SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR (Colchicine and spironolactone in patients with myocardial infarction) SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia-driven target vessel revascularization within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention for STEMI based on the Thrombectomy vs percutaneous coronary intervention alone in STEMI (TOTAL) trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%. Overall, 733 patients were enrolled from 8 countries with a mean age 60 years, 19.4% diabetes mellitus, 41.3% anterior MI, and median door-to-balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2 to 6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI, or target vessel revascularization were 2.7%, 1.9%, 1.0%, respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4%, and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared with the performance goal based on previous trials.

Intravascular Lithotripsy for Calcium Modification in Chronic Total Occlusion Percutaneous Coronary Intervention.

Intravascular lithotripsy (IVL) has been shown to be safe and effective for calcium modification in nonocclusive coronary artery disease (CAD), but there are only case reports of its use in calcified chronic total occlusions (CTO). We report data from an international multicenter registry of IVL use during CTO percutaneous coronary intervention (PCI) and provide provisional data regarding its efficacy and safety. During the study period, IVL was used in 55 of 1053 (5.2%) CTO PCI procedures. IVL was used within the occluded segment after successful CTO crossing in 53 procedures and during incomplete CTO crossing in 2 cases. The mean J-CTO score was 3.1. CTO PCI technical and procedural success was achieved in 53 (96%) and 51 (93%) cases. Six patients had a procedural complication, with 3 main vessel perforations (5%). Two had covered stent implantation, one required pericardiocentesis, and one was managed conservatively. All had combination therapy with another calcium modification device. Two patients had a procedural myocardial infarction (PMI) (4%), and two others had a major adverse cardiovascular event (MACE) (4%) at a median follow-up of 13 (4-21) months. IVL can effectively facilitate calcium modification during CTO PCI. More data are required to establish the efficacy and safety of IVL and other calcium modification devices when used extraplaque or in combination during CTO PCI.

Harmonic imaging improves estimation of left ventricular mass.

OBJECTIVES: To assess the effect of tissue harmonic imaging (THI) on assessment of left ventricular mass index (LVMI) measurements by M-mode trans-thoracic echocardiography, when compared with magnetic resonance imaging (MRI). METHODS: 20 hypertensive male subjects were studied. LVMI was measured in all subjects by both gradient-echo MRI (Lscelsint Prestige 1.9 T) and by transthoracic echocardiography (ATL HDI 5000). M-mode echocardiography recordings were taken for each patient, two with fundamental imaging (FI) and two using THI in a randomised order and the images unlabelled. Recordings were analysed off-line, by a blinded observer. LVMI by MRI was calculated using Simpson's rule on serial short axis slices of 8 mm thickness. Data are expressed as mean +/- SD. RESULTS: There was a difference in LVMI measurements between FI and THI (LVMI) (79 +/- 20 vs. 93 +/- 25 g2; p < 0.001). A lower mean difference was obtained by THI, compared to FI, when compared with MRI (2 +/- 15 vs. -32 +/- 22 g2; p < 0.001) suggesting that FI underestimates LVMI. Inter-observer variability was similar between THI and FI (4.5 +/- 15 vs. 6.4 +/- 15 g2; p = 0.46). CONCLUSION: In hypertensive males, M-mode echo derived from FI underestimated LVMI. These results imply that widely accepted reference ranges for LVMI using FI are not applicable when THI is used.