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1.
Circ Cardiovasc Interv ; : CIRCINTERVENTIONS121010796, 2022 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-35045732

RESUMO

BACKGROUND: The applicability of resting indices to guide noninfarct-related artery revascularization in ST-elevation myocardial infarction is unknown. METHODS: We analyzed the correlation and prognostic value of fractional flow reserve (FFR) and resting distal coronary to aortic pressure ratio (Pd/Pa) in all patients of the Compare-Acute trial in whom, after successful primary percutaneous coronary intervention, the noninfarct-related artery was interrogated by both and treated medically. The treating cardiologist was blinded to these values. The primary end point was the composite of target vessel (interrogated noninfarct-related artery) related nonfatal target vessel myocardial infarction and target vessel repeat revascularization at 36 months. RESULTS: Five hundred seventeen patients (665 vessels) were included. On receiver-operating characteristic analysis, the optimal Pd/Pa cut off for FFR≤0.80 was 0.905 (C statistic: 0.894). The diagnostic accuracy of Pd/Pa was 80.15% (95% CI, 76.91%-83.12%) with respect to FFR. During the 36-month follow-up, 130 target vessel revascularization and 14 target vessel myocardial infarction occurred. FFR and Pd/Pa had a diagnostic accuracy to predict these events of 62.86% (95% CI, 59.06%-66.54%) and 56.84% (95% CI, 52.98%-60.64%), respectively (P=0.20). When they were discrepant, FFR was significantly better than Pd/Pa in identifying which vessels could be safely deferred (P=0.048). CONCLUSIONS: Immediately after successful primary percutaneous coronary intervention, resting Pd/Pa has a diagnostic accuracy of 80% with respect to FFR measured in the noninfarct-related artery. FFR is not significantly superior in predicting target vessel myocardial infarction and target vessel revascularization during 36 months of follow-up but, in case FFR and Pd/Pa are discrepant, FFR is superior in identifying which nonculprit vessels can be safely deferred. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01399736.

2.
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.

3.
JACC Case Rep ; 4(1): 44-48, 2022 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-35036943

RESUMO

We present a case of calcified chronic total occlusion of the left anterior descending coronary artery with ambiguous cap at the bifurcation with a large diagonal branch, in which intravascular lithoplasty balloon was used to modify the calcified proximal cap and facilitate wire crossing. (Level of Difficulty: Advanced.).

4.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-34961732

RESUMO

INTRODUCTION AND OBJECTIVES: The efficacy and safety of ticagrelor vs prasugrel in patients with acute coronary syndromes (ACS) according to body mass index (BMI) remain unstudied. We assessed the efficacy and safety of ticagrelor vs prasugrel in patients with ACS according to BMI. METHODS: Patients (n=3987) were grouped into 3 categories: normal weight (BMI <25kg/m2; n=1084), overweight (BMI ≥ 25 to <30kg/m2; n=1890), and obesity (BMI ≥ 30kg/m2; n=1013). The primary efficacy endpoint was the 1 year incidence of all-cause death, myocardial infarction, or stroke. The secondary safety endpoint was the 1 year incidence of Bleeding Academic Research Consortium type 3 to 5 bleeding. RESULTS: The primary endpoint occurred in 63 patients assigned to ticagrelor and 39 patients assigned to prasugrel in the normal weight group (11.7% vs 7.5%; HR, 1.62; 95%CI, 1.09-2.42; P=.018), 78 patients assigned to ticagrelor and 58 patients assigned to prasugrel in the overweight group (8.3% vs 6.2%; HR, 1.36; 95%CI, 0.97-1.91; P=.076), and 43 patients assigned to ticagrelor and 37 patients assigned to prasugrel in the obesity group (8.6% vs 7.3%; HR, 1.18; 95%CI, 0.76-1.84; P=.451). The 1-year incidence of bleeding events did not differ between ticagrelor and prasugrel in patients with normal weight (6.5% vs 6.6%; P=.990), overweight (5.6% vs 5.0%; P=.566) or obesity (4.4% vs 2.8%; P=.219). There was no significant treatment arm-by-BMI interaction regarding the primary endpoint (Pint=.578) or secondary endpoint (Pint=.596). CONCLUSIONS: In patients with ACS, BMI did not significantly impact the treatment effect of ticagrelor vs prasugrel in terms of efficacy or safety. CLINICAL TRIAL REGISTRATION: NCT01944800.

