One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. RESULTS: 82 patients (5%) were discharged with ≤3-month DAPT (57 ±â€¯27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ±â€¯75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). CONCLUSIONS: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Use of Proxis for percutaneous coronary intervention in patients with totally occluded saphenous vein grafts: an alternative approach.

Surgery is a common approach for diffuse coronary artery disease. Saphenous vein grafts are frequently used but are characterized by degeneration and high incidence of failure at 10 years. Percutaneous coronary intervention is preferred over re-operation because of age, comorbidity and the diffusion of coronary artery disease. With the saphenous vein graft occluded, percutaneous coronary intervention of native vessels and medical therapy alone are commonly suggested. We report three cases of patients with totally occluded saphenous vein grafts with suitable characteristics for treatment with Proxis, a device able to induce a proximal protection of the target vessel, minimizing the risk of distal embolization as well as the quantity of contrast required. In all patients there were no complications or cardiac enzyme elevations, and each case resulted in complete revascularization immediately postprocedure. Patients were asymptomatic at 6-month follow-up and procedural success was shown in two patients that consented to follow-up angiography. We conclude that Proxis could be a valuable tool for percutaneous coronary intervention of totally occluded saphenous vein grafts in patients who are poor candidates for percutaneous coronary intervention of native vessel; nevertheless these observations should be confirmed by a long-term follow-up controlled study.