A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs. - - PowerPoint PPT Presentation

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A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs. - - PowerPoint PPT Presentation

Dec 08, 2023 268 likes •509 views

A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs. a BMS with Short DAPT in Patients with Coronary Artery Disease Older than 75 Years. The SENIOR Trial O . Varenne, S. Cook, G. Sideris, S. Kedev, T. Cuisset, D. Carri, T.

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A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs. a BMS with Short DAPT in Patients with Coronary Artery Disease Older than 75 Years. The SENIOR Trial

  • O. Varenne, S. Cook, G. Sideris, S. Kedev, T. Cuisset, D. Carrié, T. Hovasse, P.

Garot, R. El Mahmoud, C. Spaulding, G. Helft, J. Diaz Fernandez, S. Brugaletta, E. Pinar Bermudez, J. Mauri Ferre, P. Commeau, E. Teiger,

  • K. Bogearts, M. Sabate, M-C. Morice and P. Sinnaeve,

for the SENIOR investigators.

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SLIDE 2

Disclosure Statement of Financial Interest

  • Lectures Fees
  • Boston Scientific
  • Abbott Vascular
  • Astra Zeneca
  • Servier

Within the past 12 months, I or my partner have had a financial interest with the organizations listed below Financial Relationship Company

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Elderly PCI patients

  • CAD is highly prevalent: complex, severe, and diffuse
  • In US national registries in 20161: 25% of PCI in patients ≥75y
  • Poorly represented in prior studies on DES and DAPT duration
  • No clear recommendation for PCI strategies

Often treated with BMS and short DAPT (*), as a strategy to limit bleeding complications2

(*) Short DAPT: 1mo in stable patients, ≥6mo in unstable patients (per ESC guidelines)

  • 1. Masoudi FA, et al. JACC 2017;69:1424-6
  • 2. Gerber Y, et al. J Interv Cardiol. 2017;30:347-55
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SLIDE 4

Drug-coated Stents

Subgroup analysis: elderly patients

  • 1. Urban P. et al. N Engl J Med. 2015;373:2038-47
  • 2. Morice MC. et al. Int J Cardiol. 2017;243:110-115
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SENIOR Study Hypothesis

www.ClinicalTrial.gov: NCT NCT02099617

To demonstrate that a thin struts DES & short BMS-like DAPT in elderly patients is associated with:

  • a lower rate of MACCE at 1 year vs. BMS (efficacy)
  • a similar risk of bleeding at 1 year vs. BMS (safety)
  • a similar risk of stent thrombosis at 1 year vs. BMS (safety)
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SENIOR Trial design

Varenne O. et al. EuroIntervention. 2017;12(13):1614-22

DES BMS Randomized (1:1), single blind trial 1,200 patients aged 75 years and above

Tailored DAPT: 1 mo in stable and 6 mo in ACS pts Prespecified by the investigator prior to randomization

Vs. Primary End Point 1y: all-cause mortality, non-fatal MI, stroke, IDTLR Secondary End Points 1y: Bleeding BARC 2-5/3-5, stent thrombosis

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Synergy™ DES used in SENIOR

Meredith I. et al. EuroInterv 2017 (in Press) doi:10.4244/EU-D-17-00529

74µm Everolimus PLGA Polymer BMS SEM of coating (x5000)

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SLIDE 8

Key Inclusion Criteria

  • Patients are 75 years old or above

and

  • Presence of ≥1 stenosis (≥70%) in any coronary (or LM ≥50%)

and

  • Stable angina
  • r
  • Silent ischemia
  • r
  • Acute coronary syndrome
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SLIDE 9

Key Exclusion Criteria

  • Unable to comply with DAPT for

at least one month (stable angina or silent ischemia) or

at least six months (acute coronary syndrome)

  • Planned surgery within one month
  • Life expectancy less than 1 year
  • Prior hemorrhagic stroke
  • Indication for surgical myocardial revascularization
  • Known allergy to aspirin or any P2Y12 inhibitor
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SLIDE 10

