Jeroen Bax. Ivabradine MDCT CA. Ivabradine MDCT CA
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1 Effects of a 10 or 15 mg single intravenous bolus of ivabradine versus placebo on heart rate control during a multidetector computed tomography coronary angiography for the evaluation of coronary artery disease on behalf of the Jeroen Bax study investigators
2 Organisation Advisory Board members NLD DEU ITA FRA POL ESP Pr J. BAX Pr S. ACHENBACH Dr. F. CADEMARTIRI Pr J. GAROT Pr M. TENDERA Pr J. ZAMORANO National Coordinators (19 countries 64 active sites) AUS BEL BGR BRA DEU DNK ESP FRA GBR HUN Pr S. WORTHLEY Pr B. GERBER Dr. I. PETROV Pr C.E. ROCHITTE Dr. A. SCHMERMUND Dr. J. LAMBRECHTSEN Dr. C. MACAYA Pr J. GAROT Dr. A. MATHUR Pr I. EDES ITA KOR NLD POL PRT ROU RUS SGP TWN Dr. F. CADEMARTIRI Pr N.S. CHUNG Pr J. BAX Pr M. TENDERA Pr R. GONCALVES Pr D.R. DIMULESCU Pr V. SINITSYN Pr. T. CHUA Dr. W. J. LEE
3 Study design Population Male or female > 18 years Not eligible for IV beta-blockers Planned to undergo a scheduled MSCT CA for the evaluation of coronary artery disease In sinus rhythm with heart rate 70 bpm Primary Study Endpoint HR control (i.e. HR 65 bpm) at the time of initiation of image acquisition during an MSCT CA procedure (Ta)
4 Study design MSCT Selection/ Inclusion T0 Study drug Ta Initiation of scan Tx Scan exit H1 H2 H4 Follow up D3 Termination The scan should be initiated as soon as HR 65 bpm If HR <65 bpm was not achieved within 15 min after the bolus, the decision to perform the CTA was left to the investigator
5 Study Drug administration Study design Randomised, unbalanced (2 ivabradine/1 placebo) study drug allocation Intravenous bolus of ivabradine or matching placebo Dosage dependent on baseline heart rate Heart rate bpm Heart rate 80 bpm 10 mg 15 mg Safety Set Full Analysis Set
6 Demography and baseline characteristics (n= 252) (n= 118) All (n= 370) Age (y) Mean (SD) 62 (11) 61 (11) 62 (11) Male % BMI (kg/m 2 ) Mean (SD) 28 (5) 28 (5) 28 (5) Heart rate (bpm) Mean (SD) 79 (9) 80 (8) 79 (8) Dosage (mg) 10 mg - HR [70-80], % mg - HR 80, %
7 Medical history and concomitant treatments (n= 252) (n= 118) Hypertension (%) Dyslipidemia (%) Diabetes (%) Heart failure (%) LVEF (in 88% pts); mean (SD) 37.8 (15.0) 37.0 (13.2) NYHA class II/III (%) Beta-blockers (%) Calcium channel blockers (%) Dihydropyridine derivative (%) Nitrates (%) 19 21
8 Reasons for non-eligibility to IV beta-blockers* (n= 252) (n= 118) 2% 10% 18% 4% 8% 18% 15% 15% 28% 40% 28% 36% Symptomatic HF COPD Asthma Symptomatic peripheral arterial disease Low sitting systolic blood pressure Other intolerance/contra-indication to BB * More then 1 reason could be reported
9 HR control ( 65 bpm) during the study Estimated difference P-value (n= 252) (n= 117) (95% CI) Ta 55% 23% 0.32 (0.22;0.42) < H1 68% 16% 0.52 (0.44;0.61) < Ta = Time of initiation of the CT procedure H1 = 1 hour after the IV bolus
10 HR control at time of CT procedure initiation (Ta) - subgroups analysis male female < 65 y 65 y HR < 80 bpm HR 80 bpm known CAD suspected CAD Difference in proportion (%) favour placebo favour ivabradine
11 Heart rate decrease: all patients (n= 252) (n= 118) (95% CI) HR at Ta* (bpm), N Mean (SD) (bpm) 67 (10) 75 (10) HR vs. baseline (SD) (bpm) -11 (8) -4 (7) -7 (-8; -5) Heart rate during contrast enhanced scan, N Mean (SD) (bpm) 65 (8) 76 (12) HR vs. baseline (SD) (bpm) -13 (8) -3 (9) -9 (-11;-7) Heart rate at H1 (bpm), N Mean (SD) (bpm) 62 (11) 77 (11) HR vs. baseline (SD) (bpm) -18 (11) -4 (10) -15 (-17; -13) Ta = time of initiation of the CT procedure H1 = 1 hours after the IV bolus * Substituted by Tx when no Ta
12 Heart rate (bpm) Heart rate evolution: all patients CONTINUOUS ECG MONITORING 12-LEAD ECG BL Ta* H1 H2 H4 Time DEND (n): (n): * Substituted by Tx when no Ta
13 MSCT scan and time to Ta (n= 252) (n= 117) Contrast enhanced MSCT scan done (%) Time to Ta* (all patients) Mean (SD) (min) 15 (9) 17 (7) * Substituted by Tx when no Ta
14 Overall procedural convenience % 80% % P = Mean: 4.2 (0.9) 3.8 (1.2) very bad bad neutral good very good
15 Radiation exposure Effective dose (ED) Patients (%) with ECTCM or AEC used ED (msv) P <0.05 NS* % of patients % 68% ECTCM AEC ED CE scan Total ED % 58% N=
16 Heart rate decrease < 50 bpm and < 40 bpm patients (%) 30 HR < 40 bpm HR < 50 bpm % 9.2% 0 BL BL to Tx *0.4% 3.6% 0.8% H1 H2 H4 DEND *representing 1 asymptomatic HR decrease
17 Adverse events (AE) AE during treatment period (untill 48h after T0) (n=252) (n=118) Nb of pts % of pts Nb of pts % of pts ALL AE Specific AE Eye disorders Bradycardia First degree AV block ALL Serious AE
18 Blood Pressure Systolic BP (mmhg) BL H1 H2 H4 DEND Diastolic BP (mmhg) BL H1 H2 H4 DEND
19 Conclusions First large trial evaluating a pure heart rate lowering drug versus placebo in the setting of a MSCT CA A single IV bolus of ivabradine during MSCT CA induces a rapid and sustained heart rate control (HR 65 bpm) is convenient for use in daily clinical setting of MSCT CA allows the performance of contrast enhanced scans in patients with high heart rate and non eligible to IV beta-blockers is well tolerated in this population, including patients with pulmonary diseases and heart failure was associated with a higher use of radiation lowering techniques and significantly lower effective radiation doses during the contrast enhanced MSCT scan
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