Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,

Randomized Comparison of Randomized Comparison of PtCr-EES PtCr-EES vs vs CoCr-ZESCoCr-ZES

in All-Comers Receiving PCIin All-Comers Receiving PCI

The HOST-ASSURE Randomized Trial The HOST-ASSURE Randomized Trial

Hyo-Soo Kim, MD/PhDKyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,

Byoung-Eun Park, Jay-Young Rhew, Hui-Kyung Jeon, In-Ho Chae

On Behalf of The HOST-ASSURE Trial Investigators

Seoul National University Hospital, Seoul, Korea

DisclosuresDisclosures

Kim HS reports receiving honorarium for

lectures and research grants from Boston

Scientific and Medtronic.

BackgroundBackground

• Second-generation DES have improved clinical outcome compared

with first-generation DES.

• Resolute (Medtronic, Minneapolis, MN, USA) is a CoCr-based

zotarolimus-eluting stent (CoCr-ZES) that showed equivalent

outcome to Xience (CoCr-based everolimus-eluting stent).

• Promus Element (Boston Scientific, Natick, MA, USA) is a PtCr-

based EES (PtCr-EES) that has limited clinical data regarding the

efficacy and safety.

• No study to compare Promus-Element vs. Resolute.

• No data on the real picture of longitudinal stent deformation

(LSD) in these newer generation DES based on the systemic review

of angiographs in the prospectively-collected cohort.

ObjectivesObjectives

[Hypothesis]

PtCr-EESPtCr-EES is Non-Inferior to CoCr-ZESCoCr-ZESRegarding Target Lesion Failure at 12 month

vs.

PtCr-EES (Promus-Element)

PtCr-EES (Promus-Element)

CoCr-ZES(Resolute)CoCr-ZES(Resolute)

Longitudinal Stent Deformation (LSD) : Longitudinal Stent Deformation (LSD) : a trade-off of thin struta trade-off of thin strut

How often does it happen? How often does it happen? Under what conditions does it occur? Under what conditions does it occur? How severe can it be? How severe can it be?

Study DesignStudy Design

PtCr-EES arm(N=2,500)

CoCr-ZES arm(N=1,250)

3,750 All Comers Receiving PCI3,750 All Comers Receiving PCI3,750 All Comers Receiving PCI3,750 All Comers Receiving PCI

Percutaneous Coronary InterventionPercutaneous Coronary Intervention

Coronary AngiographyCoronary Angiography

Target Lesion Failure at 12 Months Post-PCI (Intention-To-Treat Analysis)Target Lesion Failure at 12 Months Post-PCI (Intention-To-Treat Analysis)

2:1 Randomization

40 Centers in Korea

Prospective, single-blinded, randomized multi-center trial

Enrollment CriteriaEnrollment Criteria

General Inclusion Criteria

Angiographic Inclusion Criteria

Exclusion Criteria

• Age ≥18 years• Ability to verbally confirm understandings

of risks, benefits and treatment alternatives with written informed consent prior to any study-related procedure

• Significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts

• Evidence of myocardial ischemiaor diameter stenosis > 70%

• Target lesion in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.25 mm

• Target lesion amenable for PCI

• LVEF <25% or cardiogenic shock • Symptomatic heart failure• Life expectancy <1 year• History of bleeding diathesis, known

coagulopathy (including HIT), abnormal CBC (Hb < 10 g/dL or PLT < 100k /μL) or refusal of blood transfusions

• GI or GU bleeding ≤ 3 monthsor major surgery ≤ 2 months

• Known hypersensitivity/contraindication to heparin, aspirin, clopidogrel, cilostazol, everolimus, zotarolimus, or contrast media

• Systemic (intravenous) Everolimus or Zotarolimus use ≤ 12 months

• Female of childbearing potential• Actively participating in another drug or

device investigational study

Study EndpointsStudy Endpoints• Primary Endpoint: Target Lesion Failure at 12 Month Target Lesion Failure at 12 Month

(a composite of cardiac death, TV-related MI, and ischemia-driven TLR)

• Secondary Endpoints– Individual components of TLF: cardiac death, TV-related MI, ID-TLR– Patient-oriented composite outcome

: all-cause death, all-cause MI, all repeat revascularization– Definite or probable ST (according to ARC definition)

• Detection of Longitudinal Stent Deformation (LSD)

