Details

Autor(en) / Beteiligte

• Harrison, Robert W., MD
• Radhakrishnan, Vaishnavi, MD
• Lam, Peter S., PhD
• Allocco, Dominic J., MD
• Brar, Sandeep, MD
• Fahy, Martin, MSc
• Fisher, Rebecca
• Ikeno, Fumiaki, MD
• Généreux, Philippe, MD
• Kimura, Takeshi, MD, PhD
• Liu, Minglei, PhD
• Lye, Weng Kit, MS
• Mintz, Gary S., MD
• Nagai, Hirofumi, PhD
• Suzuki, Yuka, MD
• White, Roseann, MA
• Allen, John C., PhD
• Krucoff, Mitchell W., MD

Titel

Rationale and design of the East–West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug eluting stent study cohorts

Ist Teil von

• The American heart journal, 2016-12, Vol.182, p.103-110

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2016

Quelle

MEDLINE

Beschreibungen/Notizen

• Abstract Background The contemporary evaluation of novel drug eluting stents (DES) includes mechanistic observations that characterize post-deployment stent behavior. Quantification of late lumen loss due to neo-intimal hyperplasia 8–13 months after stent implantation, via quantitative coronary angiography (QCA) constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, while understanding their comparability across geographic populations could enhance global DES evaluation. Objective The East–West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8–13 months of follow up. Methods Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements. Conclusion Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow up for novel stent designs.