

Coronary angio 3 DES in plcx, 1 DES in LAD

Successful wiring to distal LCX with microcatheter back up

predilation 1.5x15mm ikazuchi balloon upto 14atm

predilation 2.5x15mm sequent balloon upto 16atm

Predilation, again

Drug delivery without stent struts DEB 2.5x26mm upto 10atm 90sec DEB 2.5x26mm upto 12atm 90sec

Final angio Treat ISR without additional stent struts

Clinical outcomes of drug eluting balloon (DEB) in treatment of coronary in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) and drug eluting stent (DES) Gachon Experience

Background Treatment of coronary in-stent restenosis (ISR) is still high incidence of recurrence of ISR. We aimed to compare the efficacy and safety of a paclitaxel drug eluting balloon (DEB) in treatment of ISR to POBA and DES.

Methods We reviewed 177patients (190 lesions, male 70.6%, mean age 64.1±11.7 years) who treated ISR with DEB or POBA or DES from January 2006 to May 2012. The primary end point was major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization)

Result We reviewed 177 patients, 190 ISR lesions Sixty five patients treated with POBA and 54 patients with DES, and 58 patients were treated with DEB. Mean clinical follow up was 16.3±11.2 months.

Baseline Characteristics POBA ( N=65) DES ( N=54) DEB ( N=58) P Age (years) 64.2 ± 12.7 64.8 ± 10.8 63.3 ± 11.8 NS Male 75.4 % 74.1 % 62.1 % NS Hypertension 67.7 % 48.1 % 62.1 % NS Diabetes 41.5 % 37 % 43.1 % NS Smoker 26.2 % 22.2 % 13.8 % NS Dyslipidemia 7.7 % 5.6 % 10.3 % NS Previous CABG 0 % 0 % 6.9 % 0.015 Previous MI 40.0 % 48.1 % 17.2 % 0.002

Target vessel POBA ( N=65) DES ( N=54) DEB ( N=58) Angiographic character LM 3.0 % 0 2.9 % LAD 46.3 % 50.0 % 50.3 % LCX 22.4 % 13.0 % 14.5 % RCA 28.4 % 37.0 % 36.2 % Previous stent Diameter 3.0 ±0.4 3.1 ± 0.4 3.0 ± 0.4 NS Length 24.2 ± 7.3 21.7 ± 5.5 22.5 ± 6.3 NS BMS 17.9 % 44.4 % 15.9 % 0.001 DES 77.6 % 44.4 % 66.7 % 0.001 ISR pattern I (focal) 56.7 % 59.3 % 59.4 % II (diffuse) 19.4 % 11.1 % 33.3 % III (proliferative) 11.9 % 7.4 % 0 IV (occlusive) 9.0 % 20.4 % 4.3 % P NS 0.004

Procedural character (DEB) Predilation 100 % DEB diameter 3.0 ± 0.3 mm DEB length 21.8 ± 4.4 mm Inflation time 45.6 ± 23.7 sec Inflation pressure 10.5 ± 2.4 atm Additonal stent use (BMS) 10.3 %

Result During the follow up, overall, total major adverse cardiac events were 20 (11.2%). There were 6 cardiac deaths (3.3%), one myocardial infarction (0.6%), and 13 target lesion revascularization (7.3%) But there was no difference between 3 groups (Table).

MACE POBA ( N=65) DES ( N=54) DEB ( N=58) Cardiac death 3 (4.5%) 2 (3.7%) 1 (1.7%) NS Myocardial Infarction 0 1 (1.9%) 0 NS P Target Lesion Revascularizatioin (TLR) 7 (10.4%) 2 (3.7%) 4 (7.1%) NS Total MACE 10 (14.9%) 4 (7.1%) 6 (10.7%) NS

Event free survival P=NS Months

Conclusion Treatment of coronary in-stent restenosis with DEB showed feasible and relatively low MACE compared to POBA and DES in small and short-term of this study. But large and long term clinical and angiographic follow up will be needed.

Potential Complication Acute thrombosis No reflow phenomenon Aneurysm formation Korean Circ J 2012;42:431-433 Catheter Cardiovasc Interv 2012

SUMMERY The DEB enhances the therapeutic modality of interventional cardiologists. The use of DEBs in selected patients may be considered as an alternative to use of DES, because of the possible reduction in the duration of dual antiplatelet therapy and avoid of the stent-in-stent approach (no second layer of metal).