Diver CE versus Guardwire Plus for thrombectomy in patients with inferior myocardial infarction: a trial of aspiration of thrombus during primary angioplasty for inferior myocardial infarction.

BACKGROUND: Different feasible and safe thrombectomy and distal protection devices have been used in clinical practice. The efficiency and safety of adjunct thrombectomy using Diver CE device (Invatec, Italy) versus Guardwire Plus device (Medtronic, USA) before percutaneous coronary intervention (PCI) were compared in patients with acute inferior ST-segment-elevation myocardial infarction (STEMI) for less than 12 hours, thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, and total occlusion of the proximal right coronary artery (= 3 mm in diameter) in a prospective randomized single-center study.

METHODS: The primary end point was the magnitude of ST-segment resolution (STR) (> 70%) measured immediately, 90 minutes and 6 hours after PCI, myocardial blush grade and slow flow or no-reflow. Secondary end points were left ventricular end-diastolic volume (LVEDV), left ventricle ejection fraction (LVEF) and major adverse cardiac events (MACEs) including death, myocardial infarction, target vessel revascularization and stroke at 30 days.

RESULTS: A total of 122 patients were equally divided into Diver CE group and Guardwire Plus group, which were comparable by age ((60 +/- 14) years vs (60 +/- 13) years), male (82% vs 84%), diabetes (31% vs 28%), previous coronary artery disease (25% vs 23%), onset-to-angiogram ((350 +/- 185) min vs (345 +/- 180) min), and use of glycoprotein IIb/IIIa inhibitor (11% vs 13%). The magnitude of ST-segment resolution was similar in the two groups as ST-segment resolution > 70% (57% vs 59%; P > 0.05). Similar slow flow/no-reflow rates were observed in the Diver CE group (8%) and the Guardwire Plus group (7%). TIMI flow grade 3 was obtained in 95% vs 97% patients, respectively (P > 0.05). Myocardial blush grade 3 was similar (70% vs 72%; P > 0.05). Thirty-day clinical outcome was comparable (LVEF, 0.54 +/- 0.12 vs 0.53 +/- 0.11; death, 3% vs 3%; myocardial infarction, 2% vs 0%; and target vessel revascularization, 2% vs 2%; P > 0.05, respectively).

CONCLUSIONS: Removal of thrombus burden with the Diver CE catheter before stenting leads to similar improvement of myocardial reperfusion in patients with inferior STEMI and total occlusion of the proximal right coronary artery (= 3 mm in diameter) compared with the Guardwire Plus device, as illustrated by a reduced risk of distal embolization and improved ST-segment resolution.