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1.
Am J Cardiol ; 2019 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-31585697

RESUMO

The protective effect of obesity on mortality in acute coronary syndromes (ACS) patients remains debated. We aimed at evaluating the impact of obesity on ischemic and bleeding events as possible explanations to the obesity paradox in ACS patients. For the purpose of this substudy, patients enrolled in the START-ANTIPLATELET registry were stratified according to body mass index (BMI) into 3 groups: normal, BMI <25 kg/m2; overweight, BMI: 25 to 29.9 kg/m2; obese, BMI ≥30 kg/m2. The primary end point was net adverse clinical end points (NACE), defined as a composite of all-cause death, myocardial infarction, stroke, and major bleeding. In n = 1,209 patients, n = 410 (33.9%) were normal, n = 538 (44.5%) were overweight and n = 261 (21.6%) were obese. Compared to the normal weight group, obese and overweight patients had a higher prevalence of cardiovascular risk factors but were younger, with a better left ventricular ejection fraction and lower PRECISE-DAPT score. At 1-year follow-up net adverse clinical endpoints was more frequently observed in normal than in overweight and obese patients (15.1%, 8.6%, and9.6%, respectively; p = 0.004), driven by a significantly higher rate of all-cause death (6.3%, 2.6%, and 3.8%, respectively; p = 0.008), whereas no significant differences were noted in terms of myocardial infarction, stroke, and major bleeding. When correcting for confounding variables, BMI loses its power in independently predicting outcomes, failing to confirm the obesity paradox in a real-world ACS population. In conclusion, our study conflicts the obesity paradox in real-world ACS population, and suggest that the reduced rate of adverse events and mortality in obese patients may be explained by relevant differences in the clinical risk profile and medications rather than BMI per se.

2.
Expert Rev Cardiovasc Ther ; 17(6): 435-447, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31213156

RESUMO

Introduction: The radial artery is currently the most widely used access site for PCI procedures both acute and stable patient settings. Thanks to advantages in pharmacological therapy as well as in interventional devices, the rate of ischemic complications following PCI has significantly decreased. Nevertheless, this has been counterbalanced by an increased risk of periprocedural and late bleeding event, that can occur both at access and non-access sites. Choice of access site for PCI is of paramount importance to reduce the risk of access-related bleeding events. Areas covered: The aim of this review is to provide an overview of the actual available evidence comparing the transradial versus transfemoral approach to reduce hemorrhagic events. The most robust evidence comes from large randomized trials, partly also from observational registries, which compared the transradial and transfemoral approach. Expert opinion: Results show that radial access has proved to be decisive in reducing the incidence of hemorrhagic events. Furthermore, it showed a significant reduction in mortality and AKI compared to transfemoral access. However, increased experience in the use of the radial approach has led to less practice in the use of the femoral approach, which may be useful in cases of emergency, complications or inability to use the radial artery.


Assuntos
Hemorragia/prevenção & controle , Intervenção Coronária Percutânea/métodos , Artéria Femoral , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Incidência , Artéria Radial , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Resultado do Tratamento
3.
Curr Vasc Pharmacol ; 2019 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-31124422

RESUMO

BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor is recommended for at least 12 months in patients after an acute coronary syndrome (ACS). However, its underuse and premature discontinuation is common in clinical practice. We aimed to investigate the impact of a dedicated follow-up strategy with clinical visits and counseling on adherence levels to ticagrelor in patients after ACS. METHODS: The PROGRESS is a prospective, randomized trial enrolling 400 ACS patients treated with ticagrelor. Patients were randomized to be followed-up in a dedicated outpatient clinic (In-person follow-up group, [IP-FU], n=200), or with scheduled for phone interviews only (Telephone follow-up group [TEL-FU], n=200), to assess ticagrelor adherence and related complications. DAPT disruption was defined as an interruption of the administration of the drug due to complications or other reasons of noncompliance, and divided according to the duration into short (1-5 days), temporary (6-30 days), and permanent (≥30 days) disruption. The primary endpoint was the rate of DAPT disruption at 1-year follow-up. RESULTS: The rate of ticagrelor disruption at 1-year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs. 5.5%; p<0.0001). IN-FU group reported a significantly lower rate of short (3.0 vs 8.5%; p=0.012) and permanent (2.0 vs 9.6%; p=0.012) disruption than TEL-FU group. The rate of major bleeding did not differ significantly between the two groups (p=0.450). CONCLUSION: The PROGRESS trial showed a net reduction in DAPT disruption in patients followed-up with clinical (in-person) follow-up visits in a dedicated outpatient clinic compared with those scheduled for phone interviews only.

