Physiological and angiographic outcomes of PCI in calcified lesions after rotational atherectomy or intravascular lithotripsy.

BACKGROUND: Percutaneous coronary interventions (PCI) in calcified coronary artery lesions are associated with impaired stent expansion, higher rate of periprocedural complications and cardiac mortality. Lesion preparation using calcium modifying techniques such as Rotational Atherectomy (RA) or Intravascular Lithotripsy (IVL) has been advocated. Studies comparing these technologies are lacking. We aimed to compare in-stent pressure gradients, evaluated by vessel fractional flow reserve (vFFR), in calcific lesions treated using either RA or IVL. METHODS: Patients undergoing either RA- or IVL-assisted PCI from two European centers were included. Propensity score matching (1:2) was performed to control for potential bias. Primary outcome was post-PCI in-stent pressure gradients calculated by vFFR (vFFRgrad). Secondary outcomes included the proportion of patients with complete functional revascularization defined as distal vFFR post-PCI (vFFRpost) ≥ 0.90. RESULTS: From a cohort of 210 patients, 105 matched patients (70 RA and 35 IVL) were included. Pre-PCI vFFR did not differ between groups (0.65 ± 0.13 RA and 0.67 ± 0.11 IVL). After PCI, in-stent pressure gradients were significantly lower in the IVL group (0.032 ± 0.026 vs 0.043 ± 0.026 in the RA group, p = 0.024). The proportions of vessels with functional complete revascularization was similar between the two groups (32.9% vs. 37.1% in the RA and IVL group, respectively; p = 0.669). CONCLUSIONS: Calcific lesions preparation with IVL is effective and resulted in lower in-stent pressure gradients compared to RA. Approximately one third of the patients undergoing PCI for a severely calcified lesion achieved functional revascularization with no difference between rotational RA and IVL.

Quantification of calcium burden by coronary CT angiography compared to optical coherence tomography.

Coronary artery calcifications (CAC) are frequently observed in patients referred for coronary CT angiography (CTA). Calcification volume (in mm3) can accurately be assessed during catheterization by optical coherence tomography (OCT). The aim of the present study was to investigate the accuracy of CTA-derived assessment of calcification volume as compared with OCT. 66 calcified plaques (32 vessels) from 31 patients undergoing OCT-guided PCI with coronary CT acquired as a standard of care were included. Coronary CT and OCT images were matched using fiduciary points. Calcified plaques were reconstructed in three dimensions to calculate calcium volume. A Passing-Bablok regression analysis and the Bland-Altman method were used to assess the agreement between imaging modalities. Twenty-seven left anterior descending arteries and 5 right coronary arteries were analyzed. Median calcium volume by CTA and OCT were 18.23 mm3 [IQR 8.09, 36.48] and 10.03 mm3 [IQR 3.6, 22.88] respectively; the Passing-Bablok analysis showed a proportional without a systematic difference (Coefficient A 0.08, 95% CI - 1.37 to 1.21, Coefficient B 1.61, 95% CI 1.45 to 1.84) and the mean difference was 9.69 mm3 (LOA - 10.2 to 29.6 mm3). No differences were observed for minimal lumen area (Coefficient A 0.07, 95% CI - 0.46 to 0.15, Coefficient B 0.85, 95% CI 0.64 to 1.2). CTA volumetric calcium evaluation overestimates calcium volume by 60% compared to OCT. This may allow for an appropriate interpretation of calcific burden in the non-invasive setting. Even in presence of calcific plaques, a good agreement in the MLA assessment was found. Coronary CT may emerge as a tool to quantify calcium burden for invasive procedural planning.

Ultra-low-dose CT for left atrium and pulmonary veins imaging using new model-based iterative reconstruction algorithm.

