Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction
Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction
Description: The goal of the trial was to evaluate embolic protection prior to percutaneous coronary intervention (PCI) compared with PCI without embolic protection in native vessels in patients with ST-elevation myocardial infarction (STEMI).
Hypothesis: Embolic protection prior to PCI will be more effective in improving myocardial perfusion than PCI without embolic protection.
Drugs/Procedures Used: Patients were randomized to embolic protection prior to PCI (n = 312) or PCI without embolic protection (n = 314).
Principal Findings: Patients were well matched with baseline characteristics. In the embolic protection group, 81% received the FilterWire device, 13% received the SpideRx device, and in the remaining patients, distal protection could not be achieved. Thrombolysis In Myocardial Infarction (TIMI) 0 or 1 flow was present in 67% of the embolic protection group and 68% of the PCI alone group. Similarly, visible thrombus was present in 68% and 75%, respectively. For the primary outcome, complete ST-segment resolution occurred in 76% of the embolic protection group and 72% of the PCI alone group (p = 0.29). There was no difference in the primary outcome among any subgroup tested. There was no difference in the maximum level of creatine-kinase (p = 0.99), troponin T (p = 0.87), or wall motion index (p = 0.35) between the groups. There was also no difference in major adverse cardiac events (5.4% vs. 3.2%, p = 0.17), respectively for embolic protection versus PCI alone.
Interpretation: Among patients with STEMI, embolic protection prior to PCI did not reduce the incidence of complete ST-segment resolution, maximum level of cardiac enzymes, wall motion index, or major adverse cardiac events compared with PCI alone. This trial complements the earlier EMERALD trial, which failed to show that GuardWire balloon occlusion improves the myocardial circulation compared with standard PCI alone. These findings are in contradistinction to the recently published TAPAS trial, which revealed that thrombus aspiration by the Export catheter significantly improved myocardial reperfusion.
Conditions:
• Coronary heart disease / Acute MI
• Coronary heart disease
Therapies:
• Stent
• PTCA
Study Design
Randomized.
Patients Screened: 1,687
Patients Enrolled: 626
Mean Follow-Up: 30 days
Mean Patient Age: 62 years
% Female: 26%
Primary Endpoints: Rate of complete (>70%) ST-segment resolution 90 minutes after PCI detected by continuous ST-segment monitoring
Secondary Endpoints: Time to >70% ST-segment resolution, maximal cardiac biomarkers, wall motion index by echocardiography at discharge, and major adverse cardiac events
Other Design Considerations: At the time of enrollment, patients underwent a second randomization to a drug-eluting stent versus a bare-metal stent
Patient Population: STEMI within 12 hours of symptom onset with total ST-elevation of 4 mm in contiguous leads, age at least 18 years, and occluded or severely stenosed coronary artery without excessive calcification or tortuousity
Exclusions: Previous MI, left main infarct-related artery, history of gastrointestinal bleeding, pregnancy, renal failure, limited (<1 year) life expectancy, or linguistic problems
References: Presented by Dr. Leif Thuesen at the i2 Summit/American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007. Kelbaek H, Terkelsen CJ, Helqvist S, et al. Randomized comparision of distal protection versus conventional treatment in primary percutaneous coronary intervention: The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION) Trial. J Am Coll Cardiol 2008;51:899-905.
Description: The goal of the trial was to evaluate embolic protection prior to percutaneous coronary intervention (PCI) compared with PCI without embolic protection in native vessels in patients with ST-elevation myocardial infarction (STEMI).
Hypothesis: Embolic protection prior to PCI will be more effective in improving myocardial perfusion than PCI without embolic protection.
Drugs/Procedures Used: Patients were randomized to embolic protection prior to PCI (n = 312) or PCI without embolic protection (n = 314).
Principal Findings: Patients were well matched with baseline characteristics. In the embolic protection group, 81% received the FilterWire device, 13% received the SpideRx device, and in the remaining patients, distal protection could not be achieved. Thrombolysis In Myocardial Infarction (TIMI) 0 or 1 flow was present in 67% of the embolic protection group and 68% of the PCI alone group. Similarly, visible thrombus was present in 68% and 75%, respectively. For the primary outcome, complete ST-segment resolution occurred in 76% of the embolic protection group and 72% of the PCI alone group (p = 0.29). There was no difference in the primary outcome among any subgroup tested. There was no difference in the maximum level of creatine-kinase (p = 0.99), troponin T (p = 0.87), or wall motion index (p = 0.35) between the groups. There was also no difference in major adverse cardiac events (5.4% vs. 3.2%, p = 0.17), respectively for embolic protection versus PCI alone.
Interpretation: Among patients with STEMI, embolic protection prior to PCI did not reduce the incidence of complete ST-segment resolution, maximum level of cardiac enzymes, wall motion index, or major adverse cardiac events compared with PCI alone. This trial complements the earlier EMERALD trial, which failed to show that GuardWire balloon occlusion improves the myocardial circulation compared with standard PCI alone. These findings are in contradistinction to the recently published TAPAS trial, which revealed that thrombus aspiration by the Export catheter significantly improved myocardial reperfusion.
Conditions:
• Coronary heart disease / Acute MI
• Coronary heart disease
Therapies:
• Stent
• PTCA
Study Design
Randomized.
Patients Screened: 1,687
Patients Enrolled: 626
Mean Follow-Up: 30 days
Mean Patient Age: 62 years
% Female: 26%
Primary Endpoints: Rate of complete (>70%) ST-segment resolution 90 minutes after PCI detected by continuous ST-segment monitoring
Secondary Endpoints: Time to >70% ST-segment resolution, maximal cardiac biomarkers, wall motion index by echocardiography at discharge, and major adverse cardiac events
Other Design Considerations: At the time of enrollment, patients underwent a second randomization to a drug-eluting stent versus a bare-metal stent
Patient Population: STEMI within 12 hours of symptom onset with total ST-elevation of 4 mm in contiguous leads, age at least 18 years, and occluded or severely stenosed coronary artery without excessive calcification or tortuousity
Exclusions: Previous MI, left main infarct-related artery, history of gastrointestinal bleeding, pregnancy, renal failure, limited (<1 year) life expectancy, or linguistic problems
References: Presented by Dr. Leif Thuesen at the i2 Summit/American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007. Kelbaek H, Terkelsen CJ, Helqvist S, et al. Randomized comparision of distal protection versus conventional treatment in primary percutaneous coronary intervention: The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION) Trial. J Am Coll Cardiol 2008;51:899-905.