TCT 2012 MSG Deck (Ous)

TCT 2012 Highlights
Trademarks may be registered and are the property of their respective owners. For distribution only in markets where the Resolute Integrity coronary stent has been approved. Not for distribution in the USA or Japan. 2012 Medtronic, Inc. All rights reserved. UC201303198EE 10/12
For distribution only in markets where the Resolute Integrity coronary stent has been approved. Not for distribution in the USA or Japan. 2011 Medtronic, Inc. All Rights Reserved. UC201202755EE 10/11
Resolute Integrity DES: Simplify the Challenge

TCT 2012 Highlights
RESOLUTE Pooled DAPT analysis When interrupted 1 month after the procedure (including those that permanently discontinued), the ST rate with Resolute DES was 0%*
Strength in real world

Powerful TWENTE 2-year results continue to confirm Resolute DES real-world performance Excellent, long-term outcomes in all-comers RESOLUTE International 3-year results
Strength in challenging subgroups

Very low event rates seen in RESOLUTE Pooled Small Vessel program and 38-mm Long Lesion subgroup
Powerful performance seen in diabetic subset within this challenging subgroup, with no difference to nondiabetics.
*ESC guidelines recommend a DAPT duration of 612 months after DES implantation in all patients and 1 year after ACS, irrespective of the type of implanted stent.
Xience V DES, Tullio Palmerini, Presented at PCR 2012
Recent DAPT Interruption Data on Second-Generation DES
DAPT Interruption
DAPT Interruption
RESOLUTE DAPT Interruption Analysis Methodology

Pooled Patient-Level Data: N= ~5000
RESOLUTE AC* RESOLUTE Int RESOLUTE US RESOLUTE Japan 1:1 RCT vs. Xience V EES (R = 1140; X = 1152) NonRCT Observational (R = 2349) 2.254.00-mm NonRCT vs. Hx Control (R = 1402) 2.503.50-mm NonRCT (R = 100) vs. Hx Control 3 yr 3 yr 2 yr
2 yr
Studies chosen due to quality of data on DAPT usage This pooled analysis included the following patients: 30.2% diabetics, 25.9% prior PCI, 45.1% ACS, RVD = 2.780.51mm, LL = 15.759.53 mm, 66.6% B2/C lesions All DAPT interruption was defined as a patient who stopped DAPT for more than 1 day, including those who never resumed. The analysis aimed to evaluate the 1-year rate of definite/probable ST for patients who had a DAPT interruption compared with those who continued DAPT without any interruption through 12 months.
* Serruys PW et al. N Engl J Med. 2010;363:136146. Silber S, et al. The Lancet. 2011;377:12411247. Neumann FJ et al. EuroIntervention. 2012;7(10):11811188. Yeung AC et al. JACC. 2011;57:17781783.
0% ST Rate in Patients Interrupting DAPT Beyond 3 Months RESOLUTE Pooled DAPT Analysis
DAPT Interruption
0% ST With First DAPT Interruption Between 112 Months RESOLUTE Pooled DAPT Analysis
DAPT Interruption
TWENTE
TWENTE Study: Independent, Real-World Study

Similar Trial Design to RESOLUTE All Comers
TWENTE N = 1391
Real-World
1:1 randomised, noninferiority trial (no lesion/vessel limitations)

PI: C. von Birgelen Thoraxcentrum Twente, Enschede, the Netherlands
Resolute DES n = 697
Xience V DES n = 694
Clinical Follow-Up
30 d
12 mo
2 yr
1 endpoint: TVFcardiac death, TVMI, clinically driven TVR at 12 mo 2 endpoints: Components of TVF, ARC ST, patient-oriented composite Major exclusion criteria: STEMI within 48 hr requiring primary PCI
von Birgelen et al. The TWENTE Trial. J Am Coll Cardiol. 2012;59(15):1350-1361. Study received an unrestricted grant from Medtronic Inc. and Abbott Laboratories.
TWENTE
Patient Baseline and Lesion Characteristics
Variable (%) Age (yr) Female Diabetes mellitus Arterial hypertension Hypercholesterolemia Current smoker Prior PCI Acute coronary syndrome
Unstable angina Non-ST-elevation-MI
Resolute ZES (N = 697) 63.9 27.5 22.7 55.4 57.0 25.3 19.9 51.9
24.7 27.3
Xience V EES (N = 694) 64.5 27.4 20.6 55.8 61.4 23.6 21.5 51.2
22.0 29.1
p-Value 0.32 0.94 0.35 0.89 0.10 0.48 0.48 0.47

