MD Conference Express ACC 2012 - (Page 14)

n C L I N I C A L T R I A L H I G H L I G H T S in final blood pressure between the 3 groups. There were no unexpected complications or deaths through 12 months. More serious adverse events (SAEs) that required hospitalization were seen in patients who were assigned to gastric bypass than sleeve gastrectomy or IMT (22% vs 9% vs 8%). Other SAEs that occurred more frequently in the surgery groups included reoperation (6% of gastric bypass patients and 2% of sleeve gastrectomy patients vs no patients in the IMT), intravenous treatment for dehydration (8% of gastric bypass and 4% of sleeve gastrectomy patients vs no IMT patients), and pneumonia, which occurred only in the gastric bypass group (4% of patients). Table 1. Secondary Efficacy Endpoints. Parameter Change in FPG (mg/dL) Change in BMI % change in HDL % change in TG % change in hsCRP 1 York, USA, presented outcomes after 2 years of follow-up in the PARTNER trial [Kodali SK et al. N Engl J Med 2012]. Inclusion criteria were severe symptomatic AS; an echo-derived aortic-valve area (AVA) ≤0.8 cm2 (or AVA index <0.5 cm2/m2) and a peak velocity ≥40 mm Hg (or peak jet velocity of >4.0 m/s); NYHA ≥II; and high surgical risk (ie, guideline-predicted risk of operative mortality ≥15%, as determined by site surgeon and cardiologist). The risk score threshold was an STS score ≥10 [http://riskcalc.sts.org/STSWebRiskCalc273/de.aspx]. The primary endpoint of the randomized, multicenter trial was all-cause mortality. Other endpoints included cardiovascular (CV) mortality, rehospitalization, strokes and transient ischemic attacks (TIAs), vascular and bleeding events, NYHA functional class, and echocardiographic measures of valve performance (including valve gradient/areas and postprocedural aortic regurgitation [AR]). At 2 years, there were no significant differences in mortality from any cause between the TAVR group (33.9%; 95% CI, 28.9 to 39.0) and the SAVR group (35.0%; 95% CI, 29.8 to 40.2; p=0.78). CV mortality was also similar in the TAVR and SAVR groups (21.4% [95% CI, 16.8 to 26.0] and 20.5% [95% CI, 15.8 to 25.3], respectively; p=0.80). The frequency of all neurological events (stroke or TIA) at 2 years was higher with TAVR than with surgical replacement (11.2% vs 6.5%; p=0.05). However, there was no significant difference in the number of overall strokes between the TAVR and SAVR groups (24 vs 20, respectively at 36 months; HR, 1.22; 95% CI, 0.67 to 2.23; p=0.52). Moderate or severe paravalvular AR was more common after TAVR than after SAVR at both 1 and 2 years (7.0% vs 1.9% at 1 year; 6.9% vs 0.9% at 2 years; p<0.001 for both comparisons). The presence of paravalvular or any AR (mild, moderate, or severe vs none or trace) after TAVR was associated with increased late mortality (HR, 2.11; 95% CI, 1.43 to 3.10; p<0.001), underscoring the importance of close clinical follow-up and echocardiography in patients after TAVR. Dr. Kodali concluded that TAVR should be considered an option for patients with severe symptomatic AS who are high risk for SAVR. He noted that TAVR remained equivalent to SAVR, with similar rates of all-cause and CV mortality, and that symptom improvement was similar in both groups. Although TAVR valve hemodynamics remained stable at 2 years, the more frequent late development of paravalvular and any significant AR following TAVR was associated with a doubling of late mortality. www.mdconferencexpress.com IMT n=41 -28.0 -1.9.0 +11.3 -14.0 -33.0 Bypass n=50 -87.0 -10.2 +28.5 -44.0 -84.0 Sleeve n=49 -63.0 -9.0 +28.4 -42.0 -80.0 p value1 0.004 <0.001 0.001 0.002 <0.001 p value2 0.003 <0.001 0.001 0.08 <0.001 Gastric bypass vs IMT; 2Sleeve vs IMT; FPG=fasting plasma glucose; BMI=body mass index; HDL= high-density lipoprotein; TG=triglycerides; hsCRP=high-sensitivity C-reactive protein. The investigators caution that the study is limited by its short duration but add that a 4-year extension is ongoing. This was also a single-center trial, and larger multicenter studies will be needed to determine whether observed improvements in glycemic control and CV risk factors and withdrawal of diabetes and CV medications translate into reductions in CV events and/or end organ failure from microvascular disease [Schauer PJ et al. N Engl J Med 2012]. TAVR Associated with Increased Late Mortality from Paravalvular Regurgitation Written by Rita Buckley One-year data from the Placement of Aortic Transcatheter Valves Trial [PARTNER; NCT00530894] showed that survival rates were similar among high-risk patients with aortic stenosis (AS) who received either transcatheter aortic valve replacement (TAVR) or surgical replacement [Smith CR et al. N Engl J Med 2011; Vinall M. MD Conference Express: ACC 2011]. Susheel K. Kodali, MD, Columbia University Medical Center, New York, New 14 May 2012 http://www.mdconferencexpress.com http://riskcalc.sts.org/STSWebRiskCalc273/de.aspx http://www.mdconferencexpress.com

Table of Contents for the Digital Edition of MD Conference Express ACC 2012

MD Conference Express ACC 2012
Table of Contents
Treatment of AMI in the Post-Herrick Era
The State of Hypertension Guidelines: 2012
ACRIN PA 4005: Coronary CTA in the ED Identifies Low-Risk Patients and Shortens Length of Stay
One-Year STAMPEDE Trial Results
TAVR Associated with Increased Late Mortality from Paravalvular Regurgitation
The CABG Surgery Off- or On- Pump- Revascularization Study (CORONARY)
The Moderate PE Treated with Thrombolysis Study (MOPETT)
Pacemaker Therapy In Patients With Neurally Mediated Syncope and Documented Asystole
Outcomes from the BRIDGE-ACS Trial
ROMICAT II: More Data Evaluating CT-First for Acute Chest Pain ED Triage
Elective PCI at Community Hospitals With Versus Without On-Site Surgery
Results from the TRA 2P-TIMI 50 Trial
The HOST-ASSURE Randomized Trial
New Monoclonal Antibody to PCSK9 Markedly Lowers LDL-C in Patients on Atorvastatin
Oral Rivaroxaban Alone for Symptomatic PE
Neutral Outcomes But Important Insights From FOCUS-CCTRN
Imaging
STEMI
Acute Coronary Syndrome
Antiplatelet Therapy
New Anti-Diabetes Agents Offer Promise in the Fight Against CVD
The New Hypertrophic Cardiomyopathy Practice Guidelines

MD Conference Express ACC 2012

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