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1.
Cardiovasc Diabetol ; 23(1): 52, 2024 02 03.
Article in English | MEDLINE | ID: mdl-38310281

ABSTRACT

BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings. RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.


Subject(s)
Coronary Artery Disease , Coronary Restenosis , Diabetes Mellitus , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/complications , Sirolimus/adverse effects , Percutaneous Coronary Intervention/adverse effects , Treatment Outcome , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Diabetes Mellitus/diagnosis , Diabetes Mellitus/epidemiology , Diabetes Mellitus/chemically induced , Registries , Coronary Restenosis/epidemiology , Coronary Restenosis/etiology
2.
JACC Cardiovasc Interv ; 16(14): 1794-1803, 2023 07 24.
Article in English | MEDLINE | ID: mdl-37495352

ABSTRACT

BACKGROUND: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications. OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease. METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee. RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881). CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease , Coronary Restenosis , Myocardial Infarction , Humans , Middle Aged , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/complications , Angioplasty, Balloon, Coronary/adverse effects , Sirolimus/adverse effects , Treatment Outcome , Myocardial Infarction/complications , Registries , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology
3.
J Cardiovasc Med (Hagerstown) ; 22(2): 94-100, 2021 02 01.
Article in English | MEDLINE | ID: mdl-32740442

ABSTRACT

AIMS: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. METHODS: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coated Materials, Biocompatible , Coronary Artery Disease/surgery , Drug-Eluting Stents , Registries , Sirolimus/pharmacology , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/pharmacology , Male , Prospective Studies , Time Factors , Treatment Outcome
5.
Future Cardiol ; 16(6): 635-643, 2020 11.
Article in English | MEDLINE | ID: mdl-32519916

ABSTRACT

Background: Epicardial fat increase has not yet a clear correlation with coronary artery disease (CAD). Aim: This study had as goal to demonstrate a relationship between an increase of epicardial fat thickness (EFT) and CAD. Materials & methods: In this observational study, we included 234 patients who underwent invasive coronary angiography. Before invasive coronary angiography, all patients underwent echocardiographic-2D for evaluation of EFT and they were divided into groups based on Gensini score and also on Syntax score. Results: EFT was significantly correlated to the presence and severity of CAD assessed by Gensini score with a cut-off value of 5.2 mm (sensitivity of 90.9%-specificity of 87.3%- area under the ROC curve = 92.1%). Conclusion: EFT increase (fat index ≥5.2 mm) evaluated by echocardiographic-2D could be considered as a risk factor for predicting CAD.


Subject(s)
Coronary Artery Disease , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Echocardiography , Humans , Severity of Illness Index
6.
J Interv Cardiol ; 2019: 6548696, 2019.
Article in English | MEDLINE | ID: mdl-31772539

ABSTRACT

OBJECTIVES: We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. METHODS: By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. RESULTS: Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. CONCLUSIONS: Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.


Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Postoperative Complications/epidemiology , Aged , Coronary Angiography/methods , Coronary Artery Disease/diagnosis , Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/pathology , Female , Humans , Male , Middle Aged , Organ Size , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Propensity Score , Treatment Outcome
7.
Catheter Cardiovasc Interv ; 93(2): 181-188, 2019 02 01.
Article in English | MEDLINE | ID: mdl-30280482

ABSTRACT

OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Coated Materials, Biocompatible , Coronary Artery Disease/therapy , Aged , Angioplasty, Balloon, Coronary/adverse effects , Coronary Artery Disease/diagnostic imaging , Equipment Design , Europe , Female , Humans , Malaysia , Male , Middle Aged , Prospective Studies , Registries , Risk Factors , Time Factors , Treatment Outcome
8.
Int J Cardiol ; 245: 69-76, 2017 Oct 15.
Article in English | MEDLINE | ID: mdl-28874301

ABSTRACT

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.


Subject(s)
Absorbable Implants/standards , Coronary Artery Disease/surgery , Diabetes Mellitus/surgery , Drug-Eluting Stents/standards , Polymers , Sirolimus/analogs & derivatives , Aged , Anti-Inflammatory Agents/administration & dosage , Cohort Studies , Coronary Artery Disease/epidemiology , Coronary Artery Disease/physiopathology , Diabetes Mellitus/epidemiology , Diabetes Mellitus/physiopathology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/standards , Registries , Sirolimus/administration & dosage
9.
Int J Cardiol ; 231: 54-60, 2017 Mar 15.
Article in English | MEDLINE | ID: mdl-28104306

ABSTRACT

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.


