Patients with multivessel coronary artery disease were randomly assigned to PCI with everolimus-eluting stents or CABG. At 2 years, the composite of death, myocardial infarction, or target-vessel ...revascularization occurred more frequently in the PCI group.
Randomized trials and observational studies have shown that the rates of most adverse clinical outcomes among patients with multivessel coronary artery disease are lower after coronary-artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI).
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Current clinical guidelines thus recommend CABG as the preferred revascularization strategy, particularly in patients with complex coronary lesions and without excessive operative risk.
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However, previous trials may have been limited by their use of first-generation drug-eluting stents. Although these stents reduced the rate of restenosis, their use was associated with a relatively high rate of stent-related thrombotic events.
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Results from the Synergy between . . .
In patients with acute myocardial infarction receiving potent antiplatelet therapy, the bleeding risk remains high during the maintenance phase. We sought data on a uniform unguided de-escalation ...strategy of dual antiplatelet therapy (DAPT) from ticagrelor to clopidogrel after acute myocardial infarction.
In this open-label, assessor-masked, multicentre, non-inferiority, randomised trial (TALOS-AMI), patients at 32 institutes in South Korea with acute myocardial infarction receiving aspirin and ticagrelor without major ischaemic or bleeding events during the first month after index percutaneous coronary intervention (PCI) were randomly assigned in a 1:1 ratio to a de-escalation (clopidogrel plus aspirin) or active control (ticagrelor plus aspirin) group. Unguided de-escalation without a loading dose of clopidogrel was adopted when switching from ticagrelor to clopidogrel. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, or bleeding type 2, 3, or 5 according to Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months. A non-inferiority test was done to assess the safety and efficacy of de-escalation DAPT compared with standard treatment. The hazard ratio (HR) for de-escalation versus active control group in a stratified Cox proportional hazards model was assessed for non-inferiority by means of an HR margin of 1·34, which equates to an absolute difference of 3·0% in the intention-to-treat population and, if significant, a superiority test was done subsequently. To ensure statistical robustness, additional analyses were also done in the per-protocol population. This trial is registered at ClinicalTrials.gov, NCT02018055.
From Feb 26, 2014, to Dec 31, 2018, from 2901 patients screened, 2697 patients were randomly assigned: 1349 patients to de-escalation and 1348 to active control groups. At 12 months, the primary endpoints occurred in 59 (4·6%) in the de-escalation group and 104 (8·2%) patients in the active control group (pnon-inferiority<0·001; HR 0·55 95% CI 0·40–0·76, psuperiority=0·0001). There was no significant difference in composite of cardiovascular death, myocardial infarction, or stroke between de-escalation (2·1%) and the active control group (3·1%; HR 0·69; 95% CI 0·42–1·14, p=0·15). Composite of BARC 2, 3, or 5 bleeding occurred less frequently in the de-escalation group (3·0% vs 5·6%, HR 0·52; 95% CI 0·35–0·77, p=0·0012).
In stabilised patients with acute myocardial infarction after index PCI, a uniform unguided de-escalation strategy significantly reduced the risk of net clinical events up to 12 months, mainly by reducing the bleeding events.
ChongKunDang Pharm, Medtronic, Abbott, and Boston Scientific.
Canakinumab, a monoclonal antibody targeting interleukin-1β, reduces inflammation and cardiovascular event rates with no effect on lipid concentrations. However, it is uncertain which patient groups ...benefit the most from treatment and whether reductions in the inflammatory biomarker high-sensitivity C-reactive protein (hsCRP) correlate with clinical benefits for individual patients.
The Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS) used computer-generated codes to randomly allocate 10 061 men and women with a history of myocardial infarction to placebo or one of three doses of canakinumab (50 mg, 150 mg, or 300 mg) given subcutaneously once every 3 months. In a prespecified secondary analysis designed to address the relationship of hsCRP reduction to event reduction in CANTOS, we evaluated the effects of canakinumab on rates of major adverse cardiovascular events, cardiovascular mortality, and all-cause mortality according to on-treatment concentrations of hsCRP. We used multivariable modelling to adjust for baseline factors associated with achieved hsCRP and multiple sensitivity analyses to address the magnitude of residual confounding. The median follow-up was 3·7 years. The trial is registered with ClinicalTrials.gov, number NCT01327846.
