Angiographic Surrogate End Points in Drug-Eluting Stent TrialsA Systematic Evaluation Based on Individual Patient Data From 11 Randomized, Controlled Trials
Stuart J. Pocock, PhD*,
Alexandra J. Lansky, MD, FACC ,
Roxana Mehran, MD, FACC,
Jeffrey J. Popma, MD, FACC ,
Martin P. Fahy, MSc,
Yingbo Na, MSc,
George Dangas, MD, PhD, FACC,
Jeffrey W. Moses, MD, FACC,
Tereza Pucelikova, MD,
David E. Kandzari, MD, FACC ,
Stephen G. Ellis, MD, FACC¶,
Martin B. Leon, MD, FACC and
Gregg W. Stone, MD, FACC,*
* London School of Hygiene and Tropical Medicine, London, United Kingdom
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Brigham and Women’s Hospital, Boston, Massachusetts
Duke University Medical Center, Durham, North Carolina
¶ Cleveland Clinic Foundation, Cleveland, Ohio.
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Figure 1 Impact of Angiographic Measures on TLR
Proportion of patients with target lesion revascularization (TLR) as a function of in-stent and in-segment late loss (LL) and follow-up percent diameter stenosis (%DS), stratified by reference vessel diameter (RVD) using individual patient data from all 11 trials. Left column = observed proportions with TLR for 12 intervals of LL and 10 intervals of follow-up %DS. Right column = corresponding smoothed logistic curves.
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Figure 2 Actual Versus Predicted Rates of TLR
Actual versus predicted rates of TLR for 22 treatment groups (13 with drug-eluting stents [DES], 9 with bare-metal stents [BMS]), using logistic models for in-stent LL (top) and follow-up %DS (bottom). Abbreviations as in Figure 1.
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Figure 3 Relationship Between Angiographic Measures and Actual TLR
Relationship of TLR to mean LL and mean follow-up %DS both in-stent and in the analysis segment for each stent treatment group in 11 randomized trials. Abbreviations as in Figures 1 and 2.
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