Objective: To evaluate the safety and efficacy of pre-stent plaque debulking strategy for percutaneous coronary intervention for CTO.
Background: Drug-eluting stents (DES) reduce lesion recurrence after percutaneous coronary intervention for chronic total occlusion (CTO). However, massive plaque burden or calcified plaque sometime hinders optimal stenting. The aim of the study was to investigate the safety and the effectiveness of pre-stent plaque debulking in CTOs. The primary end-point was the angiographic restenosis rate at 6 months. Secondary end-points were the major adverse cardiac event (MACE) at 30 days and at 1 year.
Method: Between October 2000 and July 2003, 266 patients with CTOs were evaluated in 21 Japanese centers. After successful wire crossing, an operator judged the indications for a debulking strategy (177 patients for rotational and 89 for directional atherectomy). The subjects were then randomly assigned to a debulking (rotational: 90, directional: 48) or non-debulking (rotational: 87, directional: 41) group.
Result: Baseline clinical and lesion characteristics showed no differences between the groups. The debulking group tended to have the higher 30-day MACE rate than the non-debulking group (15.9% vs 8.5%, P=0.07). Although binary 6 month restenosis rates did not reach statistical significance (debulking 23.8% vs non-debulking 34.6%; P=0.072), the 1-year MACE rate was lower in the debulking group than in the non-debulking group (27.5% vs 39.8%; P=0.033).
Conclusion: This study demonstrated that pre-stent plaque debulking of CTO was associated with a favorable mid-term outcome with lower target revascularization rate in the debulking group than in the non-debulking group.