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

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. 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. Despite advances in technology, percutaneous coronary intervention (PCI) of severely calcified coronary lesions remains a challenge. Contemporary studies have shown that the presence of moderate or severe coronary calcification at the target lesion is associated with a substantial increase in death, myocardial infarction (MI), stent thrombosis, and need for revascularization.1Genereux P. Madhavan M.V. Mintz G.S. Maehara A. Palmerini T. Lasalle L. Xu K. McAndrew T. Kirtane A. Lansky A.J. Brener S.J. Mehran R. Stone G.W. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trials.J Am Coll Cardiol. 2014; 63: 1845-1854Crossref PubMed Scopus (299) Google Scholar, 2Bangalore S. Vlachos H.A. Selzer F. Wilensky R.L. Kip K.E. Williams D.O. Faxon D.P. Percutaneous coronary intervention of moderate to severe calcified coronary lesions: insights from the National Heart, Lung, and Blood Institute Dynamic Registry.Catheter Cardiovasc Interv. 2011; 77: 22-28Crossref PubMed Scopus (74) Google Scholar, 3Bourantas C.V. Zhang Y.J. Garg S. Iqbal J. Valgimigli M. Windecker S. Mohr F.W. Silber S. Vries T. Onuma Y. Garcia-Garcia H.M. Morel M.A. Serruys P.W. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials.Heart. 2014; 100: 1158-1164Crossref PubMed Scopus (183) Google Scholar, 4Xu Y. Mintz G.S. Tam A. McPherson J.A. Iniguez A. Fajadet J. Fahy M. Weisz G. De Bruyne B. Serruys P.W. Stone G.W. Maehara A. Prevalence, distribution, predictors, and outcomes of patients with calcified nodules in native coronary arteries: a 3-vessel intravascular ultrasound analysis from Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT).Circulation. 2012; 126: 537-545Crossref PubMed Scopus (96) Google Scholar, 5Madhavan M.V. Tarigopula M. Mintz G.S. Maehara A. Stone G.W. Genereux P. Coronary artery calcification: pathogenesis and prognostic implications.J Am Coll Cardiol. 2014; 63: 1703-1714Crossref PubMed Scopus (321) Google Scholar, 6Moussa I. Ellis S.G. Jones M. Kereiakes D.J. McMartin D. Rutherford B. Mehran R. Collins M. Leon M.B. Popma J.J. Russell M.E. Stone G.W. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV substudy).Am J Cardiol. 2005; 96: 1242-1247Abstract Full Text Full Text PDF PubMed Scopus (115) Google Scholar Coronary calcification is frequent, with about 1/3 of the lesions treated by PCI presenting with a substantial amount of calcification angiographically.1Genereux P. Madhavan M.V. Mintz G.S. Maehara A. Palmerini T. Lasalle L. Xu K. McAndrew T. Kirtane A. Lansky A.J. Brener S.J. Mehran R. Stone G.W. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trials.J Am Coll Cardiol. 2014; 63: 1845-1854Crossref PubMed Scopus (299) Google Scholar Current therapeutic options to manage calcified lesions (e.g., cutting/scoring balloons and rotational atherectomy) are associated with a high rate of restenosis and stent failure at long-term follow-up.5Madhavan M.V. Tarigopula M. Mintz G.S. Maehara A. Stone G.W. Genereux P. Coronary artery calcification: pathogenesis and prognostic implications.J Am Coll Cardiol. 2014; 63: 1703-1714Crossref PubMed Scopus (321) Google Scholar Recently, the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial demonstrated favorable procedural and 30-day outcomes with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, Minnesota) in the treatment of severely calcified lesions, resulting in its Food and Drug Administration (FDA) approval.7Chambers J.W. Feldman R.L. Himmelstein S.I. Bhatheja R. Villa A.E. Strickman N.E. Shlofmitz R.A. Dulas D.D. Arab D. Khanna P.K. Lee A.C. Ghali M.G. Shah R.R. Davis T.P. Kim C.Y. Tai Z. Patel K.C. Puma J.A. Makam P. Bertolet B.D. Nseir G.Y. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).JACC Cardiovasc Interv. 