Re- Setting our COMPASS for Secondary Prevention in Atherosclerotic Vascular Disease
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- Octavia Barker
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1 Re- Setting our COMPASS for Secondary Prevention in Atherosclerotic Vascular Disease Robert C. Welsh, MD, FRCPC Professor of Medicine, University of Alberta Zone Clinical Department Head, Cardiac Sciences Inspiring Innovation and Knowledge Leaders in Patient Care
2 Robert C. Welsh, MD, FRCPC Faculty Disclosure (12 months): Research and Clinical Trials: Abbott Vascular, Astra Zeneca, Bayer, BMS, Boehringer Ingelheim, CIHR, CSL Behring LLC, Edwards Lifesciences, Eli Lilly, Jansen, Johnson and Johnson, Pfizer, Population Health Research Institute, University of Alberta Hospital Foundation Consulting Fees/Honoraria: Amgen, Astra Zeneca, Bayer, Bristol Myers- Squibb/Pfizer, Canadian Cardiovascular Society Other: University of Alberta (employee), Alberta Health Services (Clinical privileges) and President, The Canadian Centre for Clinicians and Scientists
3 Overview 1. Review the Dual Pathway approach to secondary prevention in atherosclerotic patients 2. Discuss the COMPASS data 1. Overall trial and the PAD and CAD cohorts 3. Initiate a discussion regarding applying the dual pathway approach to patients in clinical practice
4 Traditional Secondary Prevention Inhibition of Pathways For Thrombus Formation Two pathways connecting tissue injury, coagulation, and platelet response. Platelet Pathway Collagen ADP Platelet activation Platelet aggregation Dual Anti- Platelet Anti- Platelet Therapy Therapy ASA + Clopidogrel/Prasugrel ASA or Ticagrelor TXA 2 Thrombin Fibrinogen Fibrin Tissue Factor Plasma Clotting cascade Prothrombin THROMBUS Coagulation Pathway Inspiring Innovation and Knowledge Leaders in Patient Care
5 Clopidogrel DAPT and all cause mortality in Secondary Prevention Extended duration dual antiplatelet therapy and mortality: a systematic review and meta-analysis Sammy Elmariah, Laura Mauri et al;; The Lancet, 2014
6 Experimental treatment of ACS Pathways For Thrombus Formation Two pathways connecting tissue injury, coagulation, and platelet response. Platelet Pathway Collagen ADP Platelet activation Platelet aggregation Dual Anti- Platelet Therapy ASA + Clopidogrel/Prasugrel or Ticagrelor TXA 2 Thrombin Fibrinogen Fibrin Tissue Factor Plasma Clotting cascade Prothrombin THROMBUS Oral Antithrombotic Coagulation Pathway Inspiring Innovation and Knowledge Leaders in Patient Care
7 Patients (n=7392) with recent STEMI or NSTEACS (80% on dual antiplatelet therapy) and 2 additional risk factors (Age 65 yrs, DM, prior MI 5 yrs, CVD, PVD, HF or LVEF <40%, CrCl <60 ml/min, no revascularization for index event) DMC recommended trial stop due to excess of clinically important bleeding without counterbalancing reduction in ischemic events TIMI Major TIMI Major or Minor ISTH Major ISTH Major or Clinically Relevant Non- Major GUSTO Severe Intracranial Fatal bleeding: Apixaban = 5 vs. Placebo = Atrial Fibrillation Dose Apixaban in ACS Bleeding vs. 0.5 vs. 0.8 vs. 1.1 vs. 1.2 vs. 0.3 vs Apixaban Better Placebo Better % Alexander et al., N Engl J Med 2011;365: Apix: 3705 Plac: 3687 CV Death/MI/Stroke Median time from index ACS to randomization: 6 (4, 7) days HR 0.95 ( ) p=0.51 Median 8 months Placebo * CrCl <40 ml/min Apixaban 5 (2.5*) mg BID Months
