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Abstract: In patients on oral anticoagulant (OAC) therapy undergoing percutaneous coronary intervention (PCI) with stent, international guidelines endorse the use of direct oral anticoagulants (DOAC) rather than vitamin K antagonists (VKA) and dual antithrombotic therapy (DAT) rather than triple antithrombotic therapy (TAT). The aim of this study was to evaluate contemporary real-world data on antithrombotic regimens and outcome in patients on OAC undergoing PCI with stent. Consecutive patients on OAC undergoing PCI were enrolled in the multicenter, prospective, observational PERSEO registry (NCT03392948). Primary end point was net adverse clinical events (NACE) with VKA versus DOAC, whereas a secondary prespecified end point was NACE with DAT versus TAT both at 1-year follow-up. From February 2018 to February 2022; in total, 1234 consecutive patients were included. The main indication for OAC was atrial fibrillation (86%), and the mean CHA 2 DS 2 VASc and HAS-BLED scores were 4 ± 2 and 3.6 ± 1, respectively. Of the 1228 patients discharged alive, 222 (18%) were on VKA and 1006 (82%) on DOAC ( P < 0.01). DAT was employed in 197 patients whereas TAT in 1028. At follow-up, NACE rate was significantly higher than VKA compared with DOAC (23% vs. 16%, P = 0.013) and confirmed after propensity score adjustment. TAT and DAT did not differ as regards NACE rate (17% vs. 19%, P = 0.864) although, compared with TAT, DAT was associated with less major bleedings (2% vs. 5%, P = 0.014), confirmed after propensity score adjustment. In conclusion, in patients on OAC undergoing PCI, DOAC, compared with VKA, was associated with a significantly lower occurrence of NACE and DAT reduced bleedings compared with TAT., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population., Methods: The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year., Results: A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients., Conclusion: In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Tarantini, Cardaioli, De Iaco, Tuccillo, De Angelis, Mauro, Boccalatte, Trivisonno, Ribichini, Vadalà, Caramanno, CaTarantini, Cardaioli, De Iaco, Tuccillo, De Angelis, Mauro, Boccalatte, Trivisonno, Ribichini, Vadalà, Caramanno, Caruso, Lombardi, Fischetti, Danesi, Abbracciavento, Lorenzoni, Gregori, Panza, Nai Fovino and Espositoruso, Lombardi, Fischetti, Danesi, Abbracciavento, Lorenzoni, Gregori, Panza, Nai Fovino and Esposito.)

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Background: Interventional radiology and cardiology procedures contribute significantly to the collective dose of radiation exposure from medical interventions. Recent and dedicated studies comparing directly these procedures in term of patient radiation exposure are lacking. Our aim was to compare radiation exposure among different interventional procedures performed under fluoroscopic guidance., Methods: The RODEO study (NCT: 02972736) is an international observational retrospective multicenter study enrolling all patients undergoing diagnostic or interventional procedures performed by different interventional operators (i.e. radiologists, interventional cardiologists or electrophysiologists) in 6 centers, without exclusion criteria. The primary end-point of the study was the comparison of dose area product (DAP) among interventional cardiology, electrophysiology or interventional radiology procedures., Results: A total of 17,711 procedures were included in the study: 13,522 interventional cardiology, 2352 electrophysiology and 1864 interventional radiology procedures. The highest DAP values were observed for interventional radiology procedures (74Gy∗cm 2 [Interquartile range 27-178Gy∗cm 2 ]), followed by interventional cardiology (40Gy∗cm 2 [22-78Gy∗cm 2 ]) and electrophysiology procedures (13Gy∗cm 2 [4-44Gy∗cm 2 ], p<0.0001). In term of specific procedures, the highest DAP values were observed in structural or valvular cardiac procedures (134Gy∗cm 2 [51-260Gy∗cm 2 ]) whereas the lowest DAP values in pacemaker insertion (11Gy∗cm 2 [4-28Gy∗cm 2 ])., Conclusion: In this large multicenter study, the highest radiation exposure was observed in procedures performed by interventional radiologists. However, among specific procedures, structural or valvular cardiac procedures were associated with the highest radiation exposure., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study., Methods and Results: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%., Conclusions: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.

