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Patients with myocardial infarction 1 to 3 years previously were assigned to ticagrelor, 90 or 60 mg twice daily, or to placebo, in addition to low-dose aspirin. At 3 years, ticagrelor reduced the risk of cardiovascular death, MI, or stroke but increased the risk of major bleeding. Myocardial infarction is a global problem. 1 In the United States alone, nearly 8 million people have a history of myocardial infarction. 2 Patients who have had a myocardial infarction are at heightened risk for recurrent ischemic events, 3 – 5 which suggests that this population may derive particular benefit from intensive secondary prevention. A key element in the pathobiology of cardiovascular ischemic events is the activated platelet. 6 Aspirin reduces the risk of ischemic events both among patients who present with an acute coronary syndrome and in secondary prevention for patients with a history of myocardial infarction. 7 The addition of a P2Y 12 receptor . . .

Drug eluting stents (DES) are associated with a 2% to 4% annual rate of target lesion failure through 5-to-10-year follow-up. The presence of a metallic protheses is a trigger for neo-atherosclerosis and very late stent thrombosis. A “leave nothing behind” strategy using Drug Coated Balloons has been suggested; however, paclitaxel coated balloons are only recommended in selected indications. Recently a novel sirolimus eluting balloon, the SELUTION SLR TM 014 PTCA balloon (SEB) (M.A. MedAlliance SA, Nyon, Switzerland) has been developed. A strategy of percutaneous coronary intervention (PCI) with SEB and provisional DES is non-inferior to a strategy of systematic DES on target vessel failure (TVF) at one and five years. If non-inferiority is met at 5 years, superiority will be tested. SELUTION DeNovo is a multi-center international open-label randomized trial. Subjects meeting eligibility criteria are randomized 1:1 to treatment of all lesions with either SEB and provisional DES or systematic DES. Major inclusion criteria are PCI indicated for ≥1 lesion considered suitable for treatment by either SEB or DES and clinical presentation with chronic coronary syndrome, unstable angina or non-ST segment elevation myocardial infarction (NSTEMI). There is no limitation in the number of lesions to be treated. Target lesions diameters are between 2 and 5 mm. Major exclusion criteria are lesions in the left main artery, chronic total occlusions, ST segment elevation myocardial infarction and unstable non-ST segment elevation myocardial infarction. Three thousand three hundred twenty six patients will be included in 50 sites in Europe and Asia. TVF rates and their components will be determined at 30 days, 6 months and annually up to 5 years post-intervention. Among secondary endpoints, bleeding events, cost-effectiveness data and net clinical benefits will be assessed. SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of PCI with SEB and provisional DES to a strategy of PCI with systematic DES on TVF at one and five years. Non-inferiority will be tested at one and five years. If non-inferiority is met at five years, superiority will be tested. [Display omitted]

This trial compared the efficacy of antiplatelet therapy with prasugrel or clopidogrel in patients with non–ST-segment elevation MI or unstable angina. Although prasugrel provides more intense platelet inhibition, clinical outcomes were similar with the two drugs. Clinical-practice guidelines for patients with acute coronary syndromes consisting of unstable angina or myocardial infarction without ST-segment elevation recommend a strategy of early invasive management (angiography within 48 to 72 hours with provisional revascularization) for patients at moderate to high risk. 1 , 2 However, analyses from clinical trials and national registries have shown that many such patients are treated medically without revascularization and that such patients have poorer long-term cardiovascular outcomes than those who undergo revascularization. 3 – 6 Even though patients with acute coronary syndromes who receive only medical therapy have an increased-risk profile, they have been underrepresented in large-scale, contemporary, randomized . . .

Activation of inflammatory pathways during acute myocardial infarction contributes to infarct size and left ventricular (LV) remodeling. The present prospective randomized clinical trial was designed to test the efficacy and safety of broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor to reduce infarct size. Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS, clinicaltrials.gov NCT01529554) is a phase II randomized, double-blind, multi-center, placebo-controlled trial on the effects of a 5-day course of oral everolimus on infarct size, LV remodeling, and inflammation in patients with acute ST-elevation myocardial infarction (STEMI). Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg every day; days 4 and 5: 5.0 mg every day) or placebo, respectively. The primary efficacy outcome is the change from baseline (defined as 12 hours to 5 days after pPCI) to 30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI). Secondary endpoints comprise corresponding changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI. Clinical events, laboratory parameters, and blood cell counts are reported as safety endpoints at 30 days. The CLEVER-ACS trial tests the hypothesis whether mTOR inhibition using everolimus at the time of an acute STEMI affects LV infarct size following successful pPCI.

Unfractionated heparin and low-molecular-weight heparins are often used to treat acute coronary syndromes. In this study, the pentasaccharide fondaparinux was found to have efficacy equal to that of enoxaparin in terms of anti-ischemic benefits but was associated with substantially less bleeding and lower long-term morbidity and mortality. Fondaparinux was found to have efficacy equal to that of enoxaparin in terms of anti-ischemic benefits but was associated with substantially less bleeding and lower long-term morbidity and mortality. The combined use of anticoagulants, 1 antiplatelet agents, 2 – 4 and an invasive strategy 5 in high-risk patients with acute coronary syndromes reduces ischemic coronary events but also increases bleeding. Bleeding may increase the risk of death, 6 myocardial infarction, and stroke. Therefore, future therapies should either preserve or enhance benefits without increasing bleeding. Unfractionated heparin and low-molecular-weight heparins are commonly used in patients with acute coronary syndromes, but enoxaparin may be modestly superior to unfractionated heparin in reducing the risk of death or myocardial infarction. 7 Fondaparinux (Arixtra, GlaxoSmithKline), a synthetic pentasaccharide, selectively binds antithrombin and causes rapid and predictable inhibition of factor Xa. . . .

