Author + information
- Philippe Genereux1,
- Nicolas Bettinger1,
- Arthur C. Lee2,
- Christopher Y. Kim3,
- Michael Lee4,
- Richard Shlofmitz5,
- Jeffrey W. Moses1,
- Gregg W. Stone1 and
- Jeffrey W. Chambers6
Recently the ORBIT II study demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS) in the treatment of severely calcified lesions. We sought to evaluate the impact of stent types used on the 1 and 2-year outcomes after OAS treatment.
ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites. The primary safety endpoint was 30-day major adverse cardiac events (MACE), the composite of cardiac death, myocardial infarction, or target vessel revascularization. For this study, patients were grouped according to the type of stent implanted at the level of the study lesion: bare metal stent (BMS), drug-eluting stent (DES) 1st generation, and DES 2nd generation.
Stent-type data were available in 435 patients (98.2%). Six patients were excluded because of multiple stent types implanted. Among the 429 patients analyzed, 43 (10.0%) had BMS, 74 (17.2%) had 1st generation DES, and 312 (72.7%) had 2nd generation DES. In general, BMS patients were older, had larger stented vessel diameter, and had longer index procedures compared to DES patients. At one and two years, MACE rates were numerically higher among patients treated with BMS compared to DES (Table). Importantly, rates of 1 and 2-year target lesion revascularization (TLR) were similarly and significantly lower among patients receiving DES 1st and 2nd generations compared to patients receiving BMS.
In patients with severely calcified lesions treated by OAS, adverse ischemic event rates were higher with BMS compared with DES 1st and 2nd generations at 2-year follow-up. Interestingly, first and second generation DES had similar low rates of TLR after OAS. These findings have important clinical implications for the selection of optimum treatment strategies for patients with severely calcified coronary lesions.
|1-yr Major adverse cardiac events||24.3% (10)||10.9% (8)||15.1% (47)||0.20|
|1-yr Cardiac death||2.5% (1)||4.1% (3)||1.6% (5)||0.44|
|1-yr Target vessel revascularization||15.1% (6)||2.8% (2)||5.2% (16)||0.03|
|1-yr Target lesion revascularization||15.3% (6)||1.4% (1)||3.9% (12)||0.007|
|2-yr Major adverse cardiac events||24.3% (10)||17.2% (12)||17.5% (54)||0.55|
|2-yr Cardiac death||2.5% (1)||5.8% (4)||2.7% (8)||0.45|
|2-yr Target vessel revascularization||15.1% (6)||7.7% (5)||7.0% (21)||0.18|
|2-yr Target lesion revascularization||15.3% (6)||6.3% (4)||5.0% (15)||0.047|
Kaplan-Meier rate estimate. Data are presented as % (number of subjects with event)