: by visual estimation of angiograph at index PCI

Statistical AssumptionStatistical Assumption

• Assumption : TLF

– 6.5% in PtCr-EES group

– 6.5% in CoCr-ZES group

TLF = 4 ~ 8% (COMPARE-II, PLATINUM, SPIRIT-IV, RESOLUTE-AC)

• Non-inferiority Margin: Hazard Ratio 1.5 (1-sided)

– Type I error (1-sided α): 2.5%

– Sampling ratio = 2:1

– Attrition rate: 5%

– Primary Analysis: Intention-to-treat analysis

– Statistical power >80% (β<0.20)

N=3,750

Non-inferiority Design for Primary Endpoint

(TLF at 12 Months)

Non-inferiority Design for Primary Endpoint

(TLF at 12 Months)

Hyo-Soo Kim

Web-based online randomization system

Dream CIS Inc. (contract research organization)

Seung-Woo Park, Young-Jin Choi, Kwangil Kim

Yong-Seok Kim, Sang Min Park, Kyung-Il Park(blinded to treatment allocation)

Trial CoordinationTrial Coordination

Random SequenceGeneration

Data Safety Monitoring Board

Data Management

Clinical Event Adjudication Committee

Principal Investigator

Hyo-Soo Kim, In-Ho Chae, Kwang Soo Cha,Byoung Eun Park, Jay Young Rhew, Hui-Kyung Jeon

Executive Committee

Participating CentersParticipating Centers40 major hospitals in Republic of Korea

Site PI

Seoul National University Hospital Kim, Hyo-Soo

Seoul National University Bundang Hospital Chae, In-Ho

Pusan National University Hospital Cha, Kwang Soo

Dankook University Hospital Park, Byoung Eun

Presbyterian Medical Center Rhew, Jay Young

Uijeongbu St. Mary’s Hospital Jeon, Hui-Kyung

Ulsan University Hospital Shin, Eun Seok

Samsung Changwon Hospital Oh, Ju Hyeon

Chonnam National University Hospital Jeong, Myung-Ho

Chungbuk National University Hospital Hwang, Kyung-Kuk

Wonju Christian Hospital Yoon, Jung-Han

Inje University Ilsan Paik Hospital Lee, Sung Yun

Boramae Medical Center Kim, Sanghyun

Dong-A Medical Center Park, Tae-Ho

Gangnam Severance Hospital Kwon, Hyuck-Moon

St. Vincent’s Hospital Moon, Keon Woong

Daegu Catholic University Medical Center Ryu, Jae-Kean

Keimyung University Dongsan Medical Center Hur, Seung-Ho

Daegu Fatima Hospital Lee, Bong-Ryul

Gyeongsang National University Hospital Park, Yong-Whi

Site PI

Konyang University Hospital Bae, Jang-Ho

Hallym University Kangdong Sacred Heart Hospital Han, Kyoo-Rok

Ewha Womans University Mokdong Hospital Park, Si-Hoon

Korea University Guro Hospital Rha, Seung-Woon

Hallym University Sacred Heart Hospital Park, Woo-Jung

Wongwang University Hospital Oh, Seok-Kyu

Korea University Anam Hospital Lim, Do-Sun

Kwangju Christian Hospital Lee, Seung-Wook

Hallym University Chuncheon Sacred Heart Hospital Hyun Hee Choi

Kyung Hee University Hospital at Gangdong Kim, Chong-Jin

Seoul Medical Center Kim, Seok-Yeon

Gachon University Gil Hospital Ahn, Taehoon

Samsung Medical Center Gwon, Hyeon-Cheol

Hallym University Kangnam Sacred Heart Hospital Lee, Namho

National Health Insurance Medical Center Jeon, Dong-Woon

Soonchunhyang University Hospital Hyun, Min-Soo

Daejun Eulji University Hospital Yu Jeong Choi

Hanyang University Guri Hospital Seong Il Choe

Kangwon National University Hospital Ryu, Dong Ryeol

Kosin University Gospel Hospital Cha, Tae-Joon

Trial FlowTrial Flow

Allocated to PtCr-EESAllocated to PtCr-EESN=2,503N=2,503

Allocated to CoCr-ZESN=1,252

Completed 1-Year F/UCompleted 1-Year F/UN=2,470 (98.7%)N=2,470 (98.7%)

Completed 1-Year F/UN=1,236 (98.7%)

