Author + information
- Evan Shlofmitz1,
- Michael Lee2,
- Brad Martinsen3,
- Ann Behrens3,
- Joseph Puma4,
- Richard Shlofmitz5 and
- Jeffrey Chambers6
- 1Cardiovascular Research Foundation, New York, New York, United States
- 2UCLA Medical Center, Los Angeles, California, United States
- 3Cardiovascular Systems, Inc., St. Paul, Minnesota, United States
- 4Mount Sinai Beth Israel, New York, New York, United States
- 5St. Francis Hospital, Roslyn, New York, United States
- 6Metropolitan Cardiology Consultants, Minneapolis, Minnesota, United States
Direct stenting (DS) offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the impact of DS after treatment with the Diamondback 360° Coronary Orbital Atherectomy System (CSI, St. Paul, MN).
ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with de novo severely calcified coronary lesions. At operator discretion, DS was utilized in 255 patients (57.6%). In this post-hoc sub-analysis we compared the procedural outcomes and 3-year MACE rate comparing patients treated with pre-stent balloon dilatation (PB) versus DS after orbital atherectomy (OA).
There were no differences in terms of gender, diabetes, renal function, and lesion location in PB and DS groups; ACC/AHA lesion classification distribution was different however, with more Type C lesions in the PB group. Total OA run time was significantly longer in the PB group (80.8 vs. 57.0 seconds; p<0.0001) and the post-OA MLD was significantly smaller in the PB group (1.2 vs. 1.3 mm; p=0.0001). Procedural success was significantly worse in patients with PB compared to those treated with DS (84.2% vs. 93.3%; p= 0.0035), driven primarily by increased in-hospital MI in patients treated with PB (14.7% vs. 5.9%; p=0.0026). Angiographic success was worse in the PB cohort (88.7% vs. 95.3%; p=0.0142) as a result of increased incidence of the composite of severe angiographic complications (10.2% vs. 4.3%; p=0.0194). No specific complication however was determined to be significantly different between the two subgroups. At 3-year follow-up, MACE occurred more frequently in patients treated with PB (29.9% vs. 19.1%; p=0.006) [Figure 1], driven by clinically significant MI (4.5% vs. 0.4%; p=0.0042) and TLR (11.5% vs. 5.1%; p=0.0176).
The use of OA facilitates DS and is associated with a high procedural success rate with low procedural complications. The favorable outcome of DS after OA is sustainable at 3-year follow-up. Comparative randomized studies are needed to assess the optimal strategy after OA.
CORONARY: Atherectomy (excluding thrombectomy)