Comparison of Platinum Chromium VersusComparison of Platinum Chromium Versus Cobalt Chromium Everolimus-Eluting Stent in

Real World Practice: Outcomes from theReal World Practice: Outcomes from the Multicenter Prospective IRIS-DES Registry

Jung-Min Ahn MD Young-Hak Kim MD PhD Duk-Woo Park MD PhD Jong-Young Lee MDJung Min Ahn, MD. Young Hak Kim, MD, PhD, Duk Woo Park, MD, PhD, Jong Young Lee, MD, Won-Jang Kim, MD, Soo-Jin Kang, MD, PhD, Seung-Whan Lee, MD, PhD, Cheol Whan Lee, MD,

PhD, Seong-Wook Park, MD, PhD, Seung-Jung Park, MD, PhD.

On the behalf of IRIS-DES Registry Investigators

H t I tit t U i it f Ul C ll f M di iHeart Institute, University of Ulsan College of MedicineAsan Medical Center, Seoul, Korea

BackgroundBackground

• Second generation DES have improved clinical outcome• Second-generation DES have improved clinical outcome compared with first-generation DES.

• Pl ti h i li l ti t t (PtC EES• Platinum chromium everolimus-eluting stent (PtCr-EES, PROMUS Element) is a new version of EES, which uses the same durable biocompatible inert fluorocopolymerthe same durable, biocompatible, inert fluorocopolymerand antiproliferative agent as the cobalt chromium everolimus-eluting stent (CoCr-EES, XIENCE V) but with g ( )a modified scaffold designed.

• One randomized trial showed comparable efficacy andOne randomized trial showed comparable efficacy and safety profiles upto 3 years, but there have been few researches in real practice.p

Objective

• The purpose of this study compared the safety• The purpose of this study compared the safety and efficacy of PtCr-EES and CoCr-EES in an unrestricted multicenter prospective cohort ofunrestricted, multicenter, prospective cohort of patients undergoing PCI in everyday clinical practicepractice.

• Addi i ll l d h i id d• Additionally, we evaluated the incidence and outcomes of longitudinal stent deformation.

Study PopulationStudy Population

• The IRIS DES registry (clinicaltrials gov number• The IRIS DES registry (clinicaltrials.gov number NCT 0178859) is a prospective, multicenter registry to assess the contemporary practice andregistry to assess the contemporary practice and outcomes of PCI.

• Between January 2008 and November 2011, a total of 6071 patients who received PtCr-EES or CoCr-EES were enrolled

Comparison of PtCr-EES and CoCr-EES f IRIS DES R i t

C ti PCI ti t i i N DES

from IRIS-DES Registry

Consecutive PCI patients receiving New DES without a mixture of other DES

Prospective Enrollment since 2007 in Korean multicenters

IRIS-K-XIENCE IRIS- IRIS-IRIS- IRIS-DESSIAN IRIS- IRIS-2010.1-2011.122008.4-2010.5

BIOMATRIXPROMUS ELEMENT

IRIS-PRIME

Registry

GENOUSSTEMICYPHER NOBORIXIENCE

K-XIENCE Registry

IRIS-NOBORI Registry

IRIS-BIOMATRIXRegistry

IRIS-ELEMENT Registry

IRIS-GENOUS Registry

XIENCE-PRIME

DESSIAN Registry

IRIS-RESOLUTE

Registry

RESOLUTEINTEGRITY

IRIS-CILOTAX Registry

CILOTAX(N=1,000)ELEMENT

(N=3,000)STEMI

(N=1,000)(N=3,600) (N=2,000)(N=3,000) (N=2,000) INTEGRITY(N=1,000) (N=1,000)