AIMS: To evaluate the feasibility of ultra-low-dose CT for left atrium and pulmonary veins using new model-based iterative reconstruction (MBIR) algorithm. METHODS AND RESULTS: Two hundred patients scheduled for catheter ablation were randomized into two groups: Group 1 (100 patients, Multidetector row CT (MDCT) with MBIR, no ECG triggering, tube voltage and tube current of 100 kV and 60 mA, respectively) and Group 2 [100 patients, MDCT with adaptive statistical iterative reconstruction algorithm (ASIR), no ECG triggering, and kV and mA tailored on patient BMI]. Image quality, CT attenuation, image noise, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR) of left atrium (LA) and pulmonary veins, and effective dose (ED) were evaluated for each exam and compared between two groups.No significant differences between groups in terms of population characteristics, cardiovascular risk factors, anatomical features, prevalence of persistent atrial fibrillation and image quality score. Statistically significant differences were found between Group 1 and Group 2 in mean attenuation, SNR, and CNR of LA. Significantly, lower values of noise were found in Group 1 versus Group 2. Group 1 showed a significantly lower mean ED in comparison with Group 2 (0.41 ± 0.04 versus 4.17 ± 2.7 mSv). CONCLUSION: The CT for LA and pulmonary veins imaging using MBIR is feasible and allows examinations with very low-radiation exposure without loss of image quality.

1-Year clinical outcomes of diabeticpatients treated with everolimus-elutingbioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials

Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treatedwith the Absorb bioresorbable vascular scaffold (BVS).Background Clinical outcomes of diabetic patients after BVS implantation have been unreported.Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients werecompared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimuselutingmetal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the AbbottVascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCEV Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus ElutingCoronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V EverolimusEluting Coronary Stent System]) were used for the comparison by applying propensity score matching.The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, targetvessel myocardial infarction, and target lesion revascularization at 1-year follow-up.Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patientstreated with the BVS (3.7% vs. 5.1%, p » 0.64). Diabetic patients treated with the BVS had a similarincidence of the DoCE compared with diabetic patients treated with EES in the matched study group(3.9% for the BVS vs. 6.4% for EES, p » 0.38). There were no differences in the incidence of definite orprobable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0%for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group).Conclusions In the present analyses, diabetic patients treated with the BVS showed...

Biological components in a standardized derivative of bovine colostrum.

Products of different origin, time of collection, and activities fall under the general term of colostrum and, therefore, great variability in composition as well as in the concentration of its components has been reported in the literature. In the present study, we describe the standardization of a bovine colostrum derivative and the characterization of its bioactive components. Evaluation of the most representative agents (lactoferrin, transferrin, IL-2, IFN-γ, tumor necrosis factor, IgG, and IgA) showed that a marked decrease in active components occurs after the first few hours. Bovine colostrum was, therefore, collected up to the fifth hour after delivery from Holstein cows, in the presence of preservatives, and immediately frozen. A protocol of centrifugation, filtration, and lyophilization was then applied to pools of colostrum from at least 30 cows to obtain a stable, sterile, standardized product. Preservatives were removed by dialysis. Evaluation of the active biological components of colostrum showed that the final product of colostrums contained significant and reproducible amounts of bioactive factors, including cytokines, immunomodulating factors, growth factors, and immunoglobulins. The final product appeared, therefore, as a sterile, pyrogen-free, standardized derivative of bovine colostrum with a high concentration of bioactive components.

Feasibility and diagnostic accuracy of a low radiation exposure protocol for prospective ECG-triggering coronary MDCT angiography.

AIM: To compare the feasibility, accuracy, and effective radiation dose (ED) of multidetector computed tomography (MDCT) in the detection of coronary artery disease using a combined ED-saving strategy including prospective electrocardiogram (ECG) triggering with a short x-ray window and a body mass index (BMI)-adapted imaging protocol using adaptive statistical iterative reconstruction (ASIR; group 1), in comparison with a prospective ECG triggering strategy alone (group 2). MATERIALS AND METHODS: One hundred and seventy patients scheduled for invasive coronary angiography (ICA) were evaluated. Fourteen patients were not eligible for MDCT. The remaining 156 patients were randomized to group 1 (78 patients) and group 2 (78 patients). Eight and 11 patients in groups 1 and 2, respectively, were excluded after randomization because the patients' heart rates were >65 beats/min. MDCT images were assessed for feasibility, signal-to-noise ration (SNR), and contrast-to-noise ratio (CNR), accuracy in detection of coronary stenoses >50% versus ICA and for ED. RESULTS: The feasibility, SNR, CNR, accuracy in a segment-based and patient-based model were similar in both groups (97 versus 95%, 14.5 ± 3.9 versus 14.2 ± 4.1, 16 ± 4.6 versus 16.5 ± 4.4, 95 versus 94% and 97 versus 99%, respectively). The ED in group 1 was 72% lower than in group 2 (2.1 ± 1.2 versus 7.5 ± 1.8 mSv, respectively; p<0.01). CONCLUSIONS: The use of a multi-parametric ED saving protocol results in a significant reduction in ED without a negative impact on accuracy.

