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1.
JACC Cardiovasc Interv ; 17(6): 771-782, 2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38538172

ABSTRACT

BACKGROUND: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear. OBJECTIVES: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD. METHODS: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD. Risk differences of the primary composite outcome of all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (UIDR), or cerebrovascular events and its individual components were compared between ICR and SCR at 1 year. RESULTS: The BIOVASC trial enrolled 1,525 patients; 917 patients presented with NSTE-ACS, of whom 459 were allocated to ICR and 458 to SCR. Incidences of the primary composite outcome were similar in the 2 groups (7.9% vs 10.1%; risk difference 2.2%; 95% CI: -1.5 to 6.0; P = 0.15). ICR was associated with a significant reduction of MIs (2.0% vs 5.3%; risk difference 3.3%; 95% CI: 0.9 to 5.7; P = 0.006), which was maintained after exclusion of procedure-related MIs occurring during the index or staged procedure (2.0% vs 4.4%; risk difference 2.4%; 95% CI: 0.1 to 4.7; P = 0.032). UIDRs were also reduced in the ICR group (4.2% vs 7.8%; risk difference 3.5%; 95% CI: 0.4 to 6.6; P = 0.018). CONCLUSIONS: ICR is safe in patients with NSTE-ACS and MVD and was associated with a reduction in MIs and UIDRs at 1 year.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/complications , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/complications , Myocardial Infarction/complications , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/complications , Stents , Treatment Outcome
2.
Lancet ; 401(10383): 1172-1182, 2023 04 08.
Article in English | MEDLINE | ID: mdl-36889333

ABSTRACT

BACKGROUND: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. METHODS: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501. FINDINGS: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, pnon-inferiority=0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] vs nine [1·2%]; HR 1·56, 95% CI 0·68-3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22-0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients vs 31 [4·2%] patients; HR 0·61, 95% CI 0·39-0·95, p=0·030). INTERPRETATION: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation. FUNDING: Erasmus University Medical Center and Biotronik.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Myocardial Infarction , Percutaneous Coronary Intervention , Male , Humans , Aged , Female , Acute Coronary Syndrome/surgery , Acute Coronary Syndrome/etiology , Percutaneous Coronary Intervention/methods , Prospective Studies , Myocardial Infarction/etiology , Treatment Outcome
3.
G Ital Cardiol (Rome) ; 23(1): 43-51, 2022 Jan.
Article in Italian | MEDLINE | ID: mdl-34985462

ABSTRACT

Fractional flow reserve (FFR) is the ratio of distal to proximal pressure during maximal hyperemia and indirectly estimates the blood flow across a stenotic coronary artery and the related degree of myocardial ischemia. Several studies have investigated the role of FFR in the setting of percutaneous myocardial revascularization and further research is ongoing. However, current evidence on FFR-guided surgical myocardial revascularization is controversial and limited. The main scientific interest is to clarify whether FFR-guided coronary artery bypass surgery is associated with clinical benefits in terms of mortality, myocardial infarction, major adverse cardiovascular events, minimally invasive surgical access compared with sternotomy and off-pump surgery. Furthermore some data suggest that conduit selection for coronary artery bypass grafting and surgical technique might be affected by FFR value. The aim of this article is to review the most recent available evidence about FFR-guided coronary artery bypass grafting and to discuss clinical implications and future perspectives.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Myocardial Infarction , Percutaneous Coronary Intervention , Coronary Angiography , Coronary Artery Bypass , Humans , Myocardial Revascularization , Treatment Outcome
4.
J Cardiovasc Med (Hagerstown) ; 22(6): 469-477, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33896930

ABSTRACT

AIMS: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. METHODS: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. RESULTS: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. CONCLUSION: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Restenosis , Drug-Eluting Stents , Paclitaxel/pharmacology , Percutaneous Coronary Intervention/adverse effects , Reoperation , Aftercare/methods , Aftercare/statistics & numerical data , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/instrumentation , Angioplasty, Balloon, Coronary/methods , Antineoplastic Agents, Phytogenic/pharmacology , Coronary Angiography/methods , Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Coronary Restenosis/diagnosis , Coronary Restenosis/epidemiology , Coronary Restenosis/surgery , Female , Humans , Italy/epidemiology , Male , Outcome and Process Assessment, Health Care , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/statistics & numerical data , Registries , Reoperation/instrumentation , Reoperation/methods , Time
5.
G Ital Cardiol (Rome) ; 19(12): 724-726, 2018 Dec.
Article in Italian | MEDLINE | ID: mdl-30520888

ABSTRACT

Patients with coronary chronic total occlusion (CTO) if symptomatic for angina or with extensive inducible ischemia at provocative tests may be revascularized percutaneously or surgically. Percutaneous revascularization can be performed by antegrade or retrograde approach. In our case, in the presence of a long CTO of the left anterior descending coronary artery, the antegrade approach was chosen using an intravascular ultrasound (IVUS) catheter positioned in a secondary branch, to accurately identify the proximal lesion cap. IVUS is useful for selecting the appropriate stent size and length to ensure lesion coverage and stent optimization and to detect related complications.


Subject(s)
Coronary Occlusion/therapy , Coronary Vessels/diagnostic imaging , Stents , Ultrasonography, Interventional/methods , Aged , Cardiac Catheterization/methods , Coronary Occlusion/diagnostic imaging , Coronary Vessels/pathology , Humans , Male , Percutaneous Coronary Intervention/methods
6.
J Cardiol Cases ; 14(2): 59-61, 2016 Aug.
Article in English | MEDLINE | ID: mdl-30546665

ABSTRACT

Spontaneous coronary artery dissection (SCAD) is a rare disease associated with high mortality rate, whose etiology and pathogenesis has been poorly understood to date. The management of these patients is still controversial. A young, otherwise healthy woman, without known underlying conditions leading to SCAD, was admitted to our Intensive Cardiology Care Unit; she had history of intense psychological stress. She was managed with a conservative approach based on watchful waiting and medical therapy. She had an uneventful course. This is a rare case of SCAD where stable hemodynamics allowed us to adopt a conservative approach. .

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