Subject(s)
Acute Coronary Syndrome/surgery , Coronary Restenosis/prevention & control , Drug-Eluting Stents , Graft Occlusion, Vascular/prevention & control , Myocardial Revascularization/methods , Platelet Aggregation Inhibitors/therapeutic use , Polymers , Acute Coronary Syndrome/drug therapy , Aged , Coronary Restenosis/epidemiology , Female , Follow-Up Studies , Graft Occlusion, Vascular/epidemiology , Humans , Incidence , Italy/epidemiology , Male , Registries , Retrospective Studies , Spain/epidemiology , Time Factors
10.
J Thorac Dis ; 9(12): 5363-5367, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29312747

ABSTRACT

Spontaneous coronary artery dissection (SCAD) is still today an underdiagnosed disease due to the absence of angiographic hallmarks in more than 70% of cases. In several cases, an intravascular imaging is a sole tool for recognizing a dissection. Particularly, optical coherence tomography analysis (OCT) could represent the gold standard technique of easy interpretation and prompt diagnosis. Here we present a rare case of multivessel spontaneous coronary artery disease (SCAD) with atypical collateral circulation.

11.
Int J Cardiol ; 214: 113-20, 2016 Jul 01.
Article in English | MEDLINE | ID: mdl-27060269

ABSTRACT

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.


Subject(s)
Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Diabetes Mellitus/therapy , Drug-Eluting Stents , Percutaneous Coronary Intervention/methods , Adult , Aged , Aged, 80 and over , Coronary Artery Disease/drug therapy , Diabetes Mellitus/drug therapy , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Retrospective Studies , Treatment Outcome , Young Adult
12.
JACC Cardiovasc Interv ; 6(10): 1012-22, 2013 Oct.
Article in English | MEDLINE | ID: mdl-24055444

ABSTRACT

OBJECTIVES: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). BACKGROUND: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. METHODS: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. RESULTS: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). CONCLUSIONS: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).


Subject(s)
Cardiovascular Agents/administration & dosage , Coronary Angiography , Coronary Artery Disease/therapy , Coronary Vessels/drug effects , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Sirolimus/analogs & derivatives , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Restenosis/etiology , Coronary Restenosis/prevention & control , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Everolimus , Feasibility Studies , Female , Humans , Italy , Male , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/prevention & control , Paclitaxel/administration & dosage , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Registries , Sirolimus/administration & dosage , Time Factors , Treatment Outcome
13.
J Cardiovasc Med (Hagerstown) ; 11(4): 299-309, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20090550

ABSTRACT

BACKGROUND: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. CONCLUSION: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.


Subject(s)
Coronary Artery Disease/surgery , Drug-Eluting Stents , Immunosuppressive Agents/administration & dosage , Research Design , Sirolimus/analogs & derivatives , Angiography , Blood Vessel Prosthesis Implantation , Clinical Protocols , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/drug therapy , Cost-Benefit Analysis , Everolimus , Humans , Myocardial Revascularization , Prospective Studies , Sirolimus/administration & dosage
14.
Ital Heart J ; 6(4): 353-6, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15902937

ABSTRACT

Coronary artery ectasia is defined as a > 1.5-fold dilation of the coronary artery compared to the diameter of adjacent normal segments. It must be distinguished from discrete aneurysms that appear in areas adjacent to coronary artery stenosis. It is usually considered a variant of coronary atherosclerosis. Dilated segments are thought to modify the rheology of blood, sluggish or turbulent flow predisposing to myocardial ischemia and its sequelae, including myocardial infarction and sudden death. We report the case of a 52-year-old man, light smoker, with arterial hypertension and family history of coronary artery disease, who was referred to our coronary care unit for an inferior ST-elevation acute myocardial infarction and presented with severe and diffuse vessel ectasia and right coronary thrombosis at coronary angiography.


Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Thrombosis/therapy , Coronary Vessels/physiopathology , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/therapy , Thrombolytic Therapy/methods , Abciximab , Acute Disease , Antibodies, Monoclonal/therapeutic use , Chest Pain/diagnosis , Chest Pain/etiology , Combined Modality Therapy , Coronary Angiography , Coronary Thrombosis/diagnostic imaging , Dilatation, Pathologic/diagnostic imaging , Dilatation, Pathologic/therapy , Follow-Up Studies , Humans , Immunoglobulin Fab Fragments/therapeutic use , Male , Middle Aged , Risk Assessment , Severity of Illness Index , Tissue Plasminogen Activator/therapeutic use , Treatment Outcome
15.
J Am Coll Cardiol ; 45(2): 238-43, 2005 Jan 18.
Article in English | MEDLINE | ID: mdl-15653021

