The East–West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts - 12/12/18
, Vaishnavi Radhakrishnan, MD a, John C. Allen, PhD b, Peter S. Lam, PhD c, Dominic J. Allocco, MD c, Sandeep Brar, MD d, Martin Fahy, MSc d, Zhen Zhang, PhD e, Rebecca Fisher, MD a, Fumiaki Ikeno, MD f, Philippe Généreux, MD g, Takeshi Kimura, MD, PhD h, Minglei Liu, PhD d, Weng Kit Lye, MSc b, Hirofumi Nagai, PhD i, Yuka Suzuki, PhD j, Roseann White, MA a, Mitchell W. Krucoff, MD aAbstract |
Background |
Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to be generalizable across jurisdictions and geographies. The objectives were to assess the comparability of in-segment LLL in Eastern and Western DES populations using the world's largest compilation of follow-up quantitative coronary angiography data.
Methods |
Data from 4 manufacturers involving 29 DES clinical trials in Eastern and Western hemispheres were compiled. “East” and “West” cohorts were defined by trial location. Independent core laboratories quantified in-segment LLL for all studies. East and West were compared before and after adjustment for clinical and anatomic covariates known to correlate with LLL via conditioning on propensity score quintiles. An international panel of experts and regulators prospectively established a clinically meaningful difference between East and West mean in-segment LLL of ±0.40 mm.
Results |
The data set comprised 2,047 East and 4,456 West patients. Unadjusted mean ± SD for West and East in-segment LLL (mm) was 0.25 ± 0.46 and 0.12 ± 0.42, respectively (difference 0.13 mm; 95% CI 0.11-0.16). Propensity score–adjusted in-segment LLL East and West least squares means were 0.11 and 0.26 mm, respectively (difference 0.15 mm; 95% CI 0.13-0.18).
Conclusions |
In the world's largest compilation of DES protocol 8- to 13-month angiographic follow-up data, clinically meaningful comparability of in-segment LLL by independent core laboratory quantitative coronary angiography in East and West cohorts was demonstrated in both unadjusted and adjusted comparisons. These findings suggest that DES LLL, once characterized, could be generalized across regulatory jurisdictions over the course of global registration efforts.
Le texte complet de cet article est disponible en PDF.Plan
Vol 206
P. 61-71 - décembre 2018 Retour au numéro
Article précédent
- Sex differences in long-term outcomes of patients across the spectrum of coronary artery disease
- Neha J. Pagidipati, Daniel W. Mudrick, Karen Chiswell, Amanda Brucker, Eric D. Peterson, Pamela S. Douglas
- Risk stratification and clinical outcomes after surgical pulmonary valve replacement
- Alexander C. Egbe, William R. Miranda, Sameh M. Said, Sorin V. Pislaru, Patricia A. Pellikka, Barry A. Borlaug, Srikanth Kothapalli, Heidi M. Connolly
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?