0.47 0.47
Multivessel treatment At least one bifurcation At least one CTO At least one in-stent restenosis At least one small vessel (RVD <2.75 mm) At least one long lesion (<27 mm) Complex Patients*
25.0 25.7 7.3 5.2 63.8 22.4 78.5
23.3 26.4 6.3 4.8 61.8 19.7 76.4
0.48 0.77 0.47 0.73 0.43 0.23 0.35
*Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 mol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI = 0). Resolute Integrity DES is currently not specifically approved for use in LVEF, renal insufficiency, unprotected left main or bypass grafts.
Low, Similar Results for Resolute DES and Xience V DES
TWENTE
Components of Target Vessel Failure (TVF)
Similar Outcomes at 2 Years for Resolute DES vs. Xience V DES

TWENTE
Low Rates of ST in Independent, Real-World Study

TWENTE
TWENTE
Patient Baseline and Lesion Characteristics

TWENTE and RESOLUTE All Comers
Variable (%) Age (yr) (mean SD) Female Diabetes mellitus Hypertension Prior percutaneous coronary intervention Acute coronary syndrome
Unstable angina Non-ST-elevation-MI ST-elevation-MI
TWENTE (N = 1391) 64.2 27.5 21.6 55.6 20.7 51.5

23.4 28.2 NA
RESOLUTE All Comers (N = 2292) 64.23 10.8 23.1 23.5 71.2 32.0 48.0
19.2 13.9 15.0
Multivessel treatment Lesion length (mm) RVD (mm) At least one bifurcation At least one in-stent restenosis At least one small vessel (RVD <2.75 mm) At least one long lesion (>27 mm) Complex Patients*
24.0 14.4 2.65 26.0 5.0 62.8 21.1 77.4
24.9 12.02 7.68 2.63 0.57 17.3 8.0 67.6 6.3 66.3
TWENTE Continues to Confirm RESOLUTE All Comers Results at 2 Years

TWENTE
RESOLUTE International
RESOLUTE International Trial Design

Prospective, Multicentre, Real-World Study
PI: J. Belardi, F-J. Neumann, P. Widimsk
Real-World (Open Label)

All patients with symptomatic coronary artery disease eligible for DES implantation (no lesion/vessel limitations)
Resolute DES n = 2200
88 international sites (Europe, Asia, Africa and South America) No angiographic follow-up 100% independent clinical event adjudication 25% randomly assigned to 100% monitoring
Clinical endpoints
30 d
6 mo
12 mo
2 yr
3 yr
Primary endpoint: Composite of cardiac death and target vessel MI at 12 mo Key secondary endpoint: ARC definite/probable stent thrombosis at 12 mo Drug therapy: ASA and clopidogrel/ticlopidine 6 mo (per guidelines)
Enrollment Reflects Real-World Practice

Similar Baseline Characteristics of RESOLUTE International and RESOLUTE All Comers
RESOLUTE International Resolute DES (n = 2349) Age (yr) 63.4 11.2
RESOLUTE All Comers

Resolute DES (n = 1140) 64.4 10.9 Xience V DES (n = 1152) 64.2 10.8 23.4 7.1 30.4 18.9 17.8 28.8
Men (%)
Diabetes mellitus (%) Insulin dependent (%) Prior MI (%) Unstable angina (%) AMI (within 12 hr) (%) AMI (within 72 hr) (%)
77.8
30.4 8.9 27.0 26.1 9.7 20.0
76.7
23.5 8.4 28.9 19.4 15.4 28.9
77.2
Lesions treated per patient

Multivessel treated (%) Small vessel (RVD 2.75 mm) Long lesion (length >18 mm) In-stent restenosis (%) Bifurcation/trifurcation (%) Total occlusion (%) Complex Patients*(%)
1.3 0.7
14.0 45.4 46.1 7.6 18.2 6.3 67.5
1.5 0.7
25.0 67.8 18.2 8.1 16.9 16.3 67.0
1.5 0.8
25.0 67.4 21.2 8.0 17.7 17.2 65.6
Excellent Safety and Efficacy Clinical Outcomes Sustained Low Event Rates Out to 3 Years
0% Stent Thrombosis for Patients Interrupting DAPT at 3 Months

RESOLUTE International Consistent with Pooled RESOLUTE 3 M DAPT Analysis
No Stent Thrombosis in Patients Interrupting DAPT Beyond 1 Month
RESOLUTE International Consistent with Pooled RESOLULTE 3 M DAPT Analysis
RESOLUTE PooledSmall Vessel Subgroup Patients with vessel diameter 2.5mm

