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1.
Lancet ; 397(10278): 985-995, 2021 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-33714389

RESUMO

BACKGROUND: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). METHODS: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. FINDINGS: Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55-70] years). Median follow-up was 3·7 (IQR 3·0-4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0-15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2-10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25-4·13) and non-culprit lesion-specific MACEs (7·83, 4·12-14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0-10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4-17·6). INTERPRETATION: Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. FUNDING: Abbott Vascular, Infraredx, and The Medicines Company.

2.
Artigo em Inglês | MEDLINE | ID: mdl-33640388

RESUMO

OBJECTIVES: The authors sought to determine whether coronary artery tortuosity negatively affects clinical outcomes after stent implantation. BACKGROUND: Coronary artery tortuosity is a common angiographic finding and has been associated with increased rates of early and late major adverse events after balloon angioplasty. METHODS: Individual patient data from 6 prospective, randomized stent trials were pooled. Outcomes at 30 days and 5 years following percutaneous coronary intervention of a single coronary lesion were analyzed according to the presence or absence of moderate/severe vessel tortuosity, as determined by an angiographic core laboratory. The primary endpoint was target vessel failure (TVF; composite of cardiac death, target vessel-related myocardial infarction [TV-MI], or ischemia-driven target vessel revascularization [ID-TVR]). RESULTS: A total of 6,951 patients were included, 729 of whom (10.5%) underwent percutaneous coronary intervention in vessels with moderate/severe tortuosity. At 30 days, TVF was more frequent in patients with versus without moderate/severe tortuosity (3.8% vs. 2.4%, hazard ratio: 1.64, 95% confidence interval: 1.09 to 2.46; p = 0.02), a difference driven by a higher rate of TV-MI. At 5 years, TVF remained increased in patients with moderate/severe tortuosity (p = 0.003), driven by higher rates of TV-MI (p = 0.003) and ID-TVR (p = 0.01). Definite stent thrombosis was also greater in patients with versus without moderate/severe tortuosity (1.9% vs. 1.0%, hazard ratio: 1.86, 95% confidence interval: 1.02 to 3.39; p = 0.04). After adjustment for baseline covariates, moderate/severe vessel tortuosity was independently associated with TV-MI and ID-TVR at 5 years (p = 0.04 for both). CONCLUSIONS: Stent implantation in vessels with moderate/severe coronary artery tortuosity is associated with increased rates of TVF due to greater rates of TV-MI and ID-TVR.

3.
Circ Cardiovasc Interv ; 14(2): e009879, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33440999

RESUMO

BACKGROUND: Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment-elevation myocardial infarction (STEMI). We sought to assess the relationship of SBT and DBT with infarct size and microvascular obstruction (MVO) after pPCI. METHODS: Individual patient data for 3115 ST-segment-elevation myocardial infarction patients undergoing pPCI in 10 randomized trials were pooled. Infarct size (% left ventricular mass) was assessed within 1 month after randomization by technetium-99 m sestamibi single-photon emission computerized tomography (3 studies) or cardiac magnetic resonance imaging (7 studies). MVO was assessed by cardiac magnetic resonance. Patients were stratified by short (≤2 hours), intermediate (2-4 hours), or long (>4 hours) SBTs, and by short (≤45 minutes), intermediate (45-90 minutes), or long (>90 minutes) DBTs. RESULTS: Median [interquartile range] SBT and DBT were 185 [130-269] and 46 [28-83] minutes, respectively. Median [interquartile range] time to infarct size assessment after pPCI was 5 [3-12] days. There was a stepwise increase in infarct size according to SBT category (adjusted difference, 2.0% [95% CI, 0.4-3.5] for intermediate versus short SBT and 4.4% [95% CI, 2.7-6.1] for long versus short SBT) but not according to DBT category (adjusted difference, 0.4% [95% CI, -1.2 to 1.9] for intermediate versus short DBT and -0.1% [95% CI, -1.0 to 3.0] for long versus short SBT). MVO was greater in patients with long versus short SBT (adjusted difference, 0.9% [95% CI, 0.3-1.4]) but was not different between patients with intermediate versus short SBT (adjusted difference, 0.1 [95% CI, -0.4 to 0.6]). There was no difference in MVO according to DBT. Results were similar in multivariable analysis with SBT and DBT included as continuous variables. CONCLUSIONS: Among 3115 patients with ST-segment-elevation myocardial infarction undergoing infarct size assessment after pPCI, SBT was more strongly correlated with infarct size and MVO than DBT.