9 withdrew 7 voluntarily 2 by physician’s decision7 were lost to follow up

17 withdrew 14 voluntarily 3 by physician’s

decision16 were lost to follow up

3,755 PatientsEnrolled and Randomized

Baseline CharacteristicsBaseline Characteristics

CharacteristicCharacteristic PtCr-EESPtCr-EES(N=2,503)(N=2,503)

CoCr-ZESCoCr-ZES(N=1,252)(N=1,252)

Age 63.1±10.8 63.5±10.7

Men 1,746 (69.8) 820 (65.6)

Body mass index 24.6±3.2 24.7±3.2

Hypertension 1,706 (68.2) 852 (68.1)

Diabetes 795 (31.8) 401 (32.0)

Dyslipidemia 1,601 (64.0) 822 (65.7)

Current smoker 823 (32.9) 369 (29.5)

Chronic renal failure 59 (2.4) 36 (2.9)

Peripheral artery disease 41 (1.6) 27 (2.2)

Cerebrovascular disease 172 (6.9) 79 (6.3)

Previous PCI 247 (9.9) 120 (9.6)

Previous bypass surgery 16 (0.6) 10 (0.8)

Pervious MI 116 (4.6) 49 (3.9)

Previous CHF 41 (1.6) 13 (1.0)

Clinical diagnosis

Slient ischemia 119 (4.8) 63 (5.0)

Stable angina 746 (29.8) 367 (29.3)

Unstable angina 903 (36.1) 476 (38.0)

NSTEMI 452 (18.1) 209 (16.7)

STEMI 283 (11.3) 137 (10.9)

ACS 65.5%

Baseline CharacteristicsBaseline Characteristics



Laboratory findings

Left ventricular ejection fraction (%) 59.9±10.4 60.4±10.2

Hemoglobin (g/dL) 13.7±1.7 13.7±1.7

Platelet count (x103/mm) 227±61 227±64

Serum creatinine (mg/dL) 1.00±0.73 1.00±0.87

Total cholesterol (mg/dL) 177±43 178±45

Triglyceride (mg/dL) 138±87 144±107

HDL-cholesterol (mg/dL) 44±12 44±11

LDL-cholesterol (mg/dL) 110±41 109±38

Medications at discharge

Aspirin 2,485 (99.3) 1,247 (99.6)

Clopidogrel 2,483 (99.2) 1,246 (99.5)

β-blocker 1,710 (68.3) 845 (67.5)

Calcium channel blocker 526 (21.0) 236 (18.8)

ACE inhibitor or ARB 1,636 (65.4) 829 (66.2)

Statin 2,122 (84.8) 1,076 (85.9)

Lesion & Procedural CharacteristicsLesion & Procedural Characteristics



Patient-Level Angiographic disease extent: 1VD 1,150 (45.9) 580 (46.3) 2VD 807 (32.2) 400 (31.9) 3VD 546 (21.8) 272 (21.7) Target lesions to be treated: One 1,766 (70.6) 909 (72.6) Two 570 (22.8) 286 (22.8) ≥ Three 167 (6.7) 57 (4.6) Use of IVUS or OCT 1,037 (41.4) 494 (39.5) Use of glycoprotein IIb/IIIa inhibitors 55 (2.2) 37 (3.0)

Lesion-Level (N=3,426) (N=1,661) Target vessel location: LMCA 74 (2.2) 37 (2.2) LAD 1,623 (47.4) 852 (51.3) LCX 751 (21.9) 324 (19.5) RCA 978 (28.5) 448 (27.0) ACC/AHA classification B2/C type 1,662 (49.7) 842 (51.7) Total occlusion 422 (12.3) 193 (11.6) Thrombus-containing 45 (1.3) 25 (1.5) Bifurcation 874 (25.6) 420 (25.3)

QCA AnalysisQCA Analysis



P ValueP Value

Before index procedure Lesion length 19.3±11.8 19.8±12.4 0.229 Reference vessel diameter 3.00±0.50 3.00±0.50 0.457 Minimum lumen diameter 0.81±0.50 0.81±0.50 0.657 Percent stenosis – % 73.1±15.4 72.8±15.5 0.470 SYNTAX score, before procedure 12.1±8.0 12.4±8.1 0.299

After index procedure SYNTAX score, after procedure 4.0±5.4 4.0±5.4 0.852 Number of stents Per lesion 1.19±0.45 1.17±0.43 0.301

Per patient 1.62±0.92 1.56±0.85 0.061 Total stent length – mm Per lesion 27.7±13.3 28.7±14.6 0.022

