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1.
Artigo em Inglês | MEDLINE | ID: mdl-35045943

RESUMO

BACKGROUND: Whether the access site influences the comparative efficacy and safety of ticagrelor and prasugrel in patients with acute coronary syndrome (ACS) undergoing invasive treatment strategy remains unstudied. METHODS: This post-hoc analysis included ACS patients undergoing invasive treatment via radial or femoral access and randomized to either ticagrelor or prasugrel in the ISAR-REACT 5 trial. The primary efficacy endpoint was the composite of death, myocardial infarction (MI) or stroke, safety endpoint was BARC 3 to 5 bleeding. Outcomes were assessed out to 12 months after randomization. RESULTS: Out of 4018 patients, 3984 underwent invasive treatment via radial or femoral access. 1479 had coronary angiography via radial access (ticagrelor, N = 748; prasugrel, N = 731) and 2505 via femoral access (ticagrelor, N = 1245; prasugrel, N = 1260). There was no interaction between access route and assignment to either ticagrelor or prasugrel regarding the primary efficacy or safety endpoints (P for interaction≥0.616). In the radial group, the primary efficacy endpoint (7.6% versus 5.8%, HR: 1.32 [0.88-1.97], P = 0.151) and the safety endpoint (4.3% versus 3.0%, HR: 1.36, [0.73-1.31], P = 0.300) were not statistically different in patients receiving either ticagrelor or prasugrel. In the femoral group, the primary efficacy endpoint occurred more frequently in patients assigned to ticagrelor as compared to prasugrel (10.3% versus 7.3%, HR: 1.44 [1.10-1.88], P = 0.006) without significant difference in terms of safety endpoint (6.4% versus 5.8%, HR: 1.14, [0.81-1.60], P = 0.470). CONCLUSIONS: In patients with ACS undergoing an invasive treatment strategy, the access route does not influence the comparative efficacy and safety of ticagrelor and prasugrel. SUMMARY FOR THE ANNOTATED TABLE OF CONTENTS: The access route used during the invasive procedure did not significantly affect the relative efficacy of ticagrelor versus prasugrel in ACS patients enrolled in the ISAR-REACT 5 trial. There was also no significant difference in bleeding events between ticagrelor and prasugrel as a function of access route. CLINICAL TRIAL REGISTRATION: NCT01944800.

2.
J Am Coll Cardiol ; 78(21): 2060-2072, 2021 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-34794687

RESUMO

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES: The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation. METHODS: The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. RESULTS: A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). CONCLUSIONS: Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).

3.
EuroIntervention ; 2021 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-34609284

RESUMO

BACKGROUND: Calcified coronary lesions present therapeutic challenges for the interventional cardiologist, often requiring rotational atherectomy (RA). AIMS: This study aimed to develop an angiographic scoring tool to predict the need for a priori RA. METHODS: A pooled analysis of the randomised ROTAXUS and PREPARE-CALC studies was carried out, (N=220 patients, N=313 lesions), by virtue of the fact that both studies made provision for crossover to RA (from balloon dilatation or modified balloon dilatation, respectively). Logistical regression techniques were employed to assess for the presence of patient- or lesion-specific factors leading to a necessity for RA. External validation was performed though retrospective calculation of the score for 192 patients who underwent bail-out RA in a single centre. RESULTS: Lesion length (odds ratio [OR] 1.02, 95% confidence interval [CI]: 1.00-1.04 per mm, p=0.04), bifurcation lesion (OR 2.60, 95% CI: 1.27-5.30, p=0.009), vessel tortuosity >45° (OR 3.49, 95% CI: 1.73-7.03, p<0.001) and severe vessel calcification (OR 11.60, 95% CI: 3.40-39.64, p<0.001) were predictive of the need for RA in multivariate analysis. Based on the regression coefficients, a scoring system was devised. The greater the score, the more likely a lesion required RA. The scoring system performed well in the external validation cohort, with 78% of patients crossing over having a score of greater than the proposed cut-off of 3. CONCLUSIONS: We provide an angiographic scoring tool to support the expeditious use of time and resources, allowing assessment of the likelihood of success of a balloon-based strategy, or the necessity for RA.