5.
Artigo em Inglês | MEDLINE | ID: mdl-34844868

RESUMO

BACKGROUND: Radial (RA) instead of femoral access (FA) for coronary interventions has become a European Society of Cardiology Class-IA guideline recommendation. But when the decision on the access site is left to the discretion of the operator, differences in adverse event rates mitigate. METHODS: We compared the 30-day outcome for RA and FA in all patients recruited for the observational German Austrian ABSORB Registry (GABI-R) in regard to all-cause mortality, stroke, myocardial infarction (MI), TIMI major bleedings (TMB) and quality of life (QoL). All patients were treated with a bioresorbable vascular scaffold. Access site was left to the discretion of the operator. RESULTS: In total, 3137 patients included by 92 centers received percutaneous coronary interventions (PCI) for acute MI in 51.5% and non-acute settings in 48.5%. RA was performed in 47.8% and had a higher median radiation exposure (3896 vs. 3082 cGycm2, p < 0.001). There was no difference in the amount of contrast used. There was also no difference in all-cause mortality (0.53% vs. 0.49%, p = 0.86), the combination of death, MI and stroke (1.87% vs. 1.83%, p = 0.94), but a trend towards more TMB (0.47% vs. 1.04%, p = 0.07) with FA. These outcomes were consistent across the subgroups of patients with ST-elevation MI, non-ST-elevation-ACS and stable coronary artery disease. Finally, QoL did not differ between RA and FA. CONCLUSIONS: In this contemporary GABI-R cohort, in which access site was left to the discretion of the operator, both access routes were safe and equal concerning QoL (ClinicalTrials.gov; NCT02066623).

6.
J Am Heart Assoc ; 10(22): e021418, 2021 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-34779234

RESUMO

BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patients with acute coronary syndrome recruited in the ISAR-REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all-cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%; P=0.267). All-cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%; P=0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89-2.28]; HRC: HR, 1.33 [95% CI, 1.04-1.72]; P for interaction=0.800). CONCLUSIONS Patients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1-year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.

7.
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.

8.
Eur J Clin Invest ; 51(12): e13670, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34541662

RESUMO

BACKGROUND: The prognostic value of in-hospital haemoglobin drop in patients with acute coronary syndrome (ACS) undergoing invasive therapy remains insufficiently investigated. MATERIALS AND METHODS: This observational study included 3838 patients with ACS with admission and in-hospital nadir haemoglobin values available. Haemoglobin drop was defined as a positive difference between admission and nadir haemoglobin values. The primary endpoint was one-year all-cause mortality. RESULTS: In-hospital haemoglobin drop occurred in 3142 patients (82%). Patients were categorized into 4 groups: no haemoglobin drop (n = 696 patients), <3 g/dl haemoglobin drop (n = 2703 patients), 3 to <5 g/dl haemoglobin drop (n = 344 patients) and ≥5 g/dl haemoglobin drop (n = 95 patients). The primary endpoint occurred in 156 patients: 17 patients (2.5%) in the group with no haemoglobin drop, 81 patients (3.0%) in the group with <3g/dl haemoglobin drop, 37 patients (10.9%) in the group with 3 to <5 g/dl haemoglobin drop and 21 patients (22.2%) in the group with ≥5 g/dl haemoglobin (adjusted hazard ratio [HR] = 1.30, 95% confidence interval 1.17 to 1.45; p < .001 for one g/dl haemoglobin drop). The association of haemoglobin drop with one-year mortality remained significant after exclusion of patients with in-hospital overt bleeding (adjusted HR = 1.27 [1.11-1.46]; p < .001 for one g/dl haemoglobin drop). The lowest haemoglobin drop associated with mortality was 1.23 g/dl in all patients (HR = 1.03 [1.02-1.04]) and 1.13 g/dl in patients without overt bleeding (HR = 1.03 [1.01-1.04]). CONCLUSIONS: In patients with ACS, in-hospital haemoglobin drop was associated with higher risk of one-year mortality even in the absence of overt bleeding.

