Incorporating KT Concepts within Clinical Trials

Transcription

1 Incorporating KT Concepts within Clinical Trials The RELY-ABLE Trial as an Example Stuart Connolly & Robby Nieuwlaat

2 Background - Dabigatran RE-LY Atrial fibrillation (AF) patients at high risk for stroke Randomized comparison 2 doses of dabigatran with warfarin 18,113 patients among 967 sites in 44 countries Study close-out December 2008 to March 2009 Many patients satisfied with taking dabigatran RELY-ABLE Offer patients on dabigatran to continue treatment Extended safety and efficacy data for 2 doses of dabigatran

3 Background - KT Total care for AF patients Most AF patients have 1 other cardiovascular problem Better management of AF and associated diseases can improve prognosis Multiple extensive guidelines difficult to integrate for care of complex patients RELY-ABLE High-risk AF patients Detailed patient data available Large number of centers: cluster randomization Large number of patients: test effect on outcomes

4 Aims of RELY-ABLE Dabigatran To collect extended safety and efficacy data for 2 doses of dabigatran for future clinical use Knowledge Translation To test whether a multifaceted KT intervention, that targets the total care of AF patients, can improve patient outcomes

5 Dabigatran etexilate 110mg bid RE-LY Documented AF Risk factor(s) for vascular events No exclusion criteria for RE-LY R Dabigatran etexilate 150mg bid Warfarin Mean follow-up 24 months End of RE-LY RELY-ABLE Patients who completed RE-LY on Dabigatran No exclusion criteria for RELY-ABLE RE-LY randomization maintained Dabigatran etexilate 110mg bid Dabigatran etexilate 150mg bid Clinical site randomization R Knowledge translation No Knowledge translation Mean follow-up for Dabigatran and Knowledge translation 24 months

6 KT Treatment Targets (1) Targets based on recent international guidelines (AHA, ACC, ADA, ESC, ESH) Hypertensives: average of last 3 SBP values <140 mmhg + Diabetes: <130 mmhg Diabetics: HbA1c <7% LDL-cholesterol: Smokers: <70 mg/dl (2.0 mmol/l) for high-risk <100 mg/dl (2.5 mmol/l) for moderate risk stop smoking

7 KT Treatment Targets (2) Rate control: heart rate <100 bpm in AF No CAD/stroke: stop ASA No SR in past year: stop AAD Systolic heart failure: prescribe ACEi/ARB + beta blocker Heart failure NYHA = 1: stop spironolactone

8 KT intervention Multifaceted KT intervention incorporating: 1. Patient-specific feedback letters to patient and physician in advance of each RELY-ABLE visit, to encourage interaction 2. Periodical feedback report cards on center performance, to encourage practice evaluation 3. Use of computer-assisted decision support to generate letters and report cards KT intervention targets management issues for which guideline recommendations are not met Opportunities to improve the total care for AF patients

9 Sample Patient Feedback Letter Page 1

10 Sample Patient Feedback Letter Page 2

11 RELY-ABLE Baseline Data

12 Number of centers Center Participation Total = 596

13 Number of patients Patient Participation Total = 5890

14 Number of patients Non-achievement of Targets - Prevention N=314 5% N=704 20% N= % N=560 47% N=434 32% N=83 44% SBP DM- SBP DM+ LDL High LDL moderate DM HbA1c Smoking

15 Non-achievement of Targets AF control Number of patients N=362 38% N=36 6% Rate control <100bpm AAD & no sinus rhythm in past year

16 Number of patients Non-achievement of Targets Drugs N=365 10% N=270 55% N=332 67% N=36 15% No CAD/stroke & no ASA HF & ACEi/ARB HF & BB HF NYHA=1 & no spironolactone

17 RELY-ABLE KT - Summary 5890 AF patients on dabigatran in 35 countries among 596 centers -> 301 centers randomized to KT Overall 4710 opportunities to improve total care of AF patients KT intervention: patient-specific audit & feedback to physician and patient, computer assistance and physician report cards Primary aim: improvement in patient outcomes KT intervention will enforce patients to get involved in their care and assist physicians to achieve targets for total AF care