Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 508
Filtrar
1.
JAMA Cardiol ; : 1-10, 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31693078

RESUMO

Importance: Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI). Objectives: To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies. Design, Setting, and Analysis: This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15 991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019. Interventions: Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy. Main Outcomes and Measures: The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding. Results: Of the 15 968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction = .045). Conclusions and Relevance: Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years. Trial Registration: ClinicalTrials.gov identifier: NCT01813435.

2.
J Am Coll Cardiol ; 74(21): 2572-2584, 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31753202

RESUMO

BACKGROUND: To date, no specific drug-eluting stent (DES) has fully proven its superiority over others in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention. OBJECTIVES: The purpose of this study was to compare the safety and efficacy of coronary artery stents in STEMI patients in a patient-level network meta-analysis. METHODS: Eligible studies were dedicated randomized controlled trials comparing different stents in STEMI patients undergoing percutaneous coronary intervention with at least 12 months of clinical follow-up. Of 19 studies identified from the published data, individual patient data were collected in 15 studies with 10,979 patients representing 87.7% of patients in the overall network of evidence. The primary endpoint was the composite of cardiac death, reinfarction, or target lesion revascularization. RESULTS: Overall, 8,487 (77.3%) of 10,979 STEMI patients were male and the mean age was 60.7 years. At a median follow-up of 3 years, compared with bare-metal stents (BMS), patients treated with paclitaxel-, sirolimus-, everolimus-, or biolimus-eluting stents had a significantly lower risk of the primary endpoint (adjusted hazard ratios [HRs]: 0.74 [95% confidence interval (CI): 0.63 to 0.88], 0.65 [95% CI: 0.49 to 0.85], 0.70 [95% CI: 0.53 to 0.91], and 0.66 [95% CI: 0.49 to 0.88], respectively). The risk of primary endpoint was not different between patients treated with BMS and zotarolimus-eluting stents (adjusted HR: 0.83 [95% CI: 0.51 to 1.38]). Among patients treated with DES, no significant difference in the risk of the primary outcome was demonstrated. Treatment with second-generation DES was associated with significantly lower risk of definite or probable stent thrombosis compared with BMS (adjusted HR: 0.61 [95% CI: 0.42 to 0.89]) and first-generation DES (adjusted HR: 0.56 [95% CI: 0.36 to 0.88]). CONCLUSIONS: In STEMI patients, DES were superior to BMS with respect to long-term efficacy. No difference in long-term efficacy and safety was observed among specific DES. Second-generation were superior to first-generation DES in reducing stent thrombosis. (Clinical Outcomes After Primary Percutaneous Coronary Intervention [PCI] Using Contemporary Drug-Eluting Stent [DES]: Evidence From the Individual Patient Data Network Meta-Analysis; CRD42018104053).

3.
EuroIntervention ; 2019 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-31746741

RESUMO

Transcatheter aortic valve implantation (TAVI) is undeniably invading the "surgical" space and expanding its indication. Over the last 5 years, there has been a real revolution in TAVI technology with the introduction of newer devices that aimed to simplify the procedure 1. These swift advances have transformed the landscape in structural heart disease and culminated in a broader use of TAVI in clinical practice 2, 3. The procedure is not only spreading worldwide but is also becoming less aggressive for the patient with the so-called "minimalist approach".

4.
Int J Cardiol ; 2019 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-31677827

RESUMO

OBJECTIVE: Fractional flow reserve (FFR) is regarded as the gold standard for the physiological assessment of intermediate coronary artery stenoses. However, FFR does not allow assessment of plaque morphology and lesion geometry. Intracoronary imaging techniques such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) can help treatment planning by optimising stent implantation, which can improve patient outcomes. The aim of this meta-analysis is to compare the efficacy of IVUS and OCT-derived metrics in detecting flow limiting stenoses in non-left main stem lesions. METHODS: A systematic review of PubMed, Medline, and Cochrane databases was performed and identified studies examining the diagnostic accuracy of IVUS and OCT in detecting significant stenoses when compared to FFR. RESULTS: A total of 33 (7537 lesions) studies (24 IVUS, 7 OCT and 2 IVUS & OCT studies) were included in the meta-analysis. Pooled analysis showed that IVUS- and OCT-derived minimum lumen area (MLA) had a similar sensitivity in predicting haemodynamically significant lesions (IVUS-MLA: 0.747 vs OCT-MLA 0.732, p = 0.519). However, OCT-MLA had a higher specificity (0.763 vs 0.665, p < 0.001) and diagnostic accuracy in detecting flow-limiting stenoses than IVUS-MLA (AUC 0.810 vs 0.754, p = 0.045). Sub-analysis of the studies with the clinically significant FFR cut-off value of 0.80 yielded similar results demonstrating that OCT-MLA has a better accuracy than IVUS-MLA in detecting haemodynamically significant stenoses (AUC 0.809 vs 0.750, p = 0.034). CONCLUSIONS: OCT with its superior image resolution appears to be the preferable intravascular imaging modality for the detection of haemodynamically significant stenoses in non-left main stem lesions.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31673850

