Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and ...carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.
In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.
We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval CI, -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001).
Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).
Objectives
A few studies suggest a significant prognostic value of silent myocardial ischaemia detected in asymptomatic patients. However, the current guidelines do not recommend stress testing in ...asymptomatic individuals. To assess the long-term prognostic value of vasodilator stress perfusion cardiovascular magnetic resonance (CMR) in asymptomatic individuals without known coronary artery disease (CAD).
Methods
Between 2009 and 2011, a retrospective cohort study with a median follow-up of 9.2 years (interquartile range: 7.8–9.6) included 1,027 consecutive asymptomatic individuals with ≥ 2 cardiovascular risk factors but without known known CAD referred for stress CMR. Major adverse cardiovascular events (MACE) included cardiovascular mortality and nonfatal myocardial infarction (MI).
Results
Among 1,027 asymptomatic subjects, 903 (87.9%) (mean age 70.6 ± 12.4 years and 46.2% males) completed the follow-up, and 91 had MACE (10.1%). Using Kaplan-Meier analysis, silent ischaemia and unrecognised MI were associated with MACE (hazard ratio HR: 8.70; 95% CI: 5.79–13.10 and HR: 3.40; 95% CI: 2.15–5.38, respectively; both
p
< 0.001). In multivariable stepwise Cox regression, silent ischaemia and unrecognised MI were independent predictors of MACE (HR: 6.66; 95% CI 4.41–9.23; and HR: 2.42; 95% CI 1.23–3.21, respectively; both
p
< 0.001). The addition of silent ischaemia and unrecognised MI led to improved model discrimination for MACE (change in C statistic from 0.66 to 0.82; NRI = 0.497; IDI = 0.070).
Conclusions
Silent ischaemia and unrecognised MI are good long-term predictors for the incidence of MACE in selected asymptomatic individuals with multiple risk factors and without known CAD. These stress CMR parameters have incremental long-term prognostic value to predict MACE over traditional risk factors.
Key Points
• Silent ischaemia and unrecognised myocardial infarction defined by stress CMR are good long-term predictors of cardiovascular events in asymptomatic individuals without known coronary artery disease.
• The addition of stress cardiac MR imaging led to improved model discrimination for cardiovascular events over traditional risk factors in this specific population.
Objectives The purpose of this study was to clarify the impact of sex-related differences in transcatheter aortic valve implantation (TAVI) for high-risk patients with severe aortic stenosis. ...Background Although TAVI is becoming a mature technique, the impact of sex differences remains unclear. Methods The TAVI patients were included prospectively in a dedicated database from October 2006. The proportion of women (n = 131) was similar to that of men (n = 129). The Edwards valve (85.4%) and CoreValve (14.6%) were used through the transfemoral (65.0%), subclavian (3.1%), or transapical (31.9%) approach. All events were defined according to Valve Academic Research Consortium criteria. Results Age was similar (83.1 ± 6.3 years), but women had less coronary and peripheral disease, less previous cardiac surgery, higher ejection fraction, and lower EuroSCORE (European System for Cardiac Operative Risk Evaluation 22.3 ± 9.0% vs. 26.2 ± 13.0%, p = 0.005). Minimal femoral size (7.74 ± 1.03 mm vs. 8.55 ± 1.34 mm, p < 0.001), annulus size (20.9 ± 1.4 vs. 22.9 ± 1.7 mm, p < 0.001), and valve size (23.9 ± 1.6 mm vs. 26.3 ± 1.5 mm, p < 0.001) were smaller in women. Device success was similar (90.8% vs. 88.4%, p = 0.516) despite more frequent iliac complications (9.0% vs. 2.5%, p = 0.030). Residual mean aortic pressure gradient (11.6 ± 4.9 vs. 10.9 ± 4.9, p = 0.279) was also similar. The 1-year survival rate was higher for women, 76% (95% confidence interval: 72% to 80%), than for men, 65% (95% confidence interval: 60% to 69%); and male sex (hazard ratio: 1.62, 95% confidence interval: 1.03 to 2.53, p = 0.037) was identified as a predictor of midterm mortality by Cox regression analysis. Conclusions Female sex is associated with better baseline clinical characteristics and improved survival, and is identified as a predictor of midterm survival after TAVI.
