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BACKGROUND Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. METHODS This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. FINDINGS Between March 12, 2013, and May 10, 2016, we ; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). INTERPRETATION Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. FUNDING Bayer AG. Methods This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, i...

AimsTo compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography (CAG)±ad hoc percutaneous coronary intervention (PCI).Methods and resultsOpen-trial randomized 1028 patients with stable angina to group A (‘non-selective’—clopidogrel 600 mg >6 h before CAG; n = 513) or group B (‘selective’—clopidogrel 600 mg in the cath-lab after CAG, only in case of PCI; n = 515). Combined primary endpoint was death/periprocedural myocardial infarction (MI)/stroke/re-intervention within 7 days. Secondary endpoints were troponin elevation and bleeding complications. Primary endpoint occurred in 0.8% group A patients vs. 1% group B (P = 0.749; 90% CI for the percentage difference −1.2–0.8). Periprocedural troponin elevation (>3× ULN) was detected in 2.6% group A vs. 3.3% group B (P = 0.475; 90% CI −2.5–1.0). Bleeding complications occurred in 3.5% group A patients vs. 1.4% group B (P = 0.025). After adjustment for covariates and factors that may influence the bleeding risk, patients in group A were shown to have more likely bleeding complications when compared with group B (OR = 3.03; 95% CI 1.14–8.10; P = 0.027).ConclusionHigh (600 mg) loading dose of clopidogrel before elective CAG increased the risk of minor bleeding complications, while the benefit on periprocedural infarction was not significant. Clopidogrel can be given safely in the catheterization laboratory between CAG and PCI in chronic stable angina patients.

BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )

In the majority of AS patients, an aortic valve procedure leads to reduction in coexistent MR. A significant decrease in the severity of MR in our study was observed regardless of etiology and preoperative grade of MR. Persistence of higher degrees of MR was associated with increased patient morbidity.

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Background Patients with ST elevation myocardial infarction (STEMI) and cardiogenic shock (CS) treated with primary percutaneous coronary intervention (pPCI) have high mortality. A recent trial demonstrated that a culprit vessel-only strategy (CV-pPCI) was superior to immediate multivessel PCI (MV-pPCI) for patients with CS and multivessel coronary artery disease (MVD). Irrespective of it and current guidelines, multivessel PCI is still often used in these patients. Purpose/Methods The study aimed to compare the characteristics and prognosis of patients with CS-STEMI and MVD treated with culprit vessel only pPCI or multivessel PCI during initial procedure. From 2016 to 2020, 23703 primary PCI patients with STEMI were included in the national all-comers registry of cardiovascular interventions. From them, a total of 1213 (5.1%) patients had cardiogenic shock and MVD at admission to the hospital. Initially 921 (75.9%) patients were treated with CV-pPCI and 292 (24.1%) with MV-pPCI. Results CV-pPCI was a preferred strategy to MV-pPCI in men (74.6% vs 25.4%; p&lt;0,001) and women (79.8% vs 20.2%; p&lt;0,001) with CS-STEMI and MVD. Patients with 3-vessel disease and left main disease had higher probability to be treated with MV-pPCI than patients with 2-vessel disease and without left main disease (28.5% vs 18.6%; p&lt;0,001 and 37.7% vs 20.6%; p&lt;0,001).The CV-pPCI and MV-pPCI group patients did not differ in age (68.1±11.2 vs 66.2±11.4 years; p=0.780), previous PCI (16.1% vs 12.0%; p=0.890) and CABG (6.2% vs 4.8%; p=0.376), chronic kidney disease (6.8% vs 8.2%; p=0.426), cardiopulmonary resuscitation (60.4% vs 58.9%; p=0.657) and pulmonary ventilation (66.8% vs 70.5%; p=0.227) at admission, localization of myocardial infarction (anterior 50.8.% vs 58.9%; p=0.671), time to reperfusion (&lt;2 hours 5.2% vs 4.8%; p=0.722) and TIMI flow 0 before PCI (63.1% vs 64.0%; p=0.675). Based on the results of logistic regression analysis, 30-days (odds ratio, 0.99; 95% CI 0.76 to 1.29; p=0.937) and 1-year (odds ratio, 0.91; 95% CI 0.69 to 1.19; p=0.477) all-cause mortality rates were similar in CV-pPCI and MV-pPCI groups. The presence of 3-vessel disease was the strongest adjusted predictor of 30-days (odds ratio, 1.61; 95% CI 1.27 to 2.04; p&lt;0.001) and 1-year (odds ratio, 1.64; 95% CI 1.30 to 2.08; p&lt;0.001) all-cause mortality in patients with STEMI and CS treated with pPCI. Conclusion Immediate multivessel primary PCI is still used in patients with CS-STEMI and MVD in routine clinical practice. We did not find difference in 30-days and 1-year mortality among patients with CS-STEMI and MVD treated either with culprit vessel-only or multivessel primary PCI. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): NV19-02-00086 supported by Ministry of Health of the Czech Republic

Mírná terapeutická hypotermie představuje účinnou neuroprotektivní léčbu pacientů po srdeční zástavě. Terapeutická hypotermie se doporučuje jako standardní resuscitační péče u pacientů po zástavě oběhu s fi brilací komor/komorovou tachykardií jako iniciálním rytmem. Mírná terapeutická hypotermie je snadno proveditelná, bez závažných nežádoucích účinků či komplikací spojených se zvýšením mortality. Cílem této první části přehledového článku o mírné terapeutické hypotermii je popsat mechanismus jejího působení, způsoby chlazení a nežádoucí příhody spojené s touto léčebnou metodou u pacientů po srdeční zástavě.