L Acido Acetilsalicilico, 120 Anni Dopo

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1 L Acido Acetilsalicilico, 120 Anni Dopo Carlo Patrono Università Cattolica del Sacro Cuore, Roma University of Pennsylvania, Philadelphia Capri Cardiovascular Conference 2.0 Capri, 7 Aprile 2017

2 Disclosure I received consultant and speakers fees from Amgen, AstraZeneca and Bayer I received grant support for investigator-initiated research from: European Commission, FP6 and FP7 Programmes Bayer AG

3

4 Mechanism of Action of Aspirin Arachidonic Acid Arachidonic Acid Aspirin COOH OCOCH 3 Aspirin COOH OH Salicylic Acid Aspirin PGG 2 PGG/H-synthase Acetylated PGG/H-synthase PGH 2 COOH O COOH COOH PGE 2, PGF 2α TXA 2 OOH O Arachidonic Acid PGG 2 Arachidonic Acid Vane 1971 Smith & Willis 1971 Ferreira,Moncada & Vane, 1971 Hamberg & Samuelsson Roth & Majerus

5 Rosalyn S. Yalow, 1977 Nobel Prize for Physiology/Medicine

6 Electrical vs Immunological Signals of Platelet Function ADP Platelet-Rich-Plasma Platelet Aggregation Increased Light Transmittance Born, Nature 1962 Whole Blood Clotting Prothrombin PL-AA Thrombin PLA 2 AA PGH-Synthase AA PGH 2 TX-Synthase PGH 2 TXA 2 H 2 O TXA 2 TXB 2 Patrono et al, Thromb Res 1980

7 Log-linear Inhibition of Platelet Cyclooxygenase Activity by Aspirin in Healthy Subjects % inhibition of TXB 2 production Mean ± SD (4) (n) 40 (5) 20 (5) mg (5) Oral Aspirin dose (14) Patrignani, Filabozzi & Patrono, J Clin Invest 1982; 69:

8 Cumulative number of vascular deaths 1000 Randomised Trial of Intravenous Streptokinase, Oral Aspirin, Both, or Neither among Cases of Suspected Acute Myocardial Infarction: ISIS Placebo infusion: 1029 vascular deaths (12.0%) Streptokinase: 791 vascular deaths (9.2%) Days of randomisation Cumulative number of vascular deaths Placebo tablets: 1016 vascular deaths (11.8%) Aspirin: 804 vascular deaths (9.4%) Days of randomisation ISIS-2 Collaborative Group, Lancet 1988; II: Cumulative number of vascular deaths Placebo infusion and tablets: 568 vascular deaths (13.2%) Streptokinase and Aspirin: 343 vascular deaths (8.0%) Days of randomisation

9 Pooled Analysis of the Effect of Aspirin only versus Control in Secondary Prevention after Transient Ischaemic Attack and Ischaemic Stroke on the Absolute Risk of Recurrent Ischaemic Stroke. Rothwell et al, Lancet 2016;388:

10 Antithrombotic Trialists Collaboration Meta-Analysis of Aspirin Trials in High-Risk Patients Aspirin dose % Vascular Events % Odds (mg daily) Aspirin Control Reduction (SE) % 15.2% 32 (6) % 14.8% 26 (3) % 17.2% 19 (3) Any dose 12.9% 16.0% 23 (2) (2P< ) BMJ 2002;324: Odds ratio (CI)

11 Does One Size Fit All? Probably yes, because: a) Inactivation of platelet COX-1 and suppression of thromboxane production are cumulative upon repeated daily dosing, and saturable at doses as low as mg daily. b) There is no evidence that higher doses (e.g., mg) are more effective than lower doses (i.e., mg), and the opposite may be true.

12 Cumulative Inhibition of Platelet COX-1 by Low Doses of Aspirin Shifts the Dose-Response Curve by a Factor Equivalent to the Daily Platelet Turnover 100 Daily dose Percent inhibition of serum TXB ID 50 =3.2 mg ID 50 =26 mg Single dose mg Aspirin Patrono et al., Circulation 1985; 72:

13 Does One Dosing Regimen Fit All? Maybe not, because there is substantial interindividual variability in the rate of recovery of platelet COX-1 activity during the 24-hour dosing interval, perhaps requiring more frequent dosing (e.g., bid) in patients with accelerated renewal of the drug target.

14 Altered Pharmacodynamics of Low-Dose Aspirin in Type 2 Diabetes COX-1 Arachidonic Acid Prostaglandin H 2 Platelet Prostaglandin G/H synthase 1 Aspirin COX-2 Thromboxane A 2 Thromboxane B 2 Platelet aggregation (inactive metabolite) COX Aspirin Aspirin T2DM Serum TXB 2 ng/ml Patrono, Rocca, De Stefano Blood 2013;121: Healthy T2DM Time (h)

15 Determinants of the Rate of Recovery of Platelet COX-1 in Patients Treated with Low-Dose Aspirin Clinical Setting Essential Thrombocythemia 1 Pharmacokinetic Determinant Pharmacodynamic Determinant Abnormal Megakaryopoiesis Type 2 Diabetes Mellitus 2 CHD or CVD without Diabetes 2 Body Weight Body Weight Platelet turnover CABG ± AVR with CPB 3 1 Pascale et al, Blood 2012; 2 Rocca et al, JTH 2012; 3 Rocca et al, CPT 2017 Platelet Turnover