4.
JACC Cardiovasc Interv ; 14(17): 1870-1883, 2021 09 13.
Artigo em Inglês | MEDLINE | ID: mdl-34503737

RESUMO

OBJECTIVES: The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown. METHODS: The XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y12 inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score-stratified analysis. RESULTS: A total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (Pnoninferiority = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (Pnoninferiority = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3- or 1-month DAPT, while BARC types 3 to 5 bleeding was reduced in both experimental groups. The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28. CONCLUSIONS: Among HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Quimioterapia Combinada , Everolimo/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento
5.
Artigo em Inglês | MEDLINE | ID: mdl-34364807

RESUMO

BACKGROUND: Permanent drug-eluting stents are associated with a steady increase of late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years. METHODS: BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints target lesion failure and rate of definite or probable stent thrombosis. RESULTS: 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischemia. Target lesion failure rate was 8.0% [95% CI:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarction, and 6 clinically-driven target lesion revascularizations. Only one target lesion failure occurred beyond 3 years; a target-vessel myocardial infarction with clinically-driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed. CONCLUSION: The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years. ANNOTATED TABLE OF CONTENTS: BIOSOLVE-II is a prospective, multi-centre, first-in-man trial enrolling 123 patients with de novo coronary artery lesions. Target lesion failure rate at 5 years was low (8.0%), including 2 cardiac deaths, 2 target-vessel myocardial infarction and 6 clinically-driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.

6.
Clin Res Cardiol ; 110(10): 1668-1679, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34255133

RESUMO

OBJECTIVES: To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). METHODS: Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. RESULTS: Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. CONCLUSION: A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.

7.
J Am Heart Assoc ; 10(12): e019815, 2021 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-34056911

RESUMO

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer-generation drug-eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target-lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P=0.003) and stent thrombosis rates (2.1% versus 0.2%; P<0.0001), whereas target-lesion revascularization was not different between the groups (5.0% versus 3.9%; P=0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89-2.08; P=0.148) but did for target-vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03-2.68; P=0.037). TLF rates were similar between bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent (12.6% versus 15.4%, P=0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable-polymer sirolimus-eluting stent showed lower TLF (7.5% versus 10.3%, P=0.045). Conclusions With newer-generation drug-eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target-vessel myocardial infarction was higher. The bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Calcificação Vascular/terapia , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Índice de Gravidade de Doença , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/mortalidade
8.
Clin Res Cardiol ; 110(10): 1574-1585, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33861369

RESUMO

OBJECTIVE: To compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness. BACKGROUND: New-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer's population. METHODS: Among patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed. RESULTS: After 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26-1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04-0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population. CONCLUSION: In the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years.

11.
Europace ; 23(8): 1227-1236, 2021 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-33611584

RESUMO

AIMS: Long-term mortality after ablation of typical atrial flutter has been found to be increased two-fold in comparison to atrial fibrillation ablations through a period of 5 years with unclear mechanism. METHODS AND RESULTS: We analysed 189 consecutive patients who underwent ablation for typical atrial flutter (AFL), in which the incidence of AF was the first manifestation of cardiac disease. According to the clinical standards of our centre, the routine recommendation was to evaluate for coronary artery disease (CAD) by invasive angiogram or computed tomography scan. We compared the AFL patients to 141 patients with paroxysmal atrial fibrillation (AFIB) without known structural heart disease who underwent ablation in the same period and who had routine coronary angiograms performed. Out of 189 patients who presented with AFL, coronary status was available in 152 patients (80.4%). Both groups were balanced for mean age (64.9 years in AFL vs. 63.2 years in AFIB; P = 0.15), body mass index (BMI; 28.8 vs. 28.5 kg/m2; P = 0.15), CHA2DS2-VASc-Score (2.20 vs. 2.04; P = 0.35), smoking status (22.2% smokers vs. 28.4%; P = 0.23), and renal function (GFR >60 mL/min in 96.7% of all patients vs. 95.7%; P = 0.76). There were significantly lower values for left ventricular ejection fraction (52.5% vs. 59.7%; P < 0.001), female sex (17.0% vs. 47.5%; P < 0.001), hyperlipidaemia (37.9% vs. 58.9%; P < 0.001), and family history of cardiovascular disease (CVD) (15.0 vs. 31.9%; P = 0.001) in the AFL vs. AFIB cohorts. Coronary artery disease with stenoses >50% was found in 26.3% of all patients with available coronary status in AFL and in 7.0% in AFIB (P < 0.001). Coronary artery disease with stenoses >75% in 16.4% in AFL whereas only in 1.4% in AFIB (P < 0.001). Multivessel disease was detected in 10.5% in AFL and 0.7% in AFIB (P < 0.001). After correction for age, left ventricular ejection fraction, BMI, CHA2DS2-VASc-Score and its individual components, smoking status, hyperlipidaemia, and family history of CVD, there was a more than five-fold increase in the likelihood of CAD with stenosis >50% in AFL as compared to AFIB [odds ratio (OR 5.26)]. A multivariate analysis was performed in the AFL group. Patients with clinically relevant stenoses (>75%) were older (70.6 years vs. 63.8 years; P = 0.001), had a higher number of risk factors (3.08 vs. 2.24; P ≤ 0.0016) and a higher CHA2DS2-VASc-Score (3.20 vs. 2.00; P < 0.0001). With logistic regression, significant CAD could be predicted by higher values for CHA2DS2-VASc-Score with an exponential rise to a pretest-probability of 42.1% at a value of 4 points. CONCLUSION: These data suggest that typical atrial flutter constitutes a manifestation of previously asymptomatic CAD. Due to the inclusion criteria, CAD has to be considered silent and chronic in most of the patients. Therefore, the presence of typical atrial flutter in formerly healthy patients should raise suspicion of otherwise silent CAD and initiate further investigations and risk stratification with particular emphasis on the individual CHA2DS2-VASc-Scores.


