ACS Registry

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					Acute Coronary Syndrome Registries

     Closing the GAP between
      Guidelines and Practice
           David Fitchett MD
         St Michael’s Hospital and
      Canadian Heart Research Centre
          Acute Coronary Syndromes
Presentation                   Suspected ACS




Emergency
Department
                   Non-ST                              ST 

                                +             +        +             +

In-hospital    Unstable              Non-Q                   Q
                Angina              Wave MI                Wave MI
Adapted from Braunwald et al        + = positive cardiac enzymes/markers
   J Am Coll Cardiol 2002
      Background: why Registry
   Randomized clinical trials revolutionize
    the treatment of acute coronary
    syndromes (ACS)
   Unclear how research-based evidence
    applies to “real world” practice in Canada
   Management and outcome of ACS
    patients after the “acute phase” have not
    been well described
What can we learn from Registries ?
   Epidemiology of acute coronary disease
   Diagnosis
       Accuracy of ECG interpretation
       Validation of Risk models
   Management
       What is being used and are there trends ?
       Outcomes when guidelines are followed
   Outcomes and management of high risk groups
       Older
       Diabetic
       Chronic Kidney Disease
 Change practice to follow evidence based guidelines
                    Early Mortality in
                     Non-ST ACS
    % of Patients
6
                       7-day                    In-hospital
5
                                                    4.9
4
3
2
         1.8           1.9          1.8
1
      n=9,461         n=1,915    n=7,800        n=27,786
0
      PURSUIT       PRISM-PLUS   GUSTO IV-ACS    CRUSADE
          Leading and Lagging Hospital Quartiles
          Acute Care
      % of Patients
100
        95                                92                 Leading Centers
80            85         86                                  Lagging Centers
                                               71
60                             64

40                                                    46           47

20                                                          24
                                                                          20

 0
      ASA <24 hrs      Blocker <24 hrs    Heparin   Clopidogrel   GP IIb/IIIa
                                                                           Roe et al
                   Leading and Lagging Hospital Quartiles:
                   Discharge Care

            % of Patients
     100
              94                                                    Leading Centers
                            89
       80            82                                             Lagging Centers
                                                         78
       60                         68      67
                                                              58        60
                                                49
       40
                                                                              36
       20

        0
                 ASA         Blocker   ACE Inhibitor*   Statin**      Clopidogrel
* LVEF < 40%
                                                                               Roe et al
** Known hyperlipidemia
Performance Matters!
Relationship between Process and Outcome
                    In-hospital Mortality
    % of Patients
8


6
        5.89
                       4.98
4                                4.55
                                             3.57
2


0
        <65%           65-75%    75-80%      >80%
          Hospital Composite Adherence Quartiles
                                                    Roe et al
              ACS Registry
   Canadian, multicentre, prospective,
    observational registry of clinical
    management practices and patient
    outcomes in ACS

   Designed to collect, analyze, and
    disseminate data on Canadian ACS
    patients
          Canadian ACS Registry
                                                   5,312 patients
                                                      51 sites
                                              (Sept 1999-June 2001)



                                                Newfoundland
                                                       New Brunswick
                                                             4 sites
 British                                                     n=333
Columbia Saskatchewan                       Quebec
                                                          P.E.I 1 site n=101
  7 sites Alberta 1 site Manitoba            9 sites
                                  Ontario             Nova Scotia
  n=942 4 sites n=249 1 site                 n=1360
                                   22 sites             2 sites
           n=394           n=26    N=1780                n=127
                  Final Diagnosis
                Other Non-cardiac
                Cardiac  5.2% Q Wave MI
                        7.7%
                                  24.2%
                  Unstable
                   Angina       Non-Q
                       34
                                Wave MI
                       %       28.9%