8 ATLAS ACS 2- TIMI 51: A randomised, double- blind, event- driven Phase III trial in patients hospitalised with ACS NO N=15,526* 2 Physician's decision whether or not to add thienopyridine 1 YES Stratum 1: ASA alone (7%) 2 Stratum 2: ASA + thienopyridine (93%) 2 Placebo (n=355) mg bid (n=349) 3 5 mg bid (n=349) 3 Placebo (n=4821) mg bid (n=4825) 3 5 mg bid (n=4827) 3 Event-driven study 983 events 2 ASA dose: mg 1 *184 patients were excluded from the efficacy analyses prior to unblinding because of trial misconduct at three sites. ACS=Acute coronary syndrome; ASA=Acetylsalicylic acid; bid=twice daily; od=once daily; TIMI=Thrombolysis In Myocardial Infarction. 1. Gibson CM, et al. Am Heart J. 2011;161: e6; 2. Mega JL, et al. N Engl J Med. 2012;366:9 19; 3. European Medicines Agency. Assessment Report EMA/CHMP/794349/2012. Inspiring Innovation and Knowledge Leaders in Patient Care
9 ATLAS ACS 2- TIMI 51: Efficacy endpoints rivaroxaban 2.5 mg bid The primary efficacy endpoint reduction was driven by reduced mortality 13 Cumulative incidence (%) CV death/mi/stroke (primary efficacy endpoint) 1,2 5 HR=0.84 mitt p=0.02 ITT p=0.007 Placebo 2.5 mg bid 10.7% 9.1% HR=0.66 mitt p=0.002 ITT p=0.005 CV death 1,2 Placebo 2.5 mg bid 4.1% 2.7% 5 All-cause death2 HR=0.68 mitt p=0.002 ITT p= mg bid Placebo 4.5% 2.9% NNT=63 NNT=71 NNT= Months Months Months Both strata. CV=Cardiovascular; HR=Hazard ratio; ITT=Intention to treat; MI=Myocardial infarction; mitt=modified intention to treat; NNT=Number needed to treat. 1. Mega JL, et al. N Engl J Med. 2012;366:9 19; 2. Gibson CM et al. LBCT.01. Presented at American Heart Association (AHA) Scientific Sessions 2011; November, Orlando, Florida, USA. Inspiring Innovation and Knowledge Leaders in Patient Care
10 ATLAS ACS 2- TIMI 51: Safety endpoints rivaroxaban 2.5 mg bid * 2-year Kaplan Meier estimate (%) vs placebo p=ns vs placebo p=ns (principal safety outcome) * p<0.001 vs placebo; p=0.04 vs placebo. CABG=Coronary artery bypass graft; ICH=Intracranial haemorrhage; NS=Not significant. 1. Mega JL, et al. N Engl J Med. 2012;366:9 19; 2. Gibson CM et al. LBCT.01. Presented at American Heart Association (AHA) Scientific Sessions 2011; November, Orlando, Florida, USA. Inspiring Innovation and Knowledge Leaders in Patient Care
11 Experimental Secondary Prevention Inhibition of Pathways For Thrombus Formation Platelet Pathway Two pathways connecting tissue injury, coagulation, and platelet response. Collagen ADP Platelet activation Platelet aggregation Safe/Effective Predictable Anti- platelet TXA 2 Thrombin Fibrinogen Fibrin Tissue Factor Plasma Clotting cascade Prothrombin THROMBUS Safe/Effective Predictable Coagulation Pathway Anti- coagulant Inspiring Innovation and Knowledge Leaders in Patient Care