ABSTRACT

OBJECTIVES: The aim of this study was to assess the relationship between systemic inflammation, atherosclerosis, and thrombosis in two distinct clinical models of atherothrombosis. BACKGROUND: Persistent unstable angina (UA) is commonly associated with coronary thrombosis and persistent systemic inflammation. METHODS: We assessed circulating markers of activation of the thrombotic and fibrinolytic cascades and systemic soluble and cellular markers of inflammation on admission in 40 patients with persisting UA (Braunwald class IIIB; group 1) and 30 patients with Leriche-Fontaine stage IIB-III peripheral artery disease awaiting revascularization (group 2). RESULTS: The extent of atherosclerosis (p < 0.01) and activation of the coagulation system were greater in group 2, which had higher thrombin-antithrombin III complexes and D-dimer levels (2.7 and 24.4 microg/l, respectively), than in group 1 (2.0 microg/l and 12.9 microg/l, p = 0.02 and p = 0.0001, respectively). In contrast, C-reactive protein and interleukin-6 levels were higher in group 1 (7.6 pg/ml and 7.8 pg/ml, respectively) than in group 2 (4.5 pg/ml and 3.0 pg/ml, p < 0.01 and p = 0.03, respectively). Moreover, neutrophil activation was only found in group 1 (neutrophil myeloperoxidase content -4.0 arbitrary units vs. +3.4 arbitrary units in group 2, p < 0.0001). These differences persisted during the initial three days of hospitalization. CONCLUSIONS: Such a large, consistent discrepancy between atherothrombotic burden and systemic inflammation suggests that atherothrombosis, by itself, is an unlikely cause of persisting, recurring UA. An understanding of the primary inflammatory mechanisms of persistent and recurrent coronary instability could open the way to novel therapeutic strategies.


Subject(s)
Angina, Unstable/blood , Peripheral Vascular Diseases/blood , Aged , Angina, Unstable/etiology , Antibodies, Bacterial/blood , Antibodies, Viral/blood , Antithrombin III , C-Reactive Protein/metabolism , Chlamydophila pneumoniae/immunology , Cytomegalovirus/immunology , Female , Fibrin Fibrinogen Degradation Products/metabolism , Helicobacter pylori/immunology , Humans , Interleukin-6/blood , Male , Middle Aged , Peptide Fragments/blood , Peptide Hydrolases/blood , Peripheral Vascular Diseases/etiology , Prothrombin
16.
Ital Heart J Suppl ; 5(8): 630-8, 2004 Aug.
Article in Italian | MEDLINE | ID: mdl-15554018

ABSTRACT

BACKGROUND: The recent introduction of drug-eluting stents (DES) has shown, in randomized controlled trials, to reduce the incidence of restenosis as compared to bare metal stents (BMS). Since their cost is considerably higher than that of BMS, the study assessed the economic impact of the adoption of this new therapy in the Sicilian clinical practice. METHODS: An economic evaluation was carried out by means of a linear decision model developed in Excel that simulated and compared costs and clinical pathway, within 1 year of the intervention, of hypothetical groups of patients with de novo lesions undergoing angioplasty with DES or BMS. Clinical data were obtained from the available literature and adapted to the Sicilian reality, using data from an original survey conducted in 7 local cath labs. The survey collected information on the anatomical case-mix of the population treated, the average number of stents used in the various procedures and the methods of treatment for in-stent restenosis. RESULTS: Compared to BMS, DES allows to avoid, on average, 11.8 revascularizations out of 100 patients over a period of 1 year, but requires to bear an incremental net cost of Euro 931 for the annual treatment of each patient. The cost-benefit ratio is more favorable for those categories of patients/lesions in which the risk of in-stent restenosis is higher and, at the same time, the number of stents implanted per procedure is lower (single-vessel diabetics and small vessels). CONCLUSIONS: The results of the study show how, within the scope of a policy that has tended more and more to rationalize the use of available health resources, the use of the expensive DES is not justified from an economic point of view in groups of patients and types of lesions in which a BMS is also associated with a lower likelihood of revascularization. Therefore, the study provides a starting point for consideration by hospital centers, suggesting the use of a mixture of DES for the treatment of lesions/patients at the highest risk of restenosis and BMS for the treatment of lesions/patients at lower risk of re-intervention.


Subject(s)
Drug Delivery Systems/economics , Stents/economics , Coronary Restenosis/economics , Coronary Restenosis/prevention & control , Cost-Benefit Analysis , Decision Trees , Humans , Italy , Linear Models , Surveys and Questionnaires
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