                                    N= 5,312


 Overall 4627 (87.1%) had a final ACS diagnosis (in-hospital
                    mortality rate 2.4%)
2925 patients had NSTE ACS (in-hospital mortality rate 1.5%)
                   ACS Registry I
   First phase provided important information about
       level of risk (e.g., based on ECG and cardiac marker
        status)
       management strategies employed (e.g., initial anti-
        platelet/thrombotic treatment, coronary angiography
        and revascularization)
       short and long-term outcomes in ACS patients on a
        Canada-wide basis
   Results indicate that, despite clear guidelines and
    evidence from clinical trials, the majority of
    patients are not optimally managed
          Multivariable Logistic Regression Model
                 to Predict 1-year Mortality
                  Independent Predictors
 Variables                          Odds Ratios (95% CI)        P value
 Age (per decade)                   1.59 (1.34-1.90)            <0.001
 Previous MI                        1.45 (1.08-1.93)            0.012
 Diabetes                           1.52 (1.13-2.03)            0.005
 Previous CHF                       1.60 (1.11-2.31)            0.012
 Systolic BP (per 10mmHg)           0.95 (0.91-1.00)            0.03
 Killip class II                    1.64 (1.19-2.26)            0.003
 Killip class III                   1.54 (0.86-2.75)            0.15
 Killip class IV                    4.15 (1.37-12.5)            0.012
 ST deviation/BBB                   1.48 (1.11-1.97)            0.007
 Abnormal biomarker                 2.21 (1.55-3.16)            <0.001
 CrCl *                             1.19 (1.11-1.27)            <0.001
Hosmer-Lemeshow goodness-of-fit P= 0.22        * Per 10 ml/min decrease
                 Medication Use at Discharge and
                         1-year Mortality

    After adjusting for age, previous MI, CHF, Killip
     class, abnormal biomarker, ST deviation/BBB on
     presentation, the discharge use of the following
     medications was associated with lower 1-year
     mortality *:
         ASA [OR=0.48 (0.36 to 0.63), P<0.001]
         Beta-blocker [OR=0.72 (0.56 to 0.92), P<0.01]
         ACE inhibitor [OR=0.76 (0.60 to 0.96), P=0.02]
         Lipid lowering agent [OR=0.72 (0.57 to 0.92), P<0.01]

    * OR= odds ratio (95% confidence interval)
             ACS Registry II
   The second phase of the ACS Registry is
    designed to close, at least in part, this
    care gap by continuing the educational
    effort and supporting it with specific
    management recommendations based on
    risk assessment
            CHRC ACS Registry II

                                                2356 ACS patients
                                                       36 sites
                                             (Oct 4, 2002 – Dec 17, 2003)




                                                         New Brunswick
                                                             1 site
 British                                                      n=50
Columbia Saskatchewan                       Quebec
  8 sites Alberta 1 site Manitoba            8 sites
                                  Ontario
  n=868 3 site n=13        1 site            n=484
                                   14 sites
           n=22            n=95     n=824
                  Patient Selection
   Consecutive patients admitted (or designated for
    admission) with a diagnosis of a non-ST segment
    elevation acute coronary syndrome (NSTE ACS):
       18 years old; AND,
       diagnosed with a NSTE ACS as defined by symptoms felt to be
        consistent with acute cardiac ischemia within 24 hours on
        symptom onset; AND,
       The qualifying acute coronary syndrome must not have been
        precipitated or accompanied by a significant co-morbidity (e.g.,
        trauma, gastrointestinal bleeding, peri-operative or peri-
        procedure MI)
          Case Selection Strategy
   First ~10 consecutive qualifying cases in
    each month
   Confirm inclusion criteria
   Patient consent for follow-up
   Enroll patient
   12-month follow-up by telephone
 Acute coronary Syndromes Strategy
for Evidence-based Risk stratification
and Treatment (ASSERT) Program (1)
   To facilitate attainment of the Registry
    objectives, the ASSERT program
    includes provision of:
       standing orders template for non-ST
        segment elevation ACS;
       poster and pocket cards summarizing an
        evidence-based approach to the initial
        management of NSTE ACS patients;
 Acute coronary Syndromes Strategy
for Evidence-based Risk stratification
and Treatment (ASSERT) Program (2)
   A PowerPoint slide set with detailed speaker’s
    notes that contains:
        Information on the “evidence-to-practice gap” and
         how we as a medical community can potentially
         close this gap;
        Some simple approaches to risk stratification that
         facilitate the choice of treatments and management
         strategies; and,
        Data from several recent clinical trials supporting an
         evidence-based medicine approach to treatment;
         and,
   A list of key references
                                           Site Number            Patient Number        Patient Initials                                         Acute
                        192                                                                                                                      Coronary
                                                                                                                                                 Syndrome
                                                                                          F     M    L                                           Registry II

