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Cardiovascular disease is common in patients with chronic kidney disease (CKD) and often results in severely calcified lesions that are difficult to cross and treat. As a result, this population may have worse clinical outcomes following percutaneous coronary intervention compared to patients without CKD. Clinical trials typically exclude this patient population.
ORBIT II patients with severely calcified coronary lesions treated with the coronary Orbital Atherectomy System (OAS) were divided into three groups based on the estimated glomerular filtration rate (eGFR, mL/min/1.73m2) at baseline: I (CKD Stages 3-5), eGFR<60 (n=115); II (CKD stages 1-2), eGFR 60 to <90 (n=218); and III (normal), eGFR≥90 (n=108).
Patients in groups I and II were older (p<0.0001), and there were more females in these two groups than in group III (p=0.0468). History of previous stroke (p=0.0351) was more prevalent in groups I and II. In addition, the total length of calcium was significantly longer in group II (p=0.0003). Similar successful stent delivery occurred in 97.4%, 97.2% and 99.1% (p=0.7006) of cases with <50% residual stenosis in 99.1%, 98.2% and 99.1% (p=0.8779) of subjects in groups I, II and III, respectively. Statistically similar low rates of severe dissection (1.7%, 5.5%, 0.9%: p=0.0709), perforation (2.6%, 1.8%, 0.9%: p=0.7343), persistent slow flow (0.9%, 1.4%, 0.0%: p=0.8110), and abrupt closure (1.7%, 1.8%, 1.9%: p=1.0000) were observed in groups I, II, and III, respectively. The 30 day Freedom from MACE rates in groups I (87.8%), II (87.1%), and III (96.3%) were similar (p=0.0555).
Severely calcified coronary lesion pre-treatment with the coronary OAS resulted in similar 30 day Freedom from MACE rates and low rates of procedural complications in CKD patients compared with the non-CKD patients despite the older demographic and longer length of calcium in the CKD patients.