BackgroundHead to head trials of clinical outcomes of sirolimus eluting polymer free vs. biodegradable polymer stents are lacking.MethodsSingle centre prospective open labeled randomised controlled clinical trial. Basis for sample size calculation was the rate of MACE from the ISAR TEST 3 trial in which the absolute difference was 10.25% with a standard deviation of 0.24. Assuming null hypothesis, 80% power and 5% alpha error, to detect a 10% difference, adjusting for 10% loss of follow up, sample size was 204. Inclusion criteria: Patients with stable coronary artery disease or recent acute coronary syndrome ( >1 week from the date of STEMI), being taken up for elective angioplasty. End points: Primary end point was MACE at 1 year and secondary end points at the end of 1 year were cardiac death, urgent target lesion revascularization, acute coronary syndrome, stroke and in-stent re-stenosis.Results204 patients were enrolled between January 2013 to July 2014, 91 in the polymer-free group and 113 in the biodegradable polymer group. Baseline characteristics were comparable between both groups. 21 patients (10.29%), were lost to follow up. MACE at 1 year were comparable in both the groups 3 of 85(3.52%) in the polymer-free group and 3 of 98(3.06%) in the biodegradable polymer group, p = 0.859. The secondary end points were also comparable between the two groups- Death- 1 of 85(1.17%) vs. 2 of 98(2.04%), p = 0.646, Stroke 0 of 85 vs. 2 of 98(2.04%), p = 0.185 and acute coronary syndrome – 2 of 85(2.35%) vs. 1 of 98(1.02%), p = 0.204. There were no instances of urgent target lesion re-vascularisation or definite stent thrombosis in either groups. In stent re-stenosis was found in 7 of 85(8.2%) in the polymer-free group vs. 6 of 98(6.12%) in the biodegradable polymer group.ConclusionThe 1 year MACE rates are comparable in patients who underwent elective coronary revascularization using sirolimus eluting polymer-free and biodegradable polymer stents.
BACKGROUND Strain imaging by speckle tracking is a well-established method to assess left ventricular function. The objective of this study was to define the utility of strain imaging in predicting obstructive coronary artery disease (CAD) in a subset of patients who do not have regional wall motion abnormality (RWMA) on routine 2D echocardiography. METHODS This is a prospective study. Consecutive patients with no RWMA scheduled to undergo coronary angiography (CAG) for clinical indications were included in the study. Longitudinal strain imaging by speckle tracking using automated functional imaging (AFI) was done by a single investigator prior to CAG. All angiograms were reported by a second investigator who was blinded to the strain imaging findings. Obstructive CAD was defined as ≥ 70% luminal stenosis of epicardial coronary arteries and/or ≥ 50% luminal stenosis of LMCA. RESULTS 129 patients were enrolled over a 7 month period (mean age 56.07±10.7, males 69%, females 31%). For detecting obstructive CAD, strain imaging had a sensitivity of 97% for LAD, 90.69% for RCA, 91.6% for LCX, a negative predictive value of 81.81% for LAD, 91.3% for RCA, 92.3% for LCX, a specificity of 15.2% for LAD, 13.9% for RCA, 22.8% for LCX and a positive predictive value of 57.6% for LAD, 34.5% for RCA and 21.3% for LCX territories. Patients with obstructive CAD had a lower global strain value of-18.37 ± 4.13 as compared to-21.18 ± 3.81 in patients who did not have obstructive CAD (p value <0.01). CONCLUSIONS Peak longitudinal strain imaging by speckle tracking is a very sensitive (ranging from 90.69% to 97.14%) test with a high negative predictive value (ranging from 75% to 92.3%) for identifying obstructive coronary artery lesions o n coronary angiography. These properties make strain imaging a good screening test to rule out significant CAD, especially when the pre-test probability is low.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.