4.
Cardiovasc Diabetol ; 20(1): 10, 2021 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-33413366

RESUMO

BACKGROUND: We investigated the association of insulin resistance (IR) with coronary plaque morphology and the risk of cardiovascular events in patients enrolled in the Providing Regional Observations to Study Predictors of Events in Coronary Tree (PROSPECT) study. METHODS: Patients with acute coronary syndromes (ACS) were divided based on DM status. Non-DM patients were further stratified according to homeostasis-model-assessment IR (HOMA-IR) index as insulin sensitive (IS; HOMA-IR ≤ 2), likely-IR (LIR; 2 < HOMA-IR < 5), or diabetic-IR (DIR; HOMA-IR ≥ 5). Coronary plaque characteristics were investigated by intravascular ultrasound. The primary endpoint was major adverse cardiac events (MACE); a composite of cardiac death, cardiac arrest, myocardial infarction, and rehospitalization for unstable/progressive angina. RESULTS: Among non-diabetic patients, 109 patients (21.5%) were categorized as LIR, and 65 patients (12.8%) as DIR. Patients with DIR or DM had significantly higher rates of echolucent plaque compared with LIR and IS. In addition, DIR and DM were independently associated with increased risk of MACE compared with IS (adjusted hazard ratio [aHR] 2.29, 95% confidence interval [CI] 1.22-4.29, p = 0.01 and aHR 2.12, 95% CI 1.19-3.75, p = 0.009, respectively). CONCLUSIONS: IR is common among patients with ACS. DM and advanced but not early stages of IR are independently associated with increased risk of adverse cardiovascular events. Trial Registration ClinicalTrials.gov Identifier: NCT00180466.

5.
Am J Cardiol ; 143: 21-28, 2021 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-33359193

RESUMO

Prior studies in patients with noncomplex coronary artery disease have demonstrated the safety of percutaneous coronary intervention (PCI) in the outpatient setting. We sought to examine the outcomes of outpatient PCI in patients with unprotected left main coronary artery disease (LMCAD). In the EXCEL trial, 1905 patients with LMCAD and site-assessed low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The primary end point was major adverse cardiovascular events (MACE; the composite of death, stroke, or myocardial infarction). In this sub-analysis, outcomes at 30 days and 5 years were analyzed according to whether PCI was performed in the outpatient versus inpatient setting. Among 948 patients with LMCAD assigned to PCI, 935 patients underwent PCI as their first procedure, including 100 (10.7%) performed in the outpatient setting. Patients who underwent outpatient compared with inpatient PCI were less likely to have experienced recent myocardial infarction. Distal left main bifurcation disease involvement and SYNTAX scores were similar between the groups. Comparing outpatient to inpatient PCI, there were no significant differences in MACE at 30 days (4.0% vs 5.0% respectively, adjusted OR 0.52 95% CI 0.12 to 2.22; p = 0.38) or 5 years (20.6% vs 22.1% respectively, adjusted OR 0.72, 95% CI 0.40 to 1.29; p = 0.27). Similar results were observed in patients with distal left main bifurcation lesions. In conclusion, in the EXCEL trial, outpatient PCI of patients with LMCAD was not associated with an excess early or late hazard of MACE. These data suggest that outpatient PCI may be safely performed in select patients with LMCAD.


