METHODS: A total of 299 patients who had undergone CACS and CCTA, and had scored zero for coronary artery calcium. Patients included had clinically appropriate indications, mainly chest pain with variable severity with no history of CAD. The presence of CAD risk factors, such as diabetes, hypertension, and smoking, was obtained from reviewing patient charts. The CCTA analysis was performed to evaluate for coronary artery stenosis and the presence of NCP. The severity of stenosis was quantified by visual estimation and divided into 0% stenosis, 1-25% stenosis, 26-50% stenosis, and more than 50% stenosis.
RESULTS: The prevalence of NCP was 6.4% (19 of the 299). Among the 19 patients with NCP, 52.6% had no identified coronary artery stenosis, 26.3% had less than 25%, and 21% had stenosis between 25 and 50%. None had stenosis greater than 50%. There was a strong association between male sex (P = 0.001), smoking (P = 0.0.004), hypertension, and NCP (P = 0.042), but no association was found between NCP and age or diabetes.
CONCLUSIONS: In patients with a high clinical suspicion of CAD, the absence of coronary artery calcification does not rule out CAD; up to 6.4% of these patients have early CAD as evidenced by NCP detected by CCTA, and none have more than 50% stenosis, However, future prognostic and long-term follow-up studies are needed to determine prognostic value of NCP in patients with 0 CACS.
Objective: To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months.
Design, Setting, and Participants: This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography.
Interventions: Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.
Main Outcomes and Measures: Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions.
Results: Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P