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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.
Am Heart J ; 265: 153-160, 2023 11.
Article in English | MEDLINE | ID: mdl-37572785

ABSTRACT

BACKGROUND: Over the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DESIGN: The PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SUMMARY: The PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI.


Subject(s)
Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Platelet Aggregation Inhibitors/therapeutic use , Drug-Eluting Stents/adverse effects , Percutaneous Coronary Intervention/methods , Polymers , Hemorrhage/chemically induced , Myocardial Infarction/etiology , Treatment Outcome , Drug Therapy, Combination
3.
Catheter Cardiovasc Interv ; 97(4): 602-611, 2021 03.
Article in English | MEDLINE | ID: mdl-32678493

ABSTRACT

OBJECTIVES: We aimed to compare intracoronary (IC) epinephrine versus conventional treatments alone in patients with ST-elevation myocardial infarction and refractory coronary no-reflow during primary percutaneous coronary intervention (PPCI). METHODS: Thirty consecutive patients with severe refractory coronary no-reflow (TIMI 0-1, MBG 0-1) during PPCI were prospectively included after initial failure of conventional treatments. Conventional treatments used in both groups included IC nitrates, thrombectomy. Glycoprotein IIb/IIIa inhibitors and adenosine. Patients received IC epinephrine or no epinephrine. RESULTS: Intracoronary administration of epinephrine yielded significantly better coronary flow patterns (28.6% TIMI 3, 64.3% TIMI 2, 7.1% TIMI 1, and 0% TIMI 0), compared to those after treatment with conventional agents alone (18.8% TIMI 3, 12.5% TIMI 2, 37.5% TIMI 1, and 31.3% TIMI 0) (p value between groups = .004). In the IC epinephrine vs. no epinephrine group there was a significant reduction of 30-day composite of death or heart failure (35.7% vs. 81.25%), improvement of ejection fraction (p = .01) and ST-segment resolution (p = .01). CONCLUSIONS: The findings of this proof-of-concept study suggest that as compared to use of conventional agents alone, IC epinephrine provides substantial improvement of coronary flow in STEMI patients with refractory no-reflow during PPCI that may result into improved prognosis.


Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Epinephrine/adverse effects , Humans , Percutaneous Coronary Intervention/adverse effects , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/therapy , Thrombectomy , Treatment Outcome
4.
Cardiovasc Diabetol ; 19(1): 215, 2020 12 18.
Article in English | MEDLINE | ID: mdl-33339541

ABSTRACT

BACKGROUND: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes-ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19. METHODS: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April). Main outcomes are the incidences of primary PCI, delayed treatment, and in-hospital mortality. RESULTS: A total of 6609 patients underwent primary PCI in 77 centers, located in 18 countries. Diabetes was observed in a total of 1356 patients (20.5%), with similar proportion between 2019 and 2020. During the pandemic, there was a significant reduction in primary PCI as compared to 2019, similar in both patients with (Incidence rate ratio (IRR) 0.79 (95% CI: 0.73-0.85, p < 0.0001) and without diabetes (IRR 0.81 (95% CI: 0.78-0.85, p < 0.0001) (p int = 0.40). We observed a significant heterogeneity among centers in the population with and without diabetes (p < 0.001, respectively). The heterogeneity among centers was not related to the incidence of death due to COVID-19 in both groups of patients. Interaction was observed for Hypertension (p = 0.024) only in absence of diabetes. Furthermore, the pandemic was independently associated with a significant increase in door-to-balloon and total ischemia times only among patients without diabetes, which may have contributed to the higher mortality, during the pandemic, observed in this group of patients. CONCLUSIONS: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a similar reduction in primary PCI procedures in both patients with and without diabetes. Hypertension had a significant impact on PCI reduction only among patients without diabetes. We observed a significant increase in ischemia time and door-to-balloon time mainly in absence of diabetes, that contributed to explain the increased mortality observed in this group of patients during the pandemic. TRIAL REGISTRATION NUMBER: NCT04412655.