Assuntos
Procedimentos Cirúrgicos Ambulatórios/métodos , Doença da Artéria Coronariana/cirurgia , Hospitalização , Intervenção Coronária Percutânea/métodos , Idoso , Angina Estável/epidemiologia , Angina Instável/epidemiologia , Ponte de Artéria Coronária , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Razão de Chances , Ensaios Clínicos Controlados Aleatórios como Assunto , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Acidente Vascular Cerebral/epidemiologia
6.
J Am Coll Cardiol ; 76(22): 2595-2606, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33243380

RESUMO

BACKGROUND: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR). OBJECTIVES: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg). RESULTS: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (pinteraction = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009). CONCLUSIONS: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.

7.
Artigo em Inglês | MEDLINE | ID: mdl-33168433

RESUMO

Treatment of lesions in small coronary vessels is associated with an increased risk of adverse cardiovascular events after percutaneous coronary intervention (PCI).We aimed to evaluate the outcomes of patients undergoing small-vessel PCI in the BIONICS trial and to identify predictors of stent failure. 1910 patients were randomized to treatment with the EluNIR™ ridaforolimus-eluting stent (RES) or Resolute™ zotarolimus-eluting stent (ZES). Small vessels were defined as reference vessel diameters (RVD) ≤2.5 mm. A Cox proportional hazards model was used to identify predictors of target lesion failure (TLF) through 2 years. Patients undergoing small vessel disease PCI had a higher frequency of diabetes, prior myocardial infarction (MI), and prior PCI. 2 year TLF was higher among patients with small vessels (9.7% vs. 5.9%, HR 1.7 [95% CI 1.22-2.37], p < 0.01), driven by increased rates of target vessel-MI and target lesion revascularization (TLR). Stent thrombosis at 2 years was higher among patients with small vessel disease (1.4% vs. 0.3%, HR 5.25 [95% CI 1.47-18.8], p < 0.01). 2 year TLF rates were similar in the RES and ZES patient groups (Pinteraction 0.86). In conclusion, patients undergoing PCI in small vessels have significantly worse outcomes despite the use of contemporary stents.

8.
J Am Coll Cardiol ; 76(14): 1609-1621, 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33004126

RESUMO

BACKGROUND: Varying definitions of procedural myocardial infarction (PMI) are in widespread use. OBJECTIVES: This study sought to determine the rates and clinical relevance of PMI using different definitions in patients with left main coronary artery disease randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) surgery in the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: The pre-specified protocol definition of PMI (PMIProt) required a large elevation of creatine kinase-MB (CK-MB), with identical threshold for both procedures. The Third Universal Definition of MI (types 4a and 5) (PMIUD) required lesser biomarker elevations but with supporting evidence of myocardial ischemia, different after PCI and CABG. For the PMIUD, troponins were used preferentially (available in 49.5% of patients), CK-MB otherwise. The multivariable relationship between each PMI type and 5-year mortality was determined. RESULTS: PMIProt occurred in 34 of 935 (3.6%) patients after PCI and 56 of 923 (6.1%) patients after CABG (difference -2.4%; 95% confidence interval [CI]: -4.4% to -0.5%; p = 0.015). The corresponding rates of PMIUD were 37 (4.0%) and 20 (2.2%), respectively (difference 1.8%; 95% CI: 0.2% to 3.4%; p = 0.025). Both PMIProt and PMIUD were associated with 5-year cardiovascular mortality (adjusted hazard ratio [HR]: 2.18 [95% CI: 1.13 to 4.23] and 2.87 [95% CI: 1.44 to 5.73], respectively). PMIProt was associated with a consistent hazard of cardiovascular mortality after both PCI and CABG (pinteraction = 0.86). Conversely, PMIUD was strongly associated with cardiovascular mortality after CABG (adjusted HR: 11.94; 95% CI: 4.84 to 29.47) but not after PCI (adjusted HR: 1.14; 95% CI: 0.35 to 3.67) (pinteraction = 0.004). Results were similar for all-cause mortality and with varying PMIUD biomarker definitions. Only large biomarker elevations (CK-MB ≥10× upper reference limit and troponin ≥70× upper reference limit) were associated with mortality. CONCLUSIONS: The rates of PMI after PCI and CABG vary greatly with different definitions. In the EXCEL trial, the pre-specified PMIProt was associated with similar hazard after PCI and CABG, whereas PMIUD was strongly associated with mortality after CABG but not after PCI. (EXCEL Clinical Trial [EXCEL]; NCT01205776).

