Comparison of acute versus stable coronary syndrome in patients treated with the Magmaris scaffold: Two-year results from the Magmaris Multicenter Italian Registry.

BACKGROUND: The magnesium Magmaris scaffold is the latest resorbable technology with low thrombogenicity, short scaffolding time, and almost complete resorption at 12 months (95 %). As compared with stable coronary artery disease (SCAD), acute coronary syndrome (ACS) is associated with increased risk of adverse clinical outcome after percutaneous coronary intervention. We analyzed the data of the Magmaris Multicenter Italian Registry to compare clinical outcomes in SCAD versus ACS patients. METHODS: We evaluated the 24-month rates of target lesion failure (TLF) and scaffold thrombosis (ST). Device implantation procedures were performed according to the manufacturer's recommendations (proper patient/lesion selection, pre-dilatation, proper scaffold sizing, and post-dilatation). Dual antiplatelet therapy was terminated after 12 months. RESULTS: Data from 207 patients (145 SCAD and 62 ACS) were collected from July 2016 to June 2018. The 2-year follow-up compliance was 92.8 % (192 patients). At 2 years, TLF rates were 7.4 % in the SCAD group and 8.8 % in the ACS group (p = 0.7); ST rates were 0 % in the SCAD group and 1.8 % in the ACS group (p = 0.1). CONCLUSION: The 2-year clinical results from the Magmaris Multicenter Italian Registry are favorable in terms of TLF and ST, indicating the safety and effectiveness of the Magmaris scaffold in both SCAD and ACS patients.

Sheathless use of Supera stent minimizes access complications in antegrade femoral puncture: Technical note with case series.

Antegrade femoral puncture (AFP) is the preferred strategy to treat lower limb obstructive disease. However, the presence of vascular calcification may be associated with procedure related adverse events, impairing endovascular device strategies. We describe a case series of superficial femoral and popliteal artery treatments by Supera stent implantation using a simple technique to significantly minimize the dimension of the antegrade femoral puncture from 6 to 4 French (Fr). All antegrade femoral punctures, crossing femoro-popliteal lesion and predilation were made with 4 Fr introducer. After preparation the Supera stent was navigated in sheathless fashion via 0.018-inch guidewire. Postdilation and final control were made replacing the 4 Fr introducer via the same guidewire. A good final result was achieved. Patients were discharged early without any complications. This minimally invasive technique in cases of infrainguinal peripheral artery disease could be feasible and effective for minimizing the risk of complications in patients with critical limb ischemia.

Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry.

BACKGROUND: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12-months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first patients suitable for MRS enrolled in 4 Italian centers. METHODS: We evaluated 12- and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months. RESULTS: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% diabetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all patients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (including 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implantation). None of the patients died for a cardiac reason. CONCLUSION: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term performance with only 2% rate of TLF increase and no ST after 1 year.

The BIOFLOW-III Italian Satellite Registry: 18-month results of the Orsiro stent in an all-comer high-risk population.

AIMS: We aimed to corroborate clinical evidence on the safety and efficacy of the ultrathin-strut biodegradable-polymer sirolimus-eluting Orsiro stent in an all-comer population including high-risk subgroups. METHODS: The nationwide, prospective, all-comer BIOFLOW-III Satellite Registry was conducted at 18 Italian sites. High-risk subgroups [diabetes, small vessels (≤2.75 mm), acute myocardial infarction (AMI), and chronic total occlusions (CTOs)] were prespecified. The primary endpoint was target lesion failure (TLF) at 12 months, a composite of cardiac death, target vessel myocardial infarction (MI), emergent coronary artery bypass graft, and clinically driven target lesion revascularization (TLR). RESULTS: In all, 601 patients were enrolled (31.9% diabetes, 34.6% AMIs) with 736 lesions (37.2% small vessels, 5.7% CTOs, and 15.5% bifurcation lesions). Cumulative TLF rate at 12 months was 4.6% [95% confidence interval (CI) 3.2-6.6]: 6.9% (95% CI 4.1-11.6) in the diabetic patients, 5.0% (95% CI 2.7-9.1) in acute MI subgroup, 4.2% (95% CI 2.3-7.7) in small vessels, and 5.3% (95% CI 1.4-19.7) in CTOs. At 18-month follow-up, TLF, target vessel revascularization, and clinically driven TLR rates in the overall population were 5.2% (95% CI 3.7-7.4), 1.8% (95% CI 1.0-3.3), and 1.6% (95% CI 0.8-3.1), respectively. Probable stent thrombosis rate was 0.5% (95% CI 0.1-1.4), whereas no definite stent thrombosis was observed. CONCLUSIONS: The study results confirmed the excellent clinical performance of the Orsiro drug-eluting stents at 18 months in the whole all-comer population and in the prespecified high-risk subgroups.

Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus.

OBJECTIVES: This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. BACKGROUND: The PF-AES has shown promising preliminary results in patients with DM. METHODS: Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). RESULTS: After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005). CONCLUSIONS: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.

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.

One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients: Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTre rEgistry).

BACKGROUND: Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. METHODS: 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. RESULTS: 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. CONCLUSIONS: The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.

Directional atherectomy of a heavy calcified axillary artery stenosis inducing critical hand ischemia.

The presence of a severe calcified peripheral artery lesion is responsible for a poor response to balloon dilation, due to significant acute vessel recoil and frequent flow-limiting dissections requiring stent implantation. This possibility could be associated with very high compression and/or fracture rates particularly in cases of lesion located at the mobile joints. In this setting directional atherectomy offers the theoretical advantages of eliminating stretch injury on arterial walls and reducing the restenosis rate by direct plaque excision. In this report, we present a case of critical hand ischemia due to a heavily calcified axillary artery lesion managed by directional atherectomy and balloon angioplasty followed by immediate angiographic success and sustained clinical benefit up to 3 years of follow-up.

Acute Coronary Syndrome in Pre- and Post-partum Women - A Review.

Acute coronary syndrome (ACS) during pregnancy and the post-partum period are weighed by a high mortality rate for the mother and foetus. They should be considered as multifactorial diseases with a special role for sexual hormones. In this setting, ACS is mostly related to an early atherosclerotic disease, even if other conditions are responsible. Indeed, an important part is due to spontaneous coronary artery dissection, more common during delivery and the post-partum period. In the remaining situation, an isolated intracoronary thrombus or a normal angiographic pattern can be found at angiography. Pathophysiology is still uncertain with different hypothetical mechanisms. Prompt diagnosis of ACS and aetiology are essential for an optimal therapeutic strategy. Difficulties in treatment management is a matter for debate, especially in pre-partum women. In the last two decades improvements of diagnostic tools, coronary angiography and subsequent percutaneous treatment have changed the natural history of this rare condition.

Myocardial ischemia due to a large coronary-pulmonary fistula with plexus-like morphology.

Congenital coronary-pulmonary artery fistula is a rare anomaly. We report the case of a coronary-pulmonary artery fistula with plexus-like morphology connecting the left main stem and proximal segments of the left anterior descending and circumflex coronary arteries to the main pulmonary artery in a 69-year-old woman. It caused inducible ischemia as revealed by myocardial perfusion tetrafosmin scintigraphy (Tc-99m SPECT). To our knowledge, no case of a large plexus-like coronary-pulmonary artery fistula from the very proximal left coronary artery has been reported. Furthermore, only a few cases report scintigraphic demonstration of severe ischemia in such a coronary anomaly.

Smooth muscle cells in human atherosclerotic plaques secrete and proliferate in response to high mobility group box 1 protein.

High mobility group box 1 protein (HMGB1) is a chromatin component leaked out by necrotic cells and actively secreted by activated myeloid cells. The extracellular protein is a potent mediator of tissue remodeling. We show here that human atherosclerotic plaques, but not normal arteries, produce extracellular HMGB1. Secreted HMGB1 originates from endothelial cells, by neointimal foam cells, and also smooth muscle cells (SMCs). SMCs are an unexpected source for secreted HMGB1, since they normally express much lower amounts of HMGB1 than other cells types, and they do not secrete it. However, cultured SMCs actively secrete HMGB1 after cholesterol loading. In turn, in response to HMGB1, SMCs proliferate, migrate, and secrete more HMGB1. Thus, SMCs are both a source and a target of HMGB1; blocking HMGB1 secretion by SMCs can be an important strategy for treatment of atherosclerotic disease and in particular restenosis.