                      Risk Stratification (choose only one)
                              Level        30-Day Death/MI                                    Features
                                                                   Prolonged/ongoing ischemic discomfort with high risk features: transient STelevation or ST
                               Higher           12-30%             depression 1mm in  2 leads; sustained ST depression 2mm; T wave inversion 1mm in
                                                                    5 leads; positive cardiac markers; recurrent ischemia; acute MI in past 4 weeks;
                                                                   hemodynamic compromise (e.g. heart failure or hypotension)
                                                                   Ongoing ischemic discomfort but no high risk features: crescendo angina preceding rest pain;
                               Intermediate      4-8%              borderline positive troponin; previous percutaneous coronary intervention or coronary artery
                                                                   bypass surgery; increased baseline risk (e.g. diabetes, age 60 years)

                                                                   No high risk or intermediate risk features: single episode of chest discomfort at rest, or
                               Lower             <2%               crescendo exertional angina; normal or non-specific abnormalities or unchanged from
                                                                   previous; may include patients with history of known CAD or with risk factors of CAD

                             Indications for
                           Management/Therapy                                                                                      If not given, why?
                                                                             Management/Therapy
                                                                                                                                   (Use Coding System)
                      Higher Intermediate         Lower                                                                             Primary         Secondary




 Risk Management       Ö


                       Ö
                                      Ö


                                      Ö
                                                    Ö               ASA/Aspirin

                                                                    Clopidogrel
                                                                            Medical treatment
                                                                                                              No



                                                                                                              No
                                                                                                                         Yes



                                                                                                                         Yes




Assessment (RMA)       Ö              Ö             Ö                       Post-stent              N/A       No         Yes



                       Ö              Ö                             Heparin                                   No         Yes

                       Ö              Ö                                      If Yes, LMWH                     No          Yes



portion of the Case    Ö
                       Ö              Ö              Ö
                                                                    GP IIb/IIIa Inhibitor
                                                                            Medical treatment

                                                                            PCI                     N/A
                                                                                                              No

                                                                                                              No
                                                                                                                         Yes

                                                                                                                         Yes




   Report Form         Ö

                       Ö
                                      Ö

                                       Ö
                                                    Ö
                                               if CAD is proven


                                                    Ö
                                               if CAD is proven
                                                                    Beta Blocker


                                                                    ACE Inhibitor
                                                                                                              No



                                                                                                              No
                                                                                                                         Yes



                                                                                                                         Yes


                       Ö               Ö            Ö               Statin                                    No         Yes
                                               if CAD is proven

                                                                    Referral for cardiac cath
                       Ö                                                    Immediate (£ 24 hours)            No         Yes

                                       Ö                                    In-hospital                       No        Yes


                      MD completing           Cardiologist             Internist              GP/Family MD              Emergency MD

                       Date: __________________________

                                                                                                                                     Page 4 of 4
   Risk Stratification for Non-ST ACS
                30-Day
  Level        Death/MI Features
                          Prolonged/ongoing ischemic discomfort with high risk features:
                          transient ST or ST 1 mm in 2 leads; sustained ST depression
  Higher       12-30%     2 mm; T wave inversion 1 mm in 5 leads; positive cardiac
                          markers; recurrent ischemia; acute MI in past 4 weeks;
                          hemodynamic compromise (e.g., heart failure or hypotension)
                          Ongoing ischemic discomfort but no high risk features: crescendo