Assuntos
Fibrilação Atrial , Flutter Atrial , Ablação por Cateter , Doença da Artéria Coronariana , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Flutter Atrial/diagnóstico , Flutter Atrial/epidemiologia , Flutter Atrial/cirurgia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Fatores de Risco , Volume Sistólico , Função Ventricular Esquerda
12.
Cardiovasc Revasc Med ; 33: 26-31, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33451925

RESUMO

BACKGROUND/PURPOSE: In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA. METHODS/MATERIALS: Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months. RESULTS: In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; pinteraction = 0.001). The need for bail-out RA was higher in patients with type-C lesions (n = 15) as compared with non-type-C lesions (n = 1). Acute lumen gain, LLL, and target lesion revascularization at 9 months were not dependent on lesion complexity and upfront lesion preparation strategy. CONCLUSIONS: In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.

13.
Clin Res Cardiol ; 110(2): 162-171, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32440723

RESUMO

AIMS: To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS. METHODS: This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR). RESULTS: Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947). CONCLUSIONS: Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.


Assuntos
Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Polímeros , Sirolimo/farmacologia , Procedimentos Cirúrgicos Operatórios , Idoso , Doença da Artéria Coronariana/complicações , Feminino , Humanos , Masculino , Prognóstico , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco
14.
Am Heart J ; 231: 147-156, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33031789

RESUMO

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina/administração & dosagem , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Aspirina/efeitos adversos , Canadá , Causas de Morte , Esquema de Medicação , Stents Farmacológicos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Acidente Vascular Cerebral , Trombose , Estados Unidos
15.
Catheter Cardiovasc Interv ; 98(5): 848-856, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32890442

RESUMO

OBJECTIVES: This analysis of pooled individual patient data (IPD) aimed to evaluate the safety and efficacy of a bioresorbable polymer sirolimus eluting stent system (BP-SES; Orsiro) compared to a durable polymer everolimus eluting stent system (DP-EES; Xience) in the pooled population as well as in subgroups. METHODS: IPD with up to 12 months follow-up of the randomized controlled trials BIOFLOW-II (NCT01356888), -IV (NCT01939249), and -V (NCT02389946) as well as the all comers registry BIOFLOW-III (NCT01553526) were pooled. A total of 3,717 subjects (2,923 in BP-SES and 794 in DP-EES) with 5,328 lesions (4,225 lesions in BP-SES and 1,103 in DP-EES) were included in the IPD. The primary endpoint was target lesion failure (TLF) at 12 months follow-up. Subgroups analyzed included diabetes, age (≥65 years), gender, complex lesions (B2/C), small vessels (reference vessel diameter ≤2.75 mm), multivessel treatment, renal disease, and patients with acute coronary syndrome. RESULTS: Overall, TLF at 12 months was significantly lower with 5.2%in the BP-SES group versus 7.6% in the DP-EES group (p = .0098). Similarly, target vessel myocardial infarction (TV-MI) was 3.1 versus 5.7% (p = .0005). The rate of stent thrombosis was similar in both groups (0.004%). By regression analysis, an independent stent effect in favor of BP-SES was observed for TLF (p = .0043) and TV-MI (p = .0364) in small vessels. CONCLUSION: Results of this IPD analysis suggest that the BP-SES with ultrathin struts is as safe as and more efficacious than DP-EES in the overall cohort and especially in small vessels.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Análise de Dados , Everolimo/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Polímeros , Desenho de Prótese , Sirolimo/efeitos adversos , Resultado do Tratamento
16.
J Interv Cardiol ; 2020: 9740938, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33223974

