Wednesday, 1 April 2015

Five follow up result for TAVI is comparable to surgery in high risk group

SAN DIEGO — In this video, Steven R. Bailey, MD, chief of cardiology at the University of Texas Health Sciences Center and Cardiology Today's Intervention Editorial Board member, discusses results from three late-breaking trials evaluating percutaneous valve technology presented at the American College of Cardiology Scientific Sessions.
He said that the 5-year results from PARTNER 1, 2-year data from CoreValve High Risk and 30-day from the PARTNER II S3 trials consistently indicate the benefits of transcatheter aortic valve replacement systems.
In PARTNER 1, researchers evaluated inoperable and operable patients, and found that TAVR recipients "feel better, live longer and live better" with a lower cost of care, Bailey said. He added that the 5-year data suggest continued valve performance without degeneration — and, in fact, that hemodynamics in the valve area were improved compared with surgery. The similar outcomes observed between surgery and TAVR recipients allow for confidence that TAVR is a viable alternative treatment, even among high-risk patients, Bailey said.
The CoreValve High Risk study compared the self-expanding transcatheter valve (CoreValve, Medtronic) with surgery, and the researchers observed better outcomes with the CoreValve at both 1 year and 2 years. Bailey said these results were "incredibly exciting," and stressed that these improved outcomes were present across all patient subtypes, regardless of age, sex, diabetes status or surgical risk.
The PARTNER II S3 trial evaluated 30-day outcomes from TAVR with the Sapien 3 system (Edwards Lifesciences) compared with earlier-generation devices. Bailey said there was a significant improvement in mortality and significant decrease in leak around the valve, which correlates with long-term outcomes. He added that these results suggest "significant progress" with the new TAVR technologies, which will continue to improve over time and offer further benefit for patients.


http://www.healio.com/cardiology/intervention/news/online/%7B9cb06d31-1b8a-45e9-a97d-c89f3527cc36%7D/video-results-from-three-trials-suggest-significant-progress-for-tavr-technology

Use of IABP was not found to improve mortality among patients with acute myocardial infarction in the RCTs

Intra-aortic Balloon Pump Therapy for Acute Myocardial Infarction:A Meta-analysis

http://archinte.jamanetwork.com/article.aspx?articleID=2210888

Importance  Intra-aortic balloon pump (IABP) therapy is a widely used intervention for acute myocardial infarction with cardiogenic shock. Guidelines, which previously strongly recommended it, have recently undergone substantial change.

Objective  To assess IABP efficacy in acute myocardial infarction.

Data Sources  Human studies found in Pubmed, Embase, and Cochrane libraries through December 2014 and in reference lists of selected articles. Search strings were “myocardial infarction” or “acute coronary syndrome” and “intra-aortic balloon pump” or “counterpulsation.”

Study Selection  Randomized clinical trials (RCTs) and observational studies comparing use of IABP with no IABP in patients with acute myocardial infarction.

Data Extraction and Synthesis  Two reviewers independently extracted the data, and risk of bias in RCTs was assessed using the Cochrane risk of bias tool. We conducted separate meta-analyses of the RCTs and observational studies. Data were quantitatively synthesized using random-effects meta-analysis.

Main Outcomes and Measures  Thirty-day mortality.

Results  There were 12 eligible RCTs randomizing 2123 patients. In the RCTs, IABP use had no statistically significant effect on mortality (odds ratio [OR], 0.96 [95% CI, 0.74-1.24]), with no significant heterogeneity among trials (I2 = 0%; P = .52). This result was consistent when studies were stratified by the presence (OR, 0.94 [95% CI, 0.69-1.28]; P = .69, I2 = 0%) or absence (OR, 0.98 [95% CI, 0.57-1.69]; P = .95, I2 = 17%) of cardiogenic shock. There were 15 eligible observational studies totaling 15 530 patients. Their results were mutually conflicting (heterogeneity I2 = 97%; P < .001), causing wide uncertainty in the summary estimate for the association with mortality (OR, 0.96 [95% CI, 0.54-1.70]). A simple index of baseline risk marker imbalance in the observational studies appeared to explain much of the heterogeneity in the observational data (R2meta = 46.2%; P < .001).

Conclusions and Relevance  :Use of IABP was not found to improve mortality among patients with acute myocardial infarction in the RCTs, regardless of whether patients had cardiogenic shock. The observational studies showed a variety of mutually contradictory associations between IABP therapy and mortality, much of which was explained by the differences between studies in the balance of risk factors between IABP and non-IABP groups.

Thursday, 26 February 2015

Ban on the use of P values in statistics

P values are widely used in science to test null hypotheses. For example, in a medical study looking at smoking and cancer, the null hypothesis could be that there is no link between the two. The closer to zero the P value gets, the greater the chance the null hypothesis is false; many researchers accept findings as ‘significant’ if the P value comes in at less than 0.05. But P values are slippery, and sometimes, significant P values vanish when experiments and statistical analyses are repeated (see Nature 506, 150–152; 2014).
http://www.nature.com/news/scientific-method-statistical-errors-1.14700