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2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study. Laura Mauri MD, MSc on behalf of the RESOLUTE US Investigators Brigham and Women’s Hospital Boston, MA ACC 2012. RESOLUTE Global Clinical Program. Enrollment Complete - In Follow Up. RESOLUTE 1.

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2 year clinical outcomes from the pivotal resolute us study

2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study

Laura Mauri MD, MSc

on behalf of the RESOLUTE US Investigators

Brigham and Women’s Hospital

Boston, MA

ACC 2012

resolute global clinical program
RESOLUTE Global Clinical Program

Enrollment Complete - In Follow Up

RESOLUTE1

Non-RCT First-in-Human (R=139)

5 yr

RESOLUTE AC2,3

1:1 RCT vs. Xience V (R=1140; X=1152)

2 yr

RESOLUTE Int4

2 yr

Non-RCT Observational (R=2349)

2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402)

2yr

RESOLUTE US5

2yr

2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control

RESOLUTE Japan

R Japan SVS

2.25 Non-RCT vs. PG (R=65)

< 1yr

38 mm sub-study Non-RCT vs. PG (R=114)

RESOLUTE US

< 1yr

R-China RCT

1:1 RCT vs. Taxus (R=200; T=200)

< 1yr

Non-RCT Observational (R=312)

< 1yr

RESOLUTE Asia

Non-RCT Observational (R=1800)

< 1yr

R-China Registry

Enrolling / Planning

Post-approval study (R=230)

plan

RI-US Registry

1 Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2 Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3 Silber S, et al. Lancet. 2011;377:1241-47. 4 Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5 Yeung AC, et al. JACC. 2011;57:1778-83.

resolute us

Resolute stent

2.25–3.5 Clinical (n=1242)

2.25–3.5 Angio/IVUS (n=100)

4.0 Angio (n=60)

38mm Clinical (n=110–175)

Hx Controls

Performance Goals

RESOLUTE US

Clinical Study Design

PI: M. Leon, L. Mauri, A. Yeung

De Novo Native Coronary Lesion

Vessel Diameter: 2.25 – 4.2 mm

Lesion Length: ≤ 27 mm

(≤ 35 mmlesions tx w/ 38 mm stent)

N = max 1577 patients

Up to 135 US sites

Clinical endpoints

30d

6mo

8mo

9mo

12mo

18mo

2yr

3yr

4yr

5yr

Angio/IVUS endpoints

  • Primary Endpoints:
    • 2.25–3.5 Clinical → Target Lesion Failure at 12mo
    • 2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo
    • 4.0 Angio → In-Segment LLL at 8mo
    • 38 mm Clinical → Target Lesion Failure at 12mo
  • Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines)

Mauri L, et al. Am Heart J.2011;161:807-14.

resolute us1
RESOLUTE US

Key Eligibility Criteria

KeyInclusion Criteria

Clinical evidence of ischemic coronary disease

Single or double de novo lesion in native coronary artery

Target lesion ≤27mm in length, diameter stenosis ≥50% <100%, and target RVD ≥2.25mm ≤4.2mm

Target vessel TIMI flow ≥2

Patient is able to take DAPT for at least 6 months

Treatment of up to two lesions, if the lesions are located in separate target vessels

KeyExclusion Criteria

Acute MI within 72 hours of index procedure

Previous PCI of target vessel within 9 months pre-procedure

Planned PCI of any vessel within 30 days post-procedure

Hx stroke or TIA within 6 months

LVEF <30%

Mauri L, et al. Am Heart J.2011;161:807-14.

resolute us2
RESOLUTE US

Patient Flow Chart

Patients Enrolled

N = 1402

1Yr Clinical Follow-up

n = 1386

98.9%

2Yr Clinical Follow-up

  • n = 1359
  • 96.9%
resolute us3
RESOLUTE US

Baseline Characteristics

Yeung AC, et al. J Am Coll Cardiol.2011;57:1778-83.

slide7

RESOLUTE US – All Patients

Target Lesion Failure to 24 Months

25

RESOLUTE US (N=1402)

RESOLUTE All Comers (N=1140)

20

RESOLUTE International (N=2349)

15

Cumulative Incidence of TLF (%)

11.2%

10

9.8%

7.3%

5

0

0

90

180

270

360

450

540

630

720

Time After Initial Procedure (Days)

Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE).