Objectives The goal of the study was to clarify the impact of post-procedural aortic regurgitation (post-AR) grade 2/4 on clinical outcomes. Background Post-AR >2/4 is known to be associated with ...poor short- to midterm outcome after transcatheter aortic valve implantation (TAVI). Methods We compared clinical outcomes in 400 consecutive TAVI recipients according to post-AR grade: grade 0 or 1 (group 1 = 74.8%), grade 2 (group 2 = 22.2%), or grade 3 or 4 (group 3 = 3.0%). Results The mean age was similar in the 3 groups (83.4 ± 6.1 years) as was the logistic EuroSCORE (22.5 ± 11.4%, 24.5 ± 11.6%, and 21.5 ± 9.4%, p = 0.28) and annulus size (22.0 ± 1.8, 22.2 ± 2.1, and 22.5 ± 2.1 mm, p = 0.53). The Edwards valve was most frequently used in group 1 compared with groups 2 and 3 (89.3%, 78.7%, and 83.3%, p = 0.03), and the implanted valve size was similar in all groups (25.6 ± 2.0, 25.4 ± 2.2, and 25.5 ± 2.2 mm, respectively, p = 0.69). Post-dilation was required more frequently in group 3 (4.7%, 24.1%, and 50.0%, respectively, p < 0.01). Post-procedural increase in mitral regurgitation was in line with the post-AR grade (0.78 ± 0.73, 1.22 ± 0.80, and 1.89 ± 0.78, respectively, p < 0.01). Despite the absence of difference in 30-day mortality, longer-term outcome was significantly poorer in patients with AR grade 2 than in those with AR grade 0 or 1 (log-rank p < 0.01), albeit better than in patients with AR grade 3 or 4 (p = 0.04), regardless of TAVI type and left ventricular function. Post-AR ≥2/4 was also identified as an independent predictor of mid- to long-term mortality (hazard ratio: 1.68, 95% confidence interval: 1.21 to 1.44, p < 0.01). Conclusions Post-AR grade 2/4 after TAVI is associated with worse outcome compared with grade 0 or 1. Careful valve selection and post-dilation when required to avoid post-AR grade 2 may contribute to improved clinical outcome after TAVI.
Abstract Objectives The aim of this study was to compare outcomes among transfemoral (TF), transaortic (TAo), and transapical (TA) transcatheter aortic valve replacement (TAVR). Background Very few ...studies have investigated the differences among TF, TAo, and TA TAVR in terms of safety and feasibility. Methods Between January 2011 and December 2014, 467 consecutive cases of TF TAVR, 289 cases of TAo TAVR, and 42 cases of TA TAVR were analyzed. Baseline characteristics, procedural characteristics, and outcomes were compared between TF and TAo and between TAo and TA approaches. Results Balloon-expandable prostheses were used in 320 cases of TF TAVR (69%), 209 cases of TAo TAVR (72%), and all cases of TA TAVR. The remaining cases were performed using self-expandable prostheses. Patient age and Society of Thoracic Surgeons score were similar (83.8 years vs. 83.7 years vs. 81.3 years and 6.2% vs. 5.8% vs. 7.1%) among all groups. Although nonsignificant, a trend toward lower 30-day mortality (5% vs. 9%; p = 0.057) was observed with TF TAVR compared with TAo TAVR. Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.067) with TF TAVR compared with TAo TAVR. There was no significant difference in 30-day mortality between TAo and TA TAVR (9% vs. 14%; p = 0.283). Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.154) with TAo TAVR compared with TA TAVR. Conclusions Although the 30-day mortality and 1-year survival rates were similar between TF and TAo TAVR patients, a trend in favor of the TF approach was observed. In addition, the TAo approach can be considered as an alternative to the TA approach when the TF approach seems unsuitable.
