Drug-coated balloon in primary PCI for stemi

DRUG-COATED BALLOON 
IN PRIMARY PCI FOR STEMI 
 Ho Hee Hwa 
 Background 
 Primary percutaneous coronary intervention 
(PPCI) is the preferred reperfusion therapy for ST 
elevation myocardial infarction (STEMI) 
 Associated with higher reperfusion rates (vs lytic) 
 ↓ rates of reinfarction, CVA and death 
 Started with primary angioplasty (POBA) 
 Associated with abrupt closure, recurrent ischaemia ; occlusion and 
restenosis at 6 mths 
 PAMI-STENT(1999) 
Routine implantation of bare metal stents associated with ↓ TVR 
 6 mth mortality rate was similar 
 CADILLAC STUDY (2002) 
Routine implantation of bare metal stents associated with ↓ TVR 
 6 mth mortality rate was similar 
Use of DES in PPCI for STEMI 
 Trials evaluating use of DES in AMI 
(Typhoon, Passion, Sesami,etc) 
 Meta-analysis of 7 trials: similar mortality 
benefit compared to BMS but ↓TLR in DES 
 Recent trial : Comfortable AMI (risk of MACE 
at 1 year lower with the biodegradable 
polymer BioMatrix stent 
5.3%
4.3%3.7%
6.0%
7.8%
11.2%
12.6%
20.0%
DES BMS
STRATEGY 8 mo 
(n = 175) 
TYPHOON 12 mo 
(n = 700) 
SESAMI 12 mo 
(n = 320) 
PASSION 12 mo 
(n = 619) 
P =0.23 
Drug-eluting stents in AMI 
(RCTs) TLR 
P <0.001 P <0.001 P =0.006 
 Coronary Stenting 
 Stenting generally accepted as routine 
revascularisation strategy 
 ACC/AHA 2013 ESC 2014 
Recommendation I I 
 LOE A A 
 Primary PCI in STEMI 
 Is it feasible to use DEB during PPCI? 
Issues with DEB in PPCI 
 Is DEB effective in a thrombus-laden 
artery? 
 Can pt tolerate prolonged balloon 
inflation? 
 Are we willing to accept a less than perfect 
result? 
 DEB in STEMI 
 DEB-AMI (drug eluting balloon in acute ST-segment 
elevation myocardial infarction) trial: a multicenter 
randomized comparison of DEB + BMS versus BMS 
versus DES in PPCI with 6-month angiographic, 
intravascular, functional, and clinical outcomes. 
 In STEMI patients, DEB + BMS implantation failed to show 
angiographic superiority to BMS only. 
 Angiographic results of DES were superior to both BMS and 
DEB. 
J Am Coll Cardiol. 2012 Jun 19;59(25):2327-37. 
X 
TTSH PPCI-DEB Registry 
 Clinical Efficacy and Safety of Drug-Coated 
Balloon Angioplasty as Primary Therapy 
 in PPCI 
 PPCI Strategy for DEB 
 Aspirate + Predilate 
 Dissection Type A-B 
 TIMI 3 flow 
 Residual stenosis < 30% 
 TIMI thrombus grade 1-2 
 DEB 
PPCI Strategy for DEB 
 Bail-out stenting when there is significant 
recoil/dissection ( > type B) 
TTSH PPCI DEB Registry 
 Study Period: Jan 2010 to April 2014 
 Number of Patients: 97 patients 
 Number of Lesions: 97 lesions 
 Male: Female (%) = 83: 17 
 Mean age : 60 + 12 yrs 
 Clinical Presentation: N/(%) 
 Ant STEMI 50(51) 
 Inf/post STEMI 47 (49) 
 LVEF (%) : 42 + 11 
TTSH PPCI DEB Registry 
 CVS Risk Factors: N/(%) 
 Smoking 48 (50) 
 Diabetes mellitus 33 (34) 
 Hyperlipidemia 50 (52) 
 Hypertension 55 (57) 
 Prior MI 13 (13) 
 Prior PCI 13 (13) 
TTSH PPCI DEB Registry 
 Angiographic and Procedural Variables: 
 No. of vessel disease N/(%) 
 1VD 38 (39) 
 2VD 33 (34) 
 3VD 26 (27) 
 Bifurcation 46 (47) 
 Glycoprotein IIb/IIIa inhibitors 78 (80) 
TTSH PPCI DEB Registry 
 Target Vessel for PCI N/(%) 
 LAD 43 (44) 
 RCA 23 (24) 
 CIRC 14 (14) 
 Others 17 (17) 
* Others include diagonal, PL/PDA, OM 
Proximal LAD (de novo ) 12 (12) 
TTSH PPCI DEB Registry 
 PCI details: N/(%) 