Hemofiltration in the prevention of radiocontrast agent induced nephropathy.

AIM: The aim of the study was to investigate the role of hemofiltration in preventing contrast nephropathy in patients with renal failure. METHODS: We randomized 114 renal failure patients undergoing percutaneous coronary interventions (PCI) to either peri-procedural hemofiltration or saline hydration. RESULTS: Contrast nephropathy occurred in 5% of hemofiltration-treated patients and in 50% in controls (P<0.01). In-hospital event rate as well as in-hospital and 1-year mortality rates were lower in patients treated with hemofiltration. CONCLUSION: In patients with renal failure undergoing PCI, peri-procedural hemofiltration is effective for the prevention of contrast nephropathy, and is associated with improved in-hospital and long-term outcome.

Angiographic findings of the multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): sirolimus-eluting stents inhibit restenosis irrespective of the vessel size.

BACKGROUND: Restenosis remains the major limitation of coronary catheter-based intervention. In small vessels, the amount of neointimal tissue is disproportionately greater than the vessel caliber, resulting in higher restenosis rates. In the Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL) trial, approximately 40% of the vessels were small (<2.5 mm). The present study evaluates the relationship between angiographic outcome and vessel diameter for sirolimus-eluting stents. METHODS AND RESULTS: Patients were randomized to receive either an 18-mm bare metal Bx VELOCITY (BS group, n=118), or a sirolimus-eluting Bx VELOCITY stent (SES group, n=120). Subgroups were stratified into tertiles according to their reference diameter (RD; stratum I, RD <2.36 mm; stratum II, RD 2.36 mm to 2.84 mm; stratum III, RD >2.84 mm). At 6-month follow-up, the restenosis rate in the SES group was 0% in all strata (versus 35%, 26%, and 20%, respectively, in the BS group). In-stent late loss was 0.01+/-0.25 versus 0.80+/-0.43 mm in stratum I, 0.01+/-0.38 versus 0.88+/-0.57 mm in stratum II, and -0.06+/-0.35 versus 0.74+/-0.57 mm in stratum III (SES versus BS). In SES, the minimal lumen diameter (MLD) remained unchanged (Delta -0.72 to 0.72 mm) in 97% of the lesions and increased (=late gain, DeltaMLD <-0.72 mm) in 3% of the lesions. Multivariate predictors for late loss were treatment allocation (P<0.001) and postprocedural MLD (P= 0.008). CONCLUSIONS: Sirolimus-eluting stents prevent neointimal proliferation and late lumen loss irrespective of the vessel diameter. The classic inverse relationship between vessel diameter and restenosis rate was seen in the bare stent group but not in the sirolimus-eluting stent group.

Contemporary antithrombotic strategies in patients undergoing coronary stent implantation.

The number of annual stenting procedures has been increasing at a rapid pace since coronary stents were first used in clinical practice just over a decade ago. Subacute stent thrombosis, which usually has serious clinical consequences, plagued the stent early experience despite intense anticoagulation therapy. The reduction of stent thrombosis was among the factors that contributed to stent growth and widespread acceptance in recent years. This was the result of improved implantation techniques, advances in adjunctive pharmacotherapy and evolution in stent designs, delivery systems and non-thrombogenic coatings. However, novel designs and materials customized for particular lesion types and newer anti-restenotic treatments could influence stent thrombogenicity. Intravascular brachytherapy and drug-eluting stents have been shown to reduce the incidence of in-stent restenosis preventing cellular proliferation. However, by interfering with the re-endothelization process they may also increase the risk of stent thrombosis. To prevent a recrudescence of this feared complication, future research direction must focus on the hemocompatibility aspects of new technologies, along with further refinement of stent-deployment techniques and antithrombotic strategies.

