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Coronary Artery Disease continues to be a widespread and growing problem worldwide. Performing PCI on calcified lesions can lead to higher MACE rates and stent under expansion/malapposition. The Orbit I trial was conducted to evaluate the safety and performance of the Diamondback 360 Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, MN, USA) for the treatment of calcified coronary lesions.
From May 2008 to July 2008, 33 patients were enrolled in ORBIT I study based on several criteria, including a de novo, coronary lesion with stenosis ≥50% and ≤100% and at least one quadrant of calcification via IVUS. The patients were treated with OAS prior to stent placement. The patients were followed for 36 months at Care Institute of Medical Sciences, Ahmedabad, India to evaluate the MACE rate.
Of the 33 patients, 90.90% (n=30/33) were males with an average age of 54.9 years. The ACC/AHA lesion class was: Type A 6.06% (n=2/33); Type B1 33.33% (n=11/33); Type B2 60.60% (n=20/33). The % diameter stenosis was 85.75%; lesion length was 15.90 mm. The procedural success was 97% (32/33) with one case where IVUS/device was not able to cross the lesion due to severe calcification. All stents were successfully deployed with 0.3% ± 1.8% residual stenosis. The observed MACE rate was as follows: in-hospital 6.06% (n=2/33); 30 days 9.09% (n=3/33); 6 months 12.12% (n=4/33); 24 months 15.15% (n=5/33); and 36 months 18.18% (n=6/33). MACE rate comprised of 2 patients with a non Q-wave MI in-hospital; one patient with non Q-wave MI at 30 days that led to TLR; and one patient with cardiac death at 6 months, 24 months and 36 months, respectively.
This case series demonstrates that OAS safely and effectively modified calcified lesions and facilitated stent delivery in this difficult-to-treat plaque morphology, which continues up to three years post index procedure.
- 2013 American College of Cardiology Foundation