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Inflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events. In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients who had myocardial infarction to receive either colchicine or placebo and either spironolactone or placebo. The results of the colchicine trial are reported here. The primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, evaluated in a time-to-event analysis. C-reactive protein was measured at 3 months in a subgroup of patients, and safety was also assessed. A total of 7062 patients at 104 centers in 14 countries underwent randomization; at the time of analysis, the vital status was unknown for 45 patients (0.6%), and this information was most likely missing at random. A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 patients (9.3%) in the placebo group over a median follow-up period of 3 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.16; P = 0.93). The incidence of individual components of the primary outcome appeared to be similar in the two groups. The least-squares mean difference in C-reactive protein levels between the colchicine group and the placebo group at 3 months, adjusted according to the baseline values, was -1.28 mg per liter (95% CI, -1.81 to -0.75). Diarrhea occurred in a higher percentage of patients with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), but the incidence of serious infections did not differ between groups. Among patients who had myocardial infarction, treatment with colchicine, when started soon after myocardial infarction and continued for a median of 3 years, did not reduce the incidence of the composite primary outcome (death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization). (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).

The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far. The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies. As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%). The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

In a registry-based trial, FFR-guided PCI of nonculprit lesions did not result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI.

In a randomized trial involving patients with STEMI and cardiogenic shock, mortality at 6 months was lower with mechanical circulatory support with a microaxial flow pump than with standard care alone.

To test whether remote ischaemic conditioning (RIC) as adjuvant to standard of care (SOC) would prevent progression towards heart failure (HF) after ST-elevation myocardial infarction (STEMI). Single-centre parallel 1:1 randomized trial (computerized block-randomization, concealed allocation) to assess superiority of RIC (3 cycles of intermittent 5 min lower limb ischaemia) over SOC in consecutive STEMI patients (NCT02313961, clinical trials.gov). From 258 patients randomized to RIC or SOC, 9 and 4% were excluded because of unconfirmed diagnosis and previously unrecognized exclusion criteria, respectively. Combined primary outcome of cardiac mortality and hospitalization for HF was reduced in RIC compared with SOC (n = 231 and 217, respectively; HR = 0.35, 95% CI 0.15–0.78) as well as each outcome in isolation. No difference was found in serum troponin I levels between groups. Median and maximum follow-up time were 2.1 and 3.7 years, respectively. In-hospital HF (RR = 0.68, 95% CI 0.47–0.98), need for diuretics (RR = 0.68, 95% CI 0.48–0.97) and inotropes and/or intra-aortic balloon pump (RR = 0.17, 95% CI 0.04–0.76) were decreased in RIC. On planned 12 months follow-up echocardiography (n = 193 and 173 in RIC and SOC, respectively) ejection fraction (EF) recovery was enhanced in patients presenting with impaired left ventricular (LV) function (10% absolute difference in median EF compared with SOC; P < 0.001). In addition to previously reported improved myocardial salvage index and reduced infarct size RIC was shown beneficial in a combined hard clinical endpoint of cardiac mortality and hospitalization for HF. Improved EF recovery was also documented in patients with impaired LV function.

Patients with ST-segment elevation MI and multivessel coronary disease who had undergone successful culprit-lesion PCI were assigned to a strategy of either PCI of all other suitable stenoses or no further revascularization. At 3 years, the risk of cardiovascular death or new MI was lower with complete revascularization.

In patients with ST-segment elevation myocardial infarction, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death and adverse cardiovascular events at 1 year.

Introduction Cardiogenic shock (CS) is a lethal complication of ST-elevation myocardial infarction (STEMI). The impact of post-procedure anticoagulants (PPAC) in STEMI-CS patients undergoing primary percutaneous coronary intervention (PPCI) remains unknown. Method In the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome registry (2014–2019), STEMI patients with CS on admission undergoing PPCI were stratified into two groups based on the use of PPAC or not. The primary outcome was all-cause mortality during hospitalization. Other outcomes including major bleeding were also investigated. Results Of 36,873 patients with STEMI, 855 eligible patients with CS undergoing PPCI were included in our study, among which 614 patients were treated by PPAC and 241 were not. Adjusted by multi-variable Cox regression, PPAC was associated with a lower risk of in-hospital all-cause mortality (14.9% vs. 30.3%; adjusted HR: 0.60; 95% CI: 0.37 to 0.97; p  = 0.037), while a non-significant difference in major bleeding (4.6% vs. 7.0%; adjusted HR: 1.05; 95% CI: 0.36 to 3.05; p  = 0.925) was observed between PPAC and non-PPAC. Consistent results were observed in the sensitivity analyses adjusted by propensity score matching and inverse probability of treatment weighting. Conclusion Our study suggested the use of PPAC in STEMI-CS patients undergoing PPCI was associated with a lower risk of in-hospital all-cause mortality without increasing the risk of major bleeding. Trial registration ClinicalTrials.gov, NCT02306616. Registered 29 November 2014.

