Strong New Data from RESOLUTE International Trial

Strength in Numbers

Low rates in all efficacy and safety endpoints

Large, high quality all-comers trial

  • 2349 real-world all-comers patients enrolled from 88 international sites
  • 100% independent clinical event adjudication
  • High degree of monitoring
  • 97.7% clinical follow-up at 12 months

RESOLUTE International: Clinical Efficacy and Safety Endpoints at 24 Months


TLF = Cardiac death, target vessel MI, clinically indicated TLR.

 

Strength in Consistency

Consistent results to RESOLUTE All Comers

Large, high quality all-comers trial

  • RESOLUTE International has similar minimal exclusion criteria to RESOLUTE All Comers
  • Total of 3489 real-world Resolute DES patients enrolled in both all-comers trials

RESOLUTE All Comers vs. RESOLUTE International at 24 Months

TLF = cardiac death, target vessel MI, clinically indicated TLR.

 

Strength in Complexity

Almost 70% of patients in RESOLUTE International are complex

All Patients


 

Resolute DES continues to show strong performance in complex patient subgroup

Composite Rates in Complex Patient Subset at 24 Months

TLF = cardiac death, target vessel MI, clinically indicated TLR.

 

Low TLR rates across complex patient subgroups

TLR Rates in RESOLUTE International Subgroups at 24 Months

 

With the exception of long lesions (treatable with a single 38-mm length stent) and small vessel patients, Resolute DES currently is not specifically approved for the patient subsets noted above.
RESOLUTE International and RESOLUTE All Comers were not specifically designed or powered for complex patients.

 

RESOLUTE International Trial Design

Large All Comer Trial

PI: J. Belardi, F–J. Neumann, P. Widimský

RESOLUTE All Comers Trial Design

 

Patient Eligibility Similar to RESOLUTE All-Comers

Inclusion Criteria

Coronary artery disease

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

Intention to electively implant at least one Resolute stent

Lesion characteristics

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

Written informed consent

 

Exclusion Criteria

Pregnancy

Inability to comply with follow-up requirements

Participation in another trial

 

Patient baseline characteristics

 
RESOLUTE International
RESOLUTE
All Comers
  Resolute DES
(n = 2349)
Resolute DES
(n = 1140)
Xience V DES
(n = 1152)
Age (yr) 63.5 ±11.2 64.4 ±10.9 64.2 ±10.8
Men (%) 77.8 76.7 77.2
Diabetes mellitus (%) 30.5 23.5 23.4
    Insulin Dependent
    (%)
9 8.4 7.1
Prior MI (%) 27 28.9 30.4
Unstable Angina (%) 26.1 19.4 18.9
AMI (within 12 hr) (%) 9.7 15.4 17.8
AMI (within 72 hr) (%) 20 28.9 28.8
Lesions treated per patient 1.3 ±0.7 1.5 ±0.7 1.5 ±0.8
Multi vessel treated (%) 14.0 25 25
Small vessel (RVD ≤2.75 mm) 45.4 67.8 67.4
Long lesion (length >18 mm) 46.1 18.2 21.2
In-stent restenosis (%) 7.6 8.1 8.0
Bifurcation/trifurcation (%) 18.2 16.9 17.7
Total occlusion (%) 6.3 16.3 17.2
Complex Patients1 (%) 67.5 67.0 65.6

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 small vessels and long lesions (treatable with a single 38-mm length stent), Resolute DES currently is not specifically approved for the patient subgroups noted above.

 

Clinical Data Overview

RESOLUTE All Comers
24 Month Results Summary

 
 

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