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 6–12 months after DES implantation in all patients and 1 year after ACS, irrespective of the type of implanted stent.
* Serruys PW et al. N Engl J Med. 2010;363:136–146. † Silber S, et al. The Lancet. 2011;377:1241–1247. ‡ Neumann FJ et al. EuroIntervention. 2012;7(10):1181–1188. §Yeung AC et al. JACC. 2011;57:1778–1783.
• 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 = 2.78±0.51mm, LL = 15.75±9.53 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.
RESOLUTE AC*† 1:1 RCT vs. Xience V™ EES (R = 1140; X = 1152) 3 yr
NonRCT Observational (R = 2349) 3 yr
2.25–4.00-mm NonRCT vs. Hx Control (R = 1402) 2 yrRESOLUTE US§
2.50–3.50-mm NonRCT (R = 100) vs. Hx ControlRESOLUTE Japan 2 yr
1º endpoint: TVFcardiac death, TVMI, clinically driven TVR at 12 mo2º endpoints: Components of TVF, ARC ST, patient-oriented composite Major exclusion criteria: STEMI within 48 hr requiring primary PCI
TWENTEN = 1391
PI: C. von BirgelenThoraxcentrum Twente,
Enschede, the Netherlands
Resolute™ DESn = 697
Xience V™ DESn = 694
TWENTE Study: Independent, Real-World Study
30 d 2 yr12 moClinicalFollow-Up
Real-World1:1 randomised, noninferiority trial
(no lesion/vessel limitations)
TWENTE
Similar Trial Design to RESOLUTE All Comers
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.
Multivessel treatment 25.0 23.3 0.48At least one bifurcation 25.7 26.4 0.77At least one CTO 7.3 6.3 0.47At least one in-stent restenosis 5.2 4.8 0.73At least one small vessel (RVD <2.75 mm) 63.8 61.8 0.43At least one long lesion (<27 mm) 22.4 19.7 0.23Complex Patients* 78.5 76.4 0.35
Patient Baseline and Lesion CharacteristicsTWENTE
*Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/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.
Unstable angina 23.4 19.2Non-ST-elevation-MI 28.2 13.9ST-elevation-MI NA 15.0
Multivessel treatment 24.0 24.9Lesion length (mm) 14.4 12.02 ± 7.68RVD (mm) 2.65 2.63 ± 0.57At least one bifurcation 26.0 17.3 At least one in-stent restenosis 5.0 8.0At least one small vessel (RVD <2.75 mm) 62.8 67.6At least one long lesion (>27 mm) 21.1 6.3Complex Patients* 77.4 66.3
Patient Baseline and Lesion CharacteristicsTWENTE and RESOLUTE All Comers
TWENTE
*Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/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.
Primary endpoint: Composite of cardiac death and target vessel MI at 12 moKey secondary endpoint: ARC definite/probable stent thrombosis at 12 moDrug therapy: ASA and clopidogrel/ticlopidine ≥6 mo (per guidelines)
Real-World (Open Label)All patients with symptomatic coronary artery
disease eligible for DES implantation(no lesion/vessel limitations)
6 mo 3 yr2 yr12 moClinical endpoints
30 d
Resolute™ DESn = 2200
88 international sites (Europe, Asia, Africa and South America)No angiographic follow-up
100% independent clinical event adjudication25% randomly assigned to 100% monitoring
*Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/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.
Meredith IT et al. EuroIntervention. 2010;5:692–697. Serruys PW et al. N Engl J Med. 2010;363:136–146. Silber S, et al. The Lancet. 2011;377:1241–47. Neumann FJ et al. EuroIntervention. 2012;7(10):1181–1188. Yeung AC et al. JACC. 2011;57:1778–1783.
RESOLUTE Pooled,38 mm Subgroup
223 Patients from the Following Highlighted Trials
RESOLUTE NonRCT First-in-Human (R = 139)
RESOLUTE All Comers 1:1 RCT vs. Xience V™ (R = 1140; X = 1152)
RESOLUTE International NonRCT Observational (R = 2349)
RESOLUTE US 2.25–4.00-mm NonRCT (R = 1402)38-mm Substudy NonRCT vs. PG (R = 114)
RESOLUTE Japan 2.50–3.50-mm NonRCT (R = 100) vs. Hx Control
R-Japan SVS 2.25-mm NonRCT vs. PG (R ≈ 63)
RESOLUTE Asia NonRCT (R ≈ 300)
R-China Registry Registry (R = 1800 max)
R-China RCT 1:1 RCT vs. Taxus™ DES (R = 200; T = 200)
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 6–12 months after DES implantation in all patients and 1 year after ACS, irrespective of the type of implanted stent.