Baseline clinical characteristics did not define patient groups with greater or lesser cardiovascular benefits when treated with canakinumab. However, trial participants allocated to canakinumab who achieved hsCRP concentrations less than 2 mg/L had a 25% reduction in major adverse cardiovascular events (multivariable adjusted hazard ratio HRadj=0·75, 95% CI 0·66–0·85, p<0·0001), whereas no significant benefit was observed among those with on-treatment hsCRP concentrations of 2 mg/L or above (HRadj=0·90, 0·79–1·02, p=0·11). For those treated with canakinumab who achieved on-treatment hsCRP concentrations less than 2 mg/L, cardiovascular mortality (HRadj=0·69, 95% CI 0·56–0·85, p=0·0004) and all-cause mortality (HRadj=0·69, 0·58–0·81, p<0·0001) were both reduced by 31%, whereas no significant reduction in these endpoints was observed among those treated with canakinumab who achieved hsCRP concentrations of 2 mg/L or above. Similar differential effects were found in analyses of the trial prespecified secondary cardiovascular endpoint (which additionally included hospitalisation for unstable angina requiring unplanned revascularisation) and in sensitivity analyses alternatively based on median reductions in hsCRP, on 50% or greater reductions in hsCRP, on the median percent reduction in hsCRP, in dose-specific analyses, and in analyses using a causal inference approach to estimate the effect of treatment among individuals who would achieve a targeted hsCRP concentration.
The magnitude of hsCRP reduction following a single dose of canakinumab might provide a simple clinical method to identify individuals most likely to accrue the largest benefit from continued treatment. These data further suggest that lower is better for inflammation reduction with canakinumab.
Novartis Pharmaceuticals.
A cohort of patients who underwent stent implantation for unprotected left main coronary artery disease was compared with a propensity-matched cohort of patients who underwent coronary-artery bypass ...grafting. The risk of death and the composite outcome of death, Q-wave myocardial infarction, or stroke did not differ significantly between the two groups. The risk of target-vessel revascularization was higher in the group that received stents.
The risk of death and the composite outcome of death, Q-wave myocardial infarction, or stroke did not differ significantly between the two groups. The risk of target-vessel revascularization was higher in the group that received stents.
Significant narrowing of the left main coronary artery puts a patient at high risk, since it can jeopardize the entire myocardium of the left ventricle, and it has the worst prognosis of any form of coronary artery disease.
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On the basis of clinical trials that show a survival benefit with bypass surgery as compared with medical treatment,
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coronary-artery bypass grafting (CABG) has been considered standard therapy for patients with left main coronary artery disease and is recommended by current practice guidelines.
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Because of concern about procedural risk and long-term durability, percutaneous coronary intervention (PCI) usually has been restricted . . .
Two trials enrolled a total of 2701 patients who had undergone implantation of a drug-eluting coronary stent and had been receiving dual antiplatelet therapy for at least 12 months. They were ...randomly assigned to either continuation or discontinuation of clopidogrel therapy. At 19.2 months after randomization, the rate of myocardial infarction or death from cardiac causes did not differ significantly between the two groups.
Patients who had undergone implantation of a drug-eluting coronary stent and had been receiving dual antiplatelet therapy for at least 12 months were randomly assigned to either continuation or discontinuation of clopidogrel therapy. At 19.2 months after randomization, the rate of myocardial infarction or death from cardiac causes did not differ significantly between the two groups.
Several pivotal clinical trials have shown that the use of drug-eluting coronary stents is associated with significant reductions in the risks of restenosis and need for target-lesion revascularization, as compared with use of bare-metal coronary stents.
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On the basis of the results of these trials, drug-eluting stents have been widely used for percutaneous coronary intervention (PCI) in clinical practice.
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However, some longer-term studies have shown that drug-eluting stents, as compared with bare-metal stents, are associated with increased rates of late stent thrombosis, death, or myocardial infarction.
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It has been proposed that the occurrence of late clinical events may be . . .
The risks and benefits of long-term dual antiplatelet therapy remain unclear.
This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In ...total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20).
Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke.
http://www.clinicaltrials.gov. Unique identifier: NCT01186146.