Patent ductus arteriosus closure using the new Amplatzer Duct Occluder. Preliminary results and review of the literature.

BACKGROUND: Patent ductus arteriosus (PDA) is the second most common congenital heart disease. A large number of surgical and transcatheter techniques for the interruption or closure of PDA has been reported. The aim of this study was to assess the immediate and short-term results of transcatheter closure of PDA using the new, self-expandable, self-centering, and repositionable Amplatzer Duct Occluder device. METHODS: We attempted occlusion of PDA with the Amplatzer Duct Occluder in seven consecutive patients, one child and six adults, four females and three males, between September 1999 and January 30th 2000. All PDAs but one were approached from the femoral venous site; the Amplatzer Duct Occluder size was selected in order to be 2 mm larger than the duct's diameter at its narrowest site and the mean PDA diameter was 5.4+/-2.5 mm (range 3-9). All patients underwent physical examination, chest X-ray and echocardiography within 48 hours and on first and third month after PDA occlusion. RESULTS: Four patients had a megaphone type (type A), and three had an elongated, conical type (type E) PDA. Four patients had immediate, complete angiographic closure of the ductus 10 minutes after the procedure, one had a trace shunt and two had small shunts which all disappeared within 48 hours. The average fluoroscopy time and procedural time were 34.4+/-10.6 min (range 21-50) and 105+/-38.9 min (range 75-190) respectively. There were no complications at follow-up. CONCLUSIONS: Transcatheter closure of PDA using the new Amplatzer Duct Occluder is an easy and effective technique. Moreover it is safe even in the presence of wide PDAs.

Transcatheter treatment of coronary artery disease and atrial septal defect with sequential implantation of coronary stent and Amplatzer septal occluder: preliminary results.

Coronary stent implantation had been established as a highly effective revascularization technique in patients with occlusive coronary artery disease. Transcatheter closure of atrial septal defects is becoming a definite alternative to surgery in properly selected patients. During a 19-month period, 6 patients (50% women; mean age, 58 +/- 17 years; range, 32-73 years) of a consecutive series of 176 prospective multicenter registry patients undergoing transcatheter atrial septal defect closure were treated with sequential percutaneous coronary revascularization and Amplatzer septal occluder implantation. Indication for revascularization was stable angina in four patients and unstable angina in two. Indication for defect closure was significant left-to-right shunt with right ventricular enlargement. Defect diameter ranged from 13 to 20 mm by transesophageal echocardiography, and the stretched diameter measured 13 to 25 mm. Procedural success of both interventions was achieved in all cases without in-hospital complications. A total of seven stents were successfully implanted in five coronary vessels. No stent was used in one patient after successful PTCA. Immediate total closure of the defect was obtained in five patients. Trivial residual shunting, observed in one patient, disappeared at 24 hr. No adverse cardiac events, recurrence of anginal symptoms, or evidence of residual shunt were observed at clinical and echocardiographic follow-up, which ranged from 60 to 390 days (mean, 258 +/- 150 days). These results suggest that sequential transcatheter therapy of coronary artery disease and atrial septal defect is safe and efficacious in selected patients.

Endovascular repair of latrogenic subclavian artery perforations using the Hemobahn stent-graft.

PURPOSE: To report the use of a new self-expanding endograft for percutaneous treatment of iatrogenic subclavian artery perforations. CASE REPORTS: The subclavian artery of 2 patients was inadvertently cannulated during percutaneous attempts to implant a permanent pacemaker in one and catheterize the subclavian vein in the other. Because both patients had serious comorbidities, endovascular repair of the subclavian perforations was performed using the Hemobahn endograft, a nitinol stent covered internally with expanded polytetrafluoroethylene. The endoprostheses were successfully deployed via an ipsilateral brachial artery access. No signs of endograft occlusion, migration, deformation, or fracture have been observed during follow-up at 12 and 10 months, respectively, in these patients. CONCLUSIONS: The Hemobahn stent-graft appears well suited to repairing subclavian artery injuries. Longer follow-up will determine if the design of this endograft will resist compression in this vascular location.