16 Acetylation of Platelet COX-1, Inhibition of TXA 2 Production and Reduction of Vascular Events by Aspirin are Saturable at Low Doses Acetylation of Platelet COX-1 Aspirin treatment In vivo In vitro (100 µm) 100 Inhibition of TXA 2 Production (14) Reduction of Vascular Events in High-Risk Patients Serum TXB 2 % Inhibition J Thromb Haemost 2014; 12: Platelet AceCOX-1 (%) % inhibition of TXB 2 production (5) (5) (4) (5) Oral Aspirin dose Mean ± SD (n) J Clin Invest 1982;69: mg Comparison Aspirin Control Reduction Asp % 15.2% 32%±6 Asp % 14.8% 26%±3 Asp % 17.2% 19%±3 Any aspirin 12.9% 16.1% 23%±2 (2P< ) BMJ 2002;324:71-86

17 Sources of Evidence Supporting a Chemopreventive Effect of Aspirin Against Gastrointestinal Cancers 1. Over 40 observational case-control studies and their metaanalysis (Algra & Rothwell, Lancet Oncol 2012). 2. Four randomized, placebo-controlled clinical trials in subjects with sporadic colorectal adenomas (Cole, JNCI 2009). 3. A placebo-controlled RCT in the Lynch syndrome with posttrial follow-up (CAPP2, NEJM 2008; Lancet 2011). 4. A post-hoc individual patient data (IPD) meta-analysis of 51 randomized controlled trials in prevention of vascular events (Rothwell et al, Lancet 2012).

18 Cancer Incidence During Six Randomised Trials of Daily Low-Dose Aspirin in Primary Prevention of Vascular Events Trial Follow-up Events/Subjects Odds 95%CI years Aspirin Control Ratio AAA 50/ / TPT 72/ / POPADAD 23/638 23/ JPAD 12/ / HOT 219/ / PPP 69/ / TOTAL 445/ / years AAA 116/ / TPT 84/ / POPADAD 22/532 37/ JPAD 3/1095 7/ HOT 75/ / PPP 24/ / TOTAL 324/ / Rothwell et al, Lancet 2012;379: Odds Ratio (95% CI) p=0.81 (het) p=0.92 (sig) p=0.79 (het) p= (sig)

19 AA PGH 2 TXA 2, PGE 2 Lipid and protein mediators, and microvescicles (rich in micrornas) are released from activated platelets and interact with adjacent resident cells and circulating cancer cells Adenoma Carcinoma Invasive and metastatic cancer cells Normal Mucosa A B C Epithelial-Mesenchymal Transition AA COX-1 PGH 2 PGH 2 mpges-1 PGIS mpges-1 PGIS PGE 2 PGI 2 15-PGDH AA COX-1 PGE 2 15-PGDH 15-keto-PGE 15-keto-PGE 2 2 COX-2 PGI 2 COX-1 AA COX-2 PGH 2 mpges-1 PGE 2 15-PGDH 15-keto-PGE 2 Tumor Growth Patrignani & Patrono, J Am Coll Cardiol 2016;68: Evasion of T-cell Mediated Immunity

20 Five-Year Risk of Vascular Events and Major Bleeding Based on Primary Prevention Trials of Aspirin vs Placebo, and Hypothetical 10% Reduction in Cancer Incidence by Age and Sex 5-year risk (%) Females, age years Non-fatal bleeding events Vascular death Non-fatal MI/stroke All cancers % 0.2% 0.9% 1.1% 2.8% % Females, age years A C A C A C A C A C A C Bleeding CVD Cancer Bleeding CVD Cancer Thun, Jacobs, Patrono Nature Rev Clin Oncol 2012;9: % 0.5% 3.9% % 5.8% %

21 Five-Year Risk of Vascular Events and Major Bleeding Based on Primary Prevention Trials of Aspirin vs Placebo, and Hypothetical 10% Reduction in Cancer Incidence by Age and Sex 5-year risk (%) % Males, age years Non-fatal bleeding events Vascular death Non-fatal MI/stroke All cancers % 3.4% % 3.1% % Males, age years A C A C A C A C A C A C Bleeding CVD Cancer Bleeding CVD Cancer Thun, Jacobs, Patrono Nature Rev Clin Oncol 2012;9: % 0.7% 8.0% % % 11.0%

22 Aspirin Use for the Primary Prevention of Cardiovascular Disease and Colorectal Cancer: U.S. Preventive Services Task Force Recommendation Statement Population Recommendation Grade Adults aged 50 to 59 years Adults aged 60 to 69 years The USPSTF recommends initiating low-dose aspirin use for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) in adults aged 50 to 59 years who have a 10% or greater 10-year CVD risk, are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years. The decision to initiate low-dose aspirin use for the primary prevention of CVD and CRC in adults aged 60 to 69 years who have a 10% or greater 10-year CVD risk should be an individual one. Persons who are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years are more likely to benefit. Persons who place a higher value on the potential benefits than the potential harms may choose to initiate low-dose aspirin. Bibbins-Domingo et al. Ann Intern Med 2016;164: B C

23 ASA: Where Do We Go From Here? Current Status Open Avenues Potential Issues The mainstay of treatment and prevention of atherothrombisis Drop Aspirin from DAPT (GLOBAL LEADERS) or TAT (PIONEER)? Develop low-dose aspirin as a chemopreventive agent? Replace aspirin with NOACs for long-term secondary prevention (COMPASS)? Ischemic Events? Primary prevention? Adjuvant therapy? Cost Loss of additional long-term benefits

24 Acknowledgments University of Chieti Catholic University, Rome Paola Patrignani Bianca Rocca Melania Dovizio Alessandro Sgambato University of Zaragoza American Cancer Society Angel Lanas University College London Michael Thun Eric Jacobs Ruth Langley European Commission FP6, EICOSANOX European Commission/EFPIA Innovative Medicines Initiative, SUMMIT

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