Standard Error based on the Greenwood Formula.

resolute us all patients
RESOLUTE US – All Patients

Safety and Efficacy Outcomes at 24 Months

Resolute ZES (n=1359/1402)

Events [%]

99/1359

58/1359

20/1359

26/1359

3/1359

ST

(ARC Def/Prob)

Cardiac

Death

TLF

TLR

TV-MI

Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.

TLR is ischemia driven.

resolute us all patients1
RESOLUTE US – All Patients

Clinical Outcomes at 12 and 24 Months

dapt to 24 months
DAPT to 24 Months

RESOLUTE US, All Comers, International Trials

97.3

95.8

R-US (N=1402)

91.1

97.1

95.5

93.5

R-INT (N=2349)

R-AC (N=1140)

93.8

93.1

73.8

84.1

67.2%

Adherence to DAPT (%)

43.9%

18.6%

Time After Initial Procedure (days)

slide11

Def/probStent Thrombosis to 24 Months

RESOLUTE US, All Comers, International Trials

25

RESOLUTE US (N=1402)

RESOLUTE All Comers (N=1140)

20

RESOLUTE International (N=2349)

15

10

5

1.9%

1.0%

0

0.2%

0

90

180

270

360

450

540

630

720

Time After Initial Procedure (days)

Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE).

Standard Error based on the Greenwood Formula.

resolute us all patients2
RESOLUTE US – All Patients

Stent Thrombosis at 24 Months

resolute us main study 2 5 3 5mm single lesion
RESOLUTE US Main Study (2.5-3.5mm single lesion)

Safety and Efficacy Outcomes at 24 Months

Resolute ZES (n=968/1001)

Events [%]

57/968

10/968

17/968

33/968

1/968

ST

(ARC Def/Prob)

Cardiac

Death

TLF

TV-MI

TLR

Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR (ischemia driven).

TLF rate at 2 years for Endeavor ZES was 8.1% (Post-hoc analysis, Pnoninferiority<0.001)

resolute us 2 25mm cohort
RESOLUTE US – 2.25mm Cohort

Safety and Efficacy Outcomes at 24 Months

Resolute ZES (n=147/150)

Events [%]

12/147

5/147

2/147

7/147

2/147

ST

(ARC Def/Prob)

Cardiac

Death

TLF

TV-MI

TLR

Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.

TLR is ischemia driven.

resolute us diabetic patients
RESOLUTE US – Diabetic Patients

Safety and Efficacy Outcomes at 24 Months

Resolute ZES (n=474/482)

Events [%]

42/474

10/474

7/474

27/474

0/474

ST

(ARC Def/Prob)

Cardiac

Death

TLF

TV-MI

TLR

Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.

TLR is ischemia driven.

resolute us diabetic patients1
RESOLUTE US – Diabetic Patients

Safety and Efficacy Outcomes at 24 Months

Diabetic (n=474/482)

Non-Diabetic (n=885/920)

Events [%]

3/885

42/474

57/885

10/474

10/885

7/474

19/885

27/474

31/885

0/474

ST

(ARC Def/Prob)

Cardiac

Death

TLF

TV-MI

TLR

Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.

TLR is ischemia driven.

resolute us4
RESOLUTE US

Conclusions

  • Out to 2 years, the TLF (primary endpoint) was consistently low in all groups studied
    • All patients 7.3%, main cohort (2.5-3.5 single lesion) 5.9%, small vessels (2.25 mm) 8.2%
  • Stent thrombosis was very low (0.2%) with only 1 new ST event after 1 year, indicating a favorable safety profile
  • Very good outcomes in the diabetic subgroup
    • Low rate of TLF (8.9%) and TLR (5.7%)
    • No stent thrombosisout to 2 years