The Academic Research Consortium (ARC)-2 initiative revisited the clinical and
angiographic end point definitions in coronary device trials, proposed in 2007, to make them …

Background—Although most clinical trials of coronary stents have measured nominally
identical safety and effectiveness end points, differences in definitions and timing of …

Objectives: Our purpose was to evaluate the heterogeneity and validity of composite end
points, major adverse cardiac events (MACE) in particular, in cardiology research …

Objectives: We sought to validate 4 angiographic measures as potential surrogates for
clinical restenosis (target lesion revascularization [TLR]) after stent implantation …

Abstract Objectives: The American College of Cardiology (ACC) established the National
Cardiovascular Data Registry (ACC–NCDR) to provide a uniform and comprehensive …

that support either the 2001 recommendations that have changed or the new or revised
recommendations are cited in parentheses at the end of each recommendation or comment …

Abstract The evaluation for European Union market approval of coronary stents falls under
the Medical Device Directive that was adopted in 1993. Specific requirements for the …

Background—Many clinical trials use composite end points to reduce sample size, but the
relative importance of each individual end point within the composite may differ between …

Managing patients with coronary artery stenosis has substantially improved since
percutaneous transluminal coronary angioplasty with balloon inflation was introduced in …

The recommendations listed in this document are, whenever possible, evidence based. An
extensive evidence review was conducted through November 2010, as well as selected …