1956 Small Vessel Patients from the Following Highlighted Trials
RESOLUTE RESOLUTE All Comers RESOLUTE International RESOLUTE US RESOLUTE Japan R-Japan SVS RESOLUTE Asia R-China Registry R-China RCT NonRCT First-in-Human (R = 139) 1:1 RCT vs. Xience V (R = 1140; X = 1152) NonRCT Observational (R = 2349) 2.254.00-mm Non-RCT (R = 1402) 38-mm Substudy NonRCT vs. PG (R = 114) 2.503.50-mm NonRCT (R = 100) vs. Hx Control 2.25-mm NonRCT vs. PG (R 63) NonRCT (R 300) Registry (R = 1800 max) 1:1 RCT vs. Taxus DES (R = 200; T = 200)
RESOLUTE Pooled, SV Subgroup
Patient Baseline and Lesion Characteristics Higher Comorbidities seen in Small Vessel Subgroup
Patient Characteristics
RVD 2.50 mm N = 1956 64.7 10.9 RVD >2.50 mm N = 3174 63.3 11.0
Lesion Characteristics
RVD 2.50 mm N = 1956 Patients, 2974 Lesions Number of diseased vessels (>50%) Single Double Triple Lesion location (%) LAD LCx RCA Left Main RVD* (mm) MLD* (mm) Lesion length* (mm) % diameter stenosis* 48.5 33.7 17.0 58.7 27.7 13.2 RVD >2.50 mm N = 3174 Patients, 3884 Lesions
% Age (yr)
p-Value <0.001
p-Value
Male
Diabetes mellitus IDDM Hypertension Hyperlipidemia Current smoker Prior MI Prior PCI Prior CABG History of stroke or TIA Clinical status: Stable angina Unstable angina Myocardial infarction
71.4
34.4 10.8 77.0 76.5 20.9 27.3 33.1 9.1 7.3
77.0
27.2 7.7 71.1 68.5 25.4 25.9 29.5 8.2 4.9
<0.001
<0.001 <0.001 <0.001 <0.001
<0.001
54.1 41.4 28.3 1.0 2.4 0.4 0.6 0.4
46.6 22.9 36.7 2.4 3.1 0.4 0.7 0.5
<0.001 <0.001 <0.001 <0.001 <0.001 0.002
0.295 0.007 0.281 0.064 <0.001
39.5 26.7 19.9
37.9 25.4 24.0
14.7 9.2
72.8 16.3
16.5 9.6
77.7 16.1
<0.001
<0.001
*For RESOLUTE International (R-Int), angiographic measurements are site reported.
No Difference Seen in SV and Overall Population at 24 Months
Low Event Rates Across Small Vessel Subgroup

No Statistical Differences Between Diabetic and Nondiabetic Patients
Low Event Rates Across Diabetic Small Vessel Subgroup
RESOLUTE Pooled, 38 mm Subgroup
RESOLUTE Pooled38-mm Subgroup
223 Patients from the Following Highlighted Trials

RESOLUTE RESOLUTE All Comers RESOLUTE International RESOLUTE US RESOLUTE Japan R-Japan SVS RESOLUTE Asia R-China Registry R-China RCT NonRCT First-in-Human (R = 139) 1:1 RCT vs. Xience V (R = 1140; X = 1152) NonRCT Observational (R = 2349) 2.254.00-mm NonRCT (R = 1402) 38-mm Substudy NonRCT vs. PG (R = 114) 2.503.50-mm NonRCT (R = 100) vs. Hx Control 2.25-mm NonRCT vs. PG (R 63) NonRCT (R 300) Registry (R = 1800 max) 1:1 RCT vs. Taxus DES (R = 200; T = 200)
Meredith IT et al. EuroIntervention. 2010;5:692697. Serruys PW et al. N Engl J Med. 2010;363:136146. Silber S, et al. The Lancet. 2011;377:124147. Neumann FJ et al. EuroIntervention. 2012;7(10):11811188. Yeung AC et al. JACC. 2011;57:17781783.
RESOLUTE 38 mm Subgroup
Patient and Lesion Characteristics

Complex Challenging Anatomies With >35% Diabetics and >90% B2/C Lesions
RESOLUTE 38 mm % Age (yr) Male Diabetes mellitus N = 223 Patients 60.9 10.6 78.9 37.7 Number of multi-vessel (2) vessels Lesion location LAD LCx RESOLUTE 38 mm N = 223 Patients, 269 Lesions 53.8
52.0 20.2
IDDM
Hypertension Hyperlipidemia Current smoker Prior MI
10.3
74.9 58.7 18.8 32.4
Lesion length Discrete (<10 mm)
4.6
Tubular (10-19.9 mm)

