Platelet inhibition PLUS low-dose anticoagulation a new paradigm for all PAD patients?

Transcription

1 Platelet inhibition PLUS low-dose anticoagulation a new paradigm for all PAD patients? Thomas HW Stadlbauer, MD Klinikum rechts der Isar, Technical University of Munich

2 Disclosure Speaker name: Thomas Stadlbauer I have the following potential conflicts of interest to report: Study-Investigator: Lecturer: Travel grant: Bayer Bayer, Daiichi Sankyo, Bristol Myer Squibb, Pfizer Bristol Myers Squibb, Pfizer, Daiichi Sankyo xxx

3 Patients with peripheral artery disease are at high risk for major cardiovascular and limb events.

4 Aspirin = > xxx

5 Antithrombotic Therapy lower limb PAD ESC Guidelines PAD 2017 Antiplatelet therapy is recommended in patients with symptomatic PAD (1C) Because of the lack of proven benefit, antiplatelet therapy is not routinely indicated in patients with isolated asypmtomatic lower limb PAD (IIIA) xxx

6 Is there evidence for the combination of antithrombotics and low-dose anticoagulants to reduce MACE and MALE rates in patients with cardiovascular disease? TIMI 51 in ACS COMPASS in stable CHD and/or PAD

7 Combination of antithrombotics and low-dose anticoagulants

8 Combination of antithrombotics and low-dose anticoagulants: TIMI 51 MACE RRR 20%

9 Combination of antithrombotics and low-dose anticoagulants: TIMI 51 P < P < Riva Placebo

10 xxx

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12 MACE RRR 24% Ended earlier after reaching superiority endpoint! xxx

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14 Combination of antithrombotics and low-dose anticoagulants: COMPASS (stable CHD / PAD) Lancet. 2017, 391:

15 Combination of antithrombotics and low-dose anticoagulants: COMPASS (PAD) Rivaroxaban 2 x 2.5 mg + Aspirin 100 mg Rivaroxaban 2 x 5 mg Aspirin 100 mg

16 xxx

17 Combination of antithrombotics and low-dose anticoagulants: COMPASS (PAD) MACE Death MI Stroke MACE RRR 28% Aspirin Aspirin + RIVA

18 Combination of antithrombotics and low-dose anticoagulants: COMPASS (PAD) MALE RRR 46% MALE: Major adverse limb events Chronic limb ischemia: Acute limb ischemia: Amputation: => severe ischemia leading to vascular intervention => limb threatening ischemia => above the forefoot

19 Major Bleeding ISHT major bleeding Fatal Symptomatic bleeding into critical organ Surgical site reoperation Requiring hospitalization xxx

20 Conclusions There is merging evidence for the combination of antithrombotics and low-dose anticoagulants ( vascular dose ) to reduce MACE and MALE rates in patients with cardiovascular disease! TIMI 51 => MACE Bleeding COMPASS => MACE Bleeding COMPASS PAD => MACE MALE Bleeding The net clinical benefit goes towards combination therapy 1000 pts. treatment 21 months 27 MACE / MALE prevented 1 critical organ bleed induced

21 Implication of all the available evidence The combination of low dose rivaroxaban twice a day with aspirin could replace aspirin alone as standard of care in patients with stable peripheral artery disease who are not at high risk for bleeding Go for it => RIVA + ASS CHD + PAD symptomatic PAD after revascularization PAD lower extremities limb at risk younger patents Hesitate dual anti-platelet therapy anticoagulation impaired renal function asymptomatic PAD High bleeding risk

22 Thank you very much!