Περιφερική Αρτηριακή Νόσος Νόσος Καρωτίδων

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1 Νεώτερα δεδομένα στην αντιαιμοπεταλιακή αγωγή που θα επηρεάσουν τις μελλοντικές κατευθυντήριες οδηγίες Περιφερική Αρτηριακή Νόσος Νόσος Καρωτίδων Μιλτιάδης Ματσάγκας, MD, PhD, FEBVS Αναπληρωτής Καθηγητής Αγγειοχειρουργικής Πανεπιστημίου Ιωαννίνων

2 PAD

3 Resistance to anti platelet therapy in PAD It is well known that some PAD patients show resistance to Aspirin (up to 20%) Matsagas et al, Ann Vasc Surg 2002 Karnabatidis D. et al, Cardiovasc Intervent Radiol 2013

4 CAPRIE: Subgroup analysis Relative Risk Reduction RRR (%) Cerebral ishemia (p/ys=12.033) p=0,26 CAD (p/ys ) p=0,66 PAD (p/ys ) p=0,0028 TOTAL (p/ys=35.155) p=0, ASA better Clopidogrel better CAPRIE Steering Committee. Lancet 1996

5 Resistance to clopidogrel Despite the initial success rate of PTCA some pts suffered recurrent ischemic events despite dual antiplatelet treatment Low response to clopidogrel?

6 The use of Drug Eluting Stents (DES) and Drug Eluting Balloons (DEB) in peripheral interventions DES initial use in tibial arteries Siablis D, et al., J Endovasc Ther, 2007 DEB in femoropopleteal lesions Tepe G, et al., NEJM, 2008 Better results? Increased risk for acute thrombosis?

7 Peripheral Transluminal Angioplasty and Stenting Resistance to clopidogrel in peripheral PTA The MIRROR study Tepe G, et al. Eur Radiol (2012) 22:

8 Resistance to clopidogrel in peripheral PTA The MIRROR study RCT 80 patients (40 to each group) Loading dose prior to intervention 500mg aspirin + 300mg clopidogrel 500mg aspirin or Maintenance dose for 6 months after the intervention 100mg aspirin + 75mg clopidogrel or 100mg aspirin Tepe G, et al. Eur Radiol (2012) 22:

9 Resistance to clopidogrel in peripheral PTA The MIRROR study Primary endpoint was the rate of patient s resistant to clopidogrel Secondary endpoints included the clinical development 6 months after the intervention Tepe G, et al. Eur Radiol (2012) 22:

10 Resistance to clopidogrel in peripheral PTA The MIRROR study Mono (ASA) vs dual (ASA + clopidogrel) therapy before and after peripheral PTA and stenting Tepe G, et al. Eur Radiol (2012) 22:

11 Resistance to clopidogrel in peripheral PTA The MIRROR study 30% of patients who had received clopidogrel were resistant Two clopidogrel patients required reintervention and revascularisation Both were resistant to clopidogrel Tepe G, et al. Eur Radiol (2012) 22:

12 Resistance to clopidogrel in peripheral PTA The MIRROR study The results seem to support the use of dual antiplatelet therapy periinterventionally and for 6 months post interventionally after endovascular treatment of PAD patients An optimal loading dose and optimal duration of the medication are difficult to determine and recommend It might be reasonable to measure clopidogrel resistance before endovascular treatment of PAD patients, at least in anatomically complex procedures Tepe G, et al. Eur Radiol (2012) 22:

13 Clopidogrel responsiveness in PAD The PRECLOP Study Spiliopoulos et al, JACC 2013

14 Clopidogrel responsiveness in PAD The PRECLOP Study Prospective study 100 pts Rutherford stage 3-6 Succesfull infrainguinal angioplasty or stenting Dual antiplatelet 1 month prior - 6m post vs single with Clop 75mg during FU Clopidogrel responsiveness prior to the procedure Spiliopoulos et al, JACC 2013