12 A Dual Pathway Approach Targeting Chronic Patients with CAD or PAD was Investigated in COMPASS CAD PAD Objective: To determine the efficacy and safety of vascular dose rivaroxaban plus aspirin compared with aspirin alone for the prevention of MI, stroke and cardiovascular death in chronic CAD or PAD Population: Chronic CAD (91%) PAD (27%) 30-day run-in* aspirin 100 mg N=27,395 R 1:1:1 2.5 mg bid + aspirin 100 mg od 5.0 mg bid Aspirin 100 mg od 30-day washout period Factorial design ± pantoprazole # Average follow-up: 23 months at early termination of study 2 Final follow-up visit Final washout period visit Antithrombotic investigations were stopped 1 year ahead of expectations in February 2017 due to overwhelming efficacy in the rivaroxaban 2.5 mg bid + aspirin arm 2 *The CAD analysis includes 1448 patients who entered COMPASS immediately post-cabg (with no run-in) 3 ; # Patients who were not receiving a proton pump inhibitor (PPI) were randomized to pantoprazole or placebo (partial factorial design); 1. Bosch J et al, Can J Cardiol 2017;33: ; 2. Eikelboom JW et al, N Engl J Med 2017;377: ; 3. Connolly SJ et al, Lancet 2017; doi: /s (17)
13 Inclusion and Exclusion Criteria Ensured That Patients Had Chronic CAD and Moderate Cardiovascular Risk Key inclusion criteria* u CAD (prior MI, multivessel coronary disease or multivessel revascularization) u Plus 1 of: Age 65 years Age <65 years plus atherosclerosis in 2 vascular beds or 2 additional risk factors Current smoker Diabetes mellitus Renal dysfunction (egfr<60 ml/min) Heart failure Non- lacunar ischaemic stroke 1 month ago Key exclusion criteria # u Stroke within the past month or any haemorrhagic or lacunar stroke u Severe HF with known ejection fraction <30% or NYHA class III or IV symptoms u Need for dual antiplatelet therapy, other non- aspirin antiplatelet therapy or oral anticoagulant therapy u egfr <15 ml/min Patients had multiple risk factors Patients with acute CAD or deemed to be at very high cardiovascular risk were excluded because of need for DAPT # Including but not limited to; # Any other exclusion criteria in conjunction with the local Product Information and any other contraindication listed in the local labelling for rivaroxaban or the comparator have to be considered Bosch J et al, Can J Cardiol 2017;33:
14 Baseline characteristics + aspirin N=9,152 N=9,117 Aspirin N=9,126 Age, yr, mean Female 22% 22% 22% SBP/DBP, mmhg, mean 136/77 136/78 136/78 Cholesterol (total), mmol/l, mean CAD 91% 90% 90% PAD 27% 27% 27% Stroke 3.8% 3.8% 3.7% Diabetes 38% 38% 38% Lipid- lowering 90% 90% 89% ACE- I/ARB 71% 72% 71%
15 Primary Outcome CV death, stroke, MI Outcome CV death, stroke, MI R + A N=9,152 Riva N=9,117 Aspirin N=9,126 Riva + aspirin vs. aspirin vs. aspirin N (%) N (%) N (%) HR (95% CI) p HR (95% CI) p 379 (4.1) 448 (4.9) 496 (5.4) 0.76 ( ) < ( ) 0.11
16 Components of primary outcome R + A N=9,152 Aspirin N=9,126 Riva + aspirin vs. aspirin N (%) N (%) HR (95% CI) p CV death 160 (1.7) 203 (2.2) 0.78 ( ) 0.02 Stroke 83 (0.9) 142 (1.6) 0.58 ( ) <0.001 MI 178 (1.9) 205 (2.2) 0.86 ( ) 0.14
17 Major bleeding components Outcome Riva + aspirin N=9,152 Aspirin N=9,126 + aspirin vs. aspirin N % N % HR 95% CI P Major bleeding < Fatal Non fatal ICH* Non- fatal other critical site* Other < * symptomatic
18 Primary efficacy and major bleeding Landmark analyses
