Disclosures. Point of Care Testing (POCT) for Anticoagulation Monitoring. Point of Care Anticoagulation Monitoring. Questions.

Transcription

1 Point of Care Testing (POCT) for Anticoagulation Monitoring Paula J. Santrach MD Consultant, Division of Transfusion Medicine Associate Professor, Laboratory Medicine Mayo Clinic Rochester, M Disclosures Relevant financial relationships OE Off label usage OE Point of Care Anticoagulation Monitoring Warfarin monitoring Multiple devices available Well-established established in many facilities Focus of today s s talk Heparin monitoring Very few POC PTT devices exist Lack of PTT standardization problematic Questions What devices are available? How are the tests performed? How good are the results? What are the pitfalls? Does point of care testing make a difference in patient outcome? POC IR Monitors POC IR Monitors Varying thromboplastins and endpoint detection methods Designed to use capillary whole blood Designed primarily for patient use Data management capabilities to enhance professional use just starting to be available Make Roche ITC Hemo- sense Abbott Model CoaguChek Classic (no longer made) CoaguChek S CoaguChek XS CoaguChek XS Plus (not FDA cleared) ProTime IRatio i-stat Prof. use Pt. use Low ISI Int. QC?

2 Questions What devices are available? How are the tests performed? How good are the results? What are the pitfalls? Does point of care testing make a difference in patient outcome? CoaguChek S Evaluation POC IR Evaluation Difference Plot CoaguChek S.5..5 y =.98x +.99 R = POC IR.5.5 POC Method Comparison 7 ProTime Evaluation CoaguChek CoaguChek S 8% 7% % 5% % % % % % >. Difference (POCT-Lab) P OC T I R y =.859x +.8 R =

3 .5. POC IR Evaluation Difference Plot ProTime Evaluation % POCT IR Evaluation Agreement between POCT and Lab.5 5% POC % % % % -.5 % -. ProTime vs CoaguChek vs >. Difference in IR (POCT-Lab) CoaguChek ProTime POC IR Evaluation Difference Plot HemoSense (IRatio) Reproducibility POC Clinic type TC Intra-device CIM Inter-device Total no. patients 5 7 o duplicates 8 IR results >8. 5 Evaluable patients 79 (95.8%) 5 (9.%) Range of IR results IRatio PLG vs CoaguChek vs IRatio BD8L vs.5 POC IR Difference Plot Intra-Reproducibility Using - CoaguChek (Thrombophilia) POC IR Difference Plot Inter-Reproducibility Using - CoaguCheks (Community Internal Medicine) POC IR Difference POC IR Difference First Result -.5 st Result First Result vs Second Result First Result vs Second Result

4 Agreement Between Duplicates % of patients Intra-device Difference Inter-device.9 -. >...5. IR.5. Anticoagulant Therapy, Target IR Range. to. Ortho RecombiPlasTin (ISI.5) at h Dade Thromboplastin C-Plus (ISI.85) at h Dade Innovin (ISI.85) at h Sample no. Davis KD et al: Arch Pathol Lab Med :97, 998 Testing Issues Testing Issues IR results which should be checked using the lab method eed for policy Be aware of expected differences between methods and increasing divergence at higher IR values Patient populations Stable vs unstable anticoagulation Method switching between outpatient & inpatient settings Concurrent administration of LMW heparin Warfarin Monitoring Method Switching Outpatient vs Inpatient /8/ 7/8/ 9// /5/ /5/ // POC IR POCT Laboratory Difference Confidence interval POC IR Monitoring Warfarin ± LMWH Warfarin Only (n=59) IR ± SD P. ±.7.77 ±.5. ±..8. <. <.. Warfarin + LMWH (n=) IR ± SD P.58 ±.5. ± ± <. <.. Pharmacotherapy 5:, 5

5 Concordant pairs o dosage change indicated by POC & Lab Dosage change indicated by POC & Lab Discordant pairs Dosage change indicated by POC but not Lab Dosage change indicated by Lab but not POC POC IR Monitoring Warfarin ± LMWH o. (%) patients Warfarin only Warfarin + LMWH (n=59) (n=) 5 () 9 (9) 5 (9) () 8 (5) (5) () (9) Testing Issues Patients with anti-phospholipid antibodies (APS) Thromb Haemost 9:9, 5 59 patients with APS vs 9 patients with atrial fibrillation 8% of patients with non-measurable ProTime IR results Pharmacotherapy 5:, 5 Questions What devices are available? How are the tests performed? How good are the results? What are the pitfalls? Does point of care testing make a difference in patient outcome? POC IR Monitoring in the Professional Setting Anticoagulation clinics Primary care clinics ursing home visits Therapeutic Control with Warfarin in the First Months of Outpatient Therapy Proportion of time spent in IR range - month - months - months n= n= n=5 Inter- Usual Inter- Usual Inter- Usual vention care vention care vention care group group group group group group (%) (%) (%) (%) (%) (%) Subtherapeutic *.9 5.* Therapeutic 8.*. 58.9* *. Supratherapeutic 9..7*. 8.*. 5.* *P<. Ann Intern Med :87, CP9- Cumulative Incidence of Major Bleeding at Months According to Intention-to-Treat to-treat Analysis Patients with major bleeding (%) 8 (7) () (7) 5 Months Ann Intern Med :87, Usual care (97) n= (7) Study intervention n= (75) P=.5 CP9-5

6 Warfarin Anticoagulation Patient Self-Monitoring Study Type TTR* White RCT +7% Ansell 995 Cohort +% Horskotte 99 5 RCT +% Hasenkam 997 Case control +% Beyth RCT +% Sawicki RCT +% GELIA 78 RCT +% ESCAT RCT +8% Cromheecke 5 RCT +% Watzke RCT +% randomized trials with a total of 9 participants comparing self- monitoring with routine anticoagulation Primary care as control group: 8 Anticoagulation clinic as control group: Lancet 7:, Patient Self-Testing Thromboembolic Events Patient Self-Testing Major Hemorrhage Odds Ratio 95% CI Odds Ratio 95% CI Self-adjust Self-adjust.9..5 on-adjust on-adjust.5..9 Total.5..8 Total Lancet 7:, Lancet 7:, Patient Self-Testing Death from All Causes Self-adjust on-adjust Total Odds Ratio % CI Lancet 7:, Self-monitoring associated with a higher rate of testing (weekly vs monthly) ot feasible for all individuals Physical limitations Training issues Attendance Failure Device problems Lancet 7:,

7 Patient Self-Testing POC IR Monitoring in Pediatrics Major issue limiting widespread use Reimbursement, particularly for Medicare patients Study J Pediatr 7:89, 995 Pediatr Cardiol :7, # pts 8 Device Biotrack Coagu- Chek Comparability / TTR r =.9, 9% agree within.8 IR units r =.9-.9,.9, 7% agree within.5 IR units Bleed? TE? Cardiol oung :9, Coagu- Chek 5.5% TTR J Pediatr Hematol Oncol 5:, 9 Coagu- Chek, Signature Jr., ProTime r =.877 r =.8 r =.885 R R Review article: Thromb Res 8:, Conclusions Point of care IR monitoring is available for use in both professional and home settings Analytical performance is acceptable Very important to match lab method or to at least understand the differences Be aware of patient population, LMWH and APS impacts Clinical outcomes acceptable in controlled trials 7