Nicolas Meneveau1, Fiona Ecarnot2, Geraud Souteyrand3, Pascal Motreff3, Christophe Caussin4, Eric Van Belle5, Patrick Ohlmann6, Olivier Morel6, Alain Grentzinger7, Michael Angioi8, Romain Chopard2, François Schiele2. 1. Department of Cardiology, EA3920, University Hospital Jean Minjoz, 25000 Besançon, France. Electronic address: nicolas.meneveau@univ-fcomte.fr. 2. Department of Cardiology, EA3920, University Hospital Jean Minjoz, 25000 Besançon, France. 3. University Hospital Gabriel Montpied, Clermont-Ferrand, France. 4. Centre Chirurgical Marie Lannelongue, Paris, France. 5. University Hospital, Lille, France. 6. Nouvel Hôpital Civil, Strasbourg, France. 7. Centre Hospitalier, Belfort, France. 8. Brabois University Hospital, Vandœuvre les Nancy, France.
Abstract
BACKGROUND: To date, no randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of coronary angioplasty for non-ST-segment elevation acute coronary syndromes. METHODS: DOCTORS is a randomized, prospective, multicenter, open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for non-ST-elevation acute coronary syndromes. Patients (n = 250) will be randomized to undergo OCT-guided angioplasty (use of OCT to optimize procedural result, including change to strategy with the possibility of additional interventions) or angioplasty under fluoroscopy alone. The primary end point is the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) measured at the end of the procedure. Secondary end points include safety of OCT in the context of angioplasty for ACS, percentage of patients in whom OCT reveals suboptimal result of stenting, percentage of patients in whom a change in procedural strategy is decided based on OCT data, correlation between quantitative measures by OCT and FFR, determination of a threshold for quantitative OCT measure that best predicts FFR ≥ 0.90, and identification of OCT variables that predict postprocedure FFR. Adverse cardiac events (death, recurrent myocardial infarction, stent thrombosis, and repeat target lesion revascularization) at 6 months will be recorded. CONCLUSION: The DOCTORS randomized trial (ClinicalTrials.gov NCT01743274) is designed to investigate whether use of OCT yields useful additional information beyond that obtained by angiography alone and, if so, whether this information changes physician strategy and impacts on the functional result of angioplasty as assessed by FFR.
RCT Entities:
BACKGROUND: To date, no randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of coronary angioplasty for non-ST-segment elevation acute coronary syndromes. METHODS: DOCTORS is a randomized, prospective, multicenter, open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for non-ST-elevation acute coronary syndromes. Patients (n = 250) will be randomized to undergo OCT-guided angioplasty (use of OCT to optimize procedural result, including change to strategy with the possibility of additional interventions) or angioplasty under fluoroscopy alone. The primary end point is the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) measured at the end of the procedure. Secondary end points include safety of OCT in the context of angioplasty for ACS, percentage of patients in whom OCT reveals suboptimal result of stenting, percentage of patients in whom a change in procedural strategy is decided based on OCT data, correlation between quantitative measures by OCT and FFR, determination of a threshold for quantitative OCT measure that best predicts FFR ≥ 0.90, and identification of OCT variables that predict postprocedure FFR. Adverse cardiac events (death, recurrent myocardial infarction, stent thrombosis, and repeat target lesion revascularization) at 6 months will be recorded. CONCLUSION: The DOCTORS randomized trial (ClinicalTrials.gov NCT01743274) is designed to investigate whether use of OCT yields useful additional information beyond that obtained by angiography alone and, if so, whether this information changes physician strategy and impacts on the functional result of angioplasty as assessed by FFR.
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