A randomised comparison of reservoir-based
polymer-free amphilimus-eluting stents versus
everolimus-eluting stents in pati...
• Patients with DM remain at high risk for in-stent restenosis and
adverse cardiovascular events despite the use of DES.
•...
Methods
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Primary endpoint:...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Results: Study flow-chart
Results: Baseline characteristics
Characteristic
AES
56 patients
EES
56 patients p value
Age 66.7 ± 9.8 67.2 ± 8.8 0.75
Hb...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
AES
50 patients
/52 lesio...
Δ -10 -5 0 +5.3 +10
Superiority Non-inferiority Inferiority
Hospital Clínico San Carlos
Madrid
Hospital Clínico San Carlos...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Secondary endpoints
0
0.5...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Pre specified subgroup an...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Interaction between glyca...
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
0.07
0.02
Late lumen loss
0.1...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Secondary endpoints:
Clin...
Hospital Clínico San Carlos
Madrid
Hospital Clínico San CarlosHospital Clínico San Carlos
Madrid
Conclusions
• First study...
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Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents in patients with diabetes mellitus: the RESERVOIR clinical trial

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A randomised comparison of reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents in patients with diabetes mellitus: the RESERVOIR clinical trial

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Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents in patients with diabetes mellitus: the RESERVOIR clinical trial

  1. 1. 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
  2. 2. • 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 flurocopolymer Conformal configuration Everolimus 100 μg/cm2 70-80 µm Co Cr Polymer-free Carbon coating Sirolimus 90 μg/cm2 Amphiphilic carrier EES AES Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid
  3. 3. Methods Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Primary endpoint: Neointimal volume obstruction by OCT Secondary: Uncovered struts, LLL, TVR Exclusion criteria Life-style changes only STEMI Bifurcation>2.5mm Left Main/ostial LAD 3V with CABG indication GFR<30 ml/min LVEF < 30% Contraindication DAPT
  4. 4. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Results: Study flow-chart
  5. 5. Results: Baseline characteristics Characteristic AES 56 patients EES 56 patients p value Age 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 Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid
  6. 6. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid AES 50 patients /52 lesions EES 49 patients /50 lesions p value Before index procedure RVD (mm) 2.69 ±0.54 2.55 ± 0.49 0.16 Diameter stenosis (% ± SD) 66.12 ± 14.88 64.72 ±12.28 0.61 After index procedure RVD (mm) 2.70 ± 0.47 2.64 ±0.48 0.50 MLD (mm) In-stent In-segment 2.51 ± 0.37 2.15 ± 0.50 2.43 ± 0.36 2.06 ± 0.53 0.24 0.37 Acute gain (mm) In-stent In-segment 1.59 ± 0.40 1.22 ± 0.46 1.54 ± 0.43 1.17 ± 0.60 0.52 0.59 Results: Baseline characteristics (QCA)
  7. 7. Δ -10 -5 0 +5.3 +10 Superiority Non-inferiority Inferiority Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Primary endpoint: Neointimal Volume Obstr. -4.1 +2.6 p for non-inferiority = 0.0003 p for superiority = 0.22
  8. 8. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Secondary endpoints 0 0.5 1 1.5 2 2.5 3 3.5 Uncovered Uncovered & malapposed AES EES 2.2 3.4 0.6 0.9 all p > 0.40
  9. 9. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Pre specified subgroup analysis
  10. 10. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Interaction between glycaemic control and stent effect dHb1 12,010,08,06,0 NVO(%) ,5000 ,4000 ,3000 ,2000 ,1000 ,0000 Hb1Ac 7.3% Cre8 better p = 0.025
  11. 11. 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 0.07 0.02 Late lumen loss 0.14 ± 0.24 0.24 ± 0.57
  12. 12. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid Secondary endpoints: Clinical events at 12 months 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
  13. 13. Hospital Clínico San Carlos Madrid Hospital Clínico San CarlosHospital Clínico San Carlos Madrid 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).

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