Background: It remains unclear whether radial access (RA), compared with femoral access (FA), mitigates the risk of acute kidney injury (AKI)., Objectives: The authors assessed the incidence of AKI in patients with acute coronary syndrome (ACS) enrolled in the MATRIX-Access (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial., Methods: Among 8,404 patients, 194 (2.3%) were excluded due to missing creatinine values, no or an incomplete coronary angiogram, or previous dialysis. The primary AKI-MATRIX endpoint was AKI, defined as an absolute (>0.5 mg/dl) or a relative (>25%) increase in serum creatinine (sCr)., Results: AKI occurred in 634 patients (15.4%) with RA and 712 patients (17.4%) with FA (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.77 to 0.98; p = 0.0181). A >25% sCr increase was noted in 633 patients (15.4%) with RA and 710 patients (17.3%) with FA (OR: 0.87; 95% CI: 0.77 to 0.98; p = 0.0195), whereas a >0.5 mg/dl absolute sCr increase occurred in 175 patients (4.3%) with RA versus 223 patients (5.4%) with FA (OR: 0.77; 95% CI: 0.63 to 0.95; p = 0.0131). By implementing the Kidney Disease Improving Global Outcomes criteria, AKI was 3-fold less prevalent and trended lower with RA (OR: 0.85; 95% CI: 0.70 to 1.03; p = 0.090), with stage 3 AKI occurring in 28 patients (0.68%) with RA versus 46 patients (1.12%) with FA (p = 0.0367). Post-intervention dialysis was needed in 6 patients (0.15%) with RA and 14 patients (0.34%) with FA (p = 0.0814). Stratified analyses suggested greater benefit with RA than FA in patients at greater risk for AKI., Conclusions: In ACS patients who underwent invasive management, RA was associated with a reduced risk of AKI compared with FA. (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transradial approach (TRA) for percutaneous coronary interventions (PCIs) is a common alternative to transfemoral approach associated with lower complications. However, a limitation of TRA is the use of large caliber guiding catheters due to the small size of the radial artery. The sheathless guiding catheter system that is in diameter 1-2 French (Fr) smaller than the corresponding introducer sheath may overcome these difficulties., Methods: From January 2010 through December 2010 in 5 Italian high-volume hospitals, 213 consecutive patients who underwent TRA-PCIs using the sheathless Eaucath guiding catheter system because of small radial artery caliber (Group 1) or undergoing bifurcation PCIs (Group 2) were enrolled in this registry. In patients of Group 1 (n = 79), a 6.5-Fr sheathless guiding catheter was employed, whereas in patients of Group 2 (n = 134) a 7.5 Fr was used., Results: Among the 213 patients enrolled, 270 vessels were treated for 316 lesions. No procedures required conversion to a conventional guiding catheter system. There were significantly more female patients in Group 1, and they were, older, shorter, and thinner than patients in Group 2. No cases of major vascular complications were observed in either groups. During procedures, adjunctive devices employed included intravascular ultrasound, thrombectomy catheters, and distal protection systems., Conclusions: The use of the sheathless guiding catheter system is feasible for TRA-PCIs in case of small radial artery caliber or intended coronary bifurcation intervention., (©2011, Wiley Periodicals, Inc.)

Background: Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) may improve discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfort associated with percutaneous coronary procedures employing RA or VCDs., Methods: We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoral approach with manual compression (MC) (276 procedures), or with either Angioseal (311 procedures) or Starclose (301 procedures) closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated during hospitalization., Results: RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p=0.03) or the VCDs (Starclose 2.7%, Angioseal 3.9%, p=0.003). There were no significant differences in major complications between MC and either the Angioseal or the Starclose. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI 0.08-0.85, p=0.03 vs MC, and OR 0.19, 95% CI 0.07-0.57, p=0.003 vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% of patients referring no discomfort (p<0.0001). Starclose and Angioseal were better tolerated than MC (27.8%, 29.3% and 8.9% patients respectively without discomfort, p<0.0001)., Conclusions: RA is associated with a significant reduction in major vascular complications compared to femoral approach even if two different VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort.

Objectives: This study sought to investigate potential protective effects of atorvastatin in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI)., Background: Randomized studies have shown that pretreatment with atorvastatin may reduce periprocedural myocardial infarction in patients with stable angina during elective PCI; however, this therapy has not been tested in patients with ACS., Methods: A total of 171 patients with non-ST-segment elevation ACS were randomized to pretreatment with atorvastatin (80 mg 12 h before PCI, with a further 40-mg preprocedure dose [n = 86]) or placebo (n = 85). All patients were given a clopidogrel 600-mg loading dose. All patients received long-term atorvastatin treatment thereafter (40 mg/day). The main end point of the trial was a 30-day incidence of major adverse cardiac events (death, myocardial infarction, or unplanned revascularization)., Results: The primary end point occurred in 5% of patients in the atorvastatin arm and in 17% of those in the placebo arm (p = 0.01); this difference was mostly driven by reduction of myocardial infarction incidence (5% vs. 15%; p = 0.04). Postprocedural elevation of creatine kinase-MB and troponin-I was also significantly lower in the atorvastatin group (7% vs. 27%, p = 0.001 and 41% vs. 58%, p = 0.039, respectively). At multivariable analysis, pretreatment with atorvastatin conferred an 88% risk reduction of 30-day major adverse cardiac events (odds ratio 0.12, 95% confidence interval 0.05 to 0.50; p = 0.004)., Conclusions: The ARMYDA-ACS trial indicates that even short-term pretreatment with atorvastatin may improve outcomes in patients with ACS undergoing early invasive strategy. These findings may support routine use of high-dose statins before intervention in patients with ACS.

Background: To better understand the mechanisms linking C reactive protein (CRP) to the risk of coronary thrombosis, we investigated the relation between inflammatory state and hemostatic response to coronary angioplasty in patients with either stable or unstable angina., Methods: Plasma levels of von Willebrand factor (vWF) antigen, vWF collagen binding activity, vWF-cleaving-protease, CRP, and whole-blood platelet reactivity were measured before and 24 h after angioplasty in 18 patients with recent unstable angina and in 17 with stable angina. Each group was divided according to preprocedural CRP levels: >or=3 mg/l (in 9 unstable and 9 stable patients) or <3 mg/l (in 9 unstable and 8 stable patients)., Results: Baseline hemostatic parameters did not differ significantly among the four subgroups of patients. After angioplasty, virtually all patients with unstable angina and raised preprocedural CRP showed increased vWF antigen (P = 0.01), vWF collagen-binding (P = 0.001), CRP (P = 0.008), and platelet reactivity (P = 0.0007) compared to baseline, whereas no significant change of these variables was seen within the other three sets of patients. In the overall population, the changes in vWF antigen and vWF-collagen-binding induced by angioplasty correlated with those in CRP levels (r = 0.47, P = 0.004 and r = 0.44, P = 0.008). Baseline levels of vWF cleaving protease and modifications of this enzyme with angioplasty did not differ significantly among subgroups., Conclusions: Our data suggest that high preprocedural levels of CRP predict a significant vWF rise after angioplasty in patients with unstable angina. The rise in vWF is associated with that in CRP and with enhanced platelet reactivity. Such changes may contribute to the worse prognosis of unstable patients with raised indices of inflammation.