2014; 7: 510-518Crossref PubMed Scopus (216) Google Scholar Whether the beneficial effects of this device seen at 30 days translate into favorable 1-year outcomes is not known. We report the prespecified analysis of the 1-year outcomes from the ORBIT II pivotal trial. The design and initial results of ORBIT II have been published previously.7Chambers J.W. Feldman R.L. Himmelstein S.I. Bhatheja R. Villa A.E. Strickman N.E. Shlofmitz R.A. Dulas D.D. Arab D. Khanna P.K. Lee A.C. Ghali M.G. Shah R.R. Davis T.P. Kim C.Y. Tai Z. Patel K.C. Puma J.A. Makam P. Bertolet B.D. Nseir G.Y. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).JACC Cardiovasc Interv. 2014; 7: 510-518Crossref PubMed Scopus (216) Google Scholar In brief, ORBIT II was a prospective, multicenter, nonblinded, single-arm clinical trial that enrolled patients with de novo severely calcified coronary lesions who underwent PCI. Key study inclusion criteria included: (1) target vessel reference diameter ≥2.5 and ≤4.0 mm with a stenosis ≥70% and <100% or a stenosis ≥50% and <70% with evidence of clinical ischemia through positive stress test, fractional flow reserve value ≤0.8, or intravascular ultrasound (IVUS) minimum lumen area ≤4.0 mm2; (2) target lesion length ≤40 mm; and (3) imaging evidence of severe calcium at the lesion site based on the angiographic presence of radio-opacities noted without cardiac motion before contrast injection involving both sides of the arterial wall in at least 1 location, total length of calcium of ≥15 mm and extending partially into the target lesion, or presence of ≥270° of calcium at 1 cross-section through IVUS. Patients were excluded if (1) the target vessel had a stent from a previous PCI unless the stent was on a different branch than the target lesion and was implanted >30 days before with no >30% in-stent restenosis; (2) recent MI (defined as creatine kinase-MB [CK-MB] >1× upper limit of laboratory normal [ULN] within 30 days of the index procedure); and (3) evidence of current left ventricular ejection fraction ≤25%. The ORBIT II trial conformed to ethical guidelines of the Declaration of Helsinki, and study participants provided informed consent. The coronary OAS uses a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands laterally through centrifugal force (up to a maximum orbit diameter for a given rotational speed) resulting in a differential sanding of coronary calcification. Two OAS configurations were used in the ORBIT II trial, pneumatic OAS and electric OAS, with crown diameter ranging from 1.25 up to 2.00 mm. Detailed description of OAS mechanism of action can be found elsewhere.8Parikh K. Chandra P. Choksi N. Khanna P. Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial.Catheter Cardiovasc Interv. 2013; 81: 1134-1139Crossref PubMed Scopus (93) Google Scholar, 9Bhatt P. Parikh P. Patel A. Chag M. Chandarana A. Parikh R. Parikh K. Orbital atherectomy system in treating calcified coronary lesions: 3-year follow-up in first human use study (ORBIT I trial).Cardiovasc Revasc Med. 2014; 15: 204-208Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar The use of other adjunctive devices, such as thrombectomy, embolic protection devices, brachytherapy, or cutting balloons, was not allowed. Pre- and postprocedure dual antiplatelet therapy was recommended to conform to the American Heart Association/American College of Cardiology/Society for Cardiovascular Angiography and Interventions joint guidelines for PCI.10Levine G.N. Bates E.R. Blankenship J.C. Bailey S.R. Bittl J.A. Cercek B. Chambers C.E. Ellis S.G. Guyton R.A. Hollenberg S.M. Khot U.N. Lange R.A. Mauri L. Mehran R. Moussa I.D. Mukherjee D. Nallamothu B.K. Ting H.H. American College of Cardiology FoundationAmerican Heart Association Task Force on Practice GuidelinesSociety for Cardiovascular Angiography and Interventions2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.J Am Coll Cardiol. 