Several studies have established the prognostic value of vasodilator stress cardiovascular magnetic resonance (CMR) in broad population of patients with suspected or known coronary artery disease ...(CAD), but this specific population of asymptomatic patients with known CAD have never been formally evaluated. To assess the long-term prognostic value of vasodilator stress perfusion CMR in asymptomatic patients with obstructive CAD.
Between 2009 and 2011, consecutive asymptomatic patients with obstructive CAD referred for vasodilator stress CMR were followed for the occurrence of major adverse cardiovascular events (MACE), defined by cardiovascular mortality or recurrent non-fatal myocardial infarction (MI). Uni- and multivariable Cox regressions were performed to determine the prognostic value of myocardial ischemia and myocardial infarction defined by late gadolinium enhancement (LGE) with ischemic pattern.
Among 1529 asymptomatic patients with obstructive CAD, 1342 (87.8%; 67.7 ± 10.5 years, 82.0% males) completed the follow-up (median 8.3 years), and 195 had MACE (14.5%). Patients without stress-induced myocardial ischemia had a low annualized rate of MACE (2.4%), whereas the annualized rate of MACE was higher for patients with mild, moderate, or severe ischemia (7.3%, 16.8%, and 42.2%, respectively; p
< 0.001). Using Kaplan-Meier analysis, myocardial ischemia and LGE were associated with MACE (hazard ratio, HR 2.52; 95% CI 1.90-3.34 and HR 2.04; 95% CI 1.38-3.03, respectively; both p < 0.001). In multivariable stepwise Cox regression, myocardial ischemia and LGE were independent predictors of MACE (HR 2.80 95% CI 2.10-3.73, p < 0.001 and HR 1.51; 95% CI 1.01-2.27, p = 0.045; respectively). The addition of myocardial ischemia and LGE led to improved model discrimination for MACE (change in C statistic from 0.61 to 0.68; NRI = 0.207; IDI = 0.021).
Vasodilator stress CMR-induced myocardial ischemia and LGE are good long-term predictors for the incidence of MACE in asymptomatic patients with obstructive CAD.
New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety ...between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.
In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.
At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.
At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)
Abstract Objectives This study sought to develop a scoring model predicting percutaneous coronary intervention (PCI) success in chronic total occlusions. Background Coronary chronic total occlusion ...is the lesion subtype in which angioplasty is most likely to fail. Chronic total occlusion for PCI (CTO-PCI) failure is associated with higher 1-year mortality and major adverse cardiac events compared with successful CTO-PCI. Although several independent predictors of final procedural success have been identified, no study has yet produced a model predicting final procedural outcome. Methods Data from 1,657 consecutive patients who underwent a first-attempt CTO-PCI were prospectively collected. The scoring model was developed in a derivation cohort of 1,143 patients (70%) using a multivariable stepwise analysis to identify independent predictors of CTO-PCI failure. The model was then validated in the remaining 514 (30%). Results The overall procedural success rate was 72.5%. Independent predictors of CTO-PCI failure were identified and included in the clinical and lesion-related score (CL-score) as follows: previous coronary artery bypass graft surgery +1.5 (odds ratio OR: 2.49, 95% confidence interval CI: 1.56 to 3.96), previous myocardial infarction +1 (OR: 1.6, 95% CI: 1.17 to 2.2), severe lesion calcification +2 (OR: 2.72, 95% CI :1.78 to 4.16), longer CTOs +1.5 (≥20 mm OR: 2.04, 95% CI: 1.54 to 2.7), non–left anterior descending coronary artery location +1 (OR: 1.56, 95% CI: 1.14 to 2.15), and blunt stump morphology +1 (OR: 1.39, 95% CI: 1.05 to 1.81). Score values of 0 to 1, >1 and <3, ≥3 and <5, and ≥5 identified subgroups at high, intermediate, low, and very low probability, respectively, of CTO-PCI success (derivation cohort: 84.9%, 74.9%, 58%, and 31.9%; p < 0,0001; validation cohort: 88.3%, 73.1%, 59.4%, and 46.2%; p < 0.0001). Conclusions This clinical and angiographic score predicted the final CTO-PCI procedural outcome of our study population.
