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Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.44 to 0.96; pnon-inferiority <0.001; psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs 11.1%, HR 0.67, 95% CI 0.46 to 0.99; p = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusions In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032.

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W e present a 70-year--old man who had a past medical history of dilated idiopathic pulmonary artery, incidentally diagnosed at the age of 23 years. He was asymptomatic until a year ago when he was admitted for an episode of anginal chest pain in the context of paroxysmal atrial fibrillation. At rapid rates, he showed pathological ST segment descent. A coronary angiography showed a slight stenosis of the left main coronary artery (LMCA). At that time, the mean pulmonary artery pressure was 36 mm Hg. After recovering sinus rhythm, the patient became asymptomatic and was discharged with β-blockers.A year later, the patient was admitted with resting angina. The echocardiogram ( Figure A) and the computed tomography-angio showed that the aneurysm had increased to 80 mm and compressed the LMCA (Figure B). This finding was confirmed on coronary angiography and intravascular ultrasound that showed a critical stenosis of LMCA ( Figure C, insert 1, and online-only Data Supplement Movie I) and normal luminal diameter of anterior descending artery ( Figure C, insert 2). In addition, the mean pulmonary artery pressure had increased >60 mm Hg.Because of the high surgical risk posed aneurysm surgery, percutaneous revascularization of LMCA with drug-eluting stent was performed with good final result ( Figure D, insert 1, and online-only Data Supplement Movie II). We also initiated specific treatment of pulmonary hypertension (PH) with phosphodiesterase-5 inhibitors and an endothelin receptor antagonist. The patient became asymptomatic and was discharged to reevaluate the surgical indication of aneurysm according to the clinical and PH evolution in the follow-up. One year later, the patient is asymptomatic with no adverse events.Extrinsic compressions of LMCA by a pulmonary artery aneurysm are extremely rare and usually associated with PH. Only case reports and small series have described this entity as a cause of angina and sudden death, and, currently, the appropriate management of these patients remains unknown.

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