BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7994179 · Received October 23, 2018

    Report

    Report Number
    9612164-2018-02870
    Event Type
    Death
    Date Received
    October 23, 2018
    Date of Event
    March 17, 2017
    Report Date
    October 23, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF PUBLICATION JOURNAL ARTICLE: COMPARISON OF 5-YEAR OUTCOMES OF PACLITAXEL-ELUTING AND ENDEAVOR ZOTAROLIMUS-ELUTING STENTS IN NEW YORK FENG QIAN,* MD, PHD , YE ZHONG, MD, MS, AND EDWARD L. HANNAN, PHD CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 91:9¿16 (2018) C 2017 WILEY PERIODICALS, INC. DOI: 10.1002/CCD.27000. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OBJECTIVES: TO EVALUATE LONG-TERM OUTCOMES IN PATIENTS UNDERGOING EITHER PACLITAXELELUTING STENTS (PES) OR ENDEAVOR ZOTAROLIMUS-ELUTING STENTS (E-ZES) PLACEMENT AND TO ASSESS COMPARATIVE EFFECTIVENESS OF PES VS. E-ZES IN DIFFERENT ¿OFF-LABEL¿ AND ¿HIGHRISK¿ PATIENT SUBGROUPS. BACKGROUND: PES AND E-ZES ARE FREQUENTLY USED IN PERCUTANEOUS CORONARY INTERVENTIONS (PCIS). HOWEVER, THE LONG-TERM COMPARATIVE EFFECTIVENESS OF PES VS. E-ZES IN REAL PRACTICE IS UNKNOWN. METHODS: WE CREATED A LONGITUDINAL DATABASE BY LINKING THE NEW YORK STATE (NYS) CARDIAC REGISTRIES, THE NYS HOSPITAL DISCHARGE FILE, THE NATIONAL DEATH INDEX, AND THE U.S. CENSUS FILE FOR PATIENTS UNDERGOING EITHER PES OR E-ZES PLACEMENT FROM JULY 2008 THROUGH DECEMBER 2009. ALL-CAUSE MORTALITY, ACUTE MYOCARDIAL INFARCTION (AMI), TARGET LESION PCI (TLPCI), AND TARGET VESSEL CORONARY ARTERY BYPASS GRAFT (TVCABG) SURGERY WERE COMPARED FOR 9 ,264 PROPENSITY SCORE MATCHED PATIENTS FOR A 5-YEAR FOLLOW-UP PERIOD USING THE KAPLAN-MEIER METHOD WITH FURTHER ADJUSTMENT USING COX PROPORTIONAL HAZARDS REGRESSION. RESULTS: WE DID NOT DETECT SIGNIFICANT DIFFERENCES BETWEEN E-ZES AND PES (REFERENCE) IN 5-YEAR MORTALITY (ADJUSTED HAZARD RATIO <(><<)>AHR>: 1.02, 95% CONFIDENCE INTERVAL <(><<)>CI>: 0.91¿1.14), AMI (AHR: 1.05, 95% CI: 0.90¿1.22), TLPCI (AHR: 0.99, 95% CI: 0.86¿1.13), AND TVCABG (AHR, 1.07, 95% CI: 0.84¿1.36). FOR SIX ¿OFF-LABEL¿ AND TWO ¿HIGH-RISK¿ SUBPOPULATIONS, WE HAD SIMILAR FINDINGS FOR THE TWO STENT GROUPS. CONCLUSION: NYS OBSERVATIONAL DATA SUGGEST THAT 5-YEAR OUTCOMES ARE COMPARABLE IN PATIENTS RECEIVING EITHER PES OR E-ZES PLACEMENT, MIRRORING THE FINDINGS OF RECENT CLINICAL TRIALS. THE FINAL STUDY POPULATION INCLUDED 4,632 1:1 PROPENSITY MATCHED PAIRS OF PATIENTS WHO RECEIVED PES ORE-ZES PLACEMENT FROM JULY 1, 2008 THROUGH DECEMBER 31, 2009. THIS GROUP WAS DERIVED FROM THE INITIAL STUDY SAMPLE CONSISTING OF 4,886 PATIENTS RECEIVING PES AND 9,190 PATIENTS RECEIVING E-ZES. THE MATCHED PATIENTS¿ DEMOGRAPHICS, SOCIOECONOMIC STATUS, PREPROCEDURE RISK FACTORS, VESSEL/LESION INFORMATION, AND HOSPITAL LEVEL AND PHYSICIAN LEVEL FACTORS ARE PRESENTED IN TABLE I. AS EXPECTED, THE DISTRIBUTIONS WERE VERY COMPARABLE BETWEEN PES AND E-ZES GROUPS. APPROXIMATELY 75% OF THE PATIENTS WERE FROM 55 TO 85 YEARS OLD. ONE THIRD OF PATIENTS WERE FEMALE AND ABOUT TWO THIRDS WERE NON- HISPANIC WHITES. A TOTAL OF 35% OF THE PATIENTS HAD PUBLIC INSURANCE (MEDICARE, 31%; MEDICAID, 4%) AND A MAJORITY HAD PRIVATE INSURANCE (61%). ABOUT 73% OF THE PATIENTS DID NOT HAVE MYOCARDIAL INFARCTION FROM SYMPTOM ONSET TO PCI. FOR COMORBIDITIES, DIABETES (32%) WAS QUITE COMMON. APPROXIMATELY 32% HAD PREVIOUS PCI AND 16% HAD PREVIOUS CABG SURGERY. OVER 70% HAD LVEF GREATER THAN 50% AND FOUR FIFTHS WERE EITHER OVERWEIGHT OR OBESE (I.E., BMI>25). IN ADDITION, OVER 86% OF PATIENTS HAD ONE OR TWO VESSELS DISEASED, NEARLY 4% HAD THE LEFT MAIN DISEASE, AND ALMOST ONE THIRD RECEIVED MULTIPLE STENTS DURING THE INDEX ADMISSION. AFTER ADJUSTING PROPENSITY MATCHED PAIRS OF PATIENTS FOR FURTHER DIFFERENCES IN PATIENT LEVEL RISK FACTORS, THERE WERE NO SIGNIFICANT DIFFERENCES IN ADJUSTED 5-YEAR PRIMARY AND SECONDARY OUTCOMES. E-ZES VS. PES ALL-CAUSE MORTALITY: ADJUSTED HAZARD RATIO <(><<)>AHR>, 1.02, 95% CONFIDENCE INTERVAL <(><<)>CI>, 0.91¿1.14, P50.76; AMI: AHR, 1.05, 95% CI, 0.90¿1.22, P50.56; TLPCI: AHR, 0.99, 95% CI, 0.86¿1.13, P50.82; TVCABG: AHR, 1.07, 95% CI: 0.84¿1.36, P50.61). THESE SUGGEST THAT AT 5 YEARS, PES AND E-ZES HAVE VERY COMPARABLE ALL-CAUSE MORTALITY, AMI, TLPCI, AND TVCABG RATES. OVERALL, WE HAD SIMILAR FINDINGS FOR ALL SIX ¿OFF-LABEL¿ AND TWO ¿HIGH-RISK¿ SUBGROUPS (SEE SUPPORTING INFORMATION EXCEPT THAT FOR PATIENTS OVER 75 YEARS OLD, PATIENTS RECEIVING E-ZES WERE MORE LIKELY TO HAVE TVCABG SURGERY DURING THE 5-YEAR FOLLOW-UP PERIOD (AHR: 2.02, 95% CI: 1.02-4.01, P50.04).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838396 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death