RESUMO

We aimed to quantitatively assess a possible difference of the neointimal quality between biodegradable polymer- (BP-) and durable polymer drug-eluting stents (DP-DESs). We conducted a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful OCT examination at planned 3-month follow-up after DES implantation were analyzed. Study population was divided into 2 groups, BP-DES versus DP-DES groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter. We performed OCT analyses of 121 lesions in 98 patients (BP-DES 55 lesions in 51 patients vs. DP-DES 66 lesions in DP-DES 53 patients). Lesion and procedural characteristics were overall well-balanced between both groups. At 3-month follow-up, neointimal thickness (BP-DES 49.3 [38.2, 57.7] µm versus DP-DES 54.7 [45.1, 70.7] µm, p = 0.059) and coverage percent (BP-DES 94.5 [89.8, 97.0]% vs. DP-DES 95.8 [91.1, 98.1]%, p = 0.083) did not significantly differ. Light intensity of superficial neointima in the BP-DES was lower than that in the DP-DES, whereas that of deep neointima did not differ between both groups. Both superficial and deep neointima of the BP-DES presented significantly lower light attenuation and backscatter than those of the DP-DES did. Almost complete coverage at 3 months in both contemporary BP- and DP-DES would support the ultra-short DAPT strategy in the upcoming decade. Nevertheless, there was a significant difference in the neointimal characteristics on OCT light property 3 months after BP- versus DP-DES implantation.Trial Registration UMIN000033009.

6.
J Am Coll Cardiol ; 74(16): 2015-2027, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31623758

RESUMO

BACKGROUND: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. OBJECTIVES: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI. METHODS: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754). CONCLUSIONS: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).

7.
Artigo em Inglês | MEDLINE | ID: mdl-31620778

RESUMO

OBJECTIVES: The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease. METHODS: The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years. RESULTS: SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG. CONCLUSIONS: In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality.

11.
Am J Cardiol ; 124(12): 1833-1840, 2019 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-31648781

RESUMO

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial.

12.
J. Am. Coll. Cardiol. ; 74(13 supl.): 115-115, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024911

RESUMO

BACKGROUND: The development of bioresorbable vascular scaffold (BRS) offers a new treatment strategy for coronary artery lesion by replacement of a permanent metallic scaffold with a temporary scaffold and eradicating a nidus for very late adverse events. The first-in-human MeRes-1 trial reported favorable safety and efficacy of thin-strut (100 mm) MeRes100 sirolimus-eluting BRS (Meril Life Sciences Pvt. Ltd., India) in patients with de novo coronary artery lesions. Hence, to reaffirm the outcomes of the MeRes-1 trial, the MeRes-1 Extend trial sought to evaluate the safety and efficacy of the MeRes100 BRS in diverse patient population in Europe, Brazil, South Africa, and Asia Pacific. METHODS: The MeRes-1 Extend was a multicenter, prospective, single-arm study of MeRes100 BRS in 64 patients from Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE), which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). Quantitative coronary angiography and optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS: Among 64 enrolled patients (mean age: 58.30 _ 9.02 years), 26.56% had diabetes mellitus and 68.75% patients presented with stable angina. Of 69 target lesions, 71.01% were classified as type B2/C; average lesion length was 14.37 _ 5.89 mm and mean reference vessel diameter was 3.03 _ 0.35 mm. Procedural and device success was achieved in 64 and 62 patients, respectively. MACE was reported in 1 patient (1.61%) at 24-month follow-up in the form of ID-TLR with absence of MI, cardiac death, or scaffold thrombosis. At 6-month angiographic follow-up in a subset of 32 patients, mean in-scaffold LLL was 0.18 _ 0.31 mm. OCT analysis (n » 21) reported 97.95 _ 3.69% strut coverage with mean scaffold area of 7.56 _ 1.79 mm2 and no evidence of strut malapposition. CONCLUSION: Based on 2-year clinical and 6-month imaging outcomes, the MeRes-1 Extend trial established favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions. (AU)


Assuntos
Doença da Artéria Coronariana , Tecidos Suporte , Stents Farmacológicos
13.
JAMA Cardiol ; 2019 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-31557763

RESUMO

Importance: The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. Objective: To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and Participants: This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. Interventions: The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and Measures: The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. Results: Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004). Conclusions and Relevance: Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial Registration: ClinicalTrials.gov identifier: NCT01813435.