Subject(s)
COVID-19/epidemiology , Diabetes Mellitus/epidemiology , Percutaneous Coronary Intervention/trends , ST Elevation Myocardial Infarction/therapy , Time-to-Treatment/trends , Aged , COVID-19/diagnosis , COVID-19/mortality , Diabetes Mellitus/diagnosis , Diabetes Mellitus/mortality , Europe/epidemiology , Female , Hospital Mortality/trends , Humans , Hypertension/epidemiology , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Registries , Retrospective Studies , Risk Factors , ST Elevation Myocardial Infarction/mortality , Time Factors , Treatment Outcome
5.
Curr Atheroscler Rep ; 22(12): 76, 2020 10 06.
Article in English | MEDLINE | ID: mdl-33025069

ABSTRACT

PURPOSE OF REVIEW: Patients diagnosed with coronary artery disease are at a high risk of subsequent cardiovascular events; therefore, secondary prevention in the form of therapeutic lifestyle changes, and drug therapies is vital. This article aims to review potential application of intra-coronary imaging for the evaluation of plaque modifications, induced by medications for secondary prevention for CAD. RECENT FINDINGS: Intra-coronary imaging provides detailed information on the atherosclerotic plaque which is the primary pathological substrate for the recurrent ischemic cardiovascular events. These modalities can detect features associated with high risk and allow serial in vivo imaging of lesions. Therefore, intravascular imaging tools have been used in landmark studies and played a role in improving our understanding of the disease processes. Changes in size and plaque composition over time can be evaluated by these tools and may help understanding the impact of a treatment. Moreover, surrogate imaging end points can be used when testing new drugs for secondary prevention.


Subject(s)
Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , PCSK9 Inhibitors , Plaque, Atherosclerotic/diagnostic imaging , Plaque, Atherosclerotic/drug therapy , Protease Inhibitors/therapeutic use , Secondary Prevention , Ultrasonography, Interventional/methods , Blood Component Removal/methods , Cholesterol, HDL/blood , Coronary Artery Disease/complications , Coronary Artery Disease/prevention & control , Humans , Plaque, Atherosclerotic/complications , Plaque, Atherosclerotic/prevention & control
6.
J Interv Cardiol ; 2020: 8865223, 2020.
Article in English | MEDLINE | ID: mdl-33132769

ABSTRACT

BACKGROUND: Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. METHODS AND RESULTS: We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003-16.761, p=0.509). CONCLUSIONS: In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.


Subject(s)
Acute Coronary Syndrome , Angioplasty, Balloon, Coronary , Coronary Restenosis , Drug-Eluting Stents , ST Elevation Myocardial Infarction , Sirolimus/pharmacology , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/epidemiology , Acute Coronary Syndrome/etiology , Acute Coronary Syndrome/surgery , Aged , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/instrumentation , Angioplasty, Balloon, Coronary/methods , Coronary Restenosis/complications , Coronary Restenosis/epidemiology , Drug-Eluting Stents/classification , Drug-Eluting Stents/statistics & numerical data , Female , Humans , Immunosuppressive Agents/pharmacology , Italy/epidemiology , Male , Outcome and Process Assessment, Health Care , Registries/statistics & numerical data , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/epidemiology
8.
Catheter Cardiovasc Interv ; 87(4): 712-9, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26541909