19 + aspirin vs aspirin Net benefit Outcome Riva + aspirin N=9,152 Aspirin N=9,126 + aspirin vs. aspirin N % N % HR 95% CI P Primary outcome + severe bleeds
20 with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double- blind, placebo- controlled trial Primary Endpoint CV Death, MI and Stroke MALE and Amputations Anand et al, Lancet, 391, 10117, January 2018, Pages
21 COMPASS Enrolled over 24,000 Patients with Advanced, Chronic CAD CAD CAD definition Number of patients (% of CAD population) 1 All patients with CAD 24,824 Prior MI 17,028 (69%) <1 year 1238 (5%) 1 <2 years 2341 (9%) 2 <5 years 4893 (20%) 5 years 8520 (34%) Multivessel coronary disease* 15,469 (62%) Prior PCI 14,862 (60%) Prior CABG 7845 (32%) Patients randomized immediately post- CABG 1448 (6%) Half of all previous MIs occurred 5 years prior to enrolment in COMPASS 1 *Refers to stenosis of 50% in 2 or more coronary arteries, confirmed using invasive coronary angiography, or non-invasive imaging or stress studies suggestive of significant ischaemia in 2 coronary territories; or in 1 coronary territory if at least 1 other territory has been revascularized 2 1. Connolly SJ et al, Lancet 2017; doi: /s (17) ; 2. Bosch J et al, Can J Cardiol 2017;33:
22 CAD 10 8 Cumulative incidence risk (%) Dual Pathway Inhibition with 2.5 mg bid + Aspirin Significantly Reduced MACE by 26% Versus Aspirin Stroke/MI/Cardiovascular death Riva 2.5 mg bid + aspirin vs aspirin Riva 5 mg bid vs aspirin HR=0.74 (95% CI ) p< HR=0.90 (95% CI ) p=0.11 Aspirin + Aspirin Outcome 2.5 mg bid + aspirin N=8313 Aspirin N=8261 N (%) N (%) HR (95% CI) MACE 347 (4) 460 (6) 2.5 mg bid + aspirin vs aspirin 0.74 ( ) p- value < CV death 139 (2) 184 (2) 0.75 ( ) Stroke 74 (1) 130 (2) 0.56 ( ) < Year MI 169 (2) 195 (2) 0.86 ( ) 0.15 Connolly SJ et al, Lancet 2017; doi: /s (17)
23 CAD Bleeding Rates Increased but Low with Vascular Dose 2.5 mg bid + Aspirin Versus Aspirin Alone Outcome 2.5 mg bid + aspirin N=8313 Aspirin N=8261 N (%) N (%) Major bleeding 263 (3) 158 (2) Fatal 14 (<1) 9 (<1) ICH 19 (<1) 19 (<1) Critical organ 36 (<1) 25 (<1) Other 194 (2) 105 (1) 2.5 mg bid + aspirin vs aspirin HR (95% CI) 1.66 ( ) 1.55 ( ) 0.99 ( ) 1.42 ( ) 1.85 ( ) No significant increase in critical organ bleeding including intracranial or fatal bleeding Connolly SJ et al, Lancet 2017; doi: /s (17) p- value < <0.0001
24 CAD 22% Reduction in Risk of the Composite Net Clinical Benefit Outcome with Vascular Dose 2.5 mg bid + Aspirin vs Aspirin Rates at mean follow- up of 23 months 2.5 mg bid + aspirin N=8313 Aspirin N=8261 N (%) N (%) HR (95% CI) 2.5 mg bid + aspirin vs aspirin p- value Net clinical benefit (CV death, stroke, MI, fatal or critical organ bleeding) 392 (5) 494 (6) 0.78 ( ) All- cause mortality 262 (3) 339 (4) CV death 139 (2) 184 (2) Non- CV death 123 (2) 155 (2) 0.77 ( ) 0.75 ( ) 0.79 ( ) For every 1000 patients with CAD treated with rivaroxaban plus aspirin, 13 MACE events would be prevented and 2 fatal or critical organ bleeds would be caused over a mean 23-month period Connolly SJ et al, Lancet 2017; doi: /s (17)