The optimal anticoagulant for patients with acute coronary syndrome treated with percutaneous coronary intervention (PCI) has not been validated in current practice of radial approach and pretreatment with potent P2Y12 inhibitors. Several studies have indicated increased bleeding rate and, in some instances, even increased mortality by the routine use of heparin and glycoprotein IIb/IIIa inhibitors compared to bivalirudin. Direct comparison of bivalirudin versus heparin alone has yielded contradictory results depending on study designs. The VALIDATE-SWEDEHEART trial is a multicenter, prospective, randomized, registry-based, controlled, and open-label clinical trial in patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing PCI pretreated with ticagrelor, prasugrel, or cangrelor. We hypothesize that bivalirudin is superior to heparin alone in reducing death, myocardial infarction, and major bleeding events at 180 days (primary end point). The trial will enroll 3,000 patients with STEMI and 3,000 patients with non-STEMI undergoing PCI. The trial will use a hybrid registry-based randomized clinical trial design where inclusion, randomization, and baseline data collection are performed using The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry. The primary composite end point (death, myocardial infarction, or major bleeding events at 180 days) will be identified through active screening after 7 and 180 days and adjudicated by a blinded central end point committee. Secondary end points and long-term outcomes will be recorded from national registries. The VALIDATE-SWEDEHEART trial is founded on a nationwide clinical registry and uses a hybrid registry-based randomized clinical trial (RRCT) design methodology to evaluate efficacy and safety of bivalirudin as compared to heparin alone for acute coronary syndrome, in a large population receiving contemporary recommended therapies including predominantly radial invasive approach and pretreatment with potent P2Y12 inhibitors. [Display omitted]

A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI. In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints. From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a -15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: -3.4%; 95% confidence interval [CI]: -11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: -0.5%; 95% CI: -5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI. www.ClinicalTrials.gov (No. NCT02835534).

Background and aims The evidence for beta-blocker therapy after myocardial infarction (MI) is randomized trials conducted more than 30 years ago, and the continued efficacy has been questioned. Design and methods The ongoing Danish (DANBLOCK) and Norwegian (BETAMI) randomized beta-blocker trials are joined to evaluate the effectiveness and risks of long-term beta-blocker therapy after MI. Patients with normal or mildly reduced left ventricular ejection fraction (LVEF ≥ 40%) will be randomized to open-label treatment with beta-blockers or no such therapy. The event-driven trial will randomize ∼5700 patients and continue until 950 primary endpoints have occurred. As of July 2023, 5228 patients have been randomized. Of the first 4000 patients randomized, median age was 62 years, 79% were men, 48% had a ST-segment elevation myocardial infarction (STEMI), and 84% had a normal LVEF. The primary endpoint is a composite of adjudicated recurrent MI, incident heart failure (HF), coronary revascularization, ischaemic stroke, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest. The primary safety endpoint includes a composite of recurrent MI, HF, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest 30 days after randomization. Secondary endpoints include each of the components of the primary endpoint, patient-reported outcomes, and other clinical outcomes linked to beta-blocker therapy. The primary analysis will be conducted according to the intention-to-treat principle using a Cox proportional hazards regression model. End of follow-up is expected in December 2024. Conclusion The combined BETAMI–DANBLOCK trial will have the potential to affect current clinical practice for beta-blocker therapy in patients with normal or mildly reduced LVEF after MI. Graphical Abstract Graphical Abstract

Endovascular therapy for stroke is generally avoided if the cerebral infarction is large. In a trial conducted in Japan, the percentage of patients who had a good functional outcome at 90 days was higher with endovascular therapy than with medical care, but there were more cerebral hemorrhages with endovascular therapy.

Primary percutaneous coronary intervention (PPCI) and fibrinolytic or thrombolytic therapy are common treatments for ST-elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention is more effective than thrombolytic therapy, but fibrinolytic therapy is still a preferable option for patients with limited access to healthcare. Alteplase is a tissue plasminogen activator (tPA) used to treat acute myocardial infarction, acute ischemic stroke, and pulmonary embolism. This study aims to compare the efficacy and safety of Altelyse (bio-similar Alteplase, Arena Life Science Company, Tehran, IRAN) versus the brand name Actilyse (Boehringer Ingelheim, GERMANY) in patients with STEMI. In this phase 3, double-blind, randomized trial, we assigned patients with STEMI to receive Altelyse or Actilyse, an intravenous bolus of 15 mg followed by an infusion of 0.75 mg/kg over 30 min (with a maximum dose of 50 mg) and continued with 0.50 mg/kg over 60 min (with a maximum dose of 35 mg). The primary endpoint was total ST-segment resolution (STR) in all leads with ST-segment elevations after 90 min of receiving fibrinolytic therapy. A total of 153 STEMI patients received Actilyse (79 patients) or Altelyse (74 patients). The mean total STR in all leads with ST elevation after 90 min was - 45.89 ± 32.92% and - 37.11 ± 35.28% in the Altelyse and Actilyse groups, respectively (the mean difference [95% confidence interval]: - 8.77 [- 19.92, 2.36]; p-value for non-inferiority: 0.0004). Among patients with STEMI, Altelyse was non-inferior to Actilyse with respect to STR after 90 min. Trial Registration Number, Date: IRCT20190729044366N1, 2019-05-25.