ABSTRACT

BACKGROUND: The use of covered stent grafts during percutaneous coronary intervention (PCI) is a life saving solution to seal acute iatrogenic vessel rupture. However, the presence of an impenetrable mechanical barrier is also appealing during treatment of friable coronary plaques but the synthetic PTFE-membrane that might trigger excessive neointimal proliferation has limited its elective-use. Pericardium tissue may offer an appealing "natural" alternative. Aim of our study is to report the consecutive 5-year single center experience with the use of pericardium-covered stents (PCS) (ITGI-Medical, Israel) in a variety of emergency and elective applications. METHODS: Nineteen consecutive patients undergoing implantation of PCS at the Royal Brompton in the last 5-years. Reasons for PCS implantation included treatment of degenerated vein grafts, large coronary aneurysms, and acute iatrogenic vessel rupture. RESULTS: Angiographic success, defined as the ability of the device to be deployed in the indexed lesion with no contrast extravasation with residual angiographic stenosis <30% and a final thrombolysis in myocardial infarction (TIMI)-3 flow was achieved in all cases. Procedural success, defined as the achievement of angiographic success without any major adverse cardiovascular event (MACE) was achieved in 94.7% of patients. In-stent restenosis (ISR) was observed in 26.3% and all patients underwent successful target vessel revascularization with DES (mean time to restenosis 9.0 ± 4.0 months). At a mean follow-up of 32.5 ± 23.3 months no acute or late stent thrombosis was observed. CONCLUSION: PCSs were effective in the treatment of friable embolization-prone coronary plaques, sealing of acute iatrogenic vessel rupture and exclusion of large aneurysms with no thrombosis but high target lesion revascularization.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coated Materials, Biocompatible , Coronary Aneurysm/therapy , Coronary Artery Disease/therapy , Coronary Vessels , Iatrogenic Disease , Pericardium/transplantation , Saphenous Vein , Stents , Vascular System Injuries/therapy , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/mortality , Animals , Coronary Aneurysm/diagnostic imaging , Coronary Aneurysm/mortality , Coronary Aneurysm/physiopathology , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Circulation , Coronary Restenosis/etiology , Coronary Thrombosis/etiology , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Coronary Vessels/surgery , Female , Heterografts , Horses , Humans , London , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Risk Factors , Saphenous Vein/diagnostic imaging , Saphenous Vein/physiopathology , Saphenous Vein/transplantation , Time Factors , Treatment Outcome , Ultrasonography, Interventional , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/mortality , Vascular System Injuries/physiopathology
9.
Catheter Cardiovasc Interv ; 87(5): 839-46, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26370357

ABSTRACT

OBJECTIVES: Optical coherence tomography (OCT) was used to investigate integrity and expansion of bioresorbable drug-eluting scaffolds (BVS) after high-pressure postdilation (HPPD). BACKGROUND: Because of concerns about the risk of BVS damage, postdilation was not recommended and applied in the existing randomized studies and most registries. Recent real world data suggest incomplete BVS expansion cause higher rates of thrombosis. In vivo confirmation of the safety of high pressure postdilation is of paramount importance. METHODS: Data from final OCT examination of consecutive implanted BVS, postdilated with noncompliant (NC) balloons at pressure ≥24 atm were analyzed. The following stent performance indices were assessed with OCT: mean and minimal lumen and scaffold area, residual area stenosis (RAS), incomplete strut apposition (ISA), tissue prolapse, eccentricity index (EI), symmetry index (SI), strut fractures, and edge dissections. RESULT: Twenty-two BVS postdilated at high pressure were analyzed. The average maximal postdilation balloon inflation (maxPD) was 28 ± 3 atm. High pressure OPN NC Balloon (SIS Medical AG, Winterthur Switzerland) was used in 41% of postdilations with a maximal PD of 30 ± 4.7 atm. Final mean and minimal lumen area were 6.8 ± 1.4 and 5.5 ± 1.4 mm(2) , respectively. OCT showed low percentage of RAS (16 ± 9.6%), and low percentage of ISA (1.8 ± 2.4%). Mean EI was 0.86 ± 0.02 and SI 0.35 ± 0.14. OCT analysis showed one edge dissection and no scaffold fractures. CONCLUSIONS: BVS deployment optimization using HPPD does not cause BVS disruption and is associated with a good BVS expansion, low rate of strut malapposition and edge dissections.


Subject(s)
Absorbable Implants , Angioplasty, Balloon, Coronary/methods , Cardiac Catheters , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Vessels/diagnostic imaging , Tomography, Optical Coherence , Aged , Angioplasty, Balloon, Coronary/adverse effects , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Pressure , Prosthesis Design , Prosthesis Failure , Risk Factors , Stress, Mechanical , Time Factors , Treatment Outcome
10.
BMC Cardiovasc Disord ; 15: 169, 2015 Dec 11.
Article in English | MEDLINE | ID: mdl-26654975