RESUMO

Objectives: To analyze the impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions. Background: The impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions is poorly investigated. Methods: We performed an as-treated analysis on 47 calcified bifurcation lesions treated with scoring/cutting balloons (SCB) and 68 lesions treated with rotational atherectomy (RA) in the PREPARE-CALC trial. Compromised side branch (SB) as assessed in the final angiogram was the primary outcome measure and was defined as any significant stenosis, dissection, or thrombolysis in myocardial infarction flow <3. Results: True bifurcation lesions were present in 49% vs. 43% of cases in the SCB and RA groups, respectively. After stent implantation, SB balloon dilatation was necessary in around one-third of cases (36% vs. 38%; p = 0.82), and a two-stent technique was performed in 21.3% vs. 25% (p = 0.75). At the end of the procedure, the SB remained compromised in 15 lesions (32%) in the SCB group and 5 lesions (7%) in the RA group (p = 0.001). Large coronary dissections were more frequently observed in the SCB group (13% vs. 2%; p = 0.02). Postprocedural levels of cardiac biomarkers were significantly higher in patients with a compromised SB at the end of the procedure. Conclusions: In the PREPARE-CALC trial, side branch compromise was more frequently observed after lesion preparation with SCB as compared with RA. Consequently, in calcified bifurcation lesions, an upfront debulking with an RA-based strategy might optimize the result in the side branch.


Assuntos
Angioplastia Coronária com Balão , Aterectomia Coronária , Angiografia Coronária/métodos , Doença da Artéria Coronariana , Vasos Coronários , Complicações Pós-Operatórias , Calcificação Vascular , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Angioplastia Coronária com Balão/estatística & dados numéricos , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/métodos , Aterectomia Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Feminino , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Risco Ajustado/métodos , Calcificação Vascular/diagnóstico , Calcificação Vascular/cirurgia
17.
Cardiovasc Revasc Med ; 21(9): 1150-1154, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32917533

RESUMO

BACKGROUND/PURPOSE: To avoid long-term effects associated with permanent implants, bioresorbable vascular scaffolds were developed, as they provide transient vessel support and disappear thereafter. The aim of the BIOSOLVE-II and -III studies was to assess the safety and performance of a magnesium-based sirolimus-eluting scaffold; we report the clinical outcomes at 3 years, 2 years after scaffold resorption. METHODS/MATERIALS: BIOSOLVE-II and BIOSOLVE-III are international, prospective multi-center studies, including 184 patients with 189 de novo lesions and stable or unstable angina, or documented silent ischemia. Acute myocardial infarction, 3-vessel coronary artery disease, and heavily calcified lesions were excluded. Antiplatelet therapy was recommended for 6 months. RESULTS: Patients were 65.5 ± 10.8 years old, and lesions were 12.1 ± 4.5 mm long and located in vessels with a diameter of 2.7 ± 0.4 mm. More than half of the lesions (56.5%) were type B2/C lesions. At 2 years, 92.5% (160/173) of patients were symptom-free and 91.5% (151/165) at 3 years; all the other patients had stable angina. At 3 years, target lesion failure occurred in 11 patients (6.3%), consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis. CONCLUSION: In a low-risk patient population, treatment with a sirolimus-eluting magnesium bioresorbable scaffold can be considered safe, in particular with no definite or probable scaffold thrombosis. ANNOTATED TABLE OF CONTENTS: BIOSOLVE-II and -III are prospective, international, multi-center studies including 184 patients with de novo lesions. At 3 years, target lesion failure was 6.3%, consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Idoso , Stents Farmacológicos/efeitos adversos , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Sirolimo , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 13(9): 1071-1082, 2020 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-32305398

RESUMO

OBJECTIVES: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. BACKGROUND: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. METHODS: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. RESULTS: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). CONCLUSIONS: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202).