9.
J Am Coll Cardiol ; 76(20): 2289-2301, 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33069847

RESUMO

BACKGROUND: Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild. OBJECTIVES: This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques. METHODS: Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically nonobstructive stenosis not intended for PCI but with IVUS plaque burden of ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) versus GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered) safety endpoint was randomized target lesion failure (cardiac death, target vessel-related MI, or clinically driven target lesion revascularization) at 24 months. The secondary (nonpowered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (cardiac death, MI, unstable angina, or progressive angina) at latest follow-up. RESULTS: A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by near-infrared spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was 2.9 mm2, and the median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and the median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9 ± 2.6 mm2 compared with 3.0 ± 1.0 mm2 in GDMT alone-treated lesions (least square means difference: 3.9 mm2; 95% confidence interval: 3.3 to 4.5; p < 0.0001). Target lesion failure at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96). Randomized lesion-related major adverse cardiac events occurred in 4.3% of BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12). CONCLUSIONS: PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA, and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial. (PROSPECT ABSORB [Providing Regional Observations to Study Predictors of Events in the Coronary Tree II Combined with a Randomized, Controlled, Intervention Trial]; NCT02171065).

10.
J Am Coll Cardiol ; 76(11): 1305-1314, 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32912445

RESUMO

BACKGROUND: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR). OBJECTIVES: This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS: A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed. RESULTS: Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (pinteraction = 0.16, 0.29, and 0.21 respectively). CONCLUSIONS: Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).

11.
Circulation ; 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32975133

RESUMO

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining mid-term outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mmHg and significant residual mitral regurgitation (MR) as ≥ moderate. Results: A total of 1,079 patients (857 ViV, 222 ViR; mean age 73.5 years ± 12.5; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days [IQR 76 - 996 days]; median echocardiographic follow-up for patients that survived 1 year 772.5 days [IQR 510 - 1211.75 days]. Four-year Kaplan-Meier survival rate was 62.5% in ViV vs. 49.5% for ViR (p<0.001). Mean gradient across the mitral valve post-procedure was 5.7 ± 2.8 mmHg (≥5mmHg, 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (p=0.09). Significant residual MR was more common in ViR patients (16.6% vs. 3.1%; p<0.001) and was associated with lower survival at 4 years (35.1% vs. 61.6%; p=0.02). The rates of MVARC-defined device success were low for both procedures (39.4% total; 32.0% ViR vs. 41.3% ViV; p=0.01), mostly related to having post-procedural mean gradient ≥5mmHg. Correlates for residual MS were smaller true internal diameter, younger age and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (SHR 4.67; 95% CI 1.74 - 12.56; p=0.002) and significant residual MR (SHR 7.88; 95% CI 2.88 - 21.53; p<0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve post-procedural hemodynamics in mitral ViV and ViR should be further explored.

12.
Eur Heart J ; 2020 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-32901285

RESUMO

The win ratio was introduced in 2012 as a new method for examining composite endpoints and has since been widely adopted in cardiovascular (CV) trials. Improving upon conventional methods for analysing composite endpoints, the win ratio accounts for relative priorities of the components and allows the components to be different types of outcomes. For example, the win ratio can combine the time to death with the number of occurrences of a non-fatal outcome such as CV-related hospitalizations (CVHs) in a single hierarchical composite endpoint. The win ratio can provide greater statistical power to detect and quantify a treatment difference by using all available information contained in the component outcomes. The win ratio can also incorporate quantitative outcomes such as exercise tests or quality-of-life scores. There is a need for more practical guidance on how best to design trials using the win ratio approach. This manuscript provides an overview of the principles behind the win ratio and provides insights into how to implement the win ratio in CV trial design and reporting, including how to determine trial size.

