Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Abstract

Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.

Rotational atherectomy before paclitaxel‐eluting stent implantation in complex calcified coronary lesions: Two‐year clinical outcome of the randomized ROTAXUS trial

“…Finally, it is important to mention that the current study reports a higher rate of TLR in comparison to data of two recently published large‐scale analyses in the field of coronary calcification, the 1‐year results from the ORBIT II trial and the pooled analysis of the HORIZONS‐AMI and ACUITY studies on ischemic outcomes after coronary intervention of calcified vessels . These differences in outcome could be partially explained by differing treatment strategies and follow‐up procedures among the three studies.…”

Long-term effects of rotational atherectomy in patients with heavy calcified coronary artery lesions: a single-centre experience

“…Similarly, abrupt closure occurred in Table 4. Univariate analysis of factors influencing the incidence of major adverse cardiac events (MACE) and major cardiac and cerebrovascular events (MACCE) after rotational atherectomy procedure CABG -coronary artery bypass grafting; CI -confidence interval; COPD -chronic obstructive pulmonary disease; DAPT -dual antiplatelet therapy; GFR -glomerular filtration rate; HR -hazard ratio; IVUs -intravascular ultrasound; LVEF -left ventricular ejection fraction; OACoral anticoagulation; PCI -percutaneous coronary intervention; RCA -right coronary artery; TIA -transient ischaemic attack 0.9% of individuals after the use of OA, and in 1.8%, after the procedure, compared with rates from 1% to 4% from other studies that reported abrupt closure during RA [11,12]. Perforations occurred in 0.9% of patients after the use of OA and in 1.8% after the procedure, compared with 0.4% to 2.5% in RA studies reporting on this complication [15].…”

“…Perforation rates of 0% to 1.5% have been reported with high-speed RA, and they differ based on technique [15]. The ORBIT II trial had among the lowest rates of this complication [11]. Similarly, abrupt closure occurred in Table 4.…”

“…Treatment of challenging calcified lesions often leads to increased MACE rates. The ORBIT II trial reported the successful stent delivery in 97.7% of the included patients and residual stenosis < 50% in 98.6% with a low angiographic complication rate [11,12]. The incidence of slow-flow and no-reflow was notably very low, occurring in < 1% of patients.…”

Patients with acute myocardial infarction and severe target lesion calcifications undergoing percutaneous coronary intervention have poor long-term prognosis

“…OA, a newcomer to coronary interventions, was first introduced in coronary arteries in 2013 in the ORBIT I trial [23]. Recent studies showed promising results of OA in hospital as well as in long-term follow-up [24,25]. On the other hand, manufacturers of both devices included thrombus-containing lesions as a contraindication to the procedure.…”