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The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

ABSTRACT: Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective.In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (? 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: NCT01092426] were indirectly compared with similar patients using observational data. For the index procedure, the comparison was with Medicare data, and for both revascularization and cardiac death in the following year, the comparison was with a pooled analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI)/Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trials. After adjusting for differences in age, gender, and comorbidities, the ORBIT II mean index procedure costs were 17% (p < 0.001) lower, approximately US$2700. Estimated mean revascularization costs were lower by US$1240 in the base case. These cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings. Even in the low-value scenario, the use of the OAS is cost-effective with a cost per life-year gained of US$11,895.Based on economic modeling, the recently approved coronary OAS device is projected to be highly cost-effective for patients who undergo PCI for severely calcified lesions.

SUBMITTER: Chambers J

PROVIDER: S-EPMC4873729 | biostudies-other | 2016 Apr

REPOSITORIES: biostudies-other

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The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

Chambers Jeffrey J Généreux Philippe P Lee Arthur A Lewin Jack J Young Christopher C Crittendon Janna J Mann Marita M Garrison Louis P LP

Therapeutic advances in cardiovascular disease 20151223 2

<h4>Background</h4>Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective.<h4>Methods and results</h4>In the absence of a head-to-he ...[more]

PMID: 26702147

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Project description:BackgroundOrbital atherectomy (OA) is a known alternative to other atherectomy devices. However, some complex patient demographics (eg, left ventricular ejection fraction <25%) were excluded from the first-in-human trial (ORBIT I) and the pivotal FDA device approval trial (ORBIT II) which evaluated the safety and efficacy of OA in severely calcified de novo coronary lesions. This single-operator cohort study aimed to examine the impact of OA on a real-world complex Veterans Affairs patient subset.MethodsRetrospective analysis was completed on 40 consecutive patients with severely calcified coronary lesions who underwent OA prior to drug-eluting stent placement at the Atlanta Veterans Affairs Medical Center from January 2015 to June 2017.ResultsOrbital atherectomy plus drug-eluting stent placement was successful in all 40 cases. Chocolate focal force balloon angioplasty was the most commonly used post-atherectomy balloon (N = 34, 85%). Few complications were observed, including one case (2.5%) of perforation and one case (2.5%) of no-reflow. Neither acute stent thrombosis nor emergent coronary artery bypass grafting was observed. The intravascular ultrasound (IVUS)-determined median [IQR] pre-procedure minimum lumen area and post-procedure minimum stent area (MSA) were 2.8 [2.2, 3.0] mm2 and 8.7 [7.7, 10.0] mm2, respectively (P < 0.0001, Mann-Whitney test). Major adverse cardiovascular events, including all-cause mortality, at 30 days and at a median [IQR] follow-up of 197.5 [35.5, 461.3] days, was 5% and 10%, respectively. During that period, one target vessel revascularization (2.5%) was observed.ConclusionsThis study indicates that OA is a useful tool in performing high-risk percutaneous coronary intervention effectively in VA patients with severely calcified coronary lesions. OA plaque modification in combination with a high utilization rate of IVUS and Chocolate focal force angioplasty facilitates stent delivery and optimal stent expansion, resulting in a large MSA.

Project description:Background Severely calcified coronary lesions with reduced left ventricular (LV) function result in worse outcomes. Atherectomy is used in treating such lesions when technically feasible. However, there is limited data examining the safety and efficacy of atherectomy without hemodynamic support in treating severely calcified coronary lesions in patients with reduced left ventricular ejection fraction (LVEF). Objective To evaluate the clinical outcomes of atherectomy in patient with reduced LVEF. Methods We searched PubMed, Cochrane CENTRAL Register and ClinicalTrials.gov (inception through July 21, 2021) for studies evaluating the outcomes of atherectomy in patients with severe LV dysfunction. We used random-effect model to calculate risk ratio (RR) with 95% confidence interval (CI). The endpoints were in-hospital and long term all-cause mortality, cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). Results A total of 7 studies consisting of 2,238 unique patients were included in the analysis. The median follow-up duration was 22.4 months. The risk of in-hospital all-cause mortality using atherectomy in patients with severely reduced LVEF compared to the patients with moderate reduced or preserved LVEF was [2.4vs.0.5%; RR:5.28; 95%CI 1.65–16.84; P = 0.005], the risk of long term all-cause mortality was [21 vs. 8.8%; RR of 2.84; 95% CI 1.16–6.95; P = 0.02]. In-hospital TVR risk was 2.0 vs. 0.6% (RR: 4.15; 95% CI 4.15–15.67; P = 0.04) and long-term TVR was [6.0 vs. 9.9%; RR of 0.75; 95% CI 0.39–1.42; P = 0.37]. In-hospital MI was [7.1 vs. 5.4%; RR 1.63; 95% CI 0.91–2.93; P = 0.10], long-term MI was [7.5 vs. 5.7; RR 1.74; 95%CI 0.95–3.18; P = 0.07). Conclusion Our meta-analysis suggested that the patients with severely reduced LVEF when using atherectomy devices experienced higher risk of clinical outcomes in the terms of all-cause mortality and cardiac mortality. As we know that the patients with severely reduced LVEF are inherently at increased risk of adverse clinical outcomes, this information should be considered hypothesis generating and utilized while discussing the risks and benefits of atherectomy in such high risk patients. Future studies should focus on the comparison of outcomes of different atherectomy devices in such patients. Adjusting for the inherent mortality risk posed by left ventricular dysfunction may be a strategy while designing a study.

Project description:BackgroundThe comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied.AimsWe sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon.MethodsIn this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success.ResultsOCT data after DES implantation were available for 70 out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon.ConclusionsIn patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.

Dataset Information

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

Publications

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

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