Discussants Milan Gupta Narendra Singh Deepak Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC MD, FRCPC, FCCS, FACC, FAHA MD, FRCPC, FCCS, FACC, FAHA Associate Clinical Professor Director, Clinical Research, Atlanta Heart Executive Director, Interventional McMaster University Specialists Cardiovascular Programs,Brigham and Medical Director, Canadian Collaborative Clinical Assistant Professor, Medical College of Women’s Hospital Heart & Vascular Center Professor of Medicine Harvard Medical School Research Network Georgia at Augusta University Brampton, ON Clinician Scientist and Co-Director, Canadian Boston, MA Collaborative Research Network Atlanta, GA
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Introduction • These are remarkable times. • We hope you and your loved ones are all safe and healthy. • We thank all frontline health care workers for their dedication during this pandemic. • For the first time in history, the live scientific sessions of the ACC were cancelled. • Instead, ACC held a virtual meeting over 3 half days using a novel format. • This program highlights the key clinical trials presented at ACC 2020, and explores the clinical implications for cardiovascular care.
Key topics at ACC 2020 Peripheral arterial disease Heart failure • VICTORIA • VOYAGER-PAD • New data from PARAGON-HF • COMPASS-DM Lipids Structural heart disease • Homozygous FH • Updates in TAVR • EPA levels in REDUCE-IT • New data from ODYSSEY Outcomes • Evolocumab for HIV patients
Key topics at ACC 2020 Peripheral arterial disease Heart failure • VICTORIA • VOYAGER-PAD • New data from PARAGON-HF • COMPASS-DM Lipids Structural heart disease • Homozygous FH • Updates in TAVR • EPA levels in REDUCE-IT • New data from ODYSSEY Outcomes • Evolocumab for HIV patients
CV prognosis remains unacceptably poor in HFrEF DAPA-HF study, 2019 Cardiovascular death Worsening HF event HR 0.82 (0.69, 0.98); p=0.029 HR 0.70 (0.59, 0.83); p=0.00003 Placebo Placebo Dapagliflozin Dapagliflozin
ACC 2020: What You Need To Know
Discussion
Key topics at ACC 2020 Peripheral arterial disease Heart failure • VICTORIA • VOYAGER-PAD • New data from PARAGON-HF • COMPASS-DM Lipids Structural heart disease • Homozygous FH • Updates in TAVR • EPA levels in REDUCE-IT • New data from ODYSSEY Outcomes • Evolocumab for HIV patients
Back ckground Risk in Patients Undergoing Outcomes in Patients with Peripheral Revascularization Acute Limb Ischemia N=393,017 • Median hospitalization 8 days (IQR 5-15) “Acute” Post “Stable” Revascularization Phase Cumulative Incidence • ~4% die at presentation Major Adverse Limb Events • ~1/5 major amputation 4x risk of ALI Long-term vs. no Revascularization • ~1/3 prolonged ICU stay MACE • ~3/4 major surgery • Outcomes after hospitalization are poor with ~15% disabled or dead Years from Index Revascularization Hess…Hiatt et al. JACC 2020 Jones…Fowkes et al. Circulation 2017 Bonaca…Sabatine et al. JACC 2017 Bonaca…Morrow et al. Circulation 2016 26
VOYAGER P ER PAD Vascul ular Out utcomes S Stud udy of of ASA A Along with Ri h Rivaroxaba ban in n Endo ndovascula lar o or Sur urgical L l Limb b Revasculariz izatio ions ns f for Periphe pheral Artery Disease Marc P. Bonaca, Rupert M. Bauersachs, Manesh R. Patel, Sonia S. Anand, Eike Sebastian Debus, Mark N. Nehler, Fabrizio Fanelli, Warren H. Capell, Nicole Jaeger, Lihong Diao, Connie N. Hess, John M. Kittelson, Lloyd P. Haskell, Scott D. Berkowitz, William R. Hiatt, for the VOYAGER PAD Steering Committee & Investigators American College of Cardiology Virtual Scientific Sessions 2020 Late-Breaking Clinical Trial March 28, 2020
Trial De Design gn *Ankle Brachial NCT02504216 6,564 Patients with Symptomatic Lower Extremity Index < 0.90 and Imaging Evidence PAD* Undergoing Peripheral Revascularization of Occlusive Disease ASA 100 daily for all Patients Clopidogrel at Investigator’s Discretion Randomized 1:1 Double Blind Rivaroxaban 2.5 mg Stratified by Placebo twice daily Revascularization Approach (Surgical or Endovascular) and Use of Clopidogrel Follow up Q6 Months, Event Driven, Median f/u 28 Months Primary Efficacy Endpoint : Acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke or cardiovascular death Principal Safety Outcome: TIMI Major Bleeding Capell WH, Bonaca MP, Nehler MR…Hiatt WR. AHJ 2018