2011; 58: e44-e122Abstract Full Text Full Text PDF PubMed Scopus (1975) Google Scholar The primary safety end point of ORBIT II was the rate of 30-day major adverse cardiac events (MACEs) as the composite of cardiac death, and target vessel revascularization MI was as with or without of stent thrombosis was and to the Windecker S. Mehran R. A. D.J. Morel M.A. Mauri L. P. Lansky A. M. Serruys P.W. end in coronary stent a for PubMed Scopus Google Scholar adverse events were by an clinical events patients were the index at 30 days and at 1 are as for were on the of available follow-up data was to predictors of 1-year MACE and target vessel revascularization for The was with if of clinical the of in the in the were to and for previous coronary artery reference vessel lesion diameter and use of bare-metal stents drug-eluting stents and for reference vessel diameter and use of were The ORBIT II trial was by Cardiovascular Systems, Inc., and was by the and the The had to the study the the to for and the and of its to 443 patients with severely calcified coronary lesions from 49 US sites were enrolled in the ORBIT II trial. were treated with OAS before stent and 1-year data were available in 433 patients follow-up time of 16.7 and procedural of the study are in were implanted in of the lesions treated of and procedural or of of of rate ischemic myocardial coronary artery coronary artery lesion length diameter stenosis reference vessel diameter College of Heart Association lesion with stent implanted of stents implanted drug-eluting drug-eluting time time as the time from the first guide was in the site to the time the guide was from the time of contrast used atherectomy system device used in atherectomy system device used and high orbital atherectomy system device time orbital atherectomy system time are time as the time from the first guide was in the site to the time the guide was from the in a are 1 the primary composite end point of MACE occurred in of with cardiac death in MI in and in of patients The target lesion revascularization rate was 4.7%, and 1 stent thrombosis occurred within 1 the of MI without or with I.D. Shah B. Mehran R. G. Stone G.W. of a of myocardial infarction after coronary an from the Society for Cardiovascular Angiography and Interventions Am Coll Cardiol. 2013; Full Text Full Text PDF PubMed Scopus Google Scholar the 1-year MI and MACE rates were and the rates of 1-year adverse clinical events by stent of was associated with a rate of MACE, and at 1 outcomes through adverse cardiac adverse cardiac events myocardial infarction creatine kinase-MB upper limit of infarction kinase-MB upper limit of myocardial myocardial infarction kinase-MB upper limit of vessel lesion vessel revascularization lesion stent rate data as rates are based on of the treated in a clinical events to stent adverse cardiac vessel lesion vessel revascularization lesion rate as from in a rate data as rates are based on of the treated rate as from Independent predictors of 1-year MACE and are in After diameter stenosis and the use of as predictors of MACE and of predictors of 1-year adverse myocardial coronary artery rate ventricular ejection fraction vessel diameter length stenosis stent drug-eluting mm mm in a The present study the long-term of treatment of severely calcified lesions the and The of the present study the favorable procedural and 30-day results J.W. Feldman R.L. Himmelstein S.I. Bhatheja R. Villa A.E. Strickman N.E. Shlofmitz R.A. Dulas D.D. Arab D. Khanna P.K. Lee A.C. Ghali M.G. Shah R.R. Davis T.P. Kim C.Y. Tai Z. Patel K.C. Puma J.A. Makam P. Bertolet B.D. Nseir G.Y. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).JACC Cardiovasc Interv. 2014; 7: 510-518Crossref PubMed Scopus (216) Google Scholar and a low rate of 1-year adverse ischemic events after treatment of this and with PCI of calcified lesions have been shown to be associated with a compared with lesions with no P. Madhavan M.V. Mintz G.S. Maehara A. Palmerini T. Lasalle L. Xu K. McAndrew T. Kirtane A. Lansky A.J. Brener S.J. Mehran R. Stone G.W. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trials.J Am Coll Cardiol. 