Background The clinical implications of optical coherence tomography (OCT) assessment following percutaneous coronary intervention are controversial. Purpose We sought to evaluate the impact of post-stent OCT findings, including significant malapposition, on long-term clinical outcomes. Methods A total of 1,290 patients with 1,348 lesions, in which OCT was performed immediately post-stent, were consecutively enrolled in the prospective OCT registry. Post-stent OCT findings were assessed to identify predictors of device-oriented clinical end points (DoCE), including cardiac death, target vessel-related myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). We also looked for significant malapposition criteria that may be associated with thrombotic events such as cardiac death, target vessel-related MI, and stent thrombosis. Results Incidences of stent edge dissection, tissue prolapse, thrombus, and malapposition after intervention were not associated with occurrence of adverse thrombotic events. However, patients with significant malapposition [total malapposition volume (TMV) ≥7.0 mm3 or TMV/stent volume ≥4.1%] exhibited more frequent thrombotic events. In multivariate analysis, smaller minimal stent area (MSA) was identified as an independent predictor for DoCE (hazard ratio [HR], 1.21 [1.01–1.45]; P=0.037). Malapposition with TMV ≥7.0 mm3 was found to be an independent predictor of thrombotic events (HR, 4.62 [1.29–16.47]; P=0.018). Conclusions Although most high-resolution OCT findings were not associated with clinical outcome, smaller MSA was associated with DoCE, driven mainly by TLR, and significant malapposition with TMV ≥7.0 mm3 was associated with more thrombotic events after drug-eluting stent implantation. Kaplan-Meier curve Funding Acknowledgement Type of funding source: None

5110 Background: The efficacy and safety of pazopanib (paz), a multikinase angiogenesis inhibitor, was evaluated in a randomized, double-blind placebo-controlled phase III study (VEG105192), in treatment-naïve and cytokine-pretreated patients (pts) with advanced RCC. Pts with progressive disease (PD) on placebo had the option to receive paz 800 mg QD via an extension study (VEG107769). Methods: Pts with ECOG PS ≤ 2, adequate organ function and no other systemic anticancer treatment since PD on VEG105192 were eligible. The primary endpoint was safety. Secondary endpoints included response rate (RR) per RECIST and progression-free survival (PFS). RR was described along with 95% confidence intervals (CIs). PFS was summarized descriptively using Kaplan-Meier estimates for the median, quartiles and PFS rates at 6, 12, and 18 mo along with approximate 95% CIs. Results: 70 placebo pts were enrolled (+ 1 paz pt as an exemption due to symptom improvement). 34 pts (48%) were treatment-naïve and 37 (52%) were cytokine pretreated (at baseline in VEG105192). Median age was 59 y (25–80); baseline ECOG PS 0 (32%), 1 (52%), and 2 (14%). Median time from randomization to placebo in VEG105192 to start of paz treatment on VEG107769 was 6.4 mo (1–18 mo). At VEG107769 clinical cut-off (May 08), 21 (30%) pts had died, 40 (56%) pts had discontinued paz, and 31 (44%) pts were still on paz. Median exposure to paz was 5.7 mo. Most pts died or discontinued paz due to PD. The majority of adverse events (AEs) were Gr 1/2. Gr 3/4 AEs were experienced by 21%/7% of pts. The most common AEs were hypertension (46%; 4% Gr 3/4), hair color changes (39%; 0% Gr 3/4), diarrhea (38%; 1% Gr 3/4), anorexia (24%; 1% Gr 3/4), and nausea (24%; 0% Gr 3/4). Two pts had fatal AEs: sudden death and gastrointestinal hemorrhage. The most common Gr 3 chemistry laboratory abnormalities were hyponatremia (7%) and elevated ALT (7%) and AST (6%); no Gr 4. RR was 32.4% (95% CI: 21.5, 43.3); median PFS was 8.3 mo (95% CI: 6.1, 11.4 mo). Conclusions: Patients with advanced RCC who developed PD on placebo in a phase III study subsequently achieved clinical benefit from paz treatment in this extension study. These findings support the continued evaluation of paz in advanced RCC. [Table: see text]

