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News from the American College of Cardiology Congress 2014

The Clinical Perspective: Part I.

The studies mentioned here were presented during the Hotline and Clinical Trial Update Sessions during the Late Breaking Clinical Trial Sessions at the 63rd annual meeting of the American College of Cardiology in Washington, USA, 2014. Apart of the Symplicity-HTN-3 study interventional trials dealing with e.g. transcatheter aortic-valve replacement or coronary stents will not be mentioned below.
Basic Sciences, Pharmacology, Genomics and Cardiovascular Pathology

The MSC-HF trial elucidated the effects of Bone-Marrow Derived Mesenchymal Stromal Cells injected intramyocardial into the left ventricle of patients with ischemic heart failure. There was no serious events within the study. After 6 months there was a significant improvement in end-systolic volume and LV ejection fraction compared to placebo.

Symplicity-HTN-3. Several studies have demonstrated that catheter-based renal denervation (ablation of the sympathetic innervation) is an effective strategy to lower blood pressure in hypertensive subjects. SYMPLICITY HTN-3 is, however, the first study that included a sham-control arm. In this phase 3 study catheter-based renal denervation for the treatment of resistant hypertension, failed to achieve its primary efficacy end point the change in office systolic blood pressure at six months. These results are remarkable in so far, that the technique is already broadly used in many hospitals of different European countries.

A large single center observational study investigated whether patients with chest pain, and a first undetectable high-sensitivity cardiac troponin (hs-cTnT level of <5 ng/l), independent of duration of symptoms, and an ECG without typical signs of ischemia, may be discharged safely. These patients have a minimal risk of MI or death within 30 days, and can be safely discharged directly from the emergency room.

The POISE-2 study investigated the use of aspirin as well as clonidine (α2- receptor blocker) in subjects undergoing noncardiac surgery. Neither aspirin nor clonidine could change the primary endpoint of death or myocardial infarction. However, aspirin lead to an increased number of major bleedings, whereas clonidine application was associated with a higher numbers of nonfatal cardiac and important hypotensions.

In the CORP-2 trial patients with two or more recurrences of pericarditis were randomized to receive on top of conventional treatment colchicine which inhibits microtubule polymerization, one of the main constituents of microtubules and therefore mitosis. Treatment with colchicine significantly reduced the number of pericarditis recurrences and rehospitalization due to recurrent pericarditis without increased side effects.

In GIPS-III non-diabetic patients that underwent PCI for STEMI were randomized to metformin 500 mg or placebo twice a day for 4 months. Patients treated with metformin had no improvement of left ventricular ejection fraction after STEMI as compared to placebo. Moreover, NTproBNP concentration and major adverse cardiac events did not differ significantly between the two groups. However, more serious adverse events including lactic acidosis were not observed in patients treated with metformin.

The SIRS trial evaluated the effect of 500 mg methylpredinsolone during heart surgery in high-risk patients. Significant differences during surgery regarding the primary outcome death were not observed compared to placebo. Periprocedural creatine kinase was increased by methylprednisolone. Thus, steroids should not be administered prophylactically to patients at high-risk patients during/before heart surgery.

In HEAT-PPCI patients with STEMI treated with unfractionated heparin had a reduced primary endpoint (reduced all-cause mortality, cerebrovascular accidents, reinfarctions, or unplanned target lesion revascularization) compared to patients treated with bivalirudin during intervention. There was also less stent thrombosis in patients treated with heparin.