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.

Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry).

BACKGROUND: To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. RESULTS: 106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). CONCLUSIONS: The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.

Saphenous Vein Graft Wrapping by Nitinol Mesh: A Word of Caution.

BACKGROUND: Saphenous vein conduits are still used in a large proportion of coronary artery bypass graft (CABG) operations. A recently commercialized nitinol mesh seems to improve venous graft patency. The aim of this study was to control nitinol mesh vein graft patency in a series of isolated CABG patients by computed tomographic (CT) scan. METHODS: In 25 patients (mean age: 61.0 ± 9.65 years), operated for isolated CABG, the eSVS nitinol mesh (Kips Bay Medical Inc., Minneapolis, Minnesota, United States) was used to wrap one vein graft in each patient. Nitinol mesh vein graft was used to revascularize the right coronary (4 patients; 16%), the posterior descending (18 patients; 72%), and the obtuse marginal (3 patients; 12%) arteries. CT scans were performed at 1, 6, and 12 months postoperatively. RESULTS: The procedure was uneventful in all patients. CT controls showed an overall patency rate of 86.9, 42.7, and 34.1% at 1, 6, and 12 months, respectively. The 4 mm mesh had a significantly higher patency rate at 12 months (83.33%) than the 3.5 mm one which showed quite unsatisfactory results (20%) (p = 0.02). Patients with graft occlusion underwent stress testing which was mildly positive in two cases. One of them underwent a percutaneous revascularization. CONCLUSION: Despite promising early results, use of nitinol mesh for saphenous veins was disappointing in our experience. Further refinements are probably needed.

P2Y12 inhibitors: pharmacologic mechanism and clinical relevance.

Platelets play a critical role in the pathogenesis of atherothrombotic processes and inhibition of platelet aggregation by antiplatelet therapy is essential and really important in the acute coronary syndromes or in the setting of percutaneous coronary intervention. The first family of adenosine diphosphate P2Y12 receptors inhibiting drug is represented by thienopyridines and among these ticlopidine was the first approved by Food and Drug Administration; actually its use is discouraged because of its potential side effects (neutropenia, anemia, gastrointestinal distress and thrombotic thrombocytopenic purpura). The second generation of thienopyridines is represented by clopidogrel that has replaced ticlopidine in the clinical practice; clopidogrel has the largest clinical experience. Prasugrel represents the third generation. It inhibits platelet aggregation by irreversibly blocking the adenosine diphosphate P2Y12 receptor. Ticagrelor, Cangrelor and Enilogrel represent the last generation of thienopyridines. This review is focused on the effects of adenosine diphosphate P2Y12 inhibitors.