9.
Artigo em Inglês | MEDLINE | ID: mdl-34468709

RESUMO

AIMS: Complex percutaneous coronary intervention (PCI) is associated with a higher risk of ischaemic events. However, no study has analysed the effect of PCI complexity on outcomes in a contemporary cohort of acute coronary syndrome (ACS) patients treated with a dual anti-platelet therapy regimen based on potent P2Y12-inhibitors. Therefore, we performed the current analysis. METHODS AND RESULTS: This analysis included all ACS patients treated with PCI in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5 trial. Complex PCI was defined as at least one of: multi-vessel PCI, ≥3 stents implanted, ≥3 lesions treated, and total stented length >60 mm. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12 months; the safety endpoint was Bleeding Academic Research Consortium types 3-5 bleeding at 12 months. Overall, 3377 patients were included in this analysis (complex PCI, n = 1429; non-complex PCI, n = 1948). The primary endpoint occurred more frequently in the complex PCI group than the non-complex PCI group [10.1% vs. 7.2%, hazard ratio (HR): 1.44, 95% confidence interval (CI) (1.14-1.82), P = 0.002], driven primarily by a higher risk of MI [HR: 1.62, (1.17-2.26), P = 0.004]. The safety endpoint was not statistically different between patients undergoing complex vs. non-complex PCI, although it was numerically higher in the complex PCI group [6.7% vs. 5.3%, HR: 1.28, (0.97-1.70), P = 0.08]. CONCLUSIONS: Acute coronary syndrome patients undergoing complex PCI have an increased incidence of ischaemic events compared with ACS patients undergoing non-complex PCI. CLINICAL TRIAL REGISTRATION: NCT01944800, Prospective, Randomized Trial of Ticagrelor Vs. Prasugrel in Patients With Acute Coronary Syndrome-Full-Text View-ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01944800.

10.
JACC Cardiovasc Interv ; 14(17): 1857-1866, 2021 09 13.
Artigo em Inglês | MEDLINE | ID: mdl-34446390

RESUMO

OBJECTIVES: The aim of this study was to assess the safety and efficacy of ticagrelor versus prasugrel for patients with acute coronary syndrome (ACS) according to their estimated glomerular filtration rates (eGFRs). BACKGROUND: The outcomes of ticagrelor versus prasugrel in patients with ACS according to eGFR have not been defined. METHODS: Patients (n = 4,012) were categorized into 3 groups: low eGFR (<60 mL/min/1.73 m2), intermediate eGFR (≥60 and <90 mL/min/1.73 m2), and high eGFR (≥90 mL/min/1.73 m2). The primary endpoint was a composite of all-cause death, myocardial infarction, and stroke; the secondary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding, both at 1 year. RESULTS: Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted HR: 1.89; 95% CI: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46). A risk excess for low eGFR was also observed for bleeding (adjusted HR: 1.55 [95% CI: 1.12-2.13] vs intermediate eGFR; adjusted HR: 1.59 [95% CI: 1.01-2.50] vs high eGFR). However, eGFR did not affect the relative efficacy and safety of ticagrelor versus prasugrel. In patients with low eGFR, the primary endpoint occurred in 20.5% with ticagrelor and in 14.7% with prasugrel (HR: 1.47; 95% CI: 1.04-2.08; P = 0.029); there was no significant difference in bleeding. CONCLUSIONS: These results show that among patients with ACS, reduction of eGFR is associated with increased risk for ischemic and bleeding events but has no significant impact on the relative efficacy and safety of ticagrelor versus prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).


Assuntos
Síndrome Coronariana Aguda , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/tratamento farmacológico , Taxa de Filtração Glomerular , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Estudos Prospectivos , Ticagrelor/efeitos adversos , Resultado do Tratamento
11.
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.

12.
J Invasive Cardiol ; 33(7): E557-E564, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34089578

RESUMO

OBJECTIVES: Performing percutaneous coronary intervention (PCI) for fractional flow reserve (FFR) positive coronary lesions improves clinical outcomes and is recommended by international guidelines. It has been hypothesized that lesions with a positive FFR but a preserved coronary flow reserve (CFR) are less likely to be flow limiting and might best be treated medically. We investigated the association of CFR in FFR-positive lesions with clinical outcomes when treated medically, as well as the treatment effect of PCI vs medical therapy in FFR-positive lesions and a preserved CFR. METHODS: We performed a substudy of the randomized, multicenter Compare-Acute trial, in which stabilized ST-segment elevation myocardial infarction (STEMI) patients with non-culprit lesions were randomized to either FFR-guided PCI or medical therapy. Based on baseline and hyperemic pressure gradients, we computed physiologic limits of CFR, the so-called pressure-bounded CFR (pb-CFR), and classified lesions as low (<2) or preserved (≥2). The primary endpoint was 12-month major adverse cardiac and cerebrovascular event (MACCE) rate, defined as a composite of death from any cause, non-fatal myocardial infarction, revascularization, or cerebrovascular events. RESULTS: A total of 980 lesions from 885 patients were included in this substudy. In lesions with FFR ≤0.80, a total of 249 patients had a pb-CFR <2 and 29 patients had a preserved CFR (pb-CFR ≥2). The rate of MACCE at 1 year was not significantly different between patients with FFR ≤0.80 and pb-CFR <2 vs patients with FFR ≤0.80 and pb-CFR ≥2 (25% vs 17%, respectively; P=.39). Because of randomization, baseline characteristics were well balanced between patients with FFR ≤0.80 and pb-CFR ≥2 treated by either by PCI or medical therapy. Importantly, in patients with FFR ≤0.80 and pb-CFR ≥2, MACCE occurred more frequently in patients treated medically vs patients treated by PCI (44% vs 0%, respectively; P=.01). CONCLUSIONS: Preserved or low pb-CFR did not alter clinical outcomes in patients with a positive FFR. Patients with FFR-positive coronary lesions but a preserved CFR had more clinical events when treated medically vs those treated with PCI.


Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Angiografia Coronária , Hemodinâmica , Humanos , Resultado do Tratamento
13.
Cardiol Ther ; 10(2): 599-607, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34181178

RESUMO

An 82-year-old woman with severe aortic valve stenosis (AS) and a significant proximal right coronary artery (RCA) stenosis presented with decompensated heart failure and acute kidney injury. She was treated with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) and trans-oesophageal echocardiography (TOE)-guided transcatheter aortic valve replacement (TAVR).

14.
JAMA Cardiol ; 6(10): 1121-1129, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34190967

RESUMO

Importance: It is unclear whether ticagrelor or prasugrel hydrochloride is superior for patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). Objective: To assess the safety and efficacy of ticagrelor vs prasugrel for patients with ACS treated with PCI. Design, Setting, and Participants: A prespecified analysis was performed of a postrandomization subgroup of 3377 patients who presented with ACS and were treated with PCI in the investigator-initiated, multicenter, phase 4, open-label Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5 randomized clinical trial, conducted from September 1, 2013, to February 28, 2018. Statistical analysis was performed from September 1, 2020, to January 30, 2021. Analysis was performed according to the intention-to-treat principle. Interventions: Patients were randomly assigned to a ticagrelor-based or prasugrel-based strategy. This analysis focuses on the subgroup of patients who underwent PCI that was formed after randomization. Main Outcomes and Measures: The primary end point was a composite consisting of all-cause death, myocardial infarction, or stroke at 12 months. The safety end point was Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding. Results: The ticagrelor group comprised 1676 patients (1323 men [78.9%]; mean [SD] age, 64.4 [12.0] years), and the prasugrel group comprised 1701 patients (1341 men [78.8%]; mean [SD] age, 64.7 [12.0] years). The primary end point occurred for 162 patients (9.8%) in the ticagrelor group and 120 patients (7.1%) in the prasugrel group (hazard ratio [HR], 1.41; 95% CI, 1.11-1.78; P = .005). Myocardial infarction occurred in 88 patients (5.3%) in the ticagrelor group compared with 55 patients (3.8%) in the prasugrel group (HR, 1.67; 95% CI, 1.19-2.34; P = .003). The safety end point, BARC type 3 to 5 bleeding, occurred in 84 of 1672 patients (5.3%) in the ticagrelor group and 78 of 1680 patients (4.9%) in the prasugrel group (HR; 1.10; 95% CI, 0.81-1.50; P = .54). Conclusions and Relevance: Among patients presenting with ACS who were treated with PCI, the incidence of the primary composite end point occurred less frequently for patients who received prasugrel compared with those who received ticagrelor. The incidence of bleeding events was comparable between the 2 groups. These results suggest that, for patients presenting with ACS who undergo PCI, a prasugrel-based strategy is superior to a ticagrelor-based strategy. However, because these observations are based on a postrandomization subgroup, these findings should be regarded as hypothesis generating and dedicated randomized clinical trials may be warranted to confirm these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT01944800.

15.
Catheter Cardiovasc Interv ; 98(4): E564-E570, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34137482

RESUMO

OBJECTIVES: To identify potential differences in 2-year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS). BACKGROUND: Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus-eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated. METHODS: German-Austrian ABSORB RegIstRy is a prospective all-comer multi-center observational study of consecutive patients who were considered for coronary revascularization with BVS. We compared 1499 patients with stable CAD to 1594 patients with ACS. Endpoints were major adverse cardiac events (MACE), TLF, and scaffold thrombosis. RESULTS: While single vessel disease was more prevalent in ACS (46% vs. 37%, p < 0.0001), lesion complexity (B2/C stenosis 37% vs. 36%, bifurcation 2.4% vs. 3.4%, p < 0.05), number of implanted scaffolds/patient (1.34 vs. 1.43), scaffold length (18 vs. 18 mm) or the rate of high pressure postdilatation (68% vs. 70%) did not differ between ACS and stable CAD. Two-year MACE rates were 11.6% in ACS and 11.4% in stable CAD, TLF occurred in 7.0% versus 7.4% and target vessel revascularization in 8.8 versus 10.2% (n.s. for all). Definite scaffold thrombosis rates were not significantly different (ACS 1.9% vs. stable CAD 2.1%). CONCLUSION: Real-world 2-year event rates after coronary revascularization with BVS are not significantly different between individuals with ACS as compared to stable CAD.


