Coronary Rotational ATherectomy Elective Versus Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure: Long-Term Outcomes of CRATER Trial.

BACKGROUND

Although rotational atherectomy (RA) has been proven to be a useful tool for severely calcified lesions in patients with chronic kidney disease (CKD), there is a paucity of data comparing an elective RA (E-RA) versus a bailout RA (B-RA) strategy.

AIMS: To compare the long-term outcomes between E-RA versus B-RA in patients with CKD.

METHODS

This prospective, multicentre, randomized study compared E-RA versus B-RA in severely calcified lesions in patients with CKD. Participants were randomized 1:1 and clinically followed. The primary endpoint was major cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR) or stent thrombosis.

RESULTS

124 patients (62 per group) were enrolled and followed up for a median of 4.2 [3.4-5.3] years. Mean age was 77.3 ± 8.3 years; 69.4% were male. There were no baseline differences between groups. There were no differences in MACE (B-RA: 23.3% vs E-RA: 21.3%; log-rank p = 0.97), death (B-RA: 36.7% vs E-RA: 41.0%; log-rank p = 0.53), cardiovascular death (B-RA: 8.3% vs E-RA: 9.8%; log-rank p = 0.71) and MI during long-term follow-up between E-RA and B-RA strategies. There was a non-significant trend toward fewer TVR events (HR: 0.69; 95% CI: 0.19-2.44; p = 0.56) and TLR events (HR: 0.51; 95% CI: 0.13-2.06; p = 0.35) in the E-RA group.

CONCLUSIONS

Both E-RA and B-RA showed a high rate of clinical events in the long-term follow-up, consistent with a high-risk population. A non-significant trend toward lower rates of TVR and TLR was observed in E-RA group.