Effect of the single major proteic fractions of the liver perchloric extract UK101 on the development of oral tumours in Syrian hamsters.

Squamous cell carcinoma of the oral cavity continues to be a major clinical problem, with about 100,000 new deaths each year worldwide. There is therefore a need to search for new tools to aid oral cancer treatment. We tested the inhibitory activity on chemical carcinogenesis of the three principal protein fractions of about 50, 14, and 8.5 kDa of the mixture UK101 derived from goat liver. These are composed principally of a glycoprotein rich in mannose residues, a protein with analogy to the heat shock protein family, and ubiquitin, respectively. The animal model employed was dimethylbenzanthracene-induced hamster cheek pouch carcinoma. Number of tumours per animal, tumour mass per animal, and proliferating cell nuclear antigen (PCNA) in non-tumour mucosa were quantified: the 14-kDa fraction was the most active; this was also confirmed by testing its corresponding recombinant material. The 50-kDa fraction was inactive, while the ubiquitin showed only low inhibitory activity. It is possible that the technique described and the results obtained could lead to an interesting clinical approach to the treatment of oral cancer.

MFP14, a multifunctional emerging protein with immunomodulatory properties, prevents spontaneous and recurrent autoimmune diabetes in NOD mice.

AIMS/HYPOTHESIS: To test the effects of multifunctional protein 14 (MFP14), which shares structural homology with heat shock proteins (HSPs), on the development of Type I (insulin-dependent) diabetes mellitus in NOD mice. METHODS: MFP14 was given to euglycaemic female NOD mice from either the 4th to the 25th or from the 12th until the 35th week, or commencing one day before islet transplantation and until the reappearance of hyperglycaemia. Pancreata from NOD mice treated with multifunctional protein 14 for 14 consecutive weeks until 18 weeks of age were examined histologically for insulitis. Anti-CD3 and/or lipopolysaccharide (LPS)-induced blood levels of interferon (IFN)-gamma, interleukin (IL)-4, IL-10, IL-12 and tumour necrosis factor (TNF)-alpha were measured by ELISA in 10 week-old female NOD mice treated for 6 consecutive weeks with either MFP14 or PBS. Unless otherwise stated, multifunctional protein 14 was administered daily 5 times a week at a dose of 25 microg. Control mice received PBS or, in selected experiments, heat-inactivated MFP14. RESULTS: MFP 14 treated mice had a significantly lower incidence of spontaneous diabetes compared to control mice. The MFP14 was equally effective both upon early and late prophylaxis and the protection persisted until week 50 in mice treated from weeks 4 to 25. Insulitis was significantly reduced by the MFP14. The MFP14 also delayed recurrence of hyperglycaemia in syngeneic islet-transplanted NOD mice. Although MFP14 reduced anti-CD3 and/or LPS-induced blood levels of IFN-gamma, TNF-alpha and IL-12 it increased IL-4 and IL-10. CONCLUSION/INTERPRETATION: The MFP14 could be a possible candidate for the prevention or early treatment of human Type I (insulin-dependent) diabetes mellitus.

Extent and distribution of in-stent intimal hyperplasia and edge effect in a non-radiation stent population.