4.
Artigo em Inglês | MEDLINE | ID: mdl-31037840

RESUMO

BACKGROUND: The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). METHODS: We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). RESULTS: Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. CONCLUSIONS: In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

5.
EuroIntervention ; 15(5): 411-417, 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-30860070

RESUMO

Percutaneous alcohol septal ablation (ASA) is an effective and minimally invasive therapeutic strategy to resolve left ventricular outflow tract obstruction (LVOTO) in patients with hypertrophic cardiomyopathy who remain symptomatic on maximally tolerated medical therapy. First performed by Sigwart in 1994, the procedure consists in determining an iatrogenic infarction of the basal interventricular septum to reduce LVOTO and alleviate symptoms. Since its first description, numerous studies have demonstrated its efficacy and safety, proposing ASA as a valid and attractive alternative to surgical septal myectomy. The success rate of the intervention is profoundly affected by patient selection and centre experience. In this review, we sought to summarise current evidence on ASA, describing the procedure and proposing a cardiomyopathy team-based approach to resolve clinical disputes in clinical practice.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Cardiomiopatia Hipertrófica , Septos Cardíacos , Humanos , Resultado do Tratamento
7.
Artigo em Inglês | MEDLINE | ID: mdl-30346080

RESUMO

OBJECTIVES: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BACKGROUND: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. METHODS: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. RESULTS: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). CONCLUSIONS: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

8.
Expert Rev Cardiovasc Ther ; 16(12): 951-962, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30352515

RESUMO

INTRODUCTION: The assessment of coronary lesions severity has always been a relevant topic in the management of the patient undergoing coronary angiography. Fractional flow reserve (FFR) has been introduced as an objective index to determine the significance of a coronary stenosis with a positive impact on clinical outcomes has been demonstrated for FFR-guided coronary interventions. However, several technical drawbacks have been pointed out in clinical practice limiting the diffusion of FFR worldwide. To exceed these limits, other indices and the quantitative flow ratio (QFR) have been recently developed and tested in clinical studies. Areas covered: This review aims to provide a brief overview of functional assessment of coronary stenosis and a particular attention to the QFR, to its validation and application studies for its potential applicability in clinical practice. QFR through a computational fluid dynamic analysis, proved to be useful in discriminating functionally significant stenosis, with an excellent correlation with FFR values, and considerable advantages in terms of acquisition time and costs. Expert opinion/commentary: QFR is an innovative angiographic-based technique that uses modern software for three-dimensional vessel reconstruction, and flow models calculation. The significant technical benefits reported in the management of patients with intermediate coronary stenosis, make it a modern, effective and usable tool.

9.
Expert Rev Med Devices ; 15(11): 807-817, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30343595

RESUMO

INTRODUCTION: Ischemic heart disease is the most common cause of mortality worldwide. In ST elevation myocardial infarction (STEMI) patients, optimization of primary percutaneous coronary intervention (pPCI) is crucial to improve myocardial savage and prevent reperfusion injury. In STEMI patients complicated with cardiogenic shock (CS), percutaneous mechanical circulatory support devices (MCS) have emerged as a therapeutic option in the management of this challenging condition and their use is rapidly increasing. Areas covered: In this review we discuss how pPCI can be optimized with respect to thrombectomy use, stent selection and revascularization strategy, in order to reduce myocardial damage and to improve clinical outcomes. Moreover, we review the recently-published data for and against the use of commercially available MCS in STEMI patients complicated by CS (intra-aortic balloon pump counterpulsation (IABP), Impella system, TandemHeart, and venous-arterial extracorporeal membrane oxygenation (VA-ECMO)). Expert commentary: In pPCI, second-generation drug-eluting stent implantation and complete revascularization are always recommended. Thrombectomy does not have any role in improving mortality. In patients with CS, current MCS have shown no improvement in mortality.