BACKGROUNDThe optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) in patients with nonvalvular atrial fibrillation (AF) remains uncertain.OBJECTIVESIn this study, the ...authors sought to compare the efficacy and safety of various antithrombotic strategies after LAAO.METHODSWe searched the Medline, Cochrane, EMBASE, LILACS, and ClinicalTrials.gov databases for studies reporting outcomes after LAAO, stratified by antithrombotic therapy prescribed at postprocedural discharge. Direct oral anticoagulants (DOACs), vitamin K antagonists (VKAs), single antiplatelet therapy (SAPT), dual antiplatelet therapy (DAPT), DOAC plus SAPT, VKA plus SAPT, and no antithrombotic therapy were analyzed. We performed a frequentist random effects model network meta-analysis to estimate the OR and 95% CI for each comparison. P-scores provided a ranking of treatments.RESULTSForty-one studies comprising 12,451 patients with nonvalvular AF were included. DAPT, DOAC, DOAC plus SAPT, and VKA were significantly superior to no therapy to prevent device-related thrombosis. DOAC was associated with lower all-cause mortality than VKA (OR: 0.39; 95% CI: 0.17-0.89; P = 0.03). Compared with SAPT, DAPT was associated with fewer thromboembolic events (OR: 0.50; 95% CI: 0.29-0.88; P = 0.02), without a difference in major bleeding. In the analysis of P-scores, DOAC monotherapy was the strategy most likely to have lower thromboembolic events and major bleeding.CONCLUSIONSIn this network meta-analysis comparing initial antithrombotic therapies after LAAO, monotherapy with DOAC had the highest likelihood of lower thromboembolic events and major bleeding. DAPT was associated with a lower incidence of thromboembolic events compared with SAPT and may be a preferred option in patients unable to tolerate anticoagulation.
The outcome of resuscitated patients after cardiac arrest complicating acute myocardial infarction remains poor, primarily because of the relatively low success rates of cardiopulmonary resuscitation ...management. Existing data suggest potential beneficial effects of early myocardial reperfusion, but the predictors of survival in these patients remain unknown.
From 1995 to 2005, 186 patients (78% men; mean age, 60.4+/-13.8 years) underwent immediate percutaneous coronary intervention after successful resuscitation for cardiac arrest complicating acute myocardial infarction. Prompt prehospital management was performed by mobile medical care units in 154 of 186 patients, whereas 32 had in-hospital cardiac arrest. Infarct location was anterior in 105 patients (56%), and shock was present on admission in 96 (52%). Percutaneous coronary intervention (stenting rate 90%) was successful in 161 of 186 patients (87%). Six-month survival rate was 100 of 186 (54%), and 6-month survival free of neurological sequelae was 46%. By multivariate analysis, predictors of 6-month survival were a shorter interval between the onset of cardiac arrest and arrival of a first responder (odds ratio, 0.67; 95% CI, 0.54 to 0.84), a shorter interval between the onset of cardiac arrest and return of spontaneous circulation (odds ratio, 0.91; 95% CI, 0.87 to 0.96), and absence of diabetes (odds ratio, 7.30; 95% CI, 1.80 to 29.41).
In patients with resuscitated cardiac arrest complicating acute myocardial infarction, prompt prehospital management and early revascularization were associated with a 54% survival rate at 6 months. A strategy including adequate prehospital management, early revascularization, and specific care in dedicated intensive care units should be strongly considered in resuscitated patients after cardiac arrest complicating acute myocardial infarction.
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