Assuntos
Síndrome Coronariana Aguda , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Implantes Absorvíveis , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/cirurgia , Áustria , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Everolimo/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
16.
Catheter Cardiovasc Interv ; 98(4): E555-E563, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34143547

RESUMO

AIMS: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure. METHODS AND RESULTS: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT. CONCLUSION: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Implantes Absorvíveis , Áustria , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
17.
Int J Cardiol ; 338: 8-13, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34126130

RESUMO

BACKGROUND: The efficacy and safety of ticagrelor versus prasugrel according to smoking status in patients with acute coronary syndromes (ACS) are not known. We assessed the efficacy and safety of ticagrelor versus prasugrel according to smoking status in patients with ACS undergoing invasive management. METHODS: This pre-specified analysis of the ISAR-REACT 5 trial included 1349 smokers and 2652 nonsmokers randomized to receive ticagrelor or prasugrel. The primary endpoint was the incidence of death, myocardial infarction, or stroke; the secondary endpoint was the incidence of Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding (both endpoints assessed at 12 months). RESULTS: There was no significant treatment arm-by-smoking status interaction regarding the efficacy outcome. The primary endpoint occurred in 47 patients (7.0%) in the ticagrelor group and 41 patients (6.2%) in the prasugrel group in smokers (hazard ratio [HR] = 1.15; 95% confidence interval [CI] 0.76-1.75; P = 0.510) and in 133 patients (10.2%) in the ticagrelor group and 94 patients (7.2%) in the prasugrel group in nonsmokers (HR = 1.44 [1.10-1.87]; P = 0.007; P for interaction = 0.378). The secondary endpoint occurred in 27 patients (4.6%) in the ticagrelor group and 33 patients (5.6%) in the prasugrel group in smokers (HR = 0.81 [0.49-1.35]; P = 0.412) and in 66 patients (6.0%) in the ticagrelor group and 46 patients (4.4%) in the prasugrel group in nonsmokers (HR = 1.38 [0.94-2.01]; P = 0.097). CONCLUSIONS: In patients with ACS undergoing an invasive management strategy, the smoking status did not significantly interact with the relative treatment effect of ticagrelor vs. prasugrel. CLINICAL TRIAL REGISTRATION: NCT01944800.


Assuntos
Síndrome Coronariana Aguda , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/epidemiologia , Humanos , não Fumantes , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Fumantes , Ticagrelor/efeitos adversos , Resultado do Tratamento
19.
Cardiol Ther ; 10(2): 569-575, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34028729

RESUMO

INTRODUCTION: Available data on management of atrial flutter in the early postoperative setting after cardiac surgery are scarce. We aimed to investigate the safety and efficacy (profile) of flutter ablation in the early postoperative phase (30 days after cardiac surgery) in a cohort of 47 consecutive patients. METHODS: Between 2007 and 2016, 47 patients who underwent ablation for postoperative typical atrial flutter were retrospectively identified and analyzed. Follow-up data were acquired from patients' records in case of rehospitalization and via follow-up calls. RESULTS: The median age of patients was 69 years, 89% male and with a median LV-EF of 55%. CAD was present in 80.8% of patients. The predominant conduction of atrial flutter was 2:1 (76.6%); 85.1% of patients had either undergone CABG, SAVR, or a combination of these two. Acute procedural success could be achieved in 100% of patients with one vascular pseudoaneurysm that was managed conservatively. No other complications occurred. After a median follow-up of 5.7 years, follow-up information regarding heart rhythm was available in 87.2% of patients. One patient (2.1%) had undergone repeat ablation for typical flutter. Two patients (4.2%) had developed atrial fibrillation, while 87.2% of patients were in sinus rhythm. CONCLUSIONS: In this small cohort, early postoperative ablation of typical flutter was associated with a favorable short- and long-term safety and efficacy profile and can be considered part of heart rhythm management options in this setting.

20.
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
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