Clinical follow-up at 1-, 6-, and 12-months, and annually up to 5 years

Participating CentersParticipating CentersSite PI Site PISite PI Site PI

Gachon University Gil Hospital Tae hoon Ahn St.carollo Hospital Jang-Hyun ChoDaejeon ST. Mary's Hospital Sung-Ho Her Sejong General Hospital Jin-Sik ParkSeoul St. Mary's Hospital Ki-Bae Seung Sejong General Hospital Rak Kyeong ChoiSt. Paul's Hospital Dong-Bin Kim Soon Chun Hyang University Hospital Nae-Hee LeeSt. Vincent's Hospital Keon-Woong Moon Soon Chun Hyang University Hospital Won-Yong ShinYeouido St. Mary's Hospital Yun-Seok Choi Soon Chun Hyang University Hospital Min-Su HyonUijeongbu St. Mary’s Hospital Jong-Min Lee Ajou University Hospital Seung-Jea TahkGangnam Severance Hospital Hyuck-Moon Kwon Pusan National University Yangsan Hospital Jun-Hong Kim Gangneung Asan Hospital Sang-Sig Cheong Pusan National University Yangsan Hospital Kook Jin ChunKangbuk Samsung Medical Center Byung-Jin Kim Yeungnam University Medical Center Jong-Seon ParkKangwon National University Hospital Bong-Ki Lee Presbyterian Medical Center Jay-Hyun RhewKonyang University Hospital Jang-Ho Bae Ulsan University Hospital Sang-Gon LeeKyungpook National University Hospital Hun-Sik Park Wonju Christian Hospital Junghan YoonKyungpook National University Hospital Hun-Sik Park Wonju Christian Hospital Junghan YoonGyeongsang National University Hospital Yongwhi Park Eulji University Hospital Sahng LeeGyeongsang National University Hospital Jin-Yong Hwang Inje University Pusan Paik Hospital Tae-Hyun YangKyunghee University Medical Center Myeong-Kon Kim Inje University Ilsan Paik Hospital Sung-Yun LeeKeimyung University Dongsan Medical Center Seung-Ho Hur Inha University Hospital Keum-Soo Park y g y g g y pKorea University Guro Hospital Seung-Un Na Chonnam National University Hospital Myung-Ho JeongKorea University Anam Hospital Do-Sun Lim ChonBuk National University Hospital Jei-Keon ChaeKwangju Christian Hospital Seung-Uk Lee Veterans Hospital Service Medical Center Keun LeeNational Health Insurance Corporation Ilsan Hospital Joo-Young Yang Cheongju St. Mary's Hospital Yong-Mo YangDankook University Hospital Byoung-Eun Park Chungnam National University Hospital Jin Ok JeongDaegu Catholic University Medical Center Kee-Sik Kim Good Samaritan Hospital Yong-Seok JungDongguk University Gyeongju Hospital Deuk-Young Nah Kangnam Sacred Heart Hospital Namho LEEDong-A Medical Center Moo-Hyun Kim Hangang Sacred Heart Hospital Min-Kyu Kim Pusan National University Hospital Taeg Jong Hong Hangang Sacred Heart Hospital Kyoung Ha ParkPusan National University Hospital Taeg-Jong Hong Hangang Sacred Heart Hospital Kyoung-Ha ParkBundang Cha Medical Center Ssng-Wook Lim Hallym University Sacred Heart Hospital Hyun- Sook KIMSeoul National University hospital Hyo-Soo Kim Hallym University Sacred Heart Hospital Woo-Jung ParkSMA-SNU Boramae Medical Center Woo-Young Chung Kangdong Sacred Heart Hospital Kyoo-Rok Han

Study PopulationStudy Population

Inclusion Criteria• All consecutive patients who have ≥1 coronary

lesion with a visual estimated DS of >50%

Inclusion Criteria

lesion with a visual estimated DS of >50%.• Revascularization was clinically indicated

Exclusion Criteria• Cardiogenic shock• A contraindication to the placement of DESsA contraindication to the placement of DESs• life expectancy <12 months.• PCI with a mixture of different types of DES• PCI with a mixture of different types of DES