ABSTRACT

BACKGROUND: Adequate expansion is critical to achieve optimal Bioresorbable Vascular Scaffolds (BVS) apposition to the vessel wall. However, compared to metallic stents, BVS present different mechanical properties. Hence, slow deployment and maintenance of balloon inflation for at least 30" is recommended for BVS implantation. However, since no evidences are available demonstrating the superiority of a longer balloon dilatation time, the implantation technique is highly variable among different centers. METHODS: A total of 24 BVS-treated lesions were included in the present analysis. After BVS deployment at 12 atmosphere (ATM) the balloon was rapidly deflated and scaffold expansion was documented with an angiogram. The same balloon was then inflated again and kept at 12 ATM for 30". Finally, a further angiogram was obtained to evaluate BVS expansion. Quantitative coronary angiography (QCA) was performed at each step. RESULTS: A significant increase of minimal luminal diameter (MLD)-to-reference scaffold diameter (RSD) ratio (MLD to RSD Ration, MR-Ratio) from 0.70 ± 0.10 after initial stent deployment to 0.79 ± 0.10 after the 30"-long balloon dilation was observed (p < 0.001). Of note, this result was consistent across all sub-segments, as well as across almost all lesion subgroups. A substantial reduction in the prevalence of residual stenosis from 29 % to 17 % was registered after the 30"-long dilation. CONCLUSIONS: Our results strongly support the maintenance of balloon inflation for at least 30" during BVS deployment to achieve optimal scaffold expansion and minimize the occurrence of residual stenosis.


Subject(s)
Absorbable Implants , Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Coronary Artery Disease/therapy , Coronary Vessels , Aged , Angioplasty, Balloon, Coronary/adverse effects , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Vessels/diagnostic imaging , Coronary Vessels/pathology , Female , Humans , Male , Middle Aged , Prosthesis Design , Time Factors , Tomography, Optical Coherence , Treatment Outcome
11.
J Clin Med ; 12(14)2023 Jul 23.
Article in English | MEDLINE | ID: mdl-37510959

ABSTRACT

The amount of coronary calcium strongly correlates with the degree of atherosclerosis and, therefore, with the rate of future cardiac events. Calcified coronary lesions still represent a challenge for interventional cardiologists, bringing not only a higher risk of immediate complications during percutaneous coronary interventions (PCI), but also a higher risk of late stent failure due to under-expansion and/or malapposition, and therefore, have a relevant prognostic impact. Accurate identification of the calcified plaques together with the analysis of their distribution pattern within the vessel wall by intracoronary imaging is important to improve the successful treatment of these lesions. The aim of this review is to guide readers through the assessment of the calcified plaque distribution using intracoronary imaging in order to select the best devices and strategies for plaque debulking and lesion preparation.

12.
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
14.
Cardiovasc Revasc Med ; 28: 1-6, 2021 07.
Article in English | MEDLINE | ID: mdl-33888418

ABSTRACT

OBJECTIVE: Our study sought to compare the 12-month clinical outcome of patients treated with paclitaxel-coated balloons (PCB) vs. sirolimus-coated balloons (SCB) during coronary angioplasty. BACKGROUND: Drug-coated balloons represent an established therapeutic tool for percutaneous coronary interventions (PCI). A comparison between PCB and SCB is still lacking. METHODS: We performed an indirect comparison between two cohorts of patients previously included into two investigator-driven registries with clinical primary endpoints, 494 treated with the Elutax SV PCB (AR Baltic, Lithuania) from the DCB RISE registry, and 596 treated with the Magic Touch SCB (Concept Medical, India) from the EASTBOURNE registry. The primary endpoint was the rate of major adverse cardiovascular events (MACE) at 12-month clinical follow-up. RESULTS: After propensity score matching, a total of 580 patients were well matched for baseline clinical and procedural characteristics and were analyzed. At 12 months there was no significant difference between the matched DCB RISE and EASTBOURNE cohorts in terms of the primary endpoint MACE (10.3% DCB RISE vs. 10.7% EASTBOURNE, p = 0.892). No significant difference was observed also regarding the rate of TLR (7.9% DCB RISE vs. 8.3% EASTBOURNE; p = 0.879, respectively). By multivariate analysis, insulin-dependent diabetes was the only predictor of MACE. CONCLUSIONS: In the SIRPAC study, the first indirect comparison between paclitaxel-coated and sirolimus coated balloons, no significant difference in clinical endpoints were found at 12-month follow-up. Randomized studies are necessary to confirm these findings.


