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AbstractObjectiveTo assess the risks and benefits of P2Y12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients’ characteristics.DesignIndividual patient level meta-analysis of randomised controlled trials.Data sourcesSearches were conducted in Ovid Medline, Embase, and three websites (www.tctmd.com, www.escardio.org, www.acc.org/cardiosourceplus) from inception to 16 July 2020. The primary authors provided individual participant data.Eligibility criteriaRandomised controlled trials comparing effects of oral P2Y12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation.Main outcome measuresThe primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.ResultsThe meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ2=0.00) and in 303 (2.94%) with P2Y12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ2=0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ2=0.03), which was consistent across subgroups, except for type of P2Y12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y12 inhibitor rather than clopidogrel was part of the DAPT regimen.ConclusionsP2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT.RegistrationPROSPERO CRD42020176853.

This study aimed to evaluate the association between intraoperative blood loss and myocardial injury after non-cardiac surgery (MINS), which is a severe and common postoperative complication. We compared the incidence of MINS based on significant intraoperative bleeding, defined as an absolute hemoglobin level < 7 g/dL, a relative hemoglobin level less than 50% of the preoperative measurement, or need for packed red cell transfusion. We also estimated a threshold for intraoperative hemoglobin level associated with MINS. We stratified a total of 15,926 non-cardiac surgical patients with intraoperative hemoglobin and postoperative cardiac troponin (cTn) measurements according to the occurrence of significant intraoperative bleeding; 13,416 (84.2%) had no significant bleeding while 2,510 (15.8%) did have significant bleeding. After an adjustment with inverse probability weighting, the incidence of MINS was higher in the significant bleeding group (35.2% vs. 16.4%; odds ratio, 1.58; 95% confidence interval, 1.43-1.75; p < 0.001). The threshold of intraoperative hemoglobin associated with MINS was estimated to be 9.9 g/dL with an area under the curve of 0.643. Intraoperative blood loss appeared to be associated with MINS. Further studies are needed to confirm these findings. The cohort was registered before patient enrollment at https://cris.nih.go.kr (KCT0004244).

Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population. We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2–5 bleeding at 18 months after the index procedure. The primary endpoint was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453. Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in 1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; pnon-inferiority=0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly between the 6-month DAPT group and the 12-month or longer DAPT group (35 [2·6%] patients vs 39 [2·9%]; hazard ratio [HR] 0·90 [95% CI 0·57–1·42]; p=0·90) and neither did stroke (11 [0·8%] patients vs 12 [0·9%]; 0·92 [0·41–2·08]; p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer DAPT group (24 [1·8%] patients vs ten [0·8%]; 2·41 [1·15–5·05]; p=0·02). 15 (1·1%) patients had stent thrombosis in the 6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 [95% CI 0·68–3·35]; p=0·32). The rate of BARC type 2–5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) in the 12-month or longer DAPT group (HR 0·69 [95% CI 0·45–1·05]; p=0·09). Results from the per-protocol analysis were similar to those from the intention-to-treat analysis. The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care. Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST.

Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation. A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent. Randomised trials comparing P2Y12 inhibitor monotherapy with DAPT after coronary revascularisation were searched in Ovid MEDLINE, Embase, and two websites (www.tctmd.com and www.escardio.org) from database inception up to May 20, 2024. Trials that included patients with an indication for long-term oral anticoagulants were excluded. The risk of bias was assessed using the revised Cochrane risk-of-bias tool. The principal investigators of the eligible trials provided IPD by means of an anonymised electronic dataset. The three ranked coprimary endpoints were major adverse cardiovascular or cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke) tested for non-inferiority in the per-protocol population; and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death tested for superiority in the intention-to-treat population. All outcomes are reported as Kaplan–Meier estimates. The non-inferiority was tested using a one-sided α of 0·025 with the prespecified non-inferiority margin of 1·15 (hazard ratio [HR] scale), followed by the ranked superiority testing at a two-sided α of 0·05. This study is registered with PROSPERO (CRD42024506083). A total of 8361 unique citations were screened, of which 610 records were considered potentially eligible during the screening of titles and abstracts. Of these, six trials that randomly assigned patients to ticagrelor monotherapy or DAPT were identified. De-escalation took place a median of 78 days (IQR 31–92) after intervention, with a median duration of treatment of 334 days (329−365). Among 23 256 patients in the per-protocol population, MACCE occurred in 297 (Kaplan–Meier estimate 2·8%) with ticagrelor monotherapy and 332 (Kaplan–Meier estimate 3·2%) with DAPT (HR 0·91 [95% CI 0·78–1·07]; p=0·0039 for non-inferiority; τ2<0·0001). Among 24 407 patients in the intention-to-treat population, the risks of BARC 3 or 5 bleeding (Kaplan–Meier estimate 0·9% vs 2·1%; HR 0·43 [95% CI 0·34–0·54]; p<0·0001 for superiority; τ2=0·079) and all-cause death (Kaplan–Meier estimate 0·9% vs 1·2%; 0·76 [0·59–0·98]; p=0·034 for superiority; τ2<0·0001) were lower with ticagrelor monotherapy. Trial sequential analysis showed strong evidence of non-inferiority for MACCE and superiority for bleeding among the overall and ACS populations (the z-curve crossed the monitoring boundaries or the required information size without crossing the futility boundaries or approaching the null). The treatment effects were heterogeneous by sex for MACCE (p interaction=0·041) and all-cause death (p interaction=0·050), indicating a possible benefit in women with ticagrelor monotherapy, and by clinical presentation for bleeding (p interaction=0·022), indicating a benefit in ACS with ticagrelor monotherapy. Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS. Ticagrelor monotherapy might also be associated with a mortality benefit, particularly among women, which warrants further investigation. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale.

Myocardial injury after noncardiac surgery (MINS) is recently accepted as a strong predictor of mortality, regardless of symptoms. However, anticoagulation is the only established treatment. This study aimed to evaluate the association between statin treatment and mortality after MINS. From January 2010 to June 2019, a total of 5,267 adult patients who were discharged after the occurrence of MINS were enrolled. The patients were divided into two groups according to statin prescription at discharge. The outcomes were 1-year and overall mortalities. Of the total 5,109 patients, 1,331 (26.1%) patients were in the statin group and 3,778 (73.9%) patients were in the no statin group. The 1-year and overall mortalities were significantly lower in the statin group compared with the no statin group (6.1% vs. 13.3%; hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.41–0.74; p < 0.001 for 1-year mortality and 15.0% vs. 25.0%; HR, 0.62; 95% CI, 0.51–0.76; p < 0.001 for overall mortality). Analyses after inverse probability treatment weighting showed similar results (HR, 0.61; 95% CI, 0.50–0.74; p < 0.001 for 1-year mortality and HR, 0.70; 95% CI, 0.54–0.90; p = 0.006 for overall mortality), and the mortalities did not differ according to the dose of statin. Our results suggest that statin treatment may be associated with improved survival after MINS. A trial is needed to confirm this finding and establish causality.

In patients with manifestations of cardiovascular disease, acetylsalicylic acid (popularly known as aspirin) has been the mainstay of treatment for decades owing to its capacity to reduce the risk of ischaemic events. Accordingly, novel antithrombotic therapies have been traditionally tested on a background of acetylsalicylic acid therapy. Although the adjunctive use of such antithrombotic therapies can potentially further reduce the risk of ischaemic events, these agents are also inevitably associated with an increased risk of bleeding. However, acetylsalicylic acid also increases the risk of bleeding, challenging the paradigm that this agent should remain the cornerstone of antiplatelet treatment when alternative antithrombotic agents are also used. Many antithrombotic compounds are characterized by increased potency and consistent efficacy, which might lessen the need for concomitant acetylsalicylic acid. Accordingly, numerous investigations are testing the hypothesis that acetylsalicylic acid-sparing regimens based on newer antithrombotic agents might have an increased net benefit for individual patients owing to the reduction in bleeding risk, without a trade-off in efficacy. This Review summarizes the state of the art relating to antithrombotic approaches with and without acetylsalicylic acid for the prevention of cardiovascular disease and cardioembolic stroke. Discussion of the scientific rationale, from bench to bedside, for ongoing studies of acetylsalicylic acid-free pharmacological strategies is included.

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.