1,200 pts ≥75 years with CAD DES N=596 BMS N=604 R MACCE 1y N=1,176 (98%)

Intended DAPT: 1 mo (57%) and 6 mo (43%)

10 pts (1.7%): withdrew 2 pts (0.3%): lost to FU 6 pts (1.0%): withdrew 6 pts (1.0%): lost to FU

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Baseline Characteristics

DES N=596 BMS N=604

Age, y 81.4±4.3 81.4±4.2 Male sex, % 61.7 62.7 BMI, kg/m2 26.3±4.3 25.9±3.9 Diabetes mellitus, % 26.6 26.0 Hypercholesterolemia, % 52.2 53.0 Hypertension*, % 71.6 80.8 Previous MI*, % 18.3 13.3 PVD*, (%) 14.7 21.0 Atrial fibrillation, % 17.3 17.9 Anemia, % 13.8 15.0

*P <0.05

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Clinical Presentation

10.9 25.5 9.6 33.3 20.3 10.3 25.8 8.6 35.6 19.7

DES BMS Stable angina Silent Ischemia STEMI NSTEMI UA

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Angiography

DES N=596 BMS N=604

Transradial approach, % 79.8 81.3 Multiple vessel disease, % 34.0 30.6 Lesion location, % LM* 3.9 1.3 LAD 54.0 52.3 LCx 29.8 26.5 RCA 35.9 37.9 Stents implanted per patient 1.7±1.0 1.6±1.0 Stent diameter per lesion (mm) 3.0±0.5 3.0±0.5 Total stent length per patient (mm) 32.6±20.8 30.3±20.3

*P <0.05

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SLIDE 14

596 482 269 256 249 240 214 102 92 89 87 87 0

Number at risk Drug-eluting stent Bare-metal stent

604 482 263 251 249 247 213 112 102 95 93 92 0

Patients on DAPT (%) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Months since Randomisation 1 2 3 4 5 6 7 8 9 10 11 12

DAPT duration

% of Patients on DAPT (%) Log-rank test P=0.77

BMS DES

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SLIDE 15

Primary End Point

Days

All-cause mortality, MI, stroke, ischemia-driven TLR

Primary EP (%)

RR 0.71 (95%CI 0.52-0.94) NNT 21

Log rank P=0.0160

16.4 % 11.6 %

18 15 12 9 6 3 50 100 150 200 250 300 350 400

BMS DES

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SLIDE 16

6.1 2 3.6 1.7 11.6 8 0.8 3.7 5.9 16.4

5 10 15 20

Mortality Stroke MI ID-TLR MACCE

MACCE Components

Patients (%)

DES BMS

P=0.20 P=0.08 P=0.92 P=0.0002 P=0.0172

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Safety Endpoints

4.5 3.5 0.5 5.0 3.6 1.4

1 2 3 4 5 6 BARC 2-5 BARC 3-5 ST (def+prob)

P=0.68 P=0.86 P=0.13 DES BMS

Patients (%)

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SLIDE 18

0% 3% 6% 9% 12% 15% 18% 21% 50 100 150 200 250 300 350 400

Net Clinical Benefit

Log-rank test P=0.0239

MACCE and BARC 2-5

BMS DES

19.2 % 14.4 %

RR 0.75, 95% CI 0.58-0.97

Patients (%)