•The STREAM-1 trial demonstrated similar outcomes with a PI strategy compared to primary PCI (PPCI) in STEMI patients presenting <3 hours of symptom onset and unable to undergo timely cardiac catheterization within 1 hour.•However, an excess of intracranial hemorrhage (ICH) in those ≥75 years receiving PI treatment was observed early in the trial prompting a dose reduction amendment of tenecteplase (TNK) to half-dose after which no further ICH occurred.•An analysis of STREAM-1 and STREAM-2 patients 60 to <75 years, found similar ST resolution and TIMI-3 patency with both half- and full-dose PI strategies with PI treatment (irrespective of TNK dose). These findings were also at least comparable than that achieved after their PPCI comparators.•Whereas the risk of ICH with half-dose PI treatment was 2.1% compared to 1.5% with full-dose PI therapy, there was substantially less major (non-ICH) bleeding. Clinical outcomes were similar to those with their respective within trial PPCI comparators. Previous studies indicate a safety risk with full-dose TNK in elderly patients. In a study of patients ≥60 years STREAM-2 (STrategic Reperfusion Early After Myocardial infarction-2), a pharmaco-invasive (PI) strategy with half-dose TNK was similar (in efficacy and safety) to primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) patients presenting <3 hours. While no treatment difference ± 75 years was observed, the role of this half-dose PI strategy in patients <75 years is unknown. In this comparison of STEAM-1 and -2, we analyzed PI strategies with full-dose (STREAM-1) versus half-dose TNK (STREAM-2) to evaluate their relative efficacy and safety in this younger STEMI cohort. We evaluated patients 60 to <75 years from STREAM-1 and STREAM-2 receiving PI treatment versus PPCI for their resolution of ST-elevation after fibrinolysis and angiography, primary efficacy composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, and safety events. Among 1103 patients, 327 received a full-dose PI strategy (STREAM-1), 289 a half-dose PI strategy (STREAM-2) and 487 PPCI (338 in STREAM-1; 149 in STREAM-2). Half- compared to full-dose TNK resulted in similar proportions of patients achieving ST resolution ≥50% (71.2% vs 68.7%, P = .519): their ICH risks were 2.1% vs 1.5%, P = .605 respectively). Following angiography, PI patients had nominally better ST resolution ≥50% compared to their PPCI counterpart (STREAM-1: 87.7% vs. 83.2%, P = .120; STREAM-2: 88.2% vs. 81.0%, P = .048) with similar primary composite outcome at 30 days (STREAM-1: 14.4% vs. 16.3%, 0.90 [0.62, 1.31]; STREAM-2: 9.0% vs 8.1%, 1.29 [0.64, 2.61]). Major (non-ICH) bleeding markedly declined in STREAM-2 compared to STREAM-1 in both treatment groups (STREAM-1: 7.1% vs. 6.0%; STREAM-2: 0.3% vs. 0.7%). In STEMI patients 60 to <75 years presenting within 3 hours of symptoms, half-dose PI treatment appears as efficacious as a full-dose PI strategy with a low systemic bleeding risk. Half-dose PI treatment deserves consideration when timely PPCI is not attainable in this important STEMI sub-group. NCT00623623, NCT02777580. [Display omitted]

Remote ischemic conditioning (RIC) and the GLP-1 analog exenatide activate different cardioprotective pathways and may have additive effects on infarct size (IS). Here, we aimed to assess the efficacy of RIC as compared with sham procedure, and of exenatide, as compared with placebo, and the interaction between both, to reduce IS in humans. We designed a two-by-two factorial, randomized controlled, blinded, multicenter, clinical trial. Patients with ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention (PPCI) within 6 h of symptoms were randomized to RIC or sham procedure and exenatide or matching placebo. The primary outcome was IS measured by late gadolinium enhancement in cardiac magnetic resonance performed 3–7 days after PPCI. The secondary outcomes were myocardial salvage index, transmurality index, left ventricular ejection fraction and relative microvascular obstruction volume. A total of 378 patients were randomly allocated, and after applying exclusion criteria, 222 patients were available for analysis. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. IS was similar between groups for the RIC (24 ± 11.8% in the RIC group vs 23.7 ± 10.9% in the sham group, P = 0.827) and the exenatide hypotheses (25.1 ± 11.5% in the exenatide group vs 22.5 ± 10.9% in the placebo group, P = 0.092). There were no effects with either RIC or exenatide on the secondary outcomes. Unexpected adverse events or side effects of RIC and exenatide were not observed. In conclusion, neither RIC nor exenatide, or its combination, were able to reduce IS in STEMI patients when administered as an adjunct to PPCI.