2014; 63: 1845-1854Crossref PubMed Scopus (299) Google Scholar, 2Bangalore S. Vlachos H.A. Selzer F. Wilensky R.L. Kip K.E. Williams D.O. Faxon D.P. Percutaneous coronary intervention of moderate to severe calcified coronary lesions: insights from the National Heart, Lung, and Blood Institute Dynamic Registry.Catheter Cardiovasc Interv. 2011; 77: 22-28Crossref PubMed Scopus (74) Google Scholar, 3Bourantas C.V. Zhang Y.J. Garg S. Iqbal J. Valgimigli M. Windecker S. Mohr F.W. Silber S. Vries T. Onuma Y. Garcia-Garcia H.M. Morel M.A. Serruys P.W. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials.Heart. 2014; 100: 1158-1164Crossref PubMed Scopus (183) Google Scholar, 5Madhavan M.V. Tarigopula M. Mintz G.S. Maehara A. Stone G.W. Genereux P. Coronary artery calcification: pathogenesis and prognostic implications.J Am Coll Cardiol. 2014; 63: 1703-1714Crossref PubMed Scopus (321) Google Scholar, 6Moussa I. Ellis S.G. Jones M. Kereiakes D.J. McMartin D. Rutherford B. Mehran R. Collins M. Leon M.B. Popma J.J. Russell M.E. Stone G.W. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV substudy).Am J Cardiol. 2005; 96: 1242-1247Abstract Full Text Full Text PDF PubMed Scopus (115) Google Scholar Coronary calcification to in coronary devices, the and stent N. Y. M. Y. of rotational atherectomy in of stent in calcified coronary Cardiovasc Interv. 2011; Full Text Full Text PDF PubMed Scopus Google Scholar and limit stent resulting in procedural results and an of ischemic adverse events. lesion remains to angiographic and clinical procedural and acute the Atherectomy to for Coronary trial to clinical of rotational atherectomy compared with for of calcified lesions before implantation in to and MACE rates (defined as a composite of death, and M. G. R. T. J. L. rotational atherectomy before paclitaxel-eluting stent implantation in calcified coronary lesions: the randomized Atherectomy to for Coronary Cardiovasc Interv. 2013; Full Text Full Text PDF PubMed Scopus Google Scholar In the results with OAS in the present study are with rates of and MACE at 1 compared with historical a of severe coronary calcification as an enrolling of the treated lesions in the ORBIT II trial were severely calcified compared with of the lesions enrolled in M. G. R. T. J. L. rotational atherectomy before paclitaxel-eluting stent implantation in calcified coronary lesions: the randomized Atherectomy to for Coronary Cardiovasc Interv. 2013; Full Text Full Text PDF PubMed Scopus Google Scholar results compared with the published pooled analysis from the Acute Catheterization and Urgent Intervention Triage and Outcomes With Revascularization and Stents in Acute Myocardial and MACE rates in patients with severe coronary calcification who underwent PCI and P. Madhavan M.V. Mintz G.S. Maehara A. Palmerini T. Lasalle L. Xu K. McAndrew T. Kirtane A. Lansky A.J. Brener S.J. Mehran R. Stone G.W. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trials.J Am Coll Cardiol. 2014; 63: 1845-1854Crossref PubMed Scopus (299) Google Scholar ORBIT II was a single-arm trial with no and from with different studies different patient different stent be the angiographic and of the ORBIT II the 1-year stent thrombosis rate is low and with previous L. M. B. Onuma Y. P. J. B. P. Serruys P.W. Windecker S. coronary stent thrombosis of a stent compared with drug-eluting a 2012; PubMed Scopus Google Scholar, T. G. D. A. M. F. G. M. Genereux P. Stone G.W. outcomes with drug-eluting and bare-metal evidence from a Am Coll Cardiol. 2014; 63: PubMed Scopus Google Scholar, T. G. D. D. F. T. M. Kim De A. G. A. Kirtane A.J. Leon M.B. Stone G.W. thrombosis with drug-eluting and bare-metal evidence from a 2012; Full Text Full Text PDF PubMed Scopus Google Scholar 1 of stent thrombosis occurred This finding is and of the beneficial effects of OAS as an in lesion for severely calcified lesions. lesion and calcification have been as predictors of stent P. Madhavan M.V. Mintz G.S. Maehara A. Palmerini T. Lasalle L. Xu K. McAndrew T. Kirtane A. Lansky A.J. Brener S.J. Mehran R. Stone G.W. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trials.J Am Coll Cardiol. 2014; 63: 1845-1854Crossref PubMed Scopus (299) Google Scholar, R. Kirtane A.J. R. D.J. T. L. R. S. P. K. Leon M.B. and outcomes of and drug-eluting stent results from of Cardiovasc Interv. 2014; 7: PubMed Scopus Google Scholar, M. Genereux P. Palmerini T. A. Madhavan M.V. Xu K. Brener S.J. Mehran R. Stone G.W. and the of stent thrombosis after percutaneous coronary intervention in patients with acute coronary an ACUITY Cardiovasc Interv. PubMed Scopus Google Scholar, T. P. F. De S. M. D. A. A. De M. D. L. D. A. N. R. De R. M. G. Genereux P. Stone G.W. D.J. Impact of and the on 1-year clinical outcomes in patients with acute coronary undergoing percutaneous coronary intervention: the Cardiovasc Interv. 2014; 7: PubMed Scopus Google Scholar with stent the Patel M. stent thrombosis in contemporary insights from intravascular Cardiovasc Interv. 2013; 81: PubMed Scopus Google Scholar, Maehara A. Mintz G.S. A. L. Popma J.J. Ellis S.G. M.A. J.A. Stone G.W. Impact of stent area on follow-up of paclitaxel-eluting an intravascular ultrasound analysis from the and and and Cardiovasc Interv. Full Text Full Text PDF PubMed Scopus Google Scholar, G.S. P. Popma J.J. Leon M.B. lesion calcification in coronary artery an intravascular ultrasound Am Coll Cardiol. Full Text PDF PubMed Scopus Google Scholar are given the of the lesions treated in ORBIT the of patients enrolled in study and the of a the of OAS to stent the favorable long-term results seen in the present OAS uses a of centrifugal with the orbital motion diameter to the This orbital results in sanding of the calcified wall and for flow with and the compared with a and atherectomy M. of rotational atherectomy different Cardiovasc PubMed Scopus Google Scholar, M. D. R. of rotational atherectomy for the of Cardiovasc PubMed Scopus Google Scholar imaging and studies are to determine the to the mechanism of OAS to the favorable outcomes in the present of the ORBIT II underwent PCI of the target lesion with the index adverse ischemic event were in patients with compared with and the use of was as an of MACE and of drug-eluting stents in patients with calcified coronary lesions: a J. PubMed Scopus Google Scholar this finding the outcomes of compared with used in lesions. This finding the favorable results of lesion OAS, if were Y. S. P. J. J.J. A. J.J. G. M. D. L. K. S. Serruys P.W. Efficacy of stent implantation in patients with calcified coronary culprit lesions: angiographic and clinical results from the II Cardiovasc Interv. PubMed Scopus Google Scholar ORBIT II has important is the first and prospective, trial including patients with severe coronary calcification angiographic enrolling criteria in the contemporary of and ORBIT II enrolled patients excluded from clinical and demonstrated outcomes with such patients. angiographic laboratory and clinical events and and adverse events. be ORBIT II was a single-arm trial, with no of the of the OAS device compared with the for treatment of severely calcified lesions not be given that no device was for treatment of calcified lesions at the time of of the trial, design of a trial was not by the adjunctive imaging such as or was not data from imaging have been and have provided insights on the therapeutic and effects of Y.J. Kim Kim Kim implantation of drug-eluting stents to a Cardiovasc Interv. 2014; 7: PubMed Scopus Google Scholar, A. R. J.A. T. S. of orbital atherectomy and adjunctive therapy on and insights into the of artery 2014; PubMed Scopus Google Scholar 49 sites randomized 443 with a of patients enrolled the OAS device was a therapeutic and of the had no previous with this be and outcomes be with The the ORBIT II The J. and of Cardiovascular Systems, Inc., and P. for in The ORBIT II trial was by Cardiovascular Systems, from Cardiovascular Systems, Inc., and from and from Cardiovascular Systems, The other have no to this

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