Does optical coherence tomography optimize results of stenting? Rationale and study design

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Imaging

Background:

• No prior randomized studies have assessed optical coherence tomography (OCT) for optimizing percutaneous coronary intervention in non-ST-segment elevation acute coronary syndromes (NSTE-ACS).
• Accurate assessment of angioplasty results is crucial for improving patient outcomes in NSTE-ACS.

Purpose of the Study:

• To evaluate the utility of OCT in optimizing angioplasty results for NSTE-ACS lesions.
• To determine if OCT guidance improves the functional outcome of coronary angioplasty compared to fluoroscopy alone.

Main Methods:

• The DOCTORS trial is a prospective, multicenter, randomized study involving 250 patients with NSTE-ACS.
• Patients are randomized to OCT-guided angioplasty or angioplasty using fluoroscopy alone.
• The primary endpoint is the functional result, measured by fractional flow reserve (FFR) post-procedure.

Main Results:

• The study will assess secondary endpoints including OCT safety, rates of suboptimal stenting, strategy changes based on OCT, and correlation between OCT measures and FFR.
• Adverse cardiac events at 6 months will be recorded to evaluate safety and efficacy.

Conclusions:

• The DOCTORS trial will ascertain if OCT provides valuable information beyond angiography.
• It will determine if this information leads to strategy changes and impacts the functional success of angioplasty, as measured by FFR.