10.
JACC Cardiovasc Interv ; 11(16): 1559-1571, 2018 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-29805111

RESUMO

OBJECTIVES: The study sought to compare the vasomotor and microcirculatory function of the infarct-related artery (IRA) between bioresorbable vascular scaffolds (BVS) and everolimus-eluting stents (EES) at 3 years. BACKGROUND: The ABSORB STEMI TROFI II study showed similar outcomes between BVS and EES in the context of ST-segment elevation myocardial infarction at 3 years. METHODS: Sixty-three consecutive event-free patients of the randomized TROFI II study were screened to undergo coronary angiography with vasomotor, microcirculatory, and optical coherence tomography (OCT) examination at 3 years. Vasomotion was defined as >4% change in mean lumen diameter to acetylcholine (ACH) and nitroglycerin as assessed by quantitative angiography. Microcirculatory examination was performed with pressure or thermodilution techniques. RESULTS: A total of 38 patients (20 BVS and 18 EES) were included. At 3 years, ≥60% of patients exhibited paradoxical vasoconstriction to ACH in the periscaffold or stent segments. Vasoconstriction to ACH and vasodilatation to nitroglycerin were more often observed in the scaffold or stent segment with BVS than with EES (77.8% vs. 25.0%; p = 0.008 and 61.1% vs. 18.8%; p = 0.018). The IRA-depending microcirculation showed similar index of resistance (23.8 vs. 22.4; p = 0.781), coronary flow reserve (2.4 vs. 1.9; p = 0.523), fractional flow reserve (0.91 vs. 0.93; p = 0.317), and absolute flow (135.5 ml/min vs. 147.3 ml/min; p = 0.791). OCT showed remaining strut footprints and larger number of intraluminal scaffold dismantling (26.3% vs. 0%; p = 0.049) in the BVS group. CONCLUSIONS: Both endothelium-dependent and -independent vasomotion of the IRA were more evident with BVS, as compared with EES, at 3 years. Functional microcirculatory parameters were mostly adequate and similar between BVS and EES. Clinical implications of these findings warrant further investigations.

11.
Am J Cardiol ; 122(1): 61-68, 2018 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-29699747

RESUMO

Acute coronary syndromes (ACS) may represent an intriguing clinical scenario for implantation of bioresorbable vascular scaffold (BRS). Nevertheless, the knowledge about the performance of these devices in patients with ACS is limited. Therefore, we performed a meta-analysis of clinical studies aiming to assess the safety and efficacy of everolimus-eluting-BRS versus everolimus-eluting-metallic stents (EES) in ACS patients undergoing percutaneous coronary intervention. Six studies enrolling 2,318 patients were included and analyzed for the risk of primary safety outcome (stent or scaffold thrombosis [ST/ScT]), primary efficacy outcome (target lesion revascularisation [TLR]), and secondary outcomes (myocardial infarction, cardiac death, all-cause death). Median follow-up was 9.5 (6 to 19.5) months. Patients treated with BRS had a significantly higher risk of definite ST/ScT compared with those receiving EES (2.3% vs 1.08%, odds ratio [OR] 2.22, 95% confidence interval [CI] 1.10 to 4.45, p = 0.03, I2 = 0%). Similarly, the risk of TLR was significantly higher in the BRS compared with EES group (3.5% vs 2.5%, OR 1.79, 95% CI 1.02 to 3.16, p = 0.04, I2 = 0%). When TLRs due to thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR 1.19, 95% CI 0.48 to 2.98, p = 0.71, I2 = 25%). Risk for secondary endpoints did not differ between the 2 groups. Results were confirmed when clinical and procedural variables were tested as potential effect modifiers in the meta-regression analysis for both primary endpoints. In conclusion, compared with those receiving EES, patients with ACS treated with BRS had increased risk of definite device thrombosis and TLR at mid-term follow-up.

12.
Minerva Cardioangiol ; 2018 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-29651826

RESUMO

Chronic heart failure (HF) is one of the main causes of mortality and morbidity worldwide and represents a growing challenge in interventional cardiology. Its prevalence is recently increasing due to the improvements in cardiac care with subsequent significant reduction in the HF acute mortality. HF may occur with either a reduced left ventricular ejection fraction (LVEF) (LVEF<40%, HFrEF) or a preserved EF (typically LVEF≥50%, HFpEF) indicative of diastolic dysfunction. Despite recent advances in drug therapies as well as in nonpharmacological strategies, including defibrillators, cardiac resynchronization therapy, LV assist devices (LVAD), mortality in HF remains high. New transcatheter implantable devices have been developed to improve the treatment of chronic HF. In this review we will summarize data on interventional HF devices that are currently approved or under investigation including treatment alternatives for mitral (MR) and tricuspid regurgitation (TR), left ventricle restoration through partitioning devices and left atrial decompression with shunting devices.