 Thrombosuction 50 (52) 
 Predilatation 100 (100) 
TTSH PPCI DEB Registry 
Baseline Thrombus Grade : N/(%) 
 Grade 5 58 (60) 
Thrombus Grade before DEB N/(%) 
 Grade 0 45 (46) 
 Grade 1 45 (46) 
 Grade 2 7 (7) 
TTSH PPCI DEB Registry 
 PCI details: N/(%) 
 POBA (DEB-only) 93 (96) 
 Stent (DEB+BMS) 4 (4) 
 Post PCI TIMI flow 
 TIMI 2 2 (2) 
 TIMI 3 95 (98) 
 Residual stenosis (%) 27 + 14 
TTSH PPCI DEB Registry 
 PCI details: N/(%) 
 Inflation time 53 + 21 s 
 Inflation pressure 10 + 3 atm 
 Reference diameter ,mm : 2.45 + 0.5 
 Mean number of DEB : 1.3 + 0.6 
 Mean size of DEB, mm : 2.6 + 0.5 
 Length of DEB, mm : 24 + 11 
TTSH PPCI DEB Registry 
Clinical Outcomes (1 Month): N= 97/(%) 
 All cause mortality 4 (4) 
 MI 0 (0) 
 TLR 0 (0) 
 Lesion thrombosis 0 (0) 
TTSH PPCI DEB Registry 
 Clinical Outcomes (9 Month): N=93/(%) 
 MACE 6 (6.4) 
 All cause mortality 1 (1) 
 MI 2 (2.1) 
 TLR 5 (5.4) 
 Lesion thrombosis 0 (0) 
June 2015 
 CASE EXAMPLES 
DCB in Primary PCI 
Anterior STEMI in Aug 2014 
DCB in Primary PCI 
DCB 2.5 x 20 RCA 
Progress 
 Pt developed inferior MI ( > 1 yr later) 
August 2014 October 2015 
LAD 
August 2014 October 2015 
DCB in Primary PCI 
DCB 2.5 x 30mm 
DCB in Primary PCI 
“First-in-Man” DCB Angioplasty in A Patient with 2 STEMIs 
Int J Cardiol. 2016 Mar 28;214:19-20 [Epub ahead of print] 
KISS strategy in bi/tri-furcation 
Keep it simple and straightforward! 
KISS strategy in bi/tri-furcation 
SP 3.5*15; 3.0*17 
3 Uses of DEB in PPCI 
 POBA of de novo lesion 
 POBA of late/very late stent thrombosis 
 Adjunctive therapy for diffuse lesion 
 DEB for very late ST 
Avoid stent-in stent approach 
 DEB as adjunctive therapy 
DEB 3.0 x 20 
Avoid excessive metal 
Stent thrombosis in STEMI 
 Horizons-AMI - Stent thrombosis ~ 3.5% 
 Comfortable-AMI 
 - 0.9% (BES) ; 2.1% (BMS) at 1 year 
 - 1.4 % (BES) ; 2.6 % (BMS) at 2 years 
 ST Rate ~ 1 to 3.5% 
Risk of Stent Thrombosis 
 Treatment of Coronary Artery Disease 
Pure Old 
Balloon 
Angioplasty 
(POBA) 
Bio-
absorbable 
Scaffold 
Bare Metal 
Stent (BMS) 
POBA 
again? 
>> DEB 
Drug Eluting 
Stent (DES) 
 PCI Cycle 
1980s 
1990s 
2000 
2010 
 NEW ERA: 
 Leaving Nothing Behind! 
 Conclusion 
 Use of DEB in PPCI for STEMI ( as primary 
therapy/adjunctive therapy) is feasible in 
selected grp of pts 
 Can be used in de novo, VLST and 
adjunctive therapy 
 Careful patient selection 
Tips and tricks in using DEB 
in PPCI 
 PCI approach: aspirate >> predilate >> DEB 
 Gp2b/3a inhibitors 
 Know how to grade dissection 
 THANK YOU 
 PAPPA study 
 EuroIntervention. 2014 Sep;10(5):584-90. 
 Safety and feasibility of a PAclitaxel-eluting balloon 
angioplasty in Primary Percutaneous coronary 
intervention in Amsterdam (PAPPA): one-year clinical 
outcome of a pilot study. 
 MACE at 1 year is low – 5% 
 2 deaths and 3 TLRs 
 PAPPA study 
 Recruited 100 patients 
 59 patients – DCB-only ; High rate of bail-
out stenting – 41 pts (41%) 
 Thrombus aspiration (96%) 
 Predilatation 
 DCB (Pantera Lux) with B:V > 1.1 ; 
minimum 60s 
 DES vs BMS 
NEJM Sept 2016 
 NORSTENT Study 
NEJM Sept 2016 
TTSH PPCI DEB Registry 
 Target lesion revascularisation: N=5 
 - All patients underwent CABG 
 - 2 cases of “true” restenosis 
 - 3 underwent CABG as part of 
 revascularisation strategy for TVD 
 DEB for de novo lesion 
SP 2.5*26 
SP 3.0*17 
 Acute Closure 
 No acute closure in our study 
 Careful patient selection