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ESC 2017 STEMI Guideline Summary Sheet

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SYNTAX 2

Escaned et al (European Heart Journal (2017) 0, 1–11,doi:10.1093/eurheartj/ehx512) report on the SYNTAX 2 trial. IFR guided intervention was associated with improved outcomes to 1 year compared with SYNTAX-PCI cohort. Note the differences in terms of lesion selection, stents per lesion etc.

ABSTRACT

Aims

To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease.

Methods and results

The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries.
The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the
original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall
708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39–0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11–0.70, P = 0.007) and revascularization (HR 0.57, 95% CI 0.37–0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27–1.73, P = 0.43) and stroke
(HR 0.69, 95% CI 0.10–4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07–0.97, P = 0.045).

Conclusion

At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted.

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Oxygen Therapy in Myocardial Infarction

Hoffmann et al report on the DETO2X-SWEDEHEART study: a randomized clinical  trial of oxygen therapy (versus ambient air) in suspected acute myocardial infarction (DOI: 10.1056/NEJMoa1706222). There was no benefit. There is an accompanying editorial: DOI: 10.1056/NEJMe1709250

ABSTRACT

BACKGROUND

The clinical effect of routine oxygen therapy in patients with suspected acute myocardial
infarction who do not have hypoxemia at baseline is uncertain.

METHODS

In this registry-based randomized clinical trial, we used nationwide Swedish registries
for patient enrollment and data collection. Patients with suspected myocardial
infarction and an oxygen saturation of 90% or higher were randomly assigned
to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered
through an open face mask) or ambient air.

RESULTS

A total of 6629 patients were enrolled. The median duration of oxygen therapy was
11.6 hours, and the median oxygen saturation at the end of the treatment period
was 99% among patients assigned to oxygen and 97% among patients assigned to
ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as
compared with 254 patients (7.7%) in the ambient-air group. The median of the
highest troponin level during hospitalization was 946.5 ng per liter in the oxygen
group and 983.0 ng per liter in the ambient-air group. The primary end point of
death from any cause within 1 year after randomization occurred in 5.0% of patients
(166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned
to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to
1.21; P = 0.80). Rehospitalization with myocardial infarction within 1 year occurred
in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to
ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P = 0.33). The results were
consistent across all predefined subgroups.

CONCLUSIONS

Routine use of supplemental oxygen in patients with suspected myocardial infarction
who did not have hypoxemia was not found to reduce 1-year all-cause mortality.

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CANTOS

Ridker et al report on the results of the CANTOS trial: DOI: 10.1056/NEJMoa1707914

There is an accompanying editorial: DOI: 10.1056/NEJMe1709904

ABSTRACT

BACKGROUND

Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved.

METHODS

We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.

RESULTS

At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31).

CONCLUSIONS

Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway
with canakinumab at a dose of 150 mg every 3 months led to a significantly lower
rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering.

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COMPASS

Eikelboom et al report on the COMPASS trial: DOI: 10.1056/NEJMoa1709118. There is an accompanying editorial by Eugene Braunwald (DOI: 10.1056/NEJMe1710241).

ABSTRACT

BACKGROUND

We evaluated whether rivaroxaban alone or in combination with aspirin would be
more effective than aspirin alone for secondary cardiovascular prevention.

METHODS

In this double-blind trial, we randomly assigned 27,395 participants with stable
atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plusaspirin group after a mean follow-up of 23 months.

RESULTS

The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin
group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z = −4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P = 0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.

CONCLUSIONS

Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.

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Multivessel FFR and Prognosis

Lee et at (European Heart Journal (2017) 00, 1–8 CLINICAL RESEARCH
doi:10.1093/eurheartj/ehx458)  report on the relationship between total atherosclerotic physiological burden as assessed by multivessel FFR and 2 year cardiac event rates.

ABSTRACT

Aims

There are limited data on the clinical implications of total physiologic atherosclerotic burden assessed by invasive
physiologic studies in patients with coronary artery disease. We investigated the prognostic implications of total physiologic atherosclerotic burden assessed by total sum of fractional flow reserve (FFR) in three vessels (3V-FFR).

Methods and results

A total of 1136 patients underwent FFR measurement in three vessels (3V FFR-FRIENDS study, NCT01621438). The patients were classified into high and low 3V-FFR groups according to the median value of 3V-FFR (2.72). Theprimary endpoint was major adverse cardiac events (MACE, a composite of cardiac death, myocardial infarction and ischaemia-driven revascularization) at 2 years. Mean angiographic percent diameter stenosis and FFR were 43.7 ± 19.3% and 0.90 ± 0.08, respectively. There was a negative correlation between 3V-FFR and estimated 2-year MACE rate (P < 0.001). The patients in low 3V-FFR group showed a higher risk of 2-year MACE than those in the high 3V-FFR group [(7.1% vs. 3.8%, hazard ratio (HR) 2.205, 95% confidence interval (CI) 1.201–4.048, P = 0.011]. The higher 2-year MACE rate was mainly driven by the higher rate of ischaemia-driven revascularization in the low 3V-FFR group (6.2% vs. 2.7%, HR 2.568, 95% CI 1.283–5.140, P = 0.008). In a multivariable adjusted model, low 3VFFR was an independent predictor of MACE (HR 2.031, 95% CI 1.078–3.830, P = 0.029).

Conclusion

Patients with high total physiologic atherosclerotic burden assessed by 3V-FFR showed higher risk of 2-year clinical events than those with low total physiologic atherosclerotic burden. The difference was mainly driven by
ischaemia-driven revascularization for both functionally significant and insignificant lesions at baseline. Three-vessel FFR might be used as a prognostic indicator in patients with coronary artery disease.

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Acute Stress-induced Cardiomyopathy

Dawson presents a useful review of Takotsubo cardiomyopathy: (http:// dx. doi. org/ 10. 1136/heartjnl- 2017- 311579).
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