EURObservational Research Programme The ESC Registry on Chronic Ischemic Coronary Disease Prof. Fausto J. Pinto, FESC, FACC, FASE, FSCAI Immediate Past-President, ESC University Hospital Sta Maria University of Lisbon, Portugal Thank you to Prof. Aldo Maggioni
Executive Committee Members Michel Komajda Chairman, FR Francesco Cosentino, Sweden Roberto Ferrari, IT Aldo Maggioni, IT Gabriel Steg, FR Luigi TAVAZZI, IT Marco Valgimigli, CH
Background 1/2 Atherosclerosis is a systemic disease The three main manifestations are: Coronary artery disease Lower extremity artery disease Cerebrovascular disease Changing environment(procedures/management). We need: RECENT data (last ESC survey 2005)... in a broad spectrum of patients with CVD... and across ESC countries In order to
Background 2/2 1. Characterize contemporary CAD/PAD patients in terms of Clinical profile Management 2. Identify potential gaps between practice and evidence based management. 3. Identify geographical variations 4. Determine short/long-term prognoses and their determinants.
CICD Registry International prospective observational longitudinal registry Pilot Phase Long-Term Phase APR 2013 DEC 2014 SEPT 2015 MAR 2017 2 420 Patients 15 000 Patients 3- YEAR FOLLOW-UP
CICD Pilot Registry: Design Cohort 1: NSTE-ACS Urgently revascularised Enrolment: cath lab N = 755 Cohort 2: Chronic CAD Electively revascularised Enrolment: cath lab N = 933 Cohort 3: Chronic CAD Not revascularised Enrolment: general hospital N = 531 Cohort 4: PAD All revascularised Enrolment: cath lab N = 201
doi: 10.1093/eurheartj/ehv437 eurheartj.oxfordjournals.org
Demographics & Baseline Characteristics 1/3 Cohorts Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) P-value N of patients 2420 755 933 531 201 Age at inclusion in years, Mean±SD 66.6±10.9 66.0±11.7 66.2±10.1 67.3±11.2 68.6±10.6 0.0087 Female Gender % 30.5 32.1 28.5 34.1 24.9 0.0318 SBP in mmhg, Mean±SD 136.5±20.2 137.7±22.0 135.4±17.7 134.7±21.0 141.3±21.3 0.0002 Diabetes mellitus % 29.2 28.5 27.2 26.0 49.3 <0.0001 Smoking status % 54.6 60.4 49.8 50.8 64.7 <0.0001 Hypertension % 82.6 80.1 84.1 81.7 86.6 0.0659 Hypercholesterolemia % 74.1 69.1 78.9 72.1 76.1 <0.0001 SD = Standard Deviation
Demographics & Baseline Characteristics 2/3 Cohorts Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) P-value N of patients 2420 755 933 531 201 Previous NSTE ACS % 20.2 22.1 17.8 26.7 6.5 <0.0001 Previous STEMI ACS % 24.5 20.7 31.2 23.5 10.9 <0.0001 Previous stable CAD % 67.5 44.4 85.1 80.4 38.3 <0.0001 Previous revascularization PCI/CABG % Previous peripheral revascularization % Previous cerebrovascular disease % 61.1 67.8 57.3 60.2 76.6 0.0003 5.9 3.7 3.2 3.2 33.3 <0.0001 16.4 11.0 14.3 17.1 44.3 <0.0001
Demographics & Baseline Characteristics 3/3 Cohorts Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) P-value N of patients 2420 755 933 531 201 History of atrial fibrillation 15.1 12.2 12.0 25.3 13.1 <0.0001 COPD % 7.0 7.0 5.3 7.9 12.1 0.0050 Chronic kidney disease % 11.5 11.4 9.3 13.6 16.5 0.0085 Malignancy 6.6 5.9 6.9 6.4 7.6 0.7977 SD = Standard Deviation