15 Clopidogrel responsiveness in PAD The PRECLOP Study 1-year clinical events Death Bleeding Major amputation Target vessel re-intervention Platelet responsiveness to clopidogrel, expressed as platelet reactivity P2Y12 reactive units (PRU) Spiliopoulos et al, JACC 2013

16 Events Spiliopoulos et al, JACC 2013

17 Clinical adverse events p<0.001 Quartile distribution of ontreatment platelet responsiveness to clopidogrel and clinical events Spiliopoulos et al, JACC 2013

18 Prediction of major events at 1y PRU value 234 Sensitivity 92.1% Specificity 84.2% Spiliopoulos et al, JACC 2013

19 Event free survival PRU value above the cut off value of 234 was the only independent predictor of increased adverse clinical events, with an adjusted hazard ratio of Spiliopoulos et al, JACC 2013

20 Event free survival Quartile Based Event Free Survival Spiliopoulos et al, JACC 2013

21 Clopidogrel responsiveness in PAD The PRECLOP Study An inadequate response to clopidogrel, identified using point of care testing just prior to the procedure, is a new strong independent predictor of reduced event free survival, adversely influencing midterm clinical outcomes of peripheral angioplasty and stenting ROC analysis identified PRU >234 as the optimal cutoff value to predict clinical outcomes of infrainguinal angioplasty or stenting. This is in line with the majority of the coronary studies, as according to a recent metaanalysis, a PRU value >230 was associated with a significant twofold increased rate of the composite endpoint of death, myocardial infarction, and stent thrombosis Brar et al, JACC 2011 Spiliopoulos et al, JACC 2013

22 Initial Experience With Ticagrelor in Patients With Critical Limb Ischemia In patients with High On Clopidogrel Platelet Reactivity Undergoing Complex Peripheral Endovascular Procedures Spiliopoulos et al, Cardiovasc Intervent Radiol 2014 Spiliopoulos et al, JACC 2013

23 Initial Experience With Ticagrelor in PAD 37 pts, 40 limbs Rutherford stage 4-6 High on clopidogrel platelet reactivity (HCPR). Platelet reaction units (PRU)>234 (VerifyNow P2Y12 assay) Dual antiplatelet ASA100mg + ticagrelor 180/90 mg twice daily Primary safety outcome: total major bleeding Primary efficacy outcome: the composite of cardiovascular death and major amputation Spiliopoulos et al, Cardiovasc Intervent Radiol 2014

24 Initial Experience With Ticagrelor in PAD No ticagrelor-related or other major complications were detected during follow-up In total, 4 periprocedural minor adverse events were noted (10.8%) Two patients (5.4%) discontinued ticagrelor intake due to reported minor adverse events Spiliopoulos et al, Cardiovasc Intervent Radiol 2014

25 Initial Experience With Ticagrelor in PAD Spiliopoulos et al, Cardiovasc Intervent Radiol 2014

26 Initial Experience With Ticagrelor in PAD Spiliopoulos et al, Cardiovasc Intervent Radiol 2014

27 In Conclusion We have now studies, even small ones, showing that dual antiplatelet therapy is superior in interventional treatment of patients with PAD High on treatment platelet reactivity (HTPR) has been identified as a independent predictor of increased clinically driven reinterventions after peripheral endovascular angioplasty or stenting and may affect as high as 30% of patients First and promising use of ticagrelor in high on treatment platelet reactivity PAD patients undergoing endovascular procedures

28 CAROTIDS

29 Antiplatelet therapy for CAS CAS should be performed under dual antiplatelet treatment with aspirin and clopidogrel Grade A Dual antiplatelet treatment should start before CAS and continue for 3 months after stenting Grade C Liapis C, et al. ESVS Guidelines 2009

30 AHA Guidelines for CAS Before and for a minimum of 30 days after CAS, dual-antiplatelet therapy with aspirin (81 to 325 mg daily) plus clopidogrel (75 mg daily) is recommended Level of Evidence: C Brott TG, et al. J Am Coll Cardiol 2011

