2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study
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Transcript of 2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study
2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study
Laura Mauri MD, MScon behalf of the RESOLUTE US
Investigators
Brigham and Women’s HospitalBoston, MA
ACC 2012
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
Non-RCT Observational (R=2349) 2 yr
2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2 yrRESOLUTE US5
2.5 – 3.5 mm Non-RCT (R=100) vs. Hx ControlRESOLUTE Japan 2 yr
R Japan SVS 2.25 Non-RCT vs. PG (R=65) < 1yr
38 mm sub-study Non-RCT vs. PG (R=114) < 1yr
RESOLUTE Asia Non-RCT Observational (R=312) < 1yr
RI-US Registry Post-approval study (R=230) plan
RESOLUTE US
RESOLUTE Global Clinical Program
Enrolling / Planning
1:1 RCT vs. Taxus (R=200; T=200)R-China RCT < 1yr
RESOLUTE Int4
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.
R-China Registry Non-RCT Observational (R=1800) < 1yr
Hx ControlsPerformance Goals
Resolute stent2.25–3.5 Clinical (n=1242)
2.25–3.5 Angio/IVUS (n=100)4.0 Angio (n=60)
38mm Clinical (n=110–175)
RESOLUTE US
PI: M. Leon, L. Mauri, A. Yeung
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)
De Novo Native Coronary LesionVessel Diameter: 2.25 – 4.2 mm
Lesion Length: ≤ 27 mm(≤ 35 mm lesions tx w/ 38 mm stent)
Clinical endpoints
Angio/IVUS endpoints6mo 4yr3yr2yr12mo 18mo8mo 5yr9mo30d
N = max 1577 patientsUp to 135 US sites
Clinical Study Design
Mauri L, et al. Am Heart J. 2011;161:807-14.
Key Inclusion 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 ≥2Patient is able to take DAPT for at
least 6 monthsTreatment of up to two lesions, if the
lesions are located in separate target vessels
Key Exclusion 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%
RESOLUTE USKey Eligibility Criteria
Mauri L, et al. Am Heart J. 2011;161:807-14.
RESOLUTE USPatient Flow Chart
1Yr Clinical Follow-upn = 1386
98.9%
Patients EnrolledN = 1402
2Yr Clinical Follow-upn = 1359
96.9%
RESOLUTE US
%All Patients
(2.25 mm – 4.00 mm diameter)N = 1402 Patients / 1573 Lesions
Age, years (mean ± SD) 64.1±10.7Male 68.3 Diabetes mellitus 34.4
IDDM 9.6 Prior PCI 32.7Reason for revascularization:
Stable angina 56.1 Unstable angina 41.9 Myocardial infarction 2.1
LAD 45.9 RVD (mm) 2.6 ± 0.5 Type B2/C lesion 75.2 Two vessel treatment 10.4Stents per patient (mean ± SD) 1.2 ± 0.5Stent length per patient (mm) 22.4 ± 10.5
Baseline Characteristics
Yeung AC, et al. J Am Coll Cardiol. 2011;57:1778-83.
25
15
10
5
00 90 180 360 450 540 630 720
Cum
ulat
ive
Inci
denc
e of
TLF
(%)
Time After Initial Procedure (Days)
RESOLUTE US (N=1402)
RESOLUTE US – All PatientsTarget Lesion Failure to 24 Months
Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.
20
270
7.3%
RESOLUTE All Comers (N=1140)RESOLUTE International (N=2349)
11.2%9.8%
RESOLUTE US – All PatientsSafety and Efficacy Outcomes at 24 Months
Resolute ZES (n=1359/1402)
TLR Cardiac Death
TV-MI ST (ARC Def/Prob)TLF
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.
Even
ts [%
]
99/1359 58/1359 20/1359 3/135926/1359
RESOLUTE US – All Patients
%12M
n = 138624M
n = 1359Death (all) 1.3 3.0
Cardiac 0.6 1.5MI (target vessel) 1.3 1.9
Q Wave 0.1 0.1Non Q wave 1.2 1.8
Cardiac death + target vessel MI 1.9 3.2ST Def/Prob (all) 0.1 0.2
Early (0-30 days) 0.1 0.1Late (31-360 days) 0.1 0.1Very late (>360 days) -- 0.1
TLR 2.8 4.3TVR 4.5 7.6TLF (cardiac death, TV-MI, TLR) 4.6 7.3TVF 6.1 10.1
Clinical Outcomes at 12 and 24 Months
30 180 360 540 7200
10
20
30
40
50
60
70
80
90
100
DAPT to 24 MonthsA
dher
ence
to D
APT
(%)
Time After Initial Procedure (days)
RESOLUTE US, All Comers, International Trials
95.597.1 93.5
73.8
67.2%
93.8 93.1
84.1
18.6%
95.897.391.1
43.9%
R-US (N=1402)
R-AC (N=1140)R-INT (N=2349)
Def/prob Stent Thrombosis to 24 MonthsRESOLUTE US, All Comers, International Trials
Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.
25
15
10
5
00 90 180 270 360 720
Time After Initial Procedure (days)
20
630540450
1.9%1.0%
RESOLUTE All Comers (N=1140)RESOLUTE International (N=2349)
RESOLUTE US (N=1402)
0.2%
% (n) 30 Daysn=1399
1 Yearn=1386
2 Year n=1359
Stent thrombosis (ARC def/prob) 0.1 (1) 0.1 (2) 0.2 (3)
Early (< 30 days) 0.1 (1) 0.1 (1) 0.1 (1)
Late (30-360 days) n/a 0.1 (1) 0.1 (1)
Very Late (>360 days) n/a n/a 0.1 (1)
RESOLUTE US – All PatientsStent Thrombosis at 24 Months
RESOLUTE US Main Study (2.5-3.5mm single lesion) Safety and Efficacy Outcomes at 24 Months
Resolute ZES (n=968/1001)
TLRCardiac Death TV-MI
ST (ARC Def/Prob)TLF
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)
Even
ts [%
]
57/968 10/968 17/968 1/96833/968
RESOLUTE US – 2.25mm Cohort Safety and Efficacy Outcomes at 24 Months
Resolute ZES (n=147/150)
TLRCardiac Death TV-MI
ST (ARC Def/Prob)TLF
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.
Even
ts [%
]
12/147 5/147 2/147 2/1477/147
RESOLUTE US – Diabetic PatientsSafety and Efficacy Outcomes at 24 Months
Resolute ZES (n=474/482)
TLRCardiac Death TV-MI
ST (ARC Def/Prob)TLF
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.
Even
ts [%
]
42/474 10/474 7/474 0/47427/474
RESOLUTE US – Diabetic PatientsSafety and Efficacy Outcomes at 24 Months
Diabetic (n=474/482)
TLRCardiac Death TV-MI
ST (ARC Def/Prob)TLF
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.
Even
ts [%
]
57/885 10/885 19/885 3/88531/885
Non-Diabetic (n=885/920)
42/474 10/474 7/474 0/47427/474
RESOLUTE US
• 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 thrombosis out to 2 years
Conclusions