Investigations during Admission/Consultation or within One Year Cohorts Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) P-value N of patients 2420 755 933 531 201 S-Creatinine in mg/dl, Mean±SD 1.15±2.68 1.06±0.72 1.05±0.78 1.43±5.51 1.16±0.91 0.0296 Fasting glucose in mg/dl, Mean±SD 116.20±44.02 124.02±47.46 109.90±38.99 110.10±37.85 127.73±55.68 <0.0001 Total cholesterol in mg/dl, Mean±SD 169.9±49.3 179.0±50.0 167.0±50.1 165.9±46.0 159.2±46.8 <0.0001 LDL in mg/dl, Mean±SD 101.7±42.7 110.4±44.8 100.7±43.1 94.9±37.8 91.6±38.7 <0.0001 SD = Standard Deviation
Stress Tests Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) N of patients 2420 755 933 531 201 Echocardiogram performed, % 69.5 84.0 60.4 77.4 35.8 LV ejection fraction (in %), Mean±SD 52.5 ±11.3 50.8 ±10.6 52.7 ±11.1 54.3 ±12.3 54.6 ±11.6 Exercise Test, % 21.2 7.0 24.3 43.9 0.0 Holter Monitoring, % 14.5 13.7 9.1 28.0 7.0 Cardiac CT, % 2.0 0.4 3.2 2.6 0.5 Cardiac MRI, % 0.9 0.3 1.7 0.4 0.5 Myocardial Scintigraphy, % 4.0 0.4 8.1 3.2 0.5 MRI= Magnetic Resonance Imaging
Drug Treatments before Hospital Admission or Consultation 1/2 Cohorts Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) P-value N of patients 2420 755 933 531 201 ACE-1, % 50.3 44.0 57.6 49.9 40.1 <0.0001 ARB, % 18.2 13.5 20.8 16.0 29.4 <0.0001 ACE-I/ARBs, % 67.8 57.4 77.5 65.2 68.4 <0.0001 Betablockers, % 63.8 54.3 73.0 67.2 46.8 <0.0001 Statins, % 67.5 49.2 79.6 67.3 79.3 <0.0001 ASA, % 68.2 52.1 79.6 65.8 81.2 <0.0001 DHP Calcium channel blockers, % Non-DHP Calcium channel blockers, % 19.6 15.5 21.7 17.8 30.5 <0.0001 2.0 2.0 1.8 2.1 2.1 0.9828 Amiodarone, % 2.8 2.2 2.1 3.7 6.3 0.0043 ACE-I = Angiotensin Converting Enzyme Inhibitor; ARBs = Angiotensin II Receptor Blockers; MRAs = Mineralocorticoid Receptor Antagonists; DHP = Dihydropyridine; ASA = Acetylsalicylic acid
Drug Treatments before Hospital Admission or Consultation 2/2 Cohort All NSTEMI (1) Elective PCI (2) Stable CAD (3) PAD (4) P-value N of patients 2420 755 933 531 201 Diuretics, % 30.7 23.6 30.8 35.7 44.6 <0.0001 MRAs, % 7.6 4.9 7.7 11.2 7.0 0.0007 Nitrates, % 11.1 10.2 14.6 8.3 5.9 0.0001 Ivabradine, % 3.1 1.9 4.4 3.6 0.0 0.0019 Ranolazine, % 1.4 0.9 1.8 1.2 1.1 0.4153 Insulin, % 9.4 10.5 6.2 8.8 22.0 <0.0001 Oral antidiabetics, % 19.9 17.3 21.4 18.7 25.3 0.0393 Oral Anticoagulants, % 9.1 5.3 8.4 13.8 14.4 <0.0001 Clopidogrel, % 29.6 22.1 41.9 15.5 38.6 <0.0001 Other anti-platelet agents excluding Clopidogrel, % 3.4 3.0 4.3 2.5 2.6 0.2434
Drug Treatments: Prescription rate at discharge Before admission or consultation At discharge 82.9 80.2 92.7 90.3 67.8 63.8 67.5 68.2 66.8 29.6 12.3 3.4 ACE-I/ARB BETA BLOCKERS STATINS ASA CLOPIDOGREL Other antiplatelet agents
Comparison of patients enrolled in the CICD Pilot (2015) and the EHS (2005) 1/2 Cohorts CICD PILOT 2015 EHS 2005 N of patients 2420 3779 Age at inclusion in years, Mean±SD 66.6±10.9 61±11 % Male 69.5 58 Medical history Diabetes mellitus % 29.2 18 Dyslipidaemia (%) 74.1 58 Hypertension (%) 82.6 62 Previous cerebrovascular Disease (%) 16.4 5 Malignancy (%) 6.6 2 CICD= Chronic Ischaemic Cardiovascular Disease; EHS= Euro Heart Survey * CICD: before/during hospitalization. EHS: during hospitalization /planned. Exercise test (76) / stress imaging (18).