Study EndpointsStudy EndpointsPrimary Endpoint

• D th• Death• Myocardial Infarction• Target vessel revascularization

Secondary End PointSecondary End Point• Cardiac and non-cardiac deaths.• Periprocedural MI (Q wave MI or CK• Periprocedural MI (Q wave MI or CK-MB>3UNL) • Spontaneous MI (cardiac enzyme elevation)Spontaneous MI (cardiac enzyme elevation).• Repeat revascularization: TVR, TLR, & NLR• Stent thrombosis: ARC definite or probable ST• Stent thrombosis: ARC definite or probable ST • Stent length and number implanted

ProcedureProcedure

• All interventions were done according to current practiceAll interventions were done according to current practice guidelines for PCI and IVUS/FFR were used at the discreti-on of operator.

• The operator was responsible for the decision to choose a specific treatment strategy.p gy

• The registry did not specify PCI treatment protocols.

• Before or during the procedure, all patients received at least 200 mg of aspirin and a 300-600 mg loading dose of l id lclopidogrel.

Follow-upFollow-up

• Clinical angiographic procedural and outcome data wereClinical, angiographic, procedural, and outcome data were prospectively recorded in the dedicated PCI database by independent research personnel.

• Patients were clinically followed up at 1, 6, and 12 months, and annually thereafter via office visits or telephone conta-and annually thereafter, via office visits or telephone contact.

• Angiographic follow up was not recommended• Angiographic follow-up was not recommended.

• All outcomes of interest were carefully verified and adjudic-ated by independent clinicians.

StatisticsStatistics• Student t-test for continuous variables• Chi-square and Fisher-exact for categorical

variables• Differences in risk-adjusted, long-term rates of

study outcomes between stent groups werestudy outcomes between stent groups were investigated with multivariable Cox proportional-hazards regressionhazards regression.

• All reported P-values are two-sided, and P-values of less than 0.05 were considered statistically significance.

Baseline CharacteristicsBaseline CharacteristicsPtC EES C C EES P lPtCr-EES(N=2990)

CoCr-EES(N=3081)

P value

Age 63 8±10 9 63 5±10 8 0 21Age 63.8±10.9 63.5±10.8 0.21

Sex, Male 2113 (70.7%) 2079 (67.5%) 0.007

DM 1013 (33.9%) 1026 (33.3%) 0.63

Hypertension 1827 (61.1%) 1922 (62.4%) 0.31

Hyperlipidemia 1088 (36.4%) 1155 (37.5%) 0.38

Smoking 872 (29.2%) 891 (28.9%) 0.83Smoking 872 (29.2%) 891 (28.9%) 0.83

Previous PCI 319 (10.7%) 454 (14.7%) <0.001

P i CABG 36 (1 2%) 62 (2 0%) 0 012Previous CABG 36 (1.2%) 62 (2.0%) 0.012

Previous MI 150 (5.0%) 159 (5.2%) 0.80

Previous CHF 81 (2.7%) 67 (2.2%) 0.18

Baseline CharacteristicsBaseline CharacteristicsPtC EES C C EES P lPtCr-EES(N=2990)

CoCr-EES(N=3081)

P value

Family History 200 (6.7%) 111 (3.6%) <0.001y y ( ) ( )

Chronic renal failure 95 (3.2%) 105 (3.4%) 0.62

Previous stroke 215 (7 2%) 252 (8 2%) 0 15Previous stroke 215 (7.2%) 252 (8.2%) 0.15

Peripheral vascular disease 62 (2.1%) 36 (1.2%) 0.005

Chronic lung disease 61 (2 0%) 92 (3 0%) 0 019Chronic lung disease 61 (2.0%) 92 (3.0%) 0.019

Ejection fraction, % 59.1±10.1 59.5±10.9 0.19

Presentation <0.001

Stable angina 1143 (38.2%) 1277 (41.4%)

Unstable angina 1008 (33.7%) 1057 (34.3%)

NSTEMI 480 (16.1%) 339 (11.0%)

STEMI 359 (12.0%) 408 (13.2%)

Lesion and Procedure CharacteristicsLesion and Procedure CharacteristicsPtC EES C C EES P lPtCr-EES(N=2990)

