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Background An increasing number of patients with coronary artery disease, who undergo percutaneous coronary intervention, also have symptomatic peripheral arterial disease. These patients have a worse long-term prognosis, but it is unclear whether the inferior outcome can be seen as early as during the first 2 years from coronary stenting. Purpose The aim of this study in all-comers was to evaluate the impact of symptomatic peripheral arterial disease on 1- and 2-year clinical outcome after coronary stenting. Methods Patient-level data from four large-scale randomised coronary drug-eluting stent trials in all-comers (TWENTE (clinicaltrials.gov: NCT01066650), DUTCH PEERS (NCT01331707), BIO-RESORT (NCT01674803), and BIONYX (NCT02508714)) were pooled to evaluate the impact of symptomatic peripheral arterial disease on clinical outcome after coronary stenting. Peripheral arterial disease was defined as a history (by anamnesis or medical record) of an obstructive arterial lesion, resulting from atherosclerosis in peripheral locations including the lower and upper extremities, carotid or vertebral arteries, and mesenteric or renal arteries. Main clinical endpoint was target vessel failure, a composite of cardiac death, target vessel related myocardial infarction, or clinically indicated target vessel revascularisation. Results Of all 9,204 trial participants, 695 (7.6%) had symptomatic peripheral arterial disease. These patients were older and had a higher cardiovascular risk profile, including a higher prevalence of diabetes, renal failure, hypertension, hypercholesterolemia, and prior stroke. At 1-year follow-up, patients with peripheral arterial disease showed significantly higher event rates of some endpoints. At 2-year follow-up, patients with peripheral arterial disease showed significantly higher rates of various clinical endpoints, including mortality (7.1% vs. 3.0%, p Conclusion Obstructive coronary artery disease with concomitant symptomatic peripheral arterial disease resulted in higher cardiovascular risk profiles and higher rates of all-cause mortality and various composite clinical endpoints during the first two years of follow-up after coronary stenting. Knowledge of these findings allows to identify patients with an increased short- and medium-term adverse event risk after percutaneous coronary intervention, which is useful for both Heart Team and informed consent discussions. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The original trials were funded by Abbott Vascular, Medtronic, Boston Scientific and Biotronik.

Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES. Methods We performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77–2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70–2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.