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

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

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

 

RESOLUTE International Trial Design

Large All Comer Trial

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

 

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.