Per patient 37.6±24.2 37.9±25.0 0.764 Minimum lumen diameter In-stent 2.61±0.43 2.62±0.45 0.465

In-segment 2.23±0.53 2.21±0.52 0.397 Diameter stenosis – % In-stent 11.0±7.4 11.2±8.1 0.538

In-segment 21.5±11.2 22.2±11.4 0.051 Acute gain – mm In-stent 1.80±0.53 1.81±0.55 0.798

In-segment 1.42±0.58 1.40±0.59 0.275

0 2 4 6 8 10 12

5.0

4.0

3.0

2.0

1.0

0.0

PtCr-EES 2,503 2,446 2,426 2,408 2,401 2,376 1,887

CoCr-ZES 1,252 1,222 1,213 1,209 1,205 1,198 952

Months After Enrollment

Tar

get

Les

ion

Fai

lure

(%

)

PtCr-EES: PtCr-EES: 2.9%2.9%

CoCr-ZES: CoCr-ZES: 2.9%2.9%

HR: 1.00 (0.67-1.50)Non-Inferiority P-value (1-sided)=0.02

Superiority P-value=0.98

Patient Number At Risk

Target Lesion FailureTarget Lesion FailureComposite of C-death, TV-related MI, ischemia-driven TLR

Hypothesis TestingHypothesis Testing

0.5 1.0 1.5 2.0

Hazard Ratio of PtCr-EES vs. CoCr-ZES

P-value Function Curve

0.0

0.2

0.4

0.6

0.8

1.0

p-va

lue

PredefinedNon-Inferiority

Margin

α=0.0247

1-sided80% CI

90% CI

95% CI

0.5 1.0 1.5

Hazard Ratio of PtCr-EES vs. CoCr-ZES

Predefined margin: 1.5

Non-inferiority P=0.0247

1.4986 : Upper 97.5% CI

97.5% CI

Clinical OutcomesClinical Outcomes

End pointEnd pointPtCr-EESPtCr-EES CoCr-ZESCoCr-ZES

HR (95% CI)HR (95% CI) P-P-valuevalue(N=2,503) (N=1,252)

Target Lesion Failure 72 (2.88%) 36 (2.88%) 1.00 (0.67-1.50) 0.983 All-Cause Death 56 (2.24%) 20 (1.60%) 1.40 (0.84-2.34) 0.194 Cardiac Death 34 (1.36%) 17 (1.36%) 1.00 (0.56-1.79) 0.997 All-Cause MI 28 (1.12%) 17 (1.36%) 0.83 (0.45-1.51) 0.533 Target Vessel-Related MI 24 (0.96%) 13 (1.04%) 0.93 (0.47-1.82) 0.822

Repeat Revascularization 74 (2.96%) 33 (2.64%) 1.13 (0.75-1.70) 0.557

Target Lesion Revascularization 31 (1.24%) 15 (1.20%) 1.04 (0.56-1.93) 0.900

Target Vessel Revascularization 42 (1.68%) 23 (1.84%) 0.92 (0.55-1.53) 0.746

Cerebrovascular Accident 17 (0.68%) 8 (0.64%) 1.07 (0.46-2.47) 0.879

Ischemic 15 (0.60%) 6 (0.48%) 1.26 (0.49-3.24) 0.636

Hemorrhagic 2 (0.08%) 2 (0.16%) 0.50 (0.07-3.55) 0.489

All PLATO Bleeding 45 (1.80%) 25 (2.00%) 0.90 (0.55-1.47) 0.674

Major Bleeding 27 (1.08%) 16 (1.28%) 0.84 (0.45-1.57) 0.591

Major, life-threatening 4 (0.16%) 4 (0.32%) 0.50 (0.13-2.00) 0.327

Major, other 23 (0.92%) 13 (1.04%) 0.89 (0.45-1.75) 0.725

Minor Bleeding 18 (0.72%) 9 (0.72%) 1.00 (0.45-2.23) 0.996

Target Vessel Failure 82 (3.28%) 42 (3.35%) 0.98 (0.68-1.42) 0.919

Patient-Oriented Clinical Outcome 135 (5.39%) 55 (4.39%) 1.24 (0.90-1.69) 0.187

PtCr-EESPtCr-EESN=2,503N=2,503

CoCr-ZESCoCr-ZESN=1,252N=1,252

Clinical Events at 12 MonthsClinical Events at 12 Months

Cardiac Death

p=0.997

1.4% 1.4%1.0% 1.0% 1.2% 1.2%

5.4%

4.4%

TV related-MI

p=0.822

Target LesionRevascularization

p=0.900

Patient-Oriented Composite

p=0.187







Stent ThrombosisStent Thrombosis

PtCr-EESPtCr-EES(N=2,503)

