Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial

Abstract Background There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. Objectives We performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter vs. antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. Methods The primary endpoints were: the time required to cross the chronic total occlusion or abort the procedure, and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were: technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment utilization. Results Between 2015 and 2017, 246 patients were randomized to CrossBoss (n=122) or wire escalation (n=124) at 11 US centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively and were similar in the two groups. Crossing time was similar: 56 (interquartile ranges: 33, 93) min in the CrossBoss and 66 (36, 105) min in the wire escalation group (p=0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%, p=1.000). There were no significant differences in the secondary study endpoints. Conclusions As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates and similar equipment utilization and cost.