13.
Am J Cardiol ; 121(9): 1039-1045, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29544865

RESUMO

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was observed more frequently in patients with STR < 50% (hazard ratio [HR] 1.556; 95% confidence interval [CI] 1.194 to 2.027; p <0.001) and in patients with STR < 70% (HR 1.460, 95% CI 1.169 to 1.824, p <0.001) compared with patients with STR > 50% and STR ≥ 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEMI, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events.

14.
Int J Cardiol ; 258: 50-54, 2018 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-29429635

RESUMO

BACKGROUND: The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. METHODS: Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. RESULTS: Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12 h from symptom onset; 64 (20.2%) were late-comers (>12 h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12 months (IQR 6-20 months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; p = 0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; p = 0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; p = 0.7) and cardiac death (0.6% vs. 0.6%; p = 0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; p = 0.1). CONCLUSIONS: BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.


Assuntos
Implantes Absorvíveis/tendências , Prótese Vascular/tendências , Sistema de Registros , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Enxerto Vascular/tendências , Idoso , Estudos de Coortes , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/tendências , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Tecidos Suporte/tendências , Enxerto Vascular/métodos
17.
Catheter Cardiovasc Interv ; 92(4): 668-677, 2018 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-29356269

RESUMO

OBJECTIVES: to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. BACKGROUND: BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. METHODS: We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. RESULTS: At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33-2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16-18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27-2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27-21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63-5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29-27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47-5.23, P = 0.46; TV-MI: 3.1 vs. 0%). CONCLUSION: At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.

18.
EuroIntervention ; 13(16): 1939-1945, 2018 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-29260713

RESUMO

AIMS: The aim of this substudy was to determine the five-year correlates of non-TV-related adverse events (AE) in STEMI patients included in the EXAMINATION trial. METHODS AND RESULTS: The EXAMINATION trial randomised 1,498 STEMI patients to bare metal or everolimus-eluting stent implantation. In this substudy, patients were analysed according to non-TV-related AE, defined as the composite of either non-TV revascularisation (non-TVR) or non-TV-related myocardial infarction (MI). At five-year follow-up, 125 patients (8.3%) exhibited 136 non-TV-related AE (124 [8.3%] non-TVR, 12 [0.8%] non-TV-related MI), accounting for 47.1% of 289 non-fatal cardiac events overall. These patients had a higher incidence of diabetes mellitus (p<0.001), arterial hypertension (p=0.032), previous MI (p=0.073), multivessel disease (p<0.001), and incomplete revascularisation (p=0.049), and a lower rate of ST-segment resolution >70% (p=0.042) as compared to the rest. At Cox analysis, previous MI (HR 1.872, 95% CI: 1.004-3.489; p=0.048), incomplete revascularisation (HR 1.746, 95% CI: 1.029-2.963; p=0.039) and diabetes (HR 1.942, 95% CI: 1.292-2.919; p=0.001) were independent correlates of non-TV-related AE. CONCLUSIONS: In STEMI patients undergoing primary percutaneous coronary intervention, previous MI, incomplete revascularisation and diabetes resulted in being independent correlates of five-year non-TV-related AE.

19.
EuroIntervention ; 14(5): e546-e553, 2018 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-28966155

RESUMO

AIMS: The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. METHODS AND RESULTS: RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR. CONCLUSIONS: Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.

20.
J Thorac Dis ; 9(Suppl 9): S959-S968, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28894602

RESUMO

Bioresorbable vascular scaffolds (BRS) represent a novel approach for coronary revascularization offering several advantages as compared to current generation DES, potentially reducing rate of late adverse events and avoiding permanent vessel caging. Nevertheless, safety concerns have been raised for an increased risk of scaffold thrombosis (ScT) in both early and late phases, probably related to a suboptimal scaffold implantation. In this context, the use of different imaging methodologies has been strongly suggested in order to guarantee an optimal implantation. We herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up.

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