Defining Staged Procedures for PCI Trials
- Spitzer E, McFadden E, Vranckx P, et al.
- Defining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document. JACC Cardiovasc Interv 2018;11:823-832.
The following are key points to remember from this guidance document on defining staged procedures for percutaneous coronary intervention (PCI) trials:
- A significant proportion (up to 10%) of patients enrolled in coronary intervention trials require more than a single procedure to complete an intended percutaneous revascularization strategy due to multivessel disease.
- In trials designed to compare stent/scaffold platforms, consistency in the definition of reintervention versus staged procedure is critical to ensure comparability among trials and to allow meaningful conclusions from pooled data and meta-analyses.
- Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines and consistency with study objectives.
- Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization.
- A staged procedure should be defined as a planned intervention performed after the first catheterization when it fulfills the following requirements:
- The intent to stage is documented, provisionally or definitely, before or within 24 hours after completion of the first procedure;
- The lesion(s) to be treated during the staged procedure should be defined upfront and should not involve the index vessel, except in specific study designs, such as trials for left main disease or chronic total occlusions (CTOs);
- The procedure should be performed within the protocol-defined time frame; and
- Stability of symptoms is required between the first and the subsequent procedure(s), because acute ischemia (including worsening of angina) would disqualify the intervention as a staged procedure.
- Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition, and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee (CEC).
- An independent CEC is critical to ensure that revascularizations after the first intervention are correctly classified as staged procedures (those considered as index lesions) or reinterventions (common component of composite endpoints).
- The following scenarios should be adjudicated as revascularizations and not as staged procedures:
- Any reintervention at the index lesion(s), which should be further classified either as clinically indicated or not. Second interventions after an investment procedure for CTOs or in the target vessel territory for left main disease, may be considered staged procedures in the target lesion or target vessel, respectively, if defined in the study protocol;
- When a procedure reported by the investigator as staged was not previously planned; and
- When the procedure occurred before the planned date due to documented objective unexpected worsening of ischemic signs and/or symptoms, and/or electrocardiographic or biomarker changes compatible with an acute coronary syndrome leading to an anticipated intervention.
- In the rare scenario in which a planned coronary artery bypass graft is performed after a first PCI (staged coronary artery bypass graft), the same conditions apply for classification of the event.
- In general, any intervention at an index lesion should be adjudicated as a reintervention, and further defined as clinically indicated or nonclinically indicated according to ancillary criteria.
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), ACS and Cardiac Biomarkers, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease
Keywords: Acute Coronary Syndrome, Angina Pectoris, Biological Markers, Cardiology Interventions, Catheterization, Coronary Artery Bypass, Coronary Artery Disease, Coronary Occlusion, Electrocardiography, Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents
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