Comparison of patients enrolled in the CICD Pilot (2015) and the EHS (2005) 2/2 Cohorts CICD PILOT 2015 EHS 2005 Investigations Echocardiography (%) 70 64 Ischemia stress tests (%)* 50 stable CAD / 37 elective PCI 76 / 18 Treatment at discharge ACE-1 65.1 40 Betablockers 80.2 67 Statins 92.7 48 Aspirin 90.3 78 Nitrates 11.1 61 Calcium channel blockers 24 27 CICD= Chronic Ischaemic Cardiovascular Disease; EHS= Euro Heart Survey * CICD: before/during hospitalization. EHS: during hospitalization /planned. Exercise test (76) / stress imaging (18).
Limitations Center selection on a voluntary basis Medical history recorded by investigator report Heterogeneity across cohorts inherent to study design Sample size inadequate for assessment of geographic variations
Conclusion 1/2 Patients enrolled in the CICD Pilot were older, had more CV risk factors and more comorbidities than reported in the previous European survey (Daly, 2005). Important differences in the clinical profile of the four cohorts were observed. Investigations remain suboptimal: #70% had an echocardiogram 50% (stable CAD) and 37% (elective PCI) only had an assessment of myocardial ischemia. Use of new imaging modalities was marginal.
Conclusion 2/2 Use of ACE-I, statins and ASA was higher than previously reported, and increased at discharge. Use of beta blockers was higher, whereas use of nitrates was lower than in the 2005 survey. Limited use of new anti-anginal drugs. Overall: Use of recommended procedures remains suboptimal Improvement in secondary prevention.
CICD LT registry Objectives Characterize contemporary CICD patients in terms of: Demographic characteristics Clinical profiles Management and diagnostic-therapeutic processes according to the clinical profiles as well as identifying gaps (and possibly their causes) between current routine treatment and evidence-based treatment recommended by ESC guidelines. To determine short- and long-term outcomes and their determinants in this population of patients.
CICD LT registry Patient Population Study population: All consecutive patients with CICD either scheduled for an elective revascularisation procedure or visited on an ambulatory basis by participating centres. Main Inclusion criteria: Patients either undergoing an elective revascularisation procedure or seen for a routine follow-up visit Patients presenting with documented CICD, defined as: Previous STEMI OR Previous NSTE ACS OR Previous coronary revascularisation OR Patients with stable coronary artery disease, defined as: Effort-induced angina or rest angina with documented myocardial ischaemia detected by exercise test or any stress imaging or documented >50% stenosis in at least 1 major coronary artery on coronary angiography Asymptomatic ischaemia with a documented >50% stenosis in at least one major coronary artery on coronary angiography Patients with NO ACS in the previous 30 days Number of targeted enrolled patients = 15,000 overall with at least 60 patients/centre
CICD LT registry Study Design Patient Follow up at 1 year, 2 years & 3 years after enrolment Types of centres: The total number of centres in each participating country will be split according to the proportion of existing centres With a catheterization laboratory Without a catheterization laboratory
CICD LT registry Enrolment Timelines Enrolment is on going End of recruitment is targeted until the end of targeted enrolment of 15 000 pts, expected Q4 2018 One year FU end of data collection: exp. Q4 2019 Two year FU end of data collection: exp. Q4 2020 Three Year FU end of data collection: exp. Q4 2021
CICD LT registry Enrolment Status 1 Countries 22 countries agreed to participate 18 countries have enrolled patients 103 contributing centres (132 confirmed participation) 3,478 patients enrolled overall (1,818 in Oct > 91% more) High participation from Russia: 31 confirmed vs 23 active centres enrolling 755 pts, mostly since October 2016 Egypt started Nov 2016: 1 active centre 71 pts more centres soon enrolment increase soon
CICD LT registry Enrolment Status 2 Ukraine newly involved Belarus reactivated Turkey participation pending
Thank you for your attention