Intermediate    4-8%
                          angina preceding rest pain; borderline positive troponin; previous
                          percutaneous coronary intervention or coronary artery bypass
                          surgery; increased baseline risk (e.g., diabetes, age 60 years)

                          No high risk or intermediate risk features: single episode of chest

  Lower         <2%       discomfort at rest, or crescendo exertional angina; ECG normal or
                          non-specific abnormalities or unchanged from previous; may
                          include patients with history of known CAD or with risk factors for
                          CAD


       Modified from Fitchett et al Can J Cardiol 2000;16:1423-32
                     and CMAJ 2001;164:1309-16
          Risk Management Approach
                     Evidence-Based Medicine Recommendations
      High Inter. Low
           ASA (Aspirin)
            Clopidogrel – Medical treatment
           Clopidogrel – Post-stent
            Heparin – Enoxaparin*
                                GP IIb/IIIa Inhibitor – Medical treatment+
                         GP IIb/IIIa Inhibitor – PCI++
*    Enoxaparin superior to unfractionated heparin
+    Eptifibatide or tirofiban
++   Eptifibatide or abciximab
          Risk Management Approach
                    Evidence-Based Medicine Recommendations
      High Inter. Low
          * -blocker
          * ACE inhibitor+
          * Statin++
              Cardiac cath referral – Initial 24 hours
                                Cardiac cath referral – In-hospital
*    If CAD is proven
+    In setting of LV dysfunction (EF<40%) and/or congestive heart failure (CHF): captopril, enalapril, lisinopril,
     ramipril, or trandolapril; in setting of CAD without LV dysfunction and/or CHF: ramipril
++   In setting of acute coronary syndromes (ACS): atorvastatin; in setting of post-ACS: pravastatin or simvastatin
                     Site Number            Patient Number        Patient Initials                                         Acute
  192                                                                                                                      Coronary
                                                                                                                           Syndrome
                                                                    F     M    L                                           Registry II

Risk Stratification (choose only one)
        Level        30-Day Death/MI                                    Features
                                             Prolonged/ongoing ischemic discomfort with high risk features: transient STelevation or ST
         Higher           12-30%             depression 1mm in  2 leads; sustained ST depression 2mm; T wave inversion 1mm in
                                              5 leads; positive cardiac markers; recurrent ischemia; acute MI in past 4 weeks;
                                             hemodynamic compromise (e.g. heart failure or hypotension)
                                             Ongoing ischemic discomfort but no high risk features: crescendo angina preceding rest pain;
         Intermediate      4-8%              borderline positive troponin; previous percutaneous coronary intervention or coronary artery
                                             bypass surgery; increased baseline risk (e.g. diabetes, age 60 years)

                                             No high risk or intermediate risk features: single episode of chest discomfort at rest, or
         Lower             <2%               crescendo exertional angina; normal or non-specific abnormalities or unchanged from



                                                                                                                                             Treatment/
                                             previous; may include patients with history of known CAD or with risk factors of CAD

       Indications for
     Management/Therapy                                                                                      If not given, why?
                                                       Management/Therapy
                                                                                                             (Use Coding System)


                                                                                                                                            management:
Higher Intermediate         Lower                                                                             Primary         Secondary


 Ö              Ö             Ö               ASA/Aspirin                               No         Yes




                                                                                                                                              o
                                              Clopidogrel
 Ö
 Ö
                Ö
                Ö             Ö
                                                      Medical treatment

                                                      Post-stent              N/A
                                                                                        No

                                                                                        No
                                                                                                   Yes

