Background— Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. Methods and Results— The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechani...

Clinical End Points in Coronary Stent Trials A Case for Standardized Definitions

A b s t r ac t Results The 4-year rates of stent thrombosis were 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P = 0.20) and 1.3% in the paclitaxel-stent group versus 0.9% in the bare-metal-stent group (P = 0.30). However, after 1 year, there were five episodes of stent thrombosis in patients with sirolimus-eluting stents versus none in patients with bare-metal stents (P = 0.025) and nine episodes in patients with paclitaxel-eluting stents versus two in patients with bare-metal stents (P = 0.028). The 4-year rates of target-lesion revascularization were markedly reduced in both the sirolimus-stent group and the paclitaxel-stent group, as compared with the bare-metal-stent groups. The rates of death or myocardial infarction did not differ significantly between the groups with drug-eluting stents and those with bare-metal stents. Conclusions Stent thrombosis after 1 year was more common with both sirolimus-eluting stents and paclitaxel-eluting stents than with bare-metal stents. Both drug-eluting stents were associated with a marked reduction in target-lesion revascularization. There were no significant differences in the cumulative rates of death or myocardial infarction at 4 years.

/pdf/safety-and-efficacy-of-sirolimus-and-paclitaxel-eluting-395d92uk7a.pdf

Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(07)60314-6.pdf

Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study

http://www.area-c54.it/public/accaha%202007%20guidelines%20on%20perioperative%20cardiovascular%20evaluation%20and%20care%20for%20noncardiac%20surgery.pdf

ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery)

http://unmhospitalist.pbworks.com/f/ACC+Preoperative+risk+2008.pdf

ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery)

Hypersensitivity Cases Associated With Drug-Eluting Coronary Stents: A Review of Available Cases From the Research on Adverse Drug Events and Reports (RADAR) Project

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Hypersensitivity Cases Associated With Drug-Eluting Coronary Stents: A Review of Available Cases From the Research on Adverse Drug Events and Reports (RADAR) Project