13.
EuroIntervention ; 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-32863246

RESUMO

AIMS: Randomized trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicenter, randomized trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes. METHODS AND RESULTS: ILUMIEN IV is a prospective, single-blind clinical investigation that will randomize between 2490 and 3656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) Post-PCI minimal stent area assessed by OCT in each randomized arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization. Clinical follow-up will continue for up to 2 years. The trial is currently enrolling, and the principal results are expected in 2022. CONCLUSIONS: The large-scale ILUMIEN IV randomized controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions.

14.
J Am Coll Cardiol ; 76(2): 159-161, 2020 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-32646564
15.
JACC Cardiovasc Interv ; 13(13): 1586-1595, 2020 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-32646701

RESUMO

OBJECTIVES: The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials. BACKGROUND: Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies. METHODS: Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates. RESULTS: Among 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01). CONCLUSIONS: In the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences.

16.
J Cardiovasc Magn Reson ; 22(1): 41, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32475350

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with severe aortic stenosis (AS). Cardiovascular magnetic resonance imaging (CMR) provides reliable and reproducible estimates for assessment of cardiac structure and function after TAVR. The goal of this study was to conduct a systematic review and meta-analysis of the literature to assess left ventricular (LV) volumes, mass and function by CMR after TAVR. METHODS: Using Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines, we searched PubMed and Embase for studies reporting CMR findings before and at least 1 month after TAVR. Main factors of interest were LV end-diastolic volume index (LVEDVi), LV end-systolic volume index (LVESVi), LV mass index (LVMi), and left ventricular ejection fraction (LVEF). Standardized mean differences (SMD) were pooled by random effects meta-analytic techniques. RESULTS: Of 453 screened publications, 10 studies (published between 2012 and 2018) were included. A total of 305 patients completed pre- and post-TAVR follow-up CMR (mean age range 78.6-85.0 years, follow-up range 6-15 months). Random effects analysis showed TAVR resulted in reduced LVEDVi (SMD: -0.25, 95% CI: - 0.43 to - 0.07, P = 0.006), LVESVi (SMD: -0.24, 95% CI: - 0.44 to - 0.05, P = 0.01), LVMi (SMD: -0.82, 95% CI: - 1.0 to - 0.63, P < 0.001) and increased LVEF (SMD: 22, 95% CI: 6 to 38%, P = 0.006). Heterogeneity across studies was low (I2: 0%, Pheterogeneity > 0.05 for all). The median reduction was 4 ml/m2 (IQR: 3.1 to 8.2) for LVEDVi, 5 ml/m2 (IQR: 3.0 to 6.0) for LVESVi, and 15.1 g/m2 (IQR: 11.8 to 18.3) for LVMi. The median increase for LVEF was 3.4% (IQR 1.0 to 4.6%). CONCLUSIONS: CMR demonstrates reverse LV remodeling occurrs within 6-15 months after TAVR, with reductions in LVEDVi, LVESVi and LVMi, and increased LVEF.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Ventrículos do Coração/diagnóstico por imagem , Imagem por Ressonância Magnética , Substituição da Valva Aórtica Transcateter , Função Ventricular Esquerda , Remodelação Ventricular , 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/fisiopatologia , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Valor Preditivo dos Testes , Recuperação de Função Fisiológica , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
17.
Artigo em Inglês | MEDLINE | ID: mdl-32592082

RESUMO

BACKGROUND: Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown. METHODS AND RESULTS: This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%, p < 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%, p = 0.03), target vessel MI (0% vs. 3.7%, p = 0.04), MACE (1.0% vs. 6.2%, p = 0.03) and TVF (1.0% vs. 6.9%, p = 0.02) were all significantly lower among Japanese patients. CONCLUSION: Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.

18.
JACC Cardiovasc Interv ; 13(12): 1417-1428, 2020 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-32553329

RESUMO

OBJECTIVES: The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (DES). BACKGROUND: Whether contemporary DES have improved the long-term prognosis after percutaneous coronary intervention in lesions with severe CAC is unknown. METHODS: Individual patient data were pooled from 18 randomized trials evaluating DES, categorized according to the presence of angiography core laboratory-confirmed moderate or severe CAC. Major endpoints were the patient-oriented composite endpoint (death, myocardial infarction [MI], or any revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac death, target vessel MI, or ischemia-driven target lesion revascularization). Multivariate Cox proportional regression with study as a random effect was used to assess 5-year outcomes. RESULTS: A total of 19,833 patients were included. Moderate or severe CAC was present in 1 or more target lesions in 6,211 patients (31.3%) and was associated with increased 5-year risk for the patient-oriented composite endpoint (adjusted hazard ratio [adjHR]: 1.12; 95% confidence interval [CI]: 1.05 to 1.20) and target lesion failure (adjHR: 1.21; 95% CI: 1.09 to 1.34), as well as death, MI, and ischemia-driven target lesion revascularization. In patients with CAC, use of second-generation DES compared with first-generation DES was associated with reductions in the 5-year risk for the patient-oriented composite endpoint (adjHR: 0.88; 95% CI: 0.78 to 1.00) and target lesion failure (adjHR: 0.73; 95% CI: 0.61 to 0.87), as well as death or MI, ischemia-driven target lesion revascularization, and stent thrombosis. The relative treatment effects of second-generation compared with first-generation DES were consistent in patients with and without moderate or severe CAC, although outcomes were consistently better with contemporary devices. CONCLUSIONS: In this large-scale study, percutaneous coronary intervention of target lesion moderate or severe CAC was associated with adverse patient-oriented and device-oriented adverse outcomes at 5 years. These detrimental effects were mitigated with second-generation DES.

19.
EuroIntervention ; 2020 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-32540793

RESUMO

AIMS: In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact clinical outcomes is unknown. METHODS AND RESULTS: OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes between groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT. CONCLUSIONS: In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12-months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit for OCT-guided PCI.

20.
Eur J Heart Fail ; 22(10): 1866-1874, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32441856

RESUMO

AIMS: Heart failure (HF) hospitalization prior to transcatheter aortic valve replacement (TAVR) is associated with increased post-procedural mortality. We sought to assess the association between recent (≤6 months) HF hospitalization and long-term adverse outcomes in patients with symptomatic, severe aortic stenosis, undergoing TAVR in the PARTNER 2 trial and registries. METHODS AND RESULTS: Intermediate to high or even prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries were included in the analysis. Clinical outcomes at 30 days and 2 years were compared between patients according to whether they were recently hospitalized for HF, using Kaplan-Meier event rates and study-stratified multivariable Cox proportional hazards regression models. A sensitivity analysis was conducted using propensity score matching. Of 3988 patients (99.8%) with available information on recent HF hospitalization, 1622 patients (40.7%) were hospitalized for HF symptoms during the 6 months prior to TAVR. After multivariable adjustments, recent HF hospitalization was associated with increased all-cause mortality at 30 days [adjusted hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.07-2.48, P = 0.02] and 2 years (adjusted HR 1.30, 95% CI 1.13-1.49, P = 0.0003), which was driven by increased cardiovascular mortality. Infective endocarditis rate at 2 years was also higher in patients with recent HF hospitalization (adjusted HR 2.35, 95% CI 1.38-4.01, P = 0.002). These results remained consistent when propensity score matching was used. CONCLUSION: In a large cohort of patients with severe symptomatic aortic stenosis from the PARTNER 2 trial and registries, all-cause and cardiovascular mortality as well as infective endocarditis rates at 2 years were higher in patients with recent HF hospitalization.

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