CoCr-EES(N=3081)

P value

Multivessel disease 1470 (49.2%) 1636 (53.1%) 0.002

LMCA disease 213 (7.1%) 323 (10.5%) <0.001

LAD disease 2189 (73.2%) 2336 (75.8%) 0.02

Bifurcation lesion 903 (30.3%) 819 (34.0%) 0.004

Total obstruction 648 (21.7%) 359 (14.7%) <0.001

Restenotic lesion 115 (3.8%) 179 (5.8%) <0.001

Long lesion 1693 (56.7%) 1882 (61.1%) <0.001

Multivessel stenting 772 (35.4) 563 (25.8) <0.001

Total treated lesion number 1.33±0.61 1.37±0.64 0.004

Total stent number 1.620.90 1.82±1.16 <0.001

Total stent length 36.9±23.2 41.7±30.0 <0.001

Average stent diameter, mm 3.17±0.44 3.22±0.44 <0.001

Unadjusted Kaplan-Meier CurveUnadjusted Kaplan-Meier Curve

PtCr -EESPrimary End Point

(Death MI or Target Vessel Revascularization)Primary End Point

(Death MI or Target Vessel Revascularization) CoCr-EES30

%

(Death, MI, or Target Vessel Revascularization)(Death, MI, or Target Vessel Revascularization)

15%

20

Inci

denc

e, %

Log-Rank P=0.12

15%15%

10

Cum

ulat

ive

I

0 120 240 360 480 600 7200

C

0 120 240 360 480 600 720

No. at RiskPtCr-EESC C EES

25782720

9002503

4502251

29903081

Days Since Procedure

CoCr-EES 2720 2503 22513081

Adjusted Kaplan-Meier CurveAdjusted Kaplan-Meier Curve

PtCr -EESPrimary End Point

(Death MI or Target Vessel Revascularization)Primary End Point

(Death MI or Target Vessel Revascularization) CoCr-EES30

%

(Death, MI, or Target Vessel Revascularization)(Death, MI, or Target Vessel Revascularization)