25 CAD Persistent Reduction in MACE with Dual Pathway Inhibition; Increased Bleeding only in the First Year Landmark analysis for key efficacy and safety outcomes 2.5 mg bid + aspirin n/n (%) Aspirin alone n/n (%) HR (95% CI) HR (95% CI) MACE <1 year 176/8313 (2) 221/8261 (3) 0.79 ( ) 1 <2 years 113/7228 (2) 169/7125 (2) 0.66 ( ) >2 years 58/3655 (2) 70/3621 (2) 0.82 ( ) Major bleeding <1 year 163/8313 (2) 70/8261 (1) 2.32 ( ) 1 <2 years 70/7189 (1) 59/7183 (1) 1.19 ( ) >2 years 30/3626 (1) 30/3628 (1) 1.05 ( ) Net clinical benefit <1 year 207/8313 (2) 237/8261 (3) 0.87 ( ) 1 <2 years 124/7201 (2) 182/7112 (3) 0.67 ( ) >2 years 61/3637 (2) 75/3604 (2) 0.80 ( ) All death <1 year 117/8313 (1) 145/8261 (2) 0.80 ( ) 1 <2 years 93/7323 (1) 120/7242 (2) 0.77 ( ) >2 years 52/3743 (1) 74/3762 (2) 0.70 ( ) Connolly SJ et al, Lancet 2017; doi: /s (17) Favours rivaroxaban 2.5 mg bid + aspirin Favours aspirin alone
26 Secondary Prevention in Atherosclerosis COMPASS in context Lipid lowering (1mmol/L) BP Lowering (10mm Hg) ACE (HOPE) COMPASS + aspirin MACE 21% 20% 22% 24% Death 9% 13% 16% 18% Stroke 15% 27% 32% 42% MI 24% 17% 20% 14% MALE % 46% HOPE Investigators. N Engl J Med 2000;342: Ettehad D, et al. Lancet 2016;387: CTT Collaboration. Lancet 2015;385: ; Collins R, et al. Lancet 2016;388:
27 CV Death, MI, or Stroke (%) Residual Risk in Stable CAD Patients Ticagrelor - Time to First Primary Efficacy Event: Composite of Cardiovascular Death, MI or Stroke N = 21,162 Median follow-up 33 months Placebo (9.0%) Ticagrelor 90 (7.8%) Ticagrelor 60 (7.8%) Ticagrelor 90 mg HR 0.85 (95% CI ) P=0.008 Ticagrelor 60 mg HR 0.84 (95% CI ) P= Months from Randomization Bonaca MP et al., NEJM 2015
28 Figure 1 Canadian Journal of Cardiology , DOI: ( /j.cjca ) Copyright 2018 Terms and Conditions
29 Anti- thrombotics Strategies for Secondary Prevention PEGASUS Ticagrelor 90 + aspirin COMPASS + aspirin PEGASUS A B C Ticagrelor 60 + aspirin MACE 15% 24% 16% CV Death 0% 18% 11% Stroke 18% 42% 25% MI 19% 14% 16% Major Bleeds - 169% - 70% - 132% ICH - 44% - 16% - 33% Amputations 70% MALE 46% All Cause Mortality 18% *Non-fatal. severe and moderate GUSTO, respectively
30 Dual Anti- thrombotic Therapy has the Same Bleeding Risk as DAPT with either Ticagrelor or Clopidogrel Primary Endpoint: TIMI Non-CABG Clinically Significant Bleeding *Hazard Ratio (95%CI) Ohman et al, Lancet, March 18, 2017 (online)
31 Adverse events leading to drug discontinuation Drugs don't work in patients who don't take them Former US Surgeon General, C. Everett Koop 1. Eikelboom JW, et al. N Engl J Med 2017;; DOI: /NEJMoa ;; Bonaca MP et al. N Engl J Med 2015
32 Contemporary Secondary Prevention Inhibition of Pathways For Thrombus Formation Platelet Pathway Two pathways connecting tissue injury, coagulation, and platelet response. Collagen ADP Platelet activation Platelet aggregation Safe/Effective Predictable Anti- platelet TXA 2 Thrombin Fibrinogen Fibrin Tissue Factor Plasma Clotting cascade Prothrombin THROMBUS Safe/Effective Predictable Coagulation Pathway Anti- coagulant Inspiring Innovation and Knowledge Leaders in Patient Care
33 Summary The Vascular Protection dose of rivaroxaban 2.5 mg bid and low dose ASA offers a new standard of care in long term secondary prevention of patients with atherosclerotic disease - - With larger reductions in MACE, Death and Stroke than previously adapted therapies (Statins, ACE- I, etc) With reductions in amputations and MALE in PAD patients