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/mortalidade , Feminino , Alemanha , Hemodinâmica , Humanos , Masculino , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Desenho de Prótese , Falha de Prótese , Recuperação de Função Fisiológica , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
19.
Coron Artery Dis ; 31(7): 578-585, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32271247

RESUMO

OBJECTIVE: To investigate the outcomes after bioresorbable scaffold (BRS) implantation in calcified coronary lesions. In calcified coronary lesions, durable metallic drug-eluting stent (DES) implantation is associated with worse clinical outcomes compared to noncalcified lesions. Although not recommended, BRSs were frequently implanted in calcified lesions in clinical practice. Their outcome is not well investigated. METHODS: Between November 2013 and January 2016, 3326 patients were enrolled in the German-Austrian ABSORB ReglstRy (GABI-R). Lesion calcification severity was classified into no (n = 1144), mild (n = 1306), and moderate-to-severe (n = 690) calcification. RESULTS: Patients with calcification were older (none: 59.1 ± 11.2 vs. mild: 61.6 ± 10.9 vs. moderate to severe: 62.4 ± 10.5 years, P < 0.001), had more diabetes (19.1 vs. 20.8 vs. 23.9%, P = 0.015), and more often had previous myocardial infarction (MI) (19.3 vs. 23.1 vs. 25.4%, P = 0.002). Despite a higher rate of postdilatations (P < 0.001), lesions with calcification had more residual stenosis (2.05 ± 9.36% vs. 3.11 ± 9.36% vs. 3.89 ± 9.39%, P < 0.001). Consequently, procedural success was achieved in 97.7 vs. 96.2 vs. 93.6% of cases in none, mild, and moderate-to-severe calcification (P < 0.001). At 24 months, cardiac death (0.3 vs. 0.7 vs. 1.6%, P = 0.009) was higher with increasing calcification. However, no significant between-group difference was observed in the incidence of target vessel MI, target vessel revascularization, or target lesion failure. The rate of probable scaffold thrombosis was significantly higher with increasing calcification. CONCLUSION: In GABI-R, ABSORB scaffolds in calcified lesions required more postdilation, led to more residual stenosis, but did not portend increased target lesion revascularization over 2 years. Nevertheless, coronary calcification severity emerged as a cardiovascular risk marker and was predictive of cardiovascular mortality. Clinicaltrial.gov NCT02066623.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários , Infarto do Miocárdio , Intervenção Coronária Percutânea , Complicações Pós-Operatórias , Calcificação Vascular , Implantes Absorvíveis/efeitos adversos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Stents Farmacológicos , Feminino , Humanos , Efeitos Adversos de Longa Duração/diagnóstico , Efeitos Adversos de Longa Duração/etiologia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Sistema de Registros , Índice de Gravidade de Doença , Tecidos Suporte/efeitos adversos , Calcificação Vascular/diagnóstico , Calcificação Vascular/cirurgia , Grau de Desobstrução Vascular
20.
Cardiovasc Revasc Med ; 21(6): 754-759, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32139281

RESUMO

BACKGROUND: Rotational atherectomy (RA) is an established treatment of calcified lesions, but has some inherent procedural hazards. However, predictors of in-hospital adverse outcomes after RA are poorly investigated. OBJECTIVE: To explore the predictors of in-hospital adverse outcomes after RA and to introduce the target vessel SYNTAX score (tvSS) as a potential causal variable. METHODS: Patients who underwent RA at our center (n = 323) were divided into two groups according to the occurrence of in-hospital adverse outcomes (a composite of residual stenosis ≥30%, persistent slow flow, dissection requiring additional stenting beyond the primary lesion, perforation, burr entrapment, and in-hospital major adverse cardiac events [MACE]). RESULTS: In-hospital adverse outcomes were more frequent in patients with severely-tortuous target vessels or lesions >20 mm, while aorto-ostial and bifurcation lesions, as well as chronic total occlusion rates, were equally distributed among patients with and without adverse outcomes. TvSS was 18 [13-24] vs. 12 [8-17] in patients with vs. without in-hospital adverse outcomes (p < 0.001). A tvSS cut-off value of 15 showed 73% sensitivity and 62% specificity for predicting in-hospital adverse outcomes. TvSS emerged as an independent predictor for in-hospital adverse outcomes along with bailout RA and reduced left ventricular ejection fraction (LVEF). However, after one year, the occurrence of in-hospital adverse outcomes was not associated with an increase in the MACE rate (log-rank p = 0.857). CONCLUSION: In-hospital adverse outcomes are higher in patients with more complex target vessel anatomies as indicated by a higher tvSS. Bailout RA and reduced LVEF emerged as additional predictors of in-hospital adverse outcomes.


Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana/terapia , Técnicas de Apoio para a Decisão , Calcificação Vascular/terapia , Idoso , Idoso de 80 Anos ou mais , Aterectomia Coronária/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/fisiopatologia , Feminino , Humanos , Masculino , Valor Preditivo dos Testes , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de Doença , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/fisiopatologia , Função Ventricular Esquerda
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