Diffuse (20 mm) Branch vessel disease B2/C lesion
24.5
70.9 47.9 91.2 25.22 8.83 2.78 0.42 0.80 0.36 71.33 11.61
Prior PCI
Cardiac status: Stable angina Unstable angina Myocardial infarction
27.4
Lesion length (mm) 39.2 47.4 13.4 RVD (mm) MLD (mm) Preprocedure % diameter stenosis
QCA measurements may have been made by careful visual estimate, online QCA or IVUS.
RESOLUTE 38-mm Subgroup Demonstrates Significantly Lower TLF Rate vs. Performance Goal Extremely Low Event Rates in Challenging Patients
RESOLUTE 38 mm
Low Rates in Challenging Diabetic Population

No Differences in Diabetics and Nondiabetics Subgroup
RESOLUTE 38 mm
Resolute Integrity DES: Simplify the Challenge

TCT 2012 Highlights
RESOLUTE Pooled DAPT analysis When interrupted 1 month after the procedure (including those that permanently discontinued), the ST rate with Resolute DES was 0%*
Strength in real world

Powerful TWENTE 2-year results continue to confirm Resolute DES real-world performance Excellent, long-term outcomes in all-comers RESOLUTE International 3-year results
Strength in challenging subgroups

Very low event rates seen in RESOLUTE Pooled Small Vessel program and 38-mm Long Lesion subgroup
Powerful performance seen in diabetic subset within this challenging subgroup, with no difference to nondiabetics.
*ESC guidelines recommend a DAPT duration of 612 months after DES implantation in all patients and 1 year after ACS, irrespective of the type of implanted stent.

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TCT 2012 Highlights

Resolute Integrity DES: Simplify the Challenge

Strength in real world

Strength in challenging subgroups

Xience V DES, Tullio Palmerini, Presented at PCR 2012

Recent DAPT Interruption Data on Second-Generation DES

RESOLUTE DAPT Interruption Analysis Methodology

TWENTE Study: Independent, Real-World Study

1:1 randomised, noninferiority trial (no lesion/vessel limitations)

Resolute DES n = 697

Xience V DES n = 694

Patient Baseline and Lesion Characteristics

p-Value 0.32 0.94 0.35 0.89 0.10 0.48 0.48 0.47

25.0 25.7 7.3 5.2 63.8 22.4 78.5

23.3 26.4 6.3 4.8 61.8 19.7 76.4

0.48 0.77 0.47 0.73 0.43 0.23 0.35

Low, Similar Results for Resolute DES and Xience V DES

Components of Target Vessel Failure (TVF)

Similar Outcomes at 2 Years for Resolute DES vs. Xience V DES

Low Rates of ST in Independent, Real-World Study

Patient Baseline and Lesion Characteristics

TWENTE (N = 1391) 64.2 27.5 21.6 55.6 20.7 51.5

24.0 14.4 2.65 26.0 5.0 62.8 21.1 77.4

TWENTE Continues to Confirm RESOLUTE All Comers Results at 2 Years

RESOLUTE International Trial Design

Real-World (Open Label)

Resolute DES n = 2200

Enrollment Reflects Real-World Practice

RESOLUTE All Comers

Lesions treated per patient

0% Stent Thrombosis for Patients Interrupting DAPT at 3 Months

No Stent Thrombosis in Patients Interrupting DAPT Beyond 1 Month

RESOLUTE International Consistent with Pooled RESOLULTE 3 M DAPT Analysis

RESOLUTE PooledSmall Vessel Subgroup Patients with vessel diameter 2.5mm

RESOLUTE Pooled, SV Subgroup

RESOLUTE Pooled, SV Subgroup

54.1 41.4 28.3 1.0 2.4 0.4 0.6 0.4

46.6 22.9 36.7 2.4 3.1 0.4 0.7 0.5

<0.001 <0.001 <0.001 <0.001 <0.001 0.002

0.295 0.007 0.281 0.064 <0.001

39.5 26.7 19.9

37.9 25.4 24.0

*For RESOLUTE International (R-Int), angiographic measurements are site reported.

No Difference Seen in SV and Overall Population at 24 Months

Low Event Rates Across Small Vessel Subgroup

No Statistical Differences Between Diabetic and Nondiabetic Patients

Low Event Rates Across Diabetic Small Vessel Subgroup

RESOLUTE Pooled, SV Subgroup

RESOLUTE Pooled, 38 mm Subgroup

RESOLUTE Pooled38-mm Subgroup

223 Patients from the Following Highlighted Trials

Patient and Lesion Characteristics

Lesion length Discrete (<10 mm)

Tubular (10-19.9 mm)

Low Rates in Challenging Diabetic Population

Resolute Integrity DES: Simplify the Challenge

Strength in real world

Strength in challenging subgroups

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