34 Baseline characteristics + aspirin N=9,152 N=9,117 Aspirin N=9,126 Age, yr, mean Female 22% 22% 22% SBP/DBP, mmhg, mean 136/77 136/78 136/78 Cholesterol (total), mmol/l, mean CAD 91% 90% 90% PAD 27% 27% 27% Stroke 3.8% 3.8% 3.7% Diabetes 38% 38% 38% Lipid- lowering 90% 90% 89% ACE- I/ARB 71% 72% 71%
35 Primary Outcome CV death, stroke, MI Outcome CV death, stroke, MI R + A N=9,152 Riva N=9,117 Aspirin N=9,126 Riva + aspirin vs. aspirin vs. aspirin N (%) N (%) N (%) HR (95% CI) p HR (95% CI) p 379 (4.1) 448 (4.9) 496 (5.4) 0.76 ( ) < ( ) 0.11
36
37 Components of primary outcome R + A N=9,152 Aspirin N=9,126 Riva + aspirin vs. aspirin N (%) N (%) HR (95% CI) p CV death 160 (1.7) 203 (2.2) 0.78 ( ) 0.02 Stroke 83 (0.9) 142 (1.6) 0.58 ( ) < MI 178 (1.9) 205 (2.2) 0.86 ( ) 0.14
38 Myocardial infarction Event R + A N=9,152 N (%) Aspirin N=9,126 N (%) HR (95% CI) Riva + aspirin vs. aspirin p MI or SCD 247 (2.7%) 289 (3.2%) 0.85 ( ) 0.06 MI, SCD, or cardiac arrest 273 (3.0%) 333 (3.6%) 0.81 ( ) 0.01 MI, SCD, resus. Cardiac arrest, or unstable angina 277 (3.0%) 331 (3.6%) 0.83 ( ) 0.02
39 Stroke severity Rankin score at 7 days or discharge R + A N=9,152 N (%) Aspirin N=9,126 N (%) + aspirin vs. aspirin HR (95% CI) P 0 15 (0.2) 30 (0.3) 0.50 ( ) (0.4) 63 (0.7) 0.57 ( ) (0.1) 17 (0.2) 0.64 ( ) (<0.1) 26 (0.3) 0.34 ( ) (<0.1) 13 (0.1) 0.92 ( ) 0.84
40 PAD: limb outcomes Outcome R + A N=2,492 N (%) A N=2,504 N (%) + aspirin vs. aspirin HR (95% CI) P MALE 30 (1.2) 56 (2.2) 0.54 ( ) <0.005 Major amputation 5 (0.2) 17 (0.7) 0.30 ( ) 0.01 MALE plus major amputation 32 (1.3) 60 (2.4) 0.54 ( ) 0.004
41 Secondary outcomes Outcome R + A N=9,152 N (%) Riva N=9,152 N (%) Aspirin N=9,126 N (%) + aspirin vs. aspirin HR (95% CI) p vs. aspirin HR (95% CI) P CHD death, Isch. stroke, MI, ALI 329 (3.6) 397 (4.4) 450 (4.9) 0.72 ( ) < ( ) 0.06 CV death, Isch. stroke, MI, ALI 389 (4.3) 453 (5.0) 516 (5.7) 0.74 ( ) < ( ) 0.04 Death 313 (3.4) 366 (4.0) 378 (4.1) 0.82 ( ) ( ) 0.66
42 Major bleeding components Outcome Riva + aspirin N=9,152 Aspirin N=9,126 + aspirin vs. aspirin N % N % HR 95% CI P Major bleeding < Fatal Non fatal ICH* Non- fatal other critical site* Other < * symptomatic
43 In patients with stable CAD or PAD 2.5mg bid + aspirin 100mg od vs. aspirin 100mg od: Reduces MACE - CV death, stroke, or MI Improves CV death and all cause death Increases major bleeding but does not increase fatal or intracranial bleeding Is associated with a net clinical benefit
44 CV Death, MI, or Stroke (%) Residual Risk in Stable CAD Patients Ticagrelor - Time to First Primary Efficacy Event: Composite of Cardiovascular Death, MI or Stroke N = 21,162 Median follow-up 33 months Placebo (9.0%) Ticagrelor 90 (7.8%) Ticagrelor 60 (7.8%) Ticagrelor 90 mg HR 0.85 (95% CI ) P=0.008 Ticagrelor 60 mg HR 0.84 (95% CI ) P= Months from Randomization Bonaca MP et al., NEJM 2015
45 Adverse events leading to discontinuation 1. Eikelboom JW, et al. N Engl J Med 2017;; DOI: /NEJMoa ;;
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