Long-term follow-up data on differential effects of intravascular ultrasound (IVUS) according to lesion complexity are limited in patients undergoing percutaneous coronary intervention (PCI). The current study compared long-term clinical outcomes between IVUS-guided and angiography-guided PCI in patients with second-generation drug-eluting stents (DES). Between February 2008 and December 2015, 5488 patients undergoing PCI with second-generation DES were recruited from an institutional registry of Samsung Medical Center. The primary outcome was a composite of cardiac death or myocardial infarction (MI) during 46 months of median follow-up (interquartile range: 32–102 months). IVUS-guided PCI was performed in 979 patients (17.8%). IVUS-guided PCI was associated with a significantly lower risk of cardiac death or MI compared with angiography-guided PCI (5.7% vs. 12.9%, hazard ratio 0.408, 95% confidence interval 0.284–0.587, p < 0.001). Results were consistent after propensity score matching analysis with 801 matched pairs. In subgroup analysis, there was no significant interaction between lesion complexity (defined by complex procedures, P interaction  = 0.819, ACC/AHA lesion classification, P interaction  = 0.401 or SYNTAX score, P interaction  = 0.149) and use of IVUS for risk of cardiac death or MI. IVUS-guided second-generation DES implantation was associated with a significantly lower long-term risk of cardiac death or MI compared with angiography guidance, regardless of lesion complexity.

The optimal strategy for long-term antiplatelet maintenance for patients who underwent percutaneous coronary intervention (PCI) remains uncertain. This study aimed to compare the efficacy and safety of clopidogrel versus aspirin monotherapy in patients who completed a standard duration of dual antiplatelet therapy (DAPT) following PCI with drug-eluting stents. In this multicentre, randomised, open-label trial, patients aged 19 years or older at high risk of recurrent ischaemic events (previous myocardial infarction at any time before enrolment, medication-treated diabetes, or complex coronary lesions) who completed a standard duration of DAPT after PCI were randomly assigned (1:1) to receive clopidogrel (75 mg once a day) or aspirin (100 mg once a day) oral monotherapy at 26 sites in South Korea. The primary endpoint was the cumulative incidence of a composite of death from any cause, myocardial infarction, or stroke, assessed in the intention-to-treat population. Adverse events were captured as part of the secondary endpoints. This trial is registered with ClinicalTrials.gov (NCT04418479). It is closed to accrual and extended follow-up is ongoing. Between Aug 10, 2020, and July 31, 2023, 5542 patients were assessed for eligibility and 5506 were randomly assigned (2752 to clopidogrel monotherapy and 2754 to aspirin monotherapy). The median time between PCI and randomisation was 17·5 months (IQR 12·6–36·1 months). During a median follow-up period of 2·3 years (IQR 1·6–3·0), the primary endpoint occurred in 92 patients in the clopidogrel group and 128 patients in the aspirin group (Kaplan–Meier estimated 3-year incidence 4·4% [95% CI 3·4–5·4] vs 6·6% [5·4–7·8]; hazard ratio 0·71 [95% CI 0·54–0·93]; p=0·013). Death from any cause occurred in 50 patients in the clopidogrel group and 70 in the aspirin group (2·4% [1·6–3·1] vs 4·0% [2·9–5·0] at 3 years; 0·71 [0·49–1·02]); myocardial infarction in 23 patients in the clopidogrel group and 42 in the aspirin group (1·0% [0·6–1·4] vs 2·2% [1·4–2·9] at 3 years; 0·54 [0·33–0·90]); and stroke in 23 in the clopidogrel group and 29 in the aspirin group (1·3% [0·7–2·0] vs 1·3% [0·8–1·7] at 3 years; 0·79 [0·46–1·36]). There was no difference in the risk of bleeding between the clopidogrel and aspirin groups (3·0% [2·0–3·9] vs 3·0% [2·2–3·9] at 3 years; 0·97 [0·67–1·42]). Clopidogrel was not associated with a higher incidence of any adverse event compared with aspirin. Among patients who were at high risk of recurrent ischaemic events and who completed the standard duration of DAPT following PCI, clopidogrel monotherapy, compared with aspirin monotherapy, significantly reduced the cumulative incidence of a composite of death from any cause, myocardial infarction, and stroke, without an apparent increase in the risk of bleeding. Dong-A ST.

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. 1 – 11 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. 12 , 13 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 . . .