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Planned rotational atherectomy safe for patients with severe calcified lesions
In patients with severely calcified coronary lesions, planned rotational atherectomy appears to be a safe treatment strategy, yielding reduced procedural and fluoroscopy times and the number of predilation balloon catheters used compared with provisional atherectomy, according to findings from the ROTATE multicenter registry.
Researchers evaluated 718 consecutive patients with calcified lesions who underwent rotational atherectomy at eight institutions between April 2002 and August 2012. Eligible participants had native coronary disease treated with bare-metal stents, first-generation drug-eluting stents or second-generation DES. Patients were stratified into two subcategories: planned rotational atherectomy (n = 358) and provisional rotational atherectomy (n = 309). Rotational atherectomy procedures were performed using the Rotablator system (Boston Scientific).
The researchers defined planned rotational atherectomy as initial treatment without prior device failure. Provisional rotational atherectomy was defined as the use of rotational atherectomy after any device failure, such as incomplete balloon expansion or the failure to cross a lesion with any device.
The primary endpoint was the incidence of in-hospital MACE. Secondary endpoints were MACE at 1-year follow-up and procedural endpoints, including total number of balloon catheters used, procedure and fluoroscopy times, and total amount of contrast medium used.
The researchers observed no significant differences between planned or provisional rotational atherectomy in in-hospital NACE, but propensity score adjustment revealed a trend toward better outcomes in the planned rotational atherectomy group (unadjusted OR = 0.76; 95% CI, 0.44-1.31; adjusted OR = 0.59; 95% CI, 0.33-1.05). The planned rotational atherectomy group had a 6.7% rate of in-hospital MI vs. 8.4% in the provisional rotational atherectomy group, with no significant differences between groups (unadjusted OR = 0.78; 95% CI, 0.44-1.39; unadjusted OR = 0.65; 95% CI, 0.35-1.2).
The number of postdilation balloon catheters used was similar between the two groups (1.12 ± 0.43 with planned rotational atherectomy vs. 1.1 ± 0.44 with provisional rotational atherectomy; P = .65), but the number of predilation balloon catheters used was significantly lower with planned rotational atherectomy (1.17 ± 0.6 vs. 1.47 ± 0.76; P < .001). Both procedures achieved final TIMI 3 flow in more than 99% of patients. Compared with patients treated with provisional rotational atherectomy, those treated with planned rotational atherectomy had decreased procedure time (65.2 ± 36.8 minutes vs. 84.4 ± 43.1 minutes; P < .001), fluoroscopy time (33.1 ± 22.9 minutes vs. 51.2 ± 29.6 minutes; P < .001) and contrast volume (232.9 ± 141.6 mL vs. 302.9 ± 150.3 mL; P < .001).
In the unadjusted population at 1 year, the planned rotational atherectomy group had a significantly higher incidence of MACE vs. the provisional rotational atherectomy group (unadjusted HR = 1.78; 95% CI, 1.16-2.74). However, these differences were attenuated after propensity-score adjustment (adjusted HR = 1.44; 95% CI, 0.92-2.26).
“The planned [rotational atherectomy] strategy appears to be safe and be associated with a reduction in procedural and fluoroscopy times, and the number of predilation balloon catheters used compared to the provisional [rotational atherectomy] group,” the researchers wrote. “If there is a high likelihood for the requirement of [rotational atherectomy], a planned [rotational atherectomy] approach may be beneficial, and operators should have a low threshold to adopt this as the default option.” – by Jennifer Byrne
Disclosure: One researcher reports serving on a Medtronic advisory board.