Orbital atherectomy for treating de novo , severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial

Lee, Michael; Généreux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M.; Martinsen, Brad J.; Himmelstein, Stevan I.; Chambers, Jeffrey

doi:10.1016/j.carrev.2017.01.011

Cited by 80 publications

(62 citation statements)

References 11 publications

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“…Trials assessing the impact of calcium are often retrospective, include pooled subjects from multiple trials, combine moderate and severe calcium, or use investigator reported calcification . In contrast, the MACE‐Trial was intended to provide a standardized assessment of outcomes in subjects treated with standard‐of‐care PCI techniques stratified by lesion calcification.…”

Section: Discussionmentioning

confidence: 99%

“…Orbital atherectomy is indicated for the treatment of de novo , severely calcified, coronary lesions and the 1‐year MACE rate in the OAS pivotal trial (ORBIT II) was lower than the severe calcium group of the MACE‐Trial (16.9% vs. 24.4%), related primarily to lower rates of MI (10.6%) and TVR (5.8%) . The high rates of MI (13.2%) and TVR (10.4%) in the MACE‐Trial severe calcium group is notable as it suggests that severe calcification negatively affects standard of care (e.g., balloon, stent) treatment.…”

Section: Discussionmentioning

confidence: 99%

“…While approximately 18%–38% of patients with atherosclerosis have calcium observed on angiography, 6%–12% can be classified as severe . Atheroablative technologies provide alternatives in these difficult to treat populations; however, most DES trials exclude patients with severely calcified lesions due to increased risk of procedural complications and poor long‐term outcomes . The Multi‐center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE‐Trial) was designed to provide further insight on the impact of calcification on procedural and long‐term outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Impact of calcification on percutaneous coronary intervention: MACE‐Trial 1‐year results

Sharma

Bolduan

Patel

et al. 2019

Cathet Cardio Intervent

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Objectives The Multi‐center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE—Trial) was designed to provide further insight on the impact of calcification on procedural and long‐term percutaneous coronary intervention outcomes. Background Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation. Methods The MACE‐Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild [N = 133], moderate [N = 99], and severe [N = 114]). Endpoints were lesion success, procedural success, and 1‐year major adverse cardiac events (MACEs). Results Presence of severe calcification had significant impact on lesion success ([83.3%] versus none/mild calcification [94.7%, P = 0.006]) and procedural success ([86.8%] versus moderate [95.0%, P = 0.028], and none/mild [97.7%, P = 0.001]). 1‐year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P < 0.001) calcification; however, no difference was noted between none/mild and moderate (P = 0.237). The risk adjusted multivariable model identified severe calcification and decreasing eGFR as predictors of 30‐day and 1‐year MACE. Conclusions In this prospective study, patients with severe calcification had significantly worse outcomes compared to those without; however, unlike previous retrospective studies, moderate calcium resulted in similar outcomes as none/mild calcium. Clinical Trial Registration URL: https://clinicaltrials.gov/ct2/show/NCT01930214. Unique Identifier: NCT01930214.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Impact of calcification on percutaneous coronary intervention: MACE‐Trial 1‐year results

Sharma

Bolduan

Patel

et al. 2019

Cathet Cardio Intervent

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“…Angiographic complications included severe, type C‐F dissections in 3.4%, perforation in 1.8%, persistent slow flow in 0.9%, and abrupt vessel closure in 1.8%. The 3‐year MACE rate was 23.5%, including cardiac death in 6.7%, MI in 11.2%, and TVR in 10.2% of patients .…”

Section: Orbital Atherectomymentioning

confidence: 99%

Orbital and rotational atherectomy during percutaneous coronary intervention for coronary artery calcification

Lee

Gordin

Stone

et al. 2017

Cathet Cardio Intervent

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Severe coronary artery calcification (CAC) increases the complexity of percutaneous coronary intervention (PCI) by inhibiting optimal stent expansion, leading to an increased risk of death, myocardial infarction, repeat revascularization, and stent thrombosis. Coronary atherectomy modifies and debulks calcified plaque to facilitate PCI. Although there is no clear consensus, and further studies are needed, the decision to perform atherectomy should be based upon the presence of fluoroscopic CAC or with the use of intravascular imaging. The management of CAC in the modern era relies on rotational and orbital atherectomy to prepare the lesion to facilitate stent delivery and optimal expansion. While the two technologies differ in equipment, technique, and mechanism of action, the available literature suggests similar efficacy and safety of the two systems, although head-to-head comparisons are limited. While rotational and orbital atherectomy have been shown to have excellent procedural success in terms of facilitating stent delivery, no system has been shown to reduce long-term major adverse cardiovascular events, although the definitive trial for orbital atherectomy has not been completed. Additional trials are needed to find the population who would derive the most benefit of atherectomy and to compare the two systems in a prospective manner.

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“…More recently, orbital atherectomy (OA) has been introduced as a novel ablative technology in which a diamond‐coated crown orbits in an elliptical path which allows the operator to control the depth of the ablation by varying the speed of advance and the RPMs. The ORBIT II study demonstrated excellent safety and performance in the treatment of heavily calcified lesions on 3‐year follow‐up …”

mentioning

confidence: 99%

Editorial: Orbital atherectomy: A portal opens

Benton

Kumar

2018

J Interven Cardiology

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Orbital atherectomy for treating de novo , severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial

Cited by 80 publications

References 11 publications

Impact of calcification on percutaneous coronary intervention: MACE‐Trial 1‐year results

Impact of calcification on percutaneous coronary intervention: MACE‐Trial 1‐year results

Orbital and rotational atherectomy during percutaneous coronary intervention for coronary artery calcification

Editorial: Orbital atherectomy: A portal opens

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