Does Optical Coherence Tomography Optimize Results of Stenting - DOCTORS
Contribution To Literature:
The DOCTORS trial showed that OCT-guided PCI results in a better functional outcome (as assessed by post-PCI FFR) compared with routine angiography-guided PCI in NSTE-ACS patients.
The goal of the trial was to assess the efficacy of optical coherence tomography (OCT) in optimizing percutaneous coronary intervention (PCI) among patients with non–ST-segment elevation acute coronary syndromes (NSTE-ACS).
Patients were randomized in a 1:1 fashion to either OCT-guided PCI (n = 120) or routine management/angiography-guided PCI (n = 120).
- Total number screened: 1,935
- Total number of enrollees: 240
- Duration of follow-up: mean 6 months
- Mean patient age: 60.5 years
- Percentage female: 22%
- Percentage diabetics: 18.8%
- Age 18-80 years
- Admitted for ACS with the following symptoms: Clinical signs of ischemia (chest pain) at rest lasting for at least 10 minutes in the previous 72 hours; and at least one of the following two criteria: 1) New ST-segment depression ≥1 mm or transitory ST-segment elevation (<30 minutes; ≥1 mm) on at least two contiguous leads of the electrocardiogram; or 2) elevation (> upper limit of normal) of cardiac enzymes (creatine kinase-myocardial band, troponin I or T)
- Indication for coronary angioplasty with stent implantation of the target lesion
- Single lesion on the culprit artery without diffuse disease on the same vessel considered to be responsible for the ACS
- Left main disease
- In-stent restenosis
- Presence of coronary artery bypass grafts
- Cardiogenic shock or severe hemodynamic instability
- Severely calcified or tortuous arteries
- Persistent ST-segment elevation
- One or more other lesions considered angiographically significant, or nonsignificant diffuse disease, located on the target vessel
- Severe renal insufficiency (estimated glomerular filtration rate ( ≤30 ml/min)
- Bacteremia or septicemia
- Severe coagulation disorders
Other salient features/characteristics:
- Single-vessel disease: 69.2%, two-vessel disease: 22.5%, three-vessel disease: 8.3%
- Infarct-related artery: left anterior descending artery: 48.3%; left circumflex artery: 22.5%; right coronary artery: 29.2%
The primary outcome, fractional flow reserve (FFR) value for OCT-guided vs. angiography-guided PCI, was 0.94 vs. 0.92, p < 0.005.
Secondary outcomes for OCT-guided vs. angiography-guided PCI, respectively:
- FFR >0.9: 82.5% vs. 64.2%, p = 0.0001
- Optimization performed post-stent: 50% vs. 22.5%, p < 0.0001, including post-PCI overinflation: 43% vs. 12.5%, p < 0.0001
- Quantitative coronary angiography diameter stenosis: 7.0% vs. 8.7%, p = 0.01
- Procedural complications: 5.8% vs. 5.8%, p = 1.0
- Contrast use: 190 cc vs. 120 cc, p < 0.0001
- Stent thrombosis: 0%
The results of this trial indicate that OCT-guided PCI results in a better functional outcome (as assessed by post-PCI FFR) compared with routine angiography-guided PCI in patients undergoing PCI of a single lesion for NSTE-ACS. There was a higher incidence of post-stent optimization procedures (such as overdilation and additional stent implantations) in the OCT arm. However, there was also higher contrast, radiation, and time utilization in the OCT group. The trial was not powered for clinical outcomes.
Stent underexpansion was relatively common (~42%), and it was an independent predictor of adverse outcomes. Although data on intravascular ultrasound use for PCI optimization have been mixed, more recent studies have been positive. Together, they suggest that invasive imaging may be helpful in optimization of PCI, particularly in patients with NSTE-ACS. This will be of particular importance for bioresorbable vascular scaffolds (BVS) (although unclear how many patients received BVS in this trial).
Meneveau N, Souteyrand G, Motreff P, et al. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non–ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS (Does Optical Coherence Tomography Optimize Results of Stenting) Study. Circulation 2016;134:906-17.
Editorial: Wijns W, Pyxaras SA. Optical Coherence Tomography Guidance for Percutaneous Intervention: The French “Doctors” Are Seeing Light at the End of the Tunnel. Circulation 2016;134:918-22.
Presented by Dr. Nicolas Meneveau at the European Society of Cardiology Congress, Rome, Italy, August 29, 2016.
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