Subject(s)
Cardiovascular Agents , Percutaneous Coronary Intervention , Cardiovascular Agents/adverse effects , Coated Materials, Biocompatible , Coronary Vessels , Humans , Paclitaxel/adverse effects , Percutaneous Coronary Intervention/adverse effects , Sirolimus/adverse effects , Time Factors , Treatment Outcome
15.
Coron Artery Dis ; 32(4): 281-287, 2021 Jun 01.
Article in English | MEDLINE | ID: mdl-33229939

ABSTRACT

BACKGROUND: While the superiority of reabsorbable-polymer drug-eluting stents (RP-DES) over bare-metal stents and first-generation durable-polymer (DP)-DES has been largely established, their advantage compared with new-generation DP-DES is still controversial. This study aimed was to compare clinical outcomes of all-comer patients undergoing percutaneous coronary intervention (PCI) with new generation DP-DES or RP-DES implantation. METHODS: We prospectively enrolled 679 consecutive patients treated with PCI with RP-DES or DP-DES. The primary endpoint was the 1-year incidence of major adverse clinical events (MACE), a composite of death, myocardial infarction (MI), and target vessel revascularization (TVR). Target lesion revascularization (TLR) and definite stent thrombosis were also recorded. RESULTS: A total of 439 (64.6%) received RP-DES and 240 (36.4%) received DP-DES. No significant difference in the incidence of MACE (5.9 vs. 4.9%; hazard ratio, 1.23; 95% confidence interval (CI), 0.61-2.49; P = 0.569), death (1.8 vs. 1.7%; hazard ratio, 1.09; 95% CI, 0.33-3.64; P = 0.882), MI (2.3 vs. 2.1%; hazard ratio, 1.05; 95% CI, 0.36-3.08; P = 0.927), TVR (2.3 vs. 1.3%; hazard ratio, 1.70; 95% CI, 0.47-6.20; P = 0.418), TLR (1.4 vs. 0.4%; hazard ratio, 3.06; 95% CI, 0.37-25.40; P = 0.301), and definite stent thrombosis (0.5 vs. 0.4%; hazard ratio, 1.09; 95% CI, 0.10-12.10; P = 0.942) was observed between RP-DES and DP-DES patients at 1-year follow-up. These results were confirmed in a propensity score-matched cohort (n = 134 per group). CONCLUSION: In our registry including a real-world population of all-comer patients undergoing PCI, RP-DES, or durable polymer-DES showed similar efficacy and safety at a 1-year follow-up.


Subject(s)
Absorbable Implants , Drug-Eluting Stents , Percutaneous Coronary Intervention , Aged , Cardiac Catheterization , Female , Humans , Male , Myocardial Infarction/epidemiology , Myocardial Revascularization/statistics & numerical data , Polymers , Prospective Studies , Registries , Thrombosis/epidemiology
16.
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
17.
Biomed Pharmacother ; 138: 111469, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33740523

ABSTRACT

BACKGROUND: Concerns have been raised on a potential interaction between renin-angiotensin system inhibitors (RASI) and the susceptibility to coronavirus disease 2019 (COVID-19). No data have been so far reported on the prognostic impact of RASI in patients suffering from ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic, which was the aim of the present study. METHODS: STEMI patients treated with primary percutaneous coronary intervention (PPCI) and enrolled in the ISACS-STEMI COVID-19 registry were included in the present sub-analysis and divided according to RASI therapy at admission. RESULTS: Our population is represented by 6095 patients, of whom 3654 admitted in 2019 and 2441 in 2020. No difference in the prevalence of SARSCoV2 infection was observed according to RASI therapy at admission (2.5% vs 2.1%, p = 0.5), which was associated with a significantly lower mortality (adjusted OR [95% CI]=0.68 [0.51-0.90], P = 0.006), confirmed in the analysis restricted to 2020 (adjusted OR [95% CI]=0.5[0.33-0.74], P = 0.001). Among the 5388 patients in whom data on in-hospital medication were available, in-hospital RASI therapy was associated with a significantly lower mortality (2.1% vs 16.7%, OR [95% CI]=0.11 [0.084-0.14], p < 0.0001), confirmed after adjustment in both periods. Among the 62 SARSCoV-2 positive patients, RASI therapy, both at admission or in-hospital, showed no prognostic effect. CONCLUSIONS: This is the first study to investigate the impact of RASI therapy on the prognosis and SARSCoV2 infection of STEMI patients undergoing PPCI during the COVID-19 pandemic. Both pre-admission and in-hospital RASI were associated with lower mortality. Among SARSCoV2-positive patients, both chronic and in-hospital RASI therapy showed no impact on survival.