Abstract Background We aimed to investigate the outcome-predicting value of a novel index of stress hyperglycemia in coronary artery disease (CAD) patients who underwent percutaneous coronary ...intervention (PCI). Methods This was a retrospective observational study. Four-thousand-three-hundred-sixty-two subjects from the COACT registry were used to estimate the risk of major adverse cardiovascular and cerebrovascular events (MACCE), which are defined as composites of all-cause death, non-fatal myocardial infarction (MI) and non-fatal stroke. The stress hyperglycemia ratio (SHR) was calculated by dividing the random serum glucose at admission with the estimated average glucose derived from HbA1c. Results Over a median follow-up of 2.5 years, 344 (7.9%), 43 (1.0%), and 89 (2.0%) cases of death, non-fatal MI, and non-fatal stroke occurred, respectively. Compared with the subjects in the lower three quartiles of SHR, the HR (95% CI) for the highest SHR quartile (Q4) group for MACCE was 1.31 (1.05, 1.64) in the total population and 1.45 (1.02, 2.06) in the non-diabetic population after adjusting for potential covariables. The risk of MACCE in the SHR Q4 group was significantly higher in patients presenting with ST-elevation MI (STEMI), which was not the case for patients presenting with other CAD types. The prognostic impact of SHR was more prominent for the 30-day MACCE. Similar results were observed in another cohort consisting of patients who only presented with acute MI. Conclusions SHR is a useful predictive marker of MACCE after PCI, especially in non-diabetic patients with STEMI, which could be utilized to identify high-risk patients for adverse outcomes.
Patients with unprotected left main coronary artery stenosis were assigned to either CABG or PCI with sirolimus-eluting stents. At 1 year, with a wide prespecified noninferiority margin, PCI was ...found to be noninferior to CABG.
Anumber of registry reports, as well as a substudy from a large, randomized trial, have indicated that percutaneous coronary intervention (PCI) may be an acceptable alternative to coronary-artery bypass grafting (CABG) in some patients with unprotected left main coronary artery stenosis.
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Recent clinical guidelines have accordingly stated that elective PCI can be considered for patients who have unprotected left main coronary artery disease, although they suggest that the aggregated evidence favors CABG.
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Whether the outcomes after PCI are similar to those after CABG remains uncertain, however, owing to the lack of large, randomized clinical trials. Registry results have . . .
The objective of this work was to investigate the long-term safety and efficacy of renal denervation in Korean patients from the Global SYMPLICITY Registry (GSR). GSR Korea is a substudy of GSR with ...additional inclusion and exclusion criteria compared to GSR, including inclusion criteria of office systolic blood pressure ≥160 mmHg, or ≥150 mmHg for type 2 diabetes patients, while receiving 3 or more antihypertensive medications without changes for 2 weeks prior to enrollment. Renal denervation was performed using a Symplicity Flex catheter for ablation in the main renal arteries. Changes in office systolic blood pressure and adverse events were collected for up to 36 months of follow-up for 102 patients in GSR Korea. In addition, adverse events and reductions in office systolic blood pressure were analyzed for patients with and without type II diabetes mellitus. Renal denervation led to mean (± standard deviation) reductions in office systolic blood pressure at 12, 24, and 36 months in GSR Korea (-26.7 ± 18.5, -30.1 ± 21.6 mmHg, and -32.5 ± 18.8, respectively). The proportion of patients with a ≥10 mmHg office systolic blood pressure reduction from baseline was 86.3% at 12 months, 86.5% at 24 months, and 89.7% at 36 months. Adverse events at 3 years were rare. In addition, reductions in office systolic blood pressure were similar for patients with vs. without diabetes mellitus (p > 0.05 at all timepoints). Office systolic blood pressure was safely reduced at up to 36 months post-renal denervation in GSR Korea, and adverse events were rare. In addition, patients with and without diabetes had similar office systolic blood pressure reductions.
Comparative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease were previously reported. However, data on ...very long-term (>10 years) outcomes are limited.
The authors compare 10-year outcomes after PCI and CABG for LMCA disease.
In this observational study of the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization) registry, the authors evaluated 2,240 patients with unprotected LMCA disease who underwent PCI (n = 1,102) or underwent CABG (n = 1,138) between January 2000 and June 2006. Adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) were compared with the use of propensity scores and inverse-probability-weighting adjustment. The follow-up was extended to at least 10 years of all patients (median 12.0 years).
In the overall cohort, there was no significant difference in adjusted risks of death and the composite outcome between the groups up to 10 years. The risk of target-vessel revascularization was significantly higher in the PCI group. In the cohort comparing drug-eluting stents and concurrent CABG, the 2 study groups did not differ significantly in the risks of death and the composite outcome at 5 years. However, after 5 years, drug-eluting stents were associated with higher risks of death (hazard ratio: 1.35; 95% confidence interval: 1.00 to 1.81) and the composite outcome (hazard ratio: 1.46; 95% confidence interval: 1.10 to 1.94) compared with CABG.
In patients with significant LMCA disease, as compared with CABG, PCI showed similar rates of death and serious composite outcomes, but a higher rate of target-vessel revascularization at 10 years. However, CABG showed lower mortality and serious composite outcome rates compared with PCI with drug-eluting stents after 5 years. (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization MAIN-COMPARE; NCT02791412)
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