14.
JAMA Cardiol ; 2019 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-31561250

RESUMO

Importance: Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. Objective: To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals. Data Sources: We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies. Study Selection: Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria. Data Extraction and Synthesis: Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed. Main Outcomes and Measures: The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years. Results: Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis. Conclusions and Relevance: The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease. Trial Registration: ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

16.
JACC Cardiovasc Interv ; 12(20): 2064-2075, 2019 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-31563682

RESUMO

OBJECTIVES: The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI. BACKGROUND: The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined. METHODS: All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value. RESULTS: A total of 968 vessels treated with PCI were screened. Post-PCI QFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurred at 2 years. The mean value of post-PCI QFR was 0.91 ± 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCI QFR <0.91 (n = 284) was significantly higher compared with vessels with post-PCI QFR ≥0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001). CONCLUSIONS: A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of-the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value ≥0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials.

17.
EuroIntervention ; 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-31498113

RESUMO

AIMS: To evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL). METHODS AND RESULTS: This is a post-hoc analysis of the Global Leaders trial, a prospective, multi-centre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet regimen [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with Biolimus A9-eluting stent (BES). The primary endpoint was the composite of the all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL, and the fourth quartile group was at significantly higher ischemic risk at two years. In that stratum (TSL≥ 46mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR]:0.67; 95% confidence interval [CI]:0.49-0.90; Pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR:0.99; 95% CI:0.66-1.49; Pinteraction =0.975). CONCLUSIONS: Ticagrelor monotherapy potentially could balance ischemic and bleeding risks, thereby achieving a net clinical benefit in patients with TSL≥ 46 mm with BES.

18.
EuroIntervention ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31475907

RESUMO

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularization procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug-release mechanisms and anti-proliferative drugs, have progressively reduced the rate of device-related adverse clinical events, and objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognized as an intra-procedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomized comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents including the mechanistic evaluation of coronary stents which recommend operational definitions of device success. While the majority of clinical trials investigating drug-eluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.

19.
EuroIntervention ; 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31543500

RESUMO

AIMS: To demonstrate the noninferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the Xience stent regarding patients oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA). METHODS AND RESULTS: The POLBOS LM study is a single-arm prospective multi-centre study enrolling 260 patients (SYNTAX score ≤32) with pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrollment will comply with objective inclusion criteria of diameter stenosis ≥50% in LMCA based on off-line quantitative coronary angiography (QCA) analyzed by an independent core laboratory using dedicated-bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the specific technical classification for the BiOSS LIM (modified MADS classification) and the stent implantation is optimized by using pre-specified intravascular ultrasound criteria. Primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularization) at 12 months. CONCLUSION: The POLBOS LM study will indicate the efficacy of BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

20.
Artigo em Inglês | MEDLINE | ID: mdl-31402574

RESUMO

BACKGROUND: Bifurcation PCI is associated with a lower rate of procedural success, especially in multivessel disease patients. We aimed to determine the impact of bifurcation treatment on 2-years clinical outcomes when a state-of-the-art PCI strategy (heart team decision-making using the SYNTAX score II, physiology guided coronary stenosis assessment, thin strut bioresorbable polymer drug-eluting stent, and intravascular ultrasound guidance) is followed. METHODS: Three-vessel disease patients enrolled in the SYNTAX II trial (n = 454) were categorized in patients with (a) ≥1 treated bifurcation (n = 126), and (b) without bifurcation (n = 281). The primary endpoint was the occurrence of major adverse cardio and cerebrovascular events (MACCE-a composite of all-cause death, stroke, any myocardial infarction, or any revascularization) at 2 years. Secondary endpoints were the occurrence of target lesion failure (TLF) defined as cardiac death, target-vessel myocardial infarction and ischemia-driven target lesion revascularization, and the individual components of the composite primary endpoint, as well as stent thrombosis. RESULTS: A total of 145 bifurcation were treated in 126 patients. At 2 years, MACCE occurred in 75/407 patients (20.7% for bifurcation versus 17.5% for nonbifurcation, hazard ratio [HR] of 1.28, CI95% 0.78-2.08, p = .32). TLF presented a trend toward higher occurrence in bifurcation (16.8% vs. 10.8%, HR 1.75, CI95% 0.99-3.09, p = .053). Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92). CONCLUSION: Bifurcation treatment in patients with three-vessel disease undergoing state-of-the-art PCI had similar event rate of MACCE but was associated with a trend toward higher incidence of TLF compared with nonbifurcation lesions.

SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA