Original title: Pivotal Trial to Evaluate the Safety and Efficacy of the Orbital Atherectomy System in Treating de Novo, Severely Calcified Coronary Lesions (ORBIT II) Reference: Jeffrey Chambers, et al. JACC Intervention 2014;7:510-8

Severely calcified coronary lesions, traditionally associated to difficult or impossible stent implantation, asymmetric stent expansion, higher post procedural events rate, more restenosis, more lesion revascularization, and stent thrombosis, have always been an important factor to take into account. 

This is a prospective study, not randomized, multicenter, including 443 patients with novo and severely calcified lesions receiving orbital atherectomy (OAS).

Primary end point was successful stent implantation and a composite of death, infarction and revascularization at 30 days. Secondary end point was angiographic success (residual lesion <50%) and the presence of severe coronary complications (C – F dissection type, perforation, slow or no reflow, and acute thrombosis).

The left anterior descending was the most frequently intervened artery (51.6%), mean lesion length was 18 mm, and mean diameter was 3.1 mm. 88.2% of patients received DES and 11.4% conventional stents. Procedural time was 52 minutes, fluoroscopy time was 18.2 minutes and contrast volume was 174 ml.

Successful stent implantation was 97.7% (primary end point) and the composite of death, infarction and revascularization at 30 days resulted in 10.4% (non Q wave infarction, 8.8; Q wave infarction, 0.9%, cardiac death, 0.2% and vessel revascularization, 1.4%). Angiographic success (secondary end point) reached 91.4% and severe complications, 7.2%.

Conclusion

Orbital atherectomy met the primary safety and efficacy end point. Calcified lesion preparation not only helped stent implantation but also improved outcomes, compared to this group’s historical series.

Editorial Comment

Severed calcified lesion preparation has traditionally been a real challenge. OAS presented a lower periprocedural AMI rate than the published rotational atherectomy cases, around 20% in different studies, and a lower coronary vascular complications rate with better periprocedural evolution at 30 days. These new devices will surely help interventionists perform more complex angioplasty procedures, with greater safety.  

Courtesy of Dr. Carlos Fava
Interventional Cardiologist
Favaloro Foundation – Buenos Aires

Dr. Carlos Fava para SOLACI.ORG