                                                                                                   Yes
                                                                                                                                                          If not given,
                                                                                                                                                           why? (Use
                                                                                                                                              o
 Ö              Ö                             Heparin                                   No         Yes

 Ö              Ö
                                                                                                                                                              coding
                                                       If Yes, LMWH                     No          Yes


                                              GP IIb/IIIa Inhibitor




                                                                                                                                              o
 Ö                                                    Medical treatment                 No         Yes

 Ö              Ö              Ö                      PCI                     N/A       No         Yes                                                       system):

                                                                                                                                                          oo
 Ö              Ö             Ö               Beta Blocker                              No         Yes




                                                                                                                                              oo
                         if CAD is proven


                 Ö
 Ö

 Ö               Ö
                              Ö
                         if CAD is proven

                              Ö
                                              ACE Inhibitor


                                              Statin
                                                                                        No


                                                                                        No
                                                                                                   Yes


                                                                                                   Yes
                                                                                                                                               X

                                                                                                                                              o
                         if CAD is proven

                                              Referral for cardiac cath
 Ö                                                    Immediate (£ 24 hours)            No         Yes




                                                                                                                                                          oo
                 Ö                                    In-hospital                       No        Yes


MD completing           Cardiologist

 Date: __________________________
                                                 Internist              GP/Family MD              Emergency MD




                                                                                                               Page 4 of 4
                                                                                                                                              oo
                                                                                                                                               X
            Anti-Thrombotic/Platelet Therapy*
                   in the First 24 Hours
            Non-ST (n=3,488)                      Non-ST (n=2,356)
      % of Patients                             % of Patients
100                                       100
       90                                       92.7             90.1% of LMWH =
80                                        80
                                                                    Enoxaparin
60                                        60                           61.9
                      51.7                               52.7
40                                        40
                             35.9
20                                        20                    25.8
               8.3                  4.8                                       9.9
 0                                         0
      ASA Clopid./ UFH LMWH IIb/IIIa            ASA Clopid./ UFH LMWH IIb/IIIa
          Ticlop.                                   Ticlop.

            Sept 1999 – June 2001                      Oct 2002 – May 2004
       Reasons Why Low Molecular Weight
        Heparin Has NOT Been Prescribed
General:                                          Antiplatelet/thrombotic:
1.   Allergy or intolerance                       6.    Active bleeding
2.   Renal insufficiency                          7.    Recent surgery or trauma
                                                  8.    History of bleeding
3.   Patient not high enough risk
                                                        disorder/coagulopathy
4.   Clinical trial evidence doesn’t              9.    History of prior stroke/TIA
     support use
                                                  10.   Thrombocytopenia
5.   Other safety concerns not                    11.   Anemia
     specified below
                                                  12.   Severe hypertension
                                                  13.   Treatment with warfarin


                    LMWH:
                        14.   Concomitant GP IIb/IIIa inhibitor use
                        15.   Planned invasive procedure
       Reasons Why Patients Are
         NOT Receiving LMWH
             (n=565)                     %
             Not high risk enough†      48.5
             Planned invasive procedure 16.1
             GP IIb/IIIa Inhibitor use   6.9
             Renal insufficiency         6.4
             Bleeding risk*              9.7
             Other safety concerns**    12.2
             Patient/family refused      0.4
                   † Including  clinical evidence/guidelines don’t support
* Including active bleeding, recent surgery/trauma, bleeding disorder/coagulopathy, anemia,
                                thrombocytopenia, on warfarin
        ** Including other comorbid conditions, prior stroke/TIA, severe hypertension
     Patients NOT Receiving LMWH
     Because Not High Enough Risk†
               25 % of Patients
                                                                  n=312
               20                          21.3
                         19.1
               15

               10

                5                                             6.2

                0
                       Low             Intermediate           High
      TIMI Risk Score: 0-2                  3-4                5-7
Estimated 14-day Death/MI: 2.9%          4.7-6.7%         11.5-19.4%