31 Clopidogrel resistance in CAS Patients to undergo CAS maybe clopidogrel nonresponders Clopidogrel dose adjustment González A, et al. J Vasc Surg 2014

32 Clopidogrel resistance in CAS Prospective study 214 pts underwent CAS under DAPT (ASA + Clop) 99 (46.3%) had high on treatment reactivity (OTR, clopidogrel nonresponders, PRU>230) Randomly assigned to Clopidogrel 75 mg or Clopidogrel 150 mg Re-assessed in 30 days González A, et al. J Vasc Surg 2014

33 Clopidogrel resistance in CAS González A, et al. J Vasc Surg 2014

34 Clopidogrel resistance in CAS González A, et al. J Vasc Surg 2014

35 Dual antiplatelet therapy and CEA

36 Dual antiplatelet therapy and CEA Safety issues to be addressed first Risk of wound hematoma at carotid endarterectomy under dual antiplatelet therapy Oldag A. et al, Langenbecks Arch Surg 2012

37 Dual antiplatelet therapy and CEA 684 pts underwent CEA 15-years period Wound hematoma (any) Aspirin 48 of 410 (11.7%) Clopidogrel 33 of 162 (20.4%) Dual therapy 27 of 112 (24.1%) Severe space-occupying hematoma needing operative re-exploration Aspirin 5 of 410 (1.2%) Clopidogrel 7 of 162 (4.3%) Dual therapy 4 of 112 (3.6%) Oldag A. et al, Langenbecks Arch Surg 2012

38 Dual antiplatelet therapy and CEA Oldag A. et al, Langenbecks Arch Surg 2012

39 Dual antiplatelet therapy and CEA Safety issues to be addressed Risk of postoperative bleeding Hale B. et al, Vascular 2013

40 Dual antiplatelet therapy and CEA 1472 pts underwent CEA 7-years period Postoperative bleeding No therapy 1.2% Aspirin 0.9% Dual therapy 4.4 % Re-operation for bleeding No therapy 1.0% Aspirin 0.5% Dual therapy 2.5% Hale B. et al, Vascular 2013

41 Dual antiplatelet therapy and CEA Hale B. et al, Vascular 2013

42 Dual antiplatelet therapy and CEA Initial experience with DAPT during and after carotid endarterectomy Pilot safety study performing CEA under DAPT Peroulis M. et al, ALPIC 2014

43 Dual antiplatelet therapy and CEA 21 pts underwent CEA 2-years period All patients were under dual antiplatelet therapy Aspirin 100mg Clopidogrel 75mg One patient (4,8%) had a post-operative ispilateral neck hematoma without need of surgical intervention NO neurologic events Peroulis M. et al, ALPIC 2014

44 In Conclusion Many patients with carotid artery disease are nonresponders to clopidogrel. The double dose adjustment is not sufficient. Carotid endarterectomy safety under dual antiplatelet treatment is quite doubtful at the moment It has to be proved if dual treatment is efficacious as well

45 Perioperative use of Aspirin in non Cardiac Surgery

46 Perioperative use of Aspirin Perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who were already on an aspirin regimen and among those who were not Devereaux P.J. et al, NEJM 2014

47 Perioperative use of Aspirin pts to undergo non-cardiac surgery 3.5-years period, 135 hospitals in 23 countries Randomly assinged Aspirin 200mg LD and 100mg/d for 30 days Placebo The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days The safety outcome was major bleeding at 30 days Devereaux P.J. et al, NEJM 2014

48 Perioperative use of Aspirin Devereaux P.J. et al, NEJM 2014

49 Perioperative use of Aspirin Devereaux P.J. et al, NEJM 2014

50 Perioperative use of Aspirin Devereaux P.J. et al, NEJM 2014

51 Perioperative use of Aspirin Devereaux P.J. et al, NEJM 2014

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