Subject(s)
Antihypertensive Agents/therapeutic use , COVID-19/mortality , Myocardial Reperfusion , SARS-CoV-2 , ST Elevation Myocardial Infarction/mortality , Aged , COVID-19/therapy , Female , Hospitalization , Humans , Male , Middle Aged , Pandemics , Percutaneous Coronary Intervention , Prognosis , Registries , Renin-Angiotensin System , ST Elevation Myocardial Infarction/therapy , COVID-19 Drug Treatment
18.
Cardiol Clin ; 38(4): 563-573, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33036718

ABSTRACT

Primary percutaneous coronary intervention is the preferred reperfusion strategy for the management of acute ST-segment elevation myocardial infarction. No reflow is characterized by the inadequate myocardial perfusion of a given segment without angiographic evidence of persistent mechanical obstruction of epicardial vessels. Both pharmacologic and device-based strategies have been tested to resolve coronary no reflow. This article provides an updated overview of the no-reflow phenomenon, discussing clinical evidence and ongoing investigations of existing and novel therapeutic strategies to counteract it.


Subject(s)
No-Reflow Phenomenon/therapy , Coronary Angiography , Coronary Circulation , Humans , Myocardial Infarction/etiology , Myocardial Infarction/therapy , No-Reflow Phenomenon/diagnosis , No-Reflow Phenomenon/physiopathology , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/therapeutic use , Prognosis , Risk Factors , Thrombectomy
20.
Echocardiography ; 25(7): 683-91, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18445059

ABSTRACT

BACKGROUND: In idiopathic and ischemic dilated cardiomyopathy (DCM) there are differences in left atrial and ventricular relaxation. We assessed the hypothesis of an influence of these dissimilarities in assessing left ventricular filling pressure (LVFP) in these two DCMs by standard Doppler and tissue Doppler imaging. In particular, we focused on early transmitral flow to early diastolic motion velocity of mitral annulus ratio (E/Ea), useful to estimate normal or elevated LVFP. However, when found in intermediate range (8-15), its role is unclear. METHODS AND RESULTS: We evaluated 26 patients with ischemic and 21 patients with idiopathic DCM. To validate the echocardiographic estimation of LVFP, a sample (12 patients) underwent LVFP assessment by catheterization. In idiopathic DCM, E/Ea directly related to duration of retrograde pulmonary venous flow (ARd) (r = 0.66 P = 0001). In ischemic DCM E/Ea inversely related only to systolic to diastolic velocity ratio of pulmonary venous flow (S/D) (r =-0.56 P = 0002). After a mean follow up of 6 months, by a second echocardiogram we observed a direct relation between E/Ea and ARd percentage variation (r = 0.52 P = 0.02) in idiopathic DCM group, whereas in the ischemic DCM group there was an inverse relation between E/Ea and S/D percentage variation (r =-0.59 P = 0.02). CONCLUSIONS: In conclusion, ARd in idiopathic and S/D in ischemic DCM might be used as specific additional information to estimate LVFP when E/Ea falls within intermediate range.


Subject(s)
Cardiomyopathy, Dilated/diagnostic imaging , Echocardiography, Doppler, Color , Echocardiography, Doppler, Pulsed , Myocardial Ischemia/diagnostic imaging , Ventricular Pressure/physiology , Aged , Analysis of Variance , Cardiac Catheterization , Cardiomyopathy, Dilated/physiopathology , Cohort Studies , Confidence Intervals , Female , Follow-Up Studies , Humans , Male , Middle Aged , Multivariate Analysis , Myocardial Ischemia/physiopathology , Probability , Regression Analysis , Reproducibility of Results , Risk Assessment , Sensitivity and Specificity , Severity of Illness Index , Ventricular Dysfunction, Left/diagnostic imaging , Ventricular Dysfunction, Left/physiopathology
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