Primary En Endpoint: Acut ute l limb i b ischemia, m major amput utation for vascul ular caus use, m myocardial i l infarctio ion, , ische hemic ic s stroke, CV de death
Primary En Endpoint & & C Components KM% 3 Years KM% 3 Years HR Rivaroxaban Placebo (95% CI) N=3286 N=3278 Primary Efficacy 17.3 19.9 0.85 Outcome (0.76 – 0.96) Acute Limb 5.24 7.74 0.67 Ischemia (0.55 – 0.82) Major Vascular 3.42 3.87 0.89 Amputation (0.68 – 1.16) Ischemic Stroke 2.70 3.01 0.87 (0.63 – 1.19) Myocardial 4.55 5.22 0.88 Infarction (0.70 – 1.12) CV Death 7.05 6.43 1.14 (0.93 – 1.40)
First E Events ts P Prevented / Cause sed f for or 10, 10,000 000 Patients ts Treated* f for or 1 1 Year -181 (-269 – -94) Primary Efficacy Outcome -110 Acute Limb Ischemia (-165 – -56) -20 Major Amputation of Vascular Etiology (-53 – 12) -42 Myocardial Infarction (-84 – -1) -19 Ischemic Stroke (-50 – 13) -10 Cardiovascular Death (-48 – 28) 29 (-2 – 60) Principal Safety Outcome -6 (-22 – 11) Intracranial Hemorrhage 0 (-10 – 11) Fatal Bleeding -300 -200 -100 0 100 200 300 Favors aspirin Favors Rivaroxaban 2.5 mg *Efficacy and safety on-treatment twice daily plus aspirin monotherapy
Summary & Conclusion • In symptomatic PAD after revascularization, ~1 in 5 have acute limb ischemia, major amputation of vascular etiology, MI, ischemic stroke or cardiovascular death at 3 years • In this population and setting, rivaroxaban 2.5 mg twice daily with aspirin compared to aspirin alone: Significantly reduces this risk with… • Benefits apparent early and continued over time • Consistent benefit across major subgroups • Broad benefits including reductions in unplanned index limb revascularization Increases bleeding: in VOYAGER PAD, there was a numerical increase in TIMI major bleeding and significantly increased ISTH major bleeding but no excess in intracranial or fatal bleeding Prevents ~6 times as many ischemic events relative to bleeds caused in PAD patients after revascularization
VOYAGE AGER P PAD Efficacy a and S Safety of R Rivaroxaban i in Patients with Symptomatic c PAD u undergoing R Revascularization with a and w without C Clopidogrel William R. Hiatt, Marc P. Bonaca*, Manesh R. Patel, Mark R. Nehler, Eike Sebastian Debus, Sonia S. Anand, Warren H Capell, Lihong Diao, Nicole Jaeger, Connie N. Hess, Akos Ferenc Pap, Scott D. Berkowitz,Eva Muehlhofer, Lloyd Haskell, David Brasil, Juraf Madaric, Henrick Sillesen, David Szalay, Rupert Bauersachs on behalf of the VOYAGER PAD Investigators American College of Cardiology Virtual Scientific Sessions 2020 Late-Breaking Clinical Trial 29 March 2020
Primary Endpoint Acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke, CV death
ISTH M Major B Bleedi eding ng W With a h and W nd Witho hout ut C Clopi pido dogrel
Summa mmary • In patients with symptomatic PAD undergoing revascularization: • The benefit of rivaroxaban plus aspirin versus aspirin alone is consistent regardless of background clopidogrel • Primary efficacy endpoint HR ~0.85 with rivaroxaban regardless of clopidogrel with NNT < 50 with or without clopidogrel • The safety of rivaroxaban plus aspirin versus aspirin alone is consistent regardless of background clopidogrel • Principal safety outcome TIMI major bleeding HR ~1.3-1.5 regardless of clopidogrel with NNH > 90 with or without clopidogrel • However, clopidogrel exposure was associated with higher rates of bleeding overall, particularly with longer durations (e.g. > 30 days)
Discussion
Key topics at ACC 2020 Peripheral arterial disease Heart failure • VICTORIA • VOYAGER-PAD • New data from PARAGON-HF • COMPASS-DM Lipids Structural heart disease • Homozygous FH • Updates in TAVR • EPA levels in REDUCE-IT • New data from ODYSSEY Outcomes • Evolocumab for HIV patients
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