Background: Comparative studies regarding the long-term clinical outcomes of statin intensity between acute myocardial infarction (AMI) patients with prediabetes and those with type 2 diabetes mellitus (T2DM), after successful implantation of newer-generation drug-eluting stents (DES) with statin treatment, are limited. We compared the 2-year clinical outcomes between these patients. Methods: A total of 11612 AMI patients were classified as statin users (n = 9893) and non-users (n = 1719). Thereafter, statin users were further divided into high-intensity (n = 2984) or low-moderate-intensity statin (n = 6909) treatment groups. Those in these two groups were further classified into patients with normoglycemia, prediabetes, and T2DM. The major outcomes were the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat coronary revascularization. Results: After adjusting for both high-intensity and low-moderate-intensity statin users, the cumulative incidences of MACE (p = 0.737, p = 0.062, respectively), all-cause death, Re-MI, and any repeat revascularization were similar between the prediabetes and T2DM groups. In the total study population, both high-intensity and low-moderate-intensity statin treatments showed comparable results. However, the beneficial effects of high-intensity compared to low-moderate-intensity statin therapy were more apparent in the normoglycemia group than hyperglycemia group, as it reduced the cumulative incidences of MACE (aHR: 1.903; 95% CI: 1.203-3.010; p = 0.006) and any repeat revascularization (aHR: 3.248; 95% CI: 1.539-6.854; p = 0.002). Conclusions: In this retrospective registry study, prediabetes and T2DM groups showed comparable clinical outcomes, after administering both high-intensity and low-moderate-intensity statin treatments. Trial registration: Retrospectively registered

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Introduction: The role of Biofreedom (polymer-free drug coated) stenting compared to coronary artery bypass graft (CABG) for coronary artery revascularization before elective surgery is unclear. Hypothesis: Biofreedom stent might be associated with better outcomes than CABG. Methods: Between January 2016 and Mar 2017, a total of 21 patients underwent percutaneous coronary intervention with Biofreedom stents before elective surgery (Biofreedom group) and 19 patients underwent CABG in the retrospective, multicenter cohort and we compared clinical outcomes between the Biofreedom group and CABG group. Primary outcomes were the period of planned operation after revascularization and the occurrence of the composite clinical endpoints (including death from any causes, myocardial infarction, stent thrombosis, stroke, any revascularization, or major bleeding). Results: During follow-up (mean 276.2± 134.3 days), all patients of Biofreedom group underwent planned surgery without delay, but 73.7% of patients in CABG group underwent surgery (p=0.04). Comparing the time to planned surgery, the Biofreedom group showed a greater incidence of performing surgery within 45 days than with CABG (72.7 vs. 31.6%, p=0.02). The Biofreedom group maintained a shorter duration of dual antiplatelet therapy (DAPT) (32.0 ± 10.0 vs 97.8 ± 88.3, p=0.005). During the entire treatment period, incidence of major bleeding after revascularization was significantly lower in Biofreedom group than CABG group (0% vs. 36.8%, p=0.007). There were no occurrence of death or stent thrombosis in the Biofreedom group. The Biofreedom group showed a significantly lower occurrence of primary outcome (7.2% versus 54.8%, HR 0.11, 95% CI 0.01 to 0.93, p=0.01, mainly due to the lower incidence of major bleeding after intervention). However, the statistical significance was not reached when only the perioperative period was observed. Conclusions: Biofreedom stent was associated with higher rate of performing planned surgery, shorter DAPT duration and lower incidence of major bleeding without increasing the risks of major cardiac event after surgery. In patients requiring coronary artery revascularization prior to elective surgery, Biofreedom stent might be a good treatment option.

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