Funding and Disclosures Non-Industry Funding NHLBI R01 HL136708-01 - - PowerPoint PPT Presentation

STENT SELECTION IN HIGH BLEEDING RISK PATIENTS

Robert W. Yeh, MD MSc MBA Director, Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Associate Chief, Interventional Cardiology, Beth Israel Deaconess Medical Center Associate Professor of Medicine, Harvard Medical School #SCAI2019 @rwyeh

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

Non-Industry Funding

NHLBI R01 HL136708-01 (EXTEND Study) NHLBI K23 HL118138 (DAPT Score) Richard and Susan Smith Center for Outcomes Research in Cardiology Industry Disclosures Research Grants: Abbott Vascular, Abiomed, AstraZeneca, Boston Scientific Advisory Board: Abbott Vascular, Boston Scientific, Medtronic Consulting: Abbott Vascular, Asahi, Boston Scientific, Merck, Teleflex

Funding and Disclosures

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

What type of stent would you use in HBR patients?

1) DES vs. BMS 2) If DES, which?

Stent Selection in HBR

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Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

Crowdsourcing

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

◼ Randomized trials comparing stent types among high bleeding risk patients ◼ Observational registries of early DAPT discontinuation with current DES ◼ Single arm IDE trials of planned short DAPT duration

What is the state of evidence?

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Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

◼ LEADERS-FREE (and ZEUS)

– Comparison of polymer-free DES to BMS among HBR patients

◼ SENIOR

– Comparison of bioresorbable-polymer DES to BMS among elderly patients

◼ ONYX ONE

– Comparison of durable polymer DES to polymer-free DES among HBR patients

Randomized trials comparing stents in HBR patients

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Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

LEADERS FREE – BioFreedom PF-DES vs BMS Patients received 1 month DAPT

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Urban et al. NEJM 2015.

SENIOR: BMS vs. BP-DES in the Elderly

Population: 1200 pts age 75 or

• lder AF undergoing PCI for

stable, silent ischemia, or acute CAD. Intervention: Randomized 1:1 to DES (Synergy) vs. BMS with 1 or 6 month DAPT based on presentation. Primary Endpoint: Death, MI, stroke or ischemia-driven TLR at 1 year.

SENIOR Presented as LBCT at #TCTDenver

Primary Endpoint at 1 year

Death, MI, stroke or ID-TLR 16% BMS vs. 12% DES HR 0.71 (0.52-0.94)

~50% stopped DAPT at 1 month, 30% between 1 and 6, and 20% continued for year

Components

Randomized Data for Durable Polymer stents

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

Data from Registries - ZES

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Silber et al. EHJ 2014.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

Data for CC-EES

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Genereux et al. Circ Intv 2015. Natsuaki et al. Cardiovasc Interv and Ther. 2015.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

Studies Ongoing

◼ EVOLVE Short DAPT - SYNERGY stent, 3 months of DAPT ◼ Xience 90/28 – Xience stent, 3 months rolling into 1 month of DAPT ◼ Onyx One Clear (US) – 1 month of DAPT ◼ All will compare ischemic and bleeding event rates against historical/non-

randomized controls.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology

◼ What has been shown in head to head trials of stents?

– PF-DES (BioFreedom) beats BMS in HBR on ischemic endpoints – BP-DES (Synergy) beats BMS in elderly patients given 1 month and 6 months of DAPT

◼ What’s coming?

– Ongoing studies will help determine the rates of ischemic events among a generalizable group of HBR patients with planned receipt of 1-3 months of DAPT with the most commonly used stents.

◼ There is a hazard for reducing DAPT duration that is mitigated, but not

eliminated, by newer stent designs.

Conclusions

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Thank you!

E: ryeh@bidmc.harvard.edu @rwyeh