RESOLUTE All Comers 24-month Outcomes:
Compelling Results in Real World Patients

Resolute DES Continues to Match Xience V DES in Primary Endpoint at 2 Years


Primary Endpoint: Target Lesion Failure at 24 Months


 

Similar Results in All Efficacy and Safety Endpoints at 2 Years

No Significant Difference in Any Endpoint at 2 Years


 

No Significant Difference in Stent Thrombosis Rates

RESOLUTE All-Comers ARC Def/Prob ST Rate at 24 Months


 

No Difference in Very Late Stent Thrombosis (VLST)

No Difference in VLST Rates


 

No Significant Difference in In-Stent Late Loss at 13-months

In-Stent Late Loss and Distribution

 

Target lesion failure = cardiac death, target vessel MI, TLR . RESOLUTE All Comers was not specifically designed or powered to compare endpoints other than TLF.
Error bars indicate a pointwise, two-sided 95% confidence interval (1.96 ± SD).
Standard error is based on the Greenwood formula.
All other p-values based on Fischer's Exact Test. p-values for outcome differences are uadjusted for multiple comparisons.

RESOLUTE All Comers 24-month Outcomes:
Powerful Performance in Complex Patients

Almost 70% of RESOLUTE All Comers patients are complex

All Patients

With the exception of long lesions (treatable with a single 38-mm length stent), Resolute DES currently is not specifically approved for the patient subsets noted in this complex patient definition.

 

Resolute DES Shows Strong Performance in Complex Patients

RESOLUTE ALL Comers 2-Year Results, Complex Patient Subgroup

Complex patient definition: Bifurcation, SVG, 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/vessel, lesion with thrombus or TO (preprocedure TIMI = 0). Currently, Resolute DES is not specifically approved for the subsets noted in this complex patient definition. p-Values are based on Fisher Exact Test. p-Values for outcome differences are unadjusted for multiple comparisons.
RESOLUTE All Comers was not specifically designed or powered for complex patient subset analysis.

 

Excellent clinical results establish Resolute DES as a strong choice in complex daily practice

Innovative RESOLUTE All Comers Trial Design

RESOLUTE All Comers Trial Design

Primary endpoint: TLF (ARC-defined): Cardiac death, target vessel MI, clinically indicated TLR at 12 months.
Secondary endpoint (powered): % Diameter stenosis (in-stent) at 13 months.
Secondary endpoints: TLF at 30 d, 6 months, 2–5 yr; Composite (all death, all MI, any revascularisation) at each FU time point; angiographic and optical coherence tomography (OCT) parameters at 13 months
Drug therapy: ASA and clopidogrel/ticlid >6 months (per guidelines)

 

Patient Eligibility

Inclusion Criteria

Coronary artery disease

  • Stable angina
  • Silent ischemia
  • Acute coronary syndrome including UA, NSTEMI and STEMI

Lesion characteristics

  • Number of lesions: no limitation
  • Number of vessels: no limitation
  • Lesion length: no limitation

Exclusion Criteria

Known allergy to
Aspirin, clopidogrel, heparin, cobalt alloy, everolimus, zotarolimus, contrast material, polymer coating

Planned, elective surgery within 6 months of PCI
Unless dual anti-platelet therapy could be maintained

Pregnancy

Participation in another Trial

 

Patient baseline characteristics

  Resolute DES
(N = 1140)
Xience V DES
(N = 1152)
p-Value
Age (yr) 64.4 ±10.9 64.2 ±10.8 NS
Men (%) 76.7 77.2 NS
Diabetes mellitus (%) 23.5 23.4 NS
ACS (%) 48.3 47.7 NS
AMI (within 12 hr) (%) 15.4 17.8 NS
AMI (within 72 hr) (%) 28.9 28.8 NS
Multivessel disease (%) 58.4 59.2 NS
Small vessel (RVD ≤2.75 mm) 67.8 67.4 NS
Long lesion (length >18 mm) 18.2 21.2 NS
In-stent restenosis (%) 8.1 8.0 NS
Bifurcation/ trifurcation 16.9 17.7 NS
Total occlusion (%) 16.3 17.2 NS
Complex Patients* (%) 67.0 65.6 NS

*Complex patient definition: Bifurcation, bypass graft, 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). With the exception of long lesions (treatable with a single 38-mm length stent), Resolute DES currently is not specifically approved for the patient subsets noted in this complex patient definition.

 

Lesion characteristics

  Resolute stent
N = 1140 patients
N = 1661 lesions
Xience V DES
N = 1152 patients
N = 1705 lesions
p-Value
Lesions treated per patient 1.46 ±0.73 1.48 ±0.77 NS
Lesion Length (mm) 11.89 ±7.50 12.15 ±7.86 NS
No. of stents per patient 1.9 ±1.2 2.0 ±1.3 0.02
Stent length per patient (mm) 34 ±24 37 ±26 0.02
Pre-stent balloon dilatation 69.5% 70.2% NS
Implantation of study stent 98.0% 96.9% NS
Lesion success 98.9% 99.1% NS
Device success 97.0% 96.6% NS
Procedure success 94.6% 94.2% NS

 

 

Clinical Data Overview

RESOLUTE All Comers
24 Month Results Summary

 
 

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