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Overall event rate 68/545 ( 11·6%) 98/568 ( 16·4%) 0·7 ( 0·5, 0·9) 0·016 Age [years] (Interaction: p=0·587) <85 48/419 ( 10·5%) 71/429 ( 15·7%) 0·7 ( 0·5, 0·9) 0·022 >= 85 20/126 ( 15·1%) 27/139 ( 18·7%) 0·8 ( 0·4, 1·4) 0·426 Atrial fibrillation (Interaction: p=0·025) No 44/448 ( 9·1%) 77/466 ( 15·8%) 0·6 ( 0·4, 0·8) 0·001 Yes 24/ 95 ( 23·8%) 21/101 ( 19·5%) 1·2 ( 0·7, 2·1) 0·452 Acute coronary syndrome (Interaction: p=0·315) No 30/297 ( 9·4%) 52/312 ( 15·7%) 0·6 ( 0·4, 0·9) 0·015 Yes 38/248 ( 14·1%) 46/256 ( 17·3%) 0·8 ( 0·5, 1·2) 0·312 Sex (Interaction: p=0·105) Male 38/341 ( 10·4%) 67/357 ( 17·9%) 0·6 ( 0·4, 0·8) 0·003 Female 30/204 ( 13·4%) 31/211 ( 13·8%) 1·0 ( 0·6, 1·6) 0·900 All-cause mortality, MI, stroke, ischaemia-driven TLR at 1 year DES (N=596) BMS (N=604) Relative Risk (95% CI) P-value DES Better BMS Better 0·5 1 1·5 2 2·5 Percentages are Kaplan-Meier estimates·

Subgroup Analyses (primary end point)

DES Better BMS Better

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Summary

All TVT 2016 faculty disclosures are listed online and on the app.

The SENIOR trial evaluated a bioabsorbable polymer DES vs. BMS in elderly patients treated with short DAPT

  • MACCE was lower with DES (11.6% vs 16.4%, p=0.0172)
  • This was mainly driven by ID-TLR (1.7% vs 5.9%, p=0.0002)
  • DAPT duration and bleeding were similar in the two groups
  • ST was low and not different (0.5% vs 1.4%, p=0.12)
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SLIDE 21

Conclusion

All TVT 2016 faculty disclosures are listed online and on the app.

PCI with a contemporary thin struts DES is more effective, and as safe as BMS in elderly patients with CAD, on a short DAPT tailored to their clinical presentation BMS should no longer be used as a strategy to reduce DAPT duration in elderly patients

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Top Enrolling Centers

Investigator Center Nb 1- G. Sideris ASAPH, APHP centers, Paris - Fr 334 2- S. Cook Université de Fribourg, Fribourg - CH 148 3- S. Kedev University Clinic of Cardiology, Skopje - MC 93 4- T. Cuisset Hôpital de la Timone, Marseille - Fr 74 5- D. Carrié CHU Rangueil, Toulouse - Fr 72 6- T. Hovasse Hôpital Privé Jacques Cartier, Massy - Fr 70 7- P. Garot Hôpital Privé Claude Galien, Quincy - Fr 59 8- J. Diaz Juan Ramon Jimenez Hospital, Huelva - SP 29 9- S. Brugaletta Hospital Clinic, Barcelona - SP 28 10- E. Pinar Hospital Universitario Virgen de la Arrixaca, Murcia - SP 24 11- F. Mauri Hospital Universati Germans Trias i Pujol, Badalona - SP 22 12- P. Commeau Polyclinique les Fleurs, Ollioules - FR 21

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Trial Organization

PI and coPIs O.Varenne (PI), P. Sinnaeve (CoPI), T. Cuisset (CoPI) Executive Committee O.Varenne, P. Sinnaeve, T. Cuisset, M. Sabate and M-C. Morice Statistics Ann Belmans and K. Bogaerts DSMB

  • ME. Bertrand (chair), J. Berland, A. Waqar.

CEC

  • A. Chieffo (chair), T. Royer, A. Pichard, B. Valeix, J.

Machecourt, J. Garot, L. Levai, C. Macaya, J. Ramón Rumoroso, V. Domigo, P. Kearney, R. Mehran, J. Escaned. CRO CERC, Massy, France (Project Leader A. Sequeira) E-CRF CLINIGRID, Paris, France. Sponsor CERIC through a grant from Boston Scientific