4.3 Article

Predicting Restenosis of Drug-Eluting Stents Placed in Real-World Clinical Practice Derivation and Validation of a Risk Model From the EVENT