                 † Including clinical evidence/guidelines don’t support
        Reasons Why Clopidogrel Has NOT
                Been Prescribed
General:                               Antiplatelet/thrombotic:
1.   Allergy or intolerance            6.    Active bleeding
2.   Renal insufficiency               7.    Recent surgery or trauma
                                       8.    History of bleeding
3.   Patient not high enough risk
                                             disorder/coagulopathy
4.   Clinical trial evidence doesn’t   9.    History of prior stroke/TIA
     support use
                                       10.   Thrombocytopenia
5.   Other safety concerns not         11.   Anemia
     specified below
                                       12.   Severe hypertension
                                       13.   Treatment with warfarin
            Reasons Why Patients Are
            NOT Receiving Clopidogrel
                    (n=850)                     %
                    Not high risk enough†      65.8
                    Bleeding risk*             13.7
                    Other safety concerns**    17.1
                    Planned invasive procedure 3.8
                    GP IIb/IIIa inhibitor use   0.1
                          † Including  clinical evidence/guidelines don’t support
       * Including active bleeding, recent surgery/trauma, bleeding disorder/coagulopathy, anemia,
                                       thrombocytopenia, on warfarin
** Including other allergy/intolerance, renal insufficiency, co-morbid conditions, prior stroke/TIA, severe
                                                 hypertension
          Use of Clopidogrel £24 Hrs
             By Presenting Risk
                    % of Patients
             100

              80

              60
                         56.4           54.2
                                                   49.3
              40

              20

               0
GRACE Risk Score:        Low        Intermediate    High
                        n=688           n=688      n=688
           Anti-Thrombotic/Platelet Therapy*
                     at Discharge
            All ACS (4,518)                         Non-ST (n=2,356)
      % of Patients                            % of Patients
100                                      100

80       87.7                                     87.4
                                         80

60                                       60
                                                               53.2
40                                       40

20                    22.4               20
                                8.7                                      8.8
 0                                        0
        ASA      Clopidogrel/ Warfarin           ASA      Clopidogrel/ Warfarin
                 Ticlopidine                              Ticlopidine
           Preliminary Results


                 Medical Therapy at Discharge
      % of Patients
100

 80     81.8
                                                              75.8
 60                                           62.9

 40

                       28.3       27.6
 20

                                                        9.6                6
  0
        Beta        Calcium      Diuretic     ACE       ARB   Statin   Other lipid
       blocker      blocker                 inhibitor                   lowering
Preliminary Results



             Lipid Lowering Use
           n=2356                         %
           Any Statin                   75.8
              Atorvastatin              54.1
              Simvastatin               36.1
              Pravastatin                6.7
              Other                      3.3
           Other lipid-lowering agent     6
      Reasons Why A Statin Has NOT Been
                 Prescribed
General:                               Statin:
1.   Allergy or intolerance            29.   No hypercholesterolemia (i.e.,
                                             treatment not indicated based
2.   Renal insufficiency                     on Canadian Working Group
3.   Patient not high enough risk            recommendations
4.   Clinical trial evidence doesn’t   30.   Treatment with other lipid
     support use                             lowering agent
5.   Other safety concerns not         31.   Abnormal liver function tests
     specified below                         indicating hepatic pathology
                 Reasons Why Patients Are
                 NOT Receiving Treatment
                                                  Statin
                     (n=534)                                %
                     Patient not high risk enough*         21.2
                     No hypercholesterolemia               47.1
                     On another lipid-lowering agent       11.9
                     Allergy/Intolerant                     2.2
                     Abnormal Liver function test(s)        2.4
                     Other comorbid conditions              5.3
                     Other safety concerns                  7.5


*Including evidence or guidelines don’t support
                    Conclusions
   Registries provide unselected real world data
   ACS management frequently discordant with
    guidelines
   Management orientated registries provide
    means to
       Inform
       Close management GAP
       Improve patient outcomes

				
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