Distal embolic protection during percutaneous coronary intervention in patients with acute coronary syndromes: the RUBY study.

OBJECTIVE

To assess the safety and feasibility of the GuardWire system as an embolic protection device during percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS).

BACKGROUND

Distal embolization occurs in approximately 15% of patients after primary angioplasty and is associated with reduced myocardial reperfusion, more extensive myocardial damage and a poor prognosis. Distal embolic protection could reduce the rate of embolic complications and improve outcome.

METHODS

329 patients (mean age 60+/-12 years) were included: 278 (84.5%) with ST-elevation myocardial infarction (STEMI), 50 (15.2%) with unstable angina/non-STEMI and 1 (0.3%) with post-infarction angina. Primary endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints were the magnitude of ST-segment resolution at 90 and 180 min post-procedure, myocardial blush grade, and angiographically visible distal emboli.

RESULTS

The GuardWire system was successfully positioned in 99% of patients. Complete ST-elevation resolution (>70%) was observed in 28.5% immediately post-procedure, and in 35.4% and 41.6% at 90 and 180 min post-procedure. TIMI-3 flow grade was achieved by 89.8% of patients after intervention and mean corrected TIMI frame count was 20.2+/-13.2. Grade-3 myocardial blush was seen in 47.7% of patients and distal emboli were angiographically visible in 7.4%. Incidence of MACE at 30 days was 3.3% (death 1.2%; Q-wave MI 0.3%; non-Q-wave MI 0.3%; coronary artery bypass graft 0.6%; repeat PCI 0.9%).

CONCLUSION

The GuardWire system was successfully positioned in nearly all patients without complications. The use of this embolic protection device in ACS patients undergoing PCI was associated with low rates of distal embolization and 30-day MACE.