Trial - Clinical Trial Results by dffhrtcv3


									               PREMIAR Trial

Protection from Distal Embolization in High-Risk
   Patients With Acute ST-Segment Elevation
     Myocardial Infarction (PREMIAR) Trial

               Presented at
     The American College of Cardiology
          Scientific Session 2006
           Presented by Dr. F. Cura
                  PREMIAR Trial: Background

 • This was a randomized study assessing the safety, efficacy, and
   performance of the SpideRX distal protection device among
   patients with ST-elevation myocardial infarction (STEMI).

 • Hypothesis: Distal protection using the SpideRX embolic protection
   device would improve ST-segment resolution after percutaneous
   coronary intervention (PCI) for STEMI.

www. Clinical trial                       Presented at ACC 2006
                   PREMIAR Trial: Study Design
     140 patients with STEMI <12 hours, reperfusion candidate. Excluding those with:
  Cardiogenic shock, CABG or PCI within last 6 months, inadequate ECG, baseline TIMI 3 flow, small vessel <2.5 mm,
    bifurcation (side branch >2.5 mm), multivessel PCI, LMCA stenosis, tortuosity, unable to deliver stent or device.
 Over 50% with LAD as target vessel, 25% GP IIb/IIIa inhibition, use of SpideRX prolonged procedure by 10 minutes, 40-
      60% of filter patients with >1 branch proximal to the stenosis, mean age 60 years, mean follow-up 12 months.

                  Primary PCI                                 Primary PCI with SpideRX Embolic
                                                                      Protection Device
                       n=70                                                 n=70

            Primary Endpoint: Degree of ST-segment resolution by continuous Holter
             monitoring measured at 60 minutes.
            Secondary Endpoints: Core laboratory analysis of TIMI frame count, distal
             embolization, and myocardial blush; ejection fraction measured by cardiac
             ultrasound; and major adverse cardiac events (MACE) at 30 days and 12

www. Clinical trial                                                             Presented at ACC 2006
             PREMIAR Trial: Primary Endpoint

         Rate of complete ST-segment resolution at 60    • The rate of complete
                         minutes (%)                       ST-segment
                                                           resolution at 60
                                                           minutes was 61% for
                    61.0                    60.1           placebo and 60.1% in
    64                                                     the distal protection
    56                                                     patients (p=NS).
    48                                                   • Baseline
                                                           characteristics were

                                                           well matched and the
    32                                                     median time from
    24                                                     symptom onset to
    16                                                     PCI was 150
     8                                                   • Baseline TIMI flow 0-
     0                                                     1 was present in 83-
                  Placebo             SpideRX patients     85% of patients.

www. Clinical trial                             Presented at ACC 2006
        PREMIAR Trial: Secondary Endpoints

         • There were no differences found in ejection fraction or no-

         • Non-significant reductions in angiographically visible
           thrombosis or distal embolization with distal protection were

www. Clinical trial                            Presented at ACC 2006
                   PREMIAR Trial: Additional Findings

               Device success, debris recapture, and necessary
                               predilation (%)                   • The SpideRX distal
                                                                   protection device
                                                                   was used
                      94.3                                         successfully in
                                                                   94.3% of patients.
% patients

                                                                 • Debris was
              60                      48.0                         captured in 48.0%.

              40                                                 • Predilation was
                                                                   required in 12.1%.
              20                                      12.1

                     Device          Debris        Predilation
                    success        recaptured

www. Clinical trial                                    Presented at ACC 2006
                     PREMIAR Trial: Summary

 • Among patients undergoing primary PCI for ST-elevation
   MI, distal protection using the SpideRX distal protection
   filter was not associated with improvements in ST-segment
   resolution, infarct size, or MACE.

www. Clinical trial               Presented at ACC 2006

To top