DRUGELUTING STENT USE IN CORONARY INTERVENTION FOR ACUTE STELEVATION MYOCARDIAL INFARCTION IS ASSOCI

1
DRUG-ELUTING STENT USE IN CORONARY INTERVENTION
FOR ACUTE ST-ELEVATION MYOCARDIAL INFARCTION IS
ASSOCIATED WITH REDUCED MORTALITY OVER BARE METAL
STENTS A STATEWIDE REGISTRY STUDY

• TUDOR D. VAGAONESCU , MD, PhD,
• ABEL E. MOREYRA, MD,
• ALAN C. WILSON, PhD,
• NORA M. COSGROVE, RN,
• JOHN B. KOSTIS, MD
• ON BEHALF OF THE
• MIDAS INVESTIGATORS

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• BACKGROUND
• PERCUTANEOUS CORONARY INTERVENTION (PCI) IS THE
  METHOD OF CHOICE TO RE-ESTABLISH CORONARY FLOW IN
  ACUTE MYOCARDIAL INFARCTION (AMI).
• CURRENT DISAGREEMENT OVER CLAIMED BENEFIT OF
  DRUG-ELUTING STENTS (DES) OVER BARE METAL STENTS
  (BMS) IN REDUCING DEATH/MI.
• RANDOMIZED TRIAL, META-ANALYSES AND REGISTRY DATA
  GIVE CONFLICTING RESULTS.

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• DESIGN
• STUDY PATIENTS WITH AMI ENROLLED IN THE (MIDAS)
  MYOCARDIAL INFARCTION DATA ACQUISITION SYSTEM
  REGISTRY
• MIDAS CONTAINS SOCIODEMOGRAPHIC AND CLINICAL DATA
  ON PATIENTS WHO WERE DISCHARGED WITH THE
  DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION (AMI)
  FROM ALL NONFEDERAL ACUTE CARE HOSPITALS IN NEW
  JERSEY LINKED TO DEATH REGISTRATION RECORDS.
• WE IDENTIFIED AMI AND STENTS BY ICD-9 DIAGNOSIS
  CODES (410.X1) AND PROCEDURE CODES (36.0X)
• INTERNATIONAL CLASSIFICATION OF DISEASES, 9TH
  REVISION, CLINICAL MODIFICATION

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• METHODS
• STUDY PATIENTS UNDERWENT INDEX PCI WITH SINGLE
  TYPE STENT (BMS OR DES)
• IN THE SETTING OF AN ACUTE ST-ELEVATION (NO
  410.71) MYOCARDIAL INFARCTION (STEMI).
• THREE YEARS FOLLOW UP COMPARING MORTALITY (ALL
  CAUSE AND CARDIOVASCULAR)

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• METHODS
• THE ANALYSIS INCLUDED AMI PATIENTS WITH STENTS
  IMPLANTED DURING PCI IN THE YEARS 2003 AND 2004
• 11,972 INDEX PCI PATIENTS WERE IDENTIFIED
• 5588 STEMI
• 5804 NSTEMI (SUBENDOCARDIAL, 410.71)
• 580 Other and Unspecified by ICD code
• DATA ON SURVIVAL WERE OBTAINED BY MATCHING THE
  MIDAS RECORDS WITH THE NEW JERSEY DEATH
  REGISTRATION FILES.

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• METHODS
• STATISTICAL ANALYSIS WAS PERFORMED USING VERSION
  9.13 SAS SOFTWARE (SAS INSTITUTE).
• KAPLAN-MEIER CURVES AND LOG RANK STATISTICS WERE
  COMPUTED BY THE LIFETEST PROCEDURE FOLLOW UP WAS
  CENSORED AT 3 YEARS AFTER DISCHARGE FOLLOWING
  STENT PLACEMENT.
• ADJUSTED COX HAZARD RATIOS WERE COMPUTED USING
  THE PROPORTIONAL HAZARDS REGRESSION PROCEDURE
  (PHREG) ADJUSTMENT WAS MADE FOR AGE, SEX, RACE,
  DIABETES, HYPERTENSION, RENAL DISEASE, ANEMIA,
  CANCER, CEREBROVASCULAR DISEASE, PRIOR AMI, USE
  OF Gp2B3A, TRANSFUSION, AND TYPE OF STENT USED
  (BMS OR DES).

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BASELINE CHARACTERISTICS DEMOGRAPHICS
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BASELINE CHARACTERISTICS COMORBIDITIES
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BASELINE CHARACTERISTICS TYPE OF MI
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BASELINE CHARACTERISTICSIN-HOSPITAL
COMPLICATIONS OF ACUTE MI
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ALL CAUSE MORTALITY AT THREE YEAR FOLLOW UP
91.5 87.0
OVERALL SURVIVAL (Proportion)
Log Rank plt.0001 Cox H.R. (adj.) 0.68
(0.57-0.81) plt.0001
N at Risk BMS 3190 2901
2834 2025 DES
2398 2261 2003
521 1 YEAR 2 YEARS
3 YEARS
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CARDIOVASCULAR MORTALITY AT THREE YEAR FOLLOW UP
94.7 91.8
OVERALL SURVIVAL (Proportion)
Log Rank plt.0001 Cox H.R. (adj.) 0.69
(0.55-0.87) p0.0012
N at Risk BMS 3190 2901
2834 2025 DES
2398 2260 2003
521 1 YEAR 2 YEARS
3 YEARS
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Summary of Survival Analysis Results(Adjusted
Cox H.R. for DES)STEMI
ADJUSTMENT WAS MADE FOR AGE, SEX, RACE,
DIABETES, HYPERTENSION, RENAL DISEASE, ANEMIA,
CANCER, CEREBROVASCULAR DISEASE, PRIOR AMI, USE
OF Gp2B3A, , TRANSFUSION, TYPE OF STENT (DES OR
BMS) USED
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CONCLUSIONS

• MIDAS DATA RECORDS FROM 2003 and 2004 SHOW THAT
  THE USE OF DRUG-ELUTING STENTS IN THE SETTING OF
  ST-ELEVATION MYOCARDIAL INFARCTION WAS
  SIGNIFICANTLY ASSOCIATED WITH REDUCTIONS OF
  3-YEAR ALL CAUSE AND CARDIOVASCULAR MORTALITY
  OVER BARE METAL STENTS.

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STUDY LIMITATIONS

• OBSERVATIONAL STUDY USING ADMINISTRATIVE DATA.
• THERE MAY BE UNMEASURED CONFOUNDING FACTORS THAT
  CONTRIBUTE TO THE PRESENT FINDINGS.
• POSSIBLE CONFOUNDERS INCLUDE
• UNKNOWN BASELINE DIFFERENCES BETWEEN THE PATIENT
  GROUPS, e.g. SELECTION BIAS
• UNKNOWN DIFFERENCES IN MEDICAL MANAGEMENT
• INCLUDING UNKNOWN DIFFERENCES IN DURATION OF DUAL
  ANTI-PLATELET THERAPY.

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STUDY STRENGTHS

• POPULATION BASED STUDY INCLUDING ALL NJ AMI
  ADMISSIONS WITHOUT EXCLUSION.
• OVER 11,000 SINGLE STENT PCI INCLUDED.
• ALL PCI INCLUDED REGARDLESS OF SUCCESS OR FAILURE
  OF REVASCULARIZATION.
• PARALLEL ANALYSIS OF DES vs BMS USE IN THE SAME
  TIME PERIOD (2003 AND 2004). CONTEMPORARY
  ANALYSIS RATHER THAN COMPARING DES WITH
  HISTORICAL CONTROLS FOR BMS).