Intimal hyperplasia within the body of the stent is the primary mechanism for in-stent restenosis; however, stent edge restenosis has been described after brachytherapy. Our current understanding about the magnitude of in vivo intimal hyperplasia and edge restenosis is limited to data obtained primarily from select, symptomatic patients requiring repeat angiography. The purpose of this study was to determine the extent and distribution of intimal hyperplasia both within the stent and along the stent edge in relatively nonselect, asymptomatic patients scheduled for 6-month intravascular ultrasound (IVUS) as part of a multicenter trial: Heparin Infusion Prior to Stenting. Planar IVUS measurements 1 mm apart were obtained throughout the stent and over a length of 10 mm proximal and distal to the stent at index and follow-up. Of the 179 patients enrolled, 140 returned for repeat angiography and IVUS at 6.4 +/- 1.9 months and had IVUS images adequate for analysis. Patients had 1.2 +/- 0.6 Palmaz-Schatz stents per vessel. There was a wide individual variation of intimal hyperplasia distribution within the stent and no mean predilection for any location. At 6 months, intimal hyperplasia occupied 29.3 +/- 16.2% of the stent volume on average. Lumen loss within 2 mm of the stent edge was due primarily to intimal proliferation. Beyond 2 mm, negative remodeling contributed more to lumen loss. Gender, age, vessel location, index plaque burden, hypercholesterolemia, diabetes, and tobacco did not predict luminal narrowing at the stent edges, but diabetes, unstable angina at presentation, and lesion length were predictive of in-stent intimal hyperplasia. In a non-radiation stent population, 29% of the stent volume is filled with intimal hyperplasia at 6 months. Lumen loss at the stent edge is due primarily to intimal proliferation.

Prevention and treatment of lethal murine endotoxemia by the novel immunomodulatory agent MFP-14.

Multifunctional protein 14 (MFP-14) is a ubiquitous protein that inhibits the production of tumor necrosis factor alpha (TNF-alpha) and gamma interferon (IFN-gamma), which are involved in the pathogenesis of sepsis. Here, lipopolysaccharide (LPS)-induced lethality in mice was markedly reduced by MFP-14. The treatment also lowered LPS-induced levels of TNF-alpha and IFN-gamma in the blood.

Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent.

UNLABELLED: Rapid technological developments have made new materials available for percutaneous coronary intervention procedures. The coronary stent in particular has undergone progressive structural improvements leading to the recent availability of a third generation of stents, namely, coated stents. The rapid evolution of the stent has often made its evaluation problematical, since trials are frequently confined to small groups of patients in single centers. The purpose of this registry was to verify the safety and efficacy of the BiodivYsio stent (a stent coated with phosphorylcholine polymer) in a broad population of patients who reflect the daily reality of coronary intervention in a cardiac catheterization laboratory. METHODS AND RESULTS: The registry was designed to collect the principal angiographic and clinical data of a consecutive series of Oreal worldO patients. Patients were treated with a BiodivYsio stent (Biocompatibles, Galway, United Kingdom) in 12 centers (11 Italian and 1 Swiss) between January 1998 and January 1999. Procedural, in-hospital, 30-day and six-month follow-up data were collected. The monitoring, data entry and statistical analyses were carried out by an independent center. During the study, 218 patients were enrolled; 165 (76%) male and 53 (24%) female, with an average age of 61.6 +/- 9.4 years (range, 36Eth 84 years). A total of 258 stents were implanted in 233 lesions (1.1 stents per lesion), of which 233 (90%) were the BiodivYsio PC coated stent, the remaining 25 implants were of other stent types. The percutaneous transluminal coronary angioplasty and stenting procedure were carried out in 109 (50%) patients with unstable angina, 65 (30%) with stable angina, 29 (13%) with acute myocardial infarction, and 15 (7%) patients with silent ischemia. Procedural success was achieved in 217/218 (99.5%) patients. Optimal results were achieved in 212 (97.7%) patients. In 34 (15.6%) cases, patients were treated with periprocedural abciximab. During the hospitalization period, one (0.4%) death occurred on day 7 due to subacute occlusion of the stent, and 3 (1.4%) myocardial infarctions were reported. At 30-day follow-up, 211 (97.2%) patients were asymptomatic, as were 189 (87%) patients at clinical follow-up at 6 months. CONCLUSIONS: This study evaluated the safety and efficacy of a third-generation stent. The results demonstrate a high procedural success rate and a low incidence of major adverse cardiac events at short- and medium-term follow-up. It appears that the BiodivYsio stent should be considered safe in clinical and/or anatomical situations with a high risk of complications, confirming the hypothesis that PC may have non-thrombogenic properties. To corroborate these results, an appropriately designed study would be required to measure the stentOs efficacy in the most suitable clinical context, i.e., clinical situations that are at the highest risk of ischemic relapse.