20

Inci

denc

e, %

HR (95%CI) 1.01 (0.87-1.18), P=0.89

10

Cum

ulat

ive

I

0 120 240 360 480 600 7200

C

0 120 240 360 480 600 720

No. at RiskPtCr-EESC C EES

Days Since Procedure

25782720

9002503

4502251

29903081CoCr-EES 2720 2503 22513081

Adjusted Kaplan-Meier CurveAdjusted Kaplan-Meier Curve

DeathDeath PtCr -EESDeathDeathCoCr-EESPtCr EES

30

% HR (95%CI) 1 27 (0 91-1 772) p=0 164

52-Year Event Rate

20

Inci

denc

e, % HR (95%CI) 1.27 (0.91-1.772), p=0.16

1 51 5 1 52

3

4

P=0.33 P=0.8

10

Cum

ulat

ive 1

1.51.5 1.5

0

1

0 120 240 360 480 600 7200

C

Cardiac Death Non-CD

0 120 240 360 480 600 720

27452986

996

2827

4992567

Days Since ProcedureNo. at RiskPtCr-EESCoCr EES

29903081 2986 2827 2567CoCr-EES 3081

Adjusted Kaplan-Meier CurveAdjusted Kaplan-Meier Curve

Myocardial InfarctionMyocardial Infarction PtCr -EES

30

%

yyCoCr-EESPtCr EES

101214

P<0.001 P=0.35

2-Year Event Rate

20

Inci

denc

e, %

HR (95%CI) 0.89 (0.71-1.11), P=0.277.4

5

468

10 P<0.001 P 0.35

10

Cum

ulat

ive

I

1.2 1.3

02

Peri-MI Spon-MI

0 120 240 360 480 600 7200

C

0 120 240 360 480 600 720

26002761

940

2603

4582362

Days Since ProcedureNo. at RiskPtCr-EESCoCr EES

29903081 2761 2603 2362CoCr-EES 3081

Adjusted Kaplan-Meier CurveAdjusted Kaplan-Meier Curve

Death or MIDeath or MI PtCr -EES

30

%

CoCr-EESPtCr EES

20

Inci

denc

e, %

HR (95%CI) 0.95 (0.79-1.13), P=0.54

10

Cum

ulat

ive

I

0 120 240 360 480 600 7200

C

0 120 240 360 480 600 720

25782720

900

2525

4492229

Days Since ProcedureNo. at RiskPtCr-EESCoCr EES

29903081 2720 2525 2229CoCr-EES 3081

Adjusted Kaplan-Meier CurveAdjusted Kaplan-Meier Curve

TVRTVR PtCr -EES

30

% 121416

P=0.30 P=0.142-Year Event Rate

P=0.51

CoCr-EESPtCr EES

20

Inci

denc

e, % HR (95%CI) 1.13 (0.86-1.50), P=0.39

7.4

4.1 3.9

9.1

4.35.36

81012

10

Cum

ulat

ive

I 3.9

024

Any TLR NLR

0 120 240 360 480 600 7200

C Any TLR NLR

0 120 240 360 480 600 720

27192931

956

2701

4772439

Days Since ProcedureNo. at RiskPtCr-EESCoCr EES

29903081 2931 2701 2439CoCr-EES 3081

Stent Thrombosis at 24 Months*Stent Thrombosis at 24 Months*Stent Thrombosis at 24 MonthsStent Thrombosis at 24 Months

1 0

0.8

1.0

P=0.33

15 (0 5)0.6

% 15 (0.5) 7 (0.4)

0.4

%

0.2

0.0 PtCr-EES (N=2990) CoCr-EES (N=3081)

* ARC defined definite and probable stent thrombosis

Incidence of Longitudinal Stent Deformation and Outcomes

Incidence of Longitudinal Stent Deformation and OutcomesDeformation and OutcomesDeformation and Outcomes

10.0 A total 2,561 lesions were retrospectively evaluated by

QCA core lab and 49 LSDs (1.9%) were identified. During a median of 1.9 years (1.0-2.5) FU,

8.0 g y ( ) ,

1 (0.04%) repeated revascularization was occurred.

37 (4.8)

4 0

6.0

% P<0.001

2.0

4.0

12 (0.7)

0.0 PtCr EES (N=767) CoCr EES (N=1804)PtCr-EES (N=767) CoCr-EES (N=1804)

I d d t P di t fI d d t P di t fIndependent Predictors of Longitudinal Stent Deformation

Independent Predictors of Longitudinal Stent Deformationgg

Odds Ratio (95% CI) P value

PtCr-EES 7.65 (3.81-15.3) <0.001

Ostial lesion 5.00 (2.69-9.31) <0.001

St t b l i 1 52 (1 03 2 22) 0 034Stent number per lesion 1.52 (1.03-2.22) 0.034

QCA:Nominal Stent LengthQCA:Nominal Stent Length

Single Stent Implantation: 1583 CoCr-EES and 563 PtCr-EES

100

g p

80

ncy,

%

Final Stent length by QCANominal Stent length

40

60

ve F

requ

en

PtCr EES: 0 98±0 12

Nominal Stent length

20

40

Cum

ulat

iv

CoCr-EES: 0.97±0.06PtCr-EES: 0.98±0.12

P=0.03

0.5 1.0 1.5 2.00

QCA:Nominal Stent Length

ConclusionConclusion

• In this large multi center prospective cohort study involving• In this large, multi-center, prospective cohort study involving

“real-world” patients undergoing PCI with DES, we found no

significant differences between PtCr-EES and CoCr-EES in

terms of clinical efficacy and safety.y y

• Longitudinal stent deformation was more frequently observed

in PtCr-EES, but was not associated with future adverse

clinical events In addition there was not a seriousclinical events. In addition, there was not a serious

systematic shortening of either stent platform.

Th k Y !!Thank You !!

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