Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer-free...

A randomised comparison of reservoir-based polymer-free amphilimus-eluting stents versus

everolimus-eluting stents in patients with diabetes mellitus: the RESERVOIR clinical trial

Rafael Romaguera, Luis Teruel, Joan A Gómez-Hospital, Josep Gomez-Lara, Salvatore Brugaletta, Eduardo Pinar, Pilar Jiménez-Quevedo, Montserrat

Gracida, Gerard Roura, Jose L Ferreiro, Eduard Montanya, Antonio Fernandez-Ortiz, Fernando Alfonso, Marco Valgimigli, Manel Sabate, Angel Cequier

Clinical trial info: NCT01710748

• Patients with DM remain at high risk for in-stent restenosis and adverse cardiovascular events despite the use of DES.

• 2nd-gen DES provide superior safety and efficacy results as compared with 1st-gen DES.

• EES is the DES with the most robust evidence of safety and efficacy.

Background

81 µm Co Cr

Non-erodable flurocopolymerConformal configuration

Everolimus 100 μg/cm2

70-80 µm Co Cr

Polymer-freeCarbon coating

Sirolimus 90 μg/cm2Amphiphilic carrier

EES AES

Hospital ClínicoSanCarlosMadrid

Hospital ClínicoSanCarlosHospital ClínicoSanCarlosMadrid

Methods



Primary endpoint: Neointimal volume obstruction by OCTSecondary: Uncovered struts, LLL, TVR

Exclusion criteriaLife-style changes onlySTEMIBifurcation>2.5mmLeft Main/ostial LAD3V with CABG indicationGFR<30 ml/minLVEF < 30%Contraindication DAPT



Results: Study flow-chart

Results: Baseline characteristics

CharacteristicAES

56 patientsEES

56 patients

p valueAge 66.7 ± 9.8 67.2 ± 8.8 0.75

Hb1Ac 7.5 ±1.2 7.5 ± 1.2 0.80

LDL cholesterol 82.8 ± 39.2 80.7 ± 32.5 0.76

Creatinine 0.99 ± 0.26 0.95 ± 0.23 0.34

Diabetic nephropathy 9 (16.1) 13 (23.2) 0.34

Diabetes treatment

- Insulin 21 (37.5) 24 (42.9) 0.563

- Biguanides 48 (53.9) 41 (74.5) 0.14

Number of vessels diseased 1.61 ± 6.5 1.61 ± 7.3 1.0

Total stent length 21.5 ± 6.9 20.7 ± 7.6 0.53

Stent diameter 3.04 ± 0.35 2.93 ± 0.33 0.07

Number of stents per lesion 1.12 ± 0.33 1.05 ± 0.22 0.19

Angiographic success 58 (100) 58 (100) 1.0





AES50 patients/52 lesions

EES49 patients/50 lesions

p value

Before index procedureRVD (mm) 2.69 ±0.54 2.55 ± 0.49 0.16Diameter stenosis (% ± SD) 66.12 ± 14.88 64.72 ±12.28 0.61After index procedureRVD (mm) 2.70 ± 0.47 2.64 ±0.48 0.50MLD (mm) In-stent In-segment

2.51 ± 0.372.15 ± 0.50

2.43 ± 0.362.06 ± 0.53

0.240.37

Acute gain (mm) In-stent In-segment

1.59 ± 0.401.22 ± 0.46

1.54 ± 0.43 1.17 ± 0.60

0.520.59

Results: Baseline characteristics (QCA)

Δ -10 -5 0 +5.3 +10

Superiority Non-inferiority Inferiority



Primary endpoint: Neointimal Volume Obstr.

-4.1 +2.6

p for non-inferiority = 0.0003 p for superiority = 0.22



Secondary endpoints

Uncovered Uncovered & malapposed

0

0.5

1

1.5

2

2.5

3

3.5

AESEES

2.2

3.4

0.60.9

all p > 0.40



Pre specified subgroup analysis



Interaction between glycaemic control and stent effect

Hb1Ac7.3%

Cre8 better

p = 0.025

AES EES p value

MLD (mm) In-stent In-segment

2.38 ± 0.44 2.09 ± 0.45

2.19 ± 0.59 1.84 ± 0.61

0.070.02

Late lumen loss

0.14 ± 0.24 0.24 ± 0.57



Secondary endpoints:Clinical events at 12 months

Cardiac death

MI Definite ST TLR TVR TVF Unscheduled non-TVR

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

1.8%

0.0% 0.0%

5.2% 5.2%

6.9%

10.7%

0.0%

1.8% 1.7%

8.6%

12.1% 12.1%

10.7%

AES EES



Conclusions

• First study to show non inferiority of a PF-DES compared to EES in DM.

(Formulation of the antiproliferative drug with an amphiphilic carrier results in non-inferior efficacy than the classic elution from durable polymers for the coronary revascularization of patients with DM)

• This trial suggests a high efficacy of AES in DM, but it must be confirmed in a large RCT (warranted).

Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer-free...

Health & Medicine

Transcript of Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer-free...