CoCr-ZES(N=1,252)

p-value

Definite or probable ST 9 (0.36%) 8 (0.67%) 0.229 Acute definite or probable ST 1 (0.04%) 1 (0.08%) 1.000 Subacute definite or probable ST 7 (0.28%) 6 (0.50%) 0.379 Early definite or probable ST 8 (0.32%) 7 (0.58%) 0.273 Late definite or probable ST 1 (0.04%) 1 (0.08%) 1.000 Definite ST 5 (0.20%) 3 (0.25%) 1.000 Acute definite ST 0 (0.00%) 1 (0.08%) 0.333 Subacute definite ST 5 (0.20%) 1 (0.08%) 0.671 Early definite ST 5 (0.20%) 2 (0.17%) 1.000 Late definite ST 0 (0.00%) 1 (0.08%) 0.333 Probable ST 4 (0.16%) 5 (0.42%) 0.171 Acute probable ST 1 (0.04%) 0 (0.00%) 1.000 Subacute probable ST 2 (0.08%) 5 (0.42%) 0.045 Early probable ST 3 (0.12%) 5 (0.42%) 0.127 Late probable ST 1 (0.04%) 0 (0.00%) 1.000 Possible ST 15 (0.60%) 6 (0.50%) 0.642 Acute possible ST 0 (0.00%) 0 (0.00%) - Subacute possible ST 0 (0.00%) 0 (0.00%) - Early possible ST 0 (0.00%) 0 (0.00%) - Late possible ST 15 (0.60%) 6 (0.50%) 0.642

Late possible ST : Any unexplained death beyond 30 days

Stent ThrombosisStent Thrombosis

Definite ST

p=1.000

0.20% 0.25%0.16%

0.42%

Probable ST

p=0.171





0.60%0.50%

Possible ST

p=0.642



0.36%

0.67%

Definite or Probable ST

p=0.229



SubgroupTarget Lesion Failure

Hazard Ratio (95% CI)P Value forInteractionPtCr-EES CoCr-ZES

Age 0.395 ≥65 years 47/1182 (4.0) 27/617 (4.4) 0.91 (0.57 -1.46) <65 years 25/1321 (1.9) 9/635 (1.4) 1.35 (0.63 -2.90) Sex 0.371 Men 43/1746 (2.5) 23/820 (2.8) 0.88 (0.53 -1.46) Women 29/757 (3.8) 13/432 (3.0) 1.29 (0.67 -2.48) Acute Coronary Syndrome 0.779 Yes 50/1638 (3.1) 26/822 (3.2) 0.97 (0.60 -1.56) No 22/865 (2.5) 10/430 (2.3) 1.09 (0.52 -2.31) Diabetes Mellitus 0.912 Yes 29/795 (3.6) 15/401 (3.7) 0.97 (0.52 -1.81) No 43/1708 (2.5) 21/851 (2.5) 1.03 (0.61 -1.74) Number of Lesions to be Treated 0.114 One 53/1766 (3.0) 22/909 (2.4) 1.25 (0.76 -2.06) More than two 19/737 (2.6) 14/343 (4.1) 0.63 (0.32 -1.25) Lesion Length 0.346 ≤ 20 mm 34/1575 (2.2) 14/765 (1.8) 1.24 (0.61 -2.50) > 20 mm 27/623 (4.3) 18/340 (5.3) 0.82 (0.47 -1.41) Reference Vessel Diameter 0.030 ≤ 2.75 mm 31/983 (3.2) 23/464 (5.0) 0.63 (0.37 -1.08) > 2.75 mm 39/1486 (2.6) 13/777 (1.7) 1.58 (0.85 -2.97) Multivessel Stenting 0.471 Yes 51/1858 (2.7) 23/927 (2.5) 0.82 (0.41 -1.63) No 21/645 (3.3) 13/325 (4.0) 1.11 (0.68 -1.82) Allocated Antiplatelet Arm 0.885 Triple Antiplatelet 37/1253 (3.0) 19/626 (3.0) 0.97 (0.56 -1.69) Double Dose Dual Antiplatelet 35/1250 (2.8) 17/626 (2.7) 1.04 (0.58 -1.85)

Overall 72/2503 (2.9) 36/1252 (2.9) 1.00 (0.67 -1.50)

Subgroup AnalysisSubgroup Analysis

0.25 0.5 1 2 4

Favors PtCr-EES Favors CoCr-ZES

5,087 lesions (3,755 Patients)

Systematic review of CAG Systematic review of CAG to assess Longitudinal Stent Deformationto assess Longitudinal Stent Deformation

PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426 CoCr-ZES: 1,661CoCr-ZES: 1,661


PtCr-EES: PtCr-EES: 3,3673,367PtCr-EES: PtCr-EES: 3,3673,367 CoCr-ZES: 1,643CoCr-ZES: 1,643


PtCr-EES: PtCr-EES: 2,5162,516PtCr-EES: PtCr-EES: 2,5162,516 CoCr-ZES: 1,256CoCr-ZES: 1,256


PtCr-EES: PtCr-EES: 1,6851,685PtCr-EES: PtCr-EES: 1,6851,685 CoCr-ZES: 818CoCr-ZES: 818

Nominal SLRmeasurable(74.3% of lesions)

AcceptableAngiographic Images(98.5% of lesions)

Post-Deployment SLRmeasurable(49.2% of lesions)

Enrolled lesions

1. Bifurcation stenting2. Overlapping stenting3. Different Projection angle

No procedure after deployment

•adjunctive ballooning•IVUS or OCT

““LSD”LSD”

3,755 Patients(5,087 lesions)

Acceptableangiographicimages

PtCr-EESPtCr-EES2,471 Patients (3,367 2,471 Patients (3,367

lesions)lesions)


lesions)lesions)

CoCr-ZES1,240 Patients (1,643

lesions)


lesions)

Longitudinal Stent DeformationLongitudinal Stent Deformation


lesions)lesions)


lesions)lesions)


lesions)


lesions)

7 (0.21%)

0 (0.00%)

P=0.104

PtCr-EESPtCr-EES CoCr-ZESCoCr-ZES

Incidence: 2.1 (95% CI: 0.8-4.3) per 1,000 lesions treated with PtCr-EES

Longitudinal Stent DeformationLongitudinal Stent Deformation• Features of LSD by visual estimation

Details of 7 Patients with LSDDetails of 7 Patients with LSD

Age/Sex

Lesion Loci

Stent Size (mm)

PrecipitatingFactor

Bifurcation

Ostial Lesion

Segment of Stent Involved

Additional Stenting Required

Future Clinical Events

61/M LMCAP-E

3.0x24Deep engagement of guiding

catheter (GC)Yes Yes Proximal part No NoNo

59/M LMCAP-E

3.0x28

Deep engagement of GC d/t trapped retrograde guidewire

(CTO) No No Proximal part No NoNo

50/F Mid LADP-E

4.0x28Deep engagement of GC d/t

trapped IVUS catheterNo No Proximal part No NoNo

72/MProximal

RCAP-E

3.0x28Deep engagement of GC d/t

trapped stentNo No Proximal part No NoNo

39/MProximal

LADP-E

4.0x28Advancing Adjunctive

Balloon catheterYes No Proximal part No NoNo

81/F Mid LADP-E


Balloon catheterYes No Proximal part Yes NoNo

68/M Mid LADP-E


Balloon catheterNo No Proximal part No NoNo

Before Deployment: 24.27 mm

After Deployment: 23.14 mm

Final: 21.05 mm

Stent Length RatioStent Length Ratio : index of systemic assessment of stent shortening: index of systemic assessment of stent shortening

Promus-Element: Promus-Element: 3.0x283.0x28 mm mm

d/t shortening by projection angle

d/t shortening by expansion

d/t shortening by 1) LSD

2) projection angle difference

Nominal Stent Length RatioNominal Stent Length Ratio

0.6

0.8

1.0

1.2

1.4

0.92±0.07 vs. 0.93±0.07(P<0.001)

PtCr-EESPtCr-EES CoCr-ZESCoCr-ZESMaximum 1.18 1.3175% Quartile 0.97 0.9850% Median 0.93 0.9425% Quartile 0.88 0.89Minimum 0.55 0.65

PtCr-EESPtCr-EES(2,516 (2,516

lesions)lesions)

CoCr-ZESCoCr-ZES(1,256 lesions)(1,256 lesions)

Nominal Stent Length (mm)

0 20 40 600

10

20

30

40

50

Final Stent Length (mm)

PtCr-EES: PtCr-EES: 0.92±0.07 (R2=0.906)

CoCr-ZES: CoCr-ZES: 0.93±0.07 (R2=0.934)

(P<0.001)

Nominal Stent Length RatioNominal Stent Length Ratio

Min 1st Q Median 3rd Q Max

PtCr-EES 0.545 0.883 0.931 0.971 1.181

CoCr-ZES 0.645 0.889 0.939 0.981 1.313

Post-Deployment Stent Length RatioPost-Deployment Stent Length Ratio

0.8

1.0

1.2

PtCr-EESPtCr-EES(1,685 lesions)(1,685 lesions)

CoCr-EESCoCr-EES(818 lesions)(818 lesions)

1.00±0.04 vs. 1.00±0.04(P=0.352)

PtCr-EESPtCr-EES CoCr-ZESCoCr-ZES

Maximum 1.29 1.30

75% Quartile 1.01 1.01

50% Median 1.00 1.00

25% Quartile 0.98 0.98

Minimum 0.78 0.85

Post-Deployment Stent Length RatioPost-Deployment Stent Length Ratio

0 10 20 30 40 500

10

20

30

40

50

PtCr-EES: PtCr-EES: 1.00±0.04 (R2=0.974)

CoCr-ZES: CoCr-ZES: 1.00±0.04 (R2=0.984)

(P=0.352)

Min 1st Q Median 3rd Q Max

PtCr-EES 0.776 0.977 0.997 1.013 1.287

CoCr-ZES 0.846 0.980 1.000 1.013 1.295

Stent Length Immediately After Deployment (mm)

Final Stent Length (mm)


Summary : Systematic review of CAG Summary : Systematic review of CAG to assess Longitudinal Stent Deformationto assess Longitudinal Stent Deformation

PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426 CoCr-ZES: 1,661CoCr-ZES: 1,661

Nominal SLR(74.3% of lesions)

Acceptable Angiographic Images(98.5% of lesions)

Post-Deployment SLR(49.2% of lesions)

LSD rare only in Promus ElementLSD rare only in Promus Element

unreliableunreliable

more reliablemore reliableno difference between two stentsno difference between two stentsIn the general tendency In the general tendency of shortening of stent platformof shortening of stent platform

LimitationsLimitations

1. Lower event rates than expected

- Expected rate of primary endpoint in the comparator: 6.5%

- Actual event rate: 2.9%

2.2. Question of under-reportingQuestion of under-reporting

- Trials done in East Asian populations have reported lower event rates.

- This study was done with highest degree of scrutiny with periodic monitoring.- F/U loss rate: 1.3%

(lower than ENDEAVOR IV, SPIRIT IV, PLATINUM, HORIZONS-AMI)

3. Longer-term clinical follow-up required

- Clinical F/U will be continued up to 3 years

4.4. ““Eyeball” estimation Eyeball” estimation of longitudinal stent deformationof longitudinal stent deformation

- Better visibility of PtCr alloy may have led to more frequent detection of LSD

1) PtCr-EES was non-inferiornon-inferior to CoCr-ZES at 1 year regarding TLF.

Clinical outcomes were very similar very similar between the two stents.

2) Both stents demonstrated outstanding safety outstanding safety as well as efficacy.efficacy.

: ST <1%; TLF <3% in PCI population of “all-comers”

3)3) LSDLSD was very rare, observed only in a few cases of PtCr-EES, and

was not associated with future adverse clinical events. not associated with future adverse clinical events. There There

was was not a serious systematic shortening not a serious systematic shortening of either stent platform. of either stent platform.

Randomized Comparison of PtCr-EES vs CoCr-ZES Randomized Comparison of PtCr-EES vs CoCr-ZES

in All-Comers Receiving PCIin All-Comers Receiving PCI

: The HOST-ASSURE Randomized Trial: The HOST-ASSURE Randomized Trial

Hyo-Soo Kim, MD/PhD

Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,

Byoung-Eun Park, Jay-Young Rhew, Hui-Kyung Jeon, In-Ho Chae

On Behalf of The HOST-ASSURE Trial Investigators

Seoul National University Hospital, Seoul, Korea

Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,

Documents

ptcrbased ees ptcrees

ees vs cocrzes

cocrzes grouptlf

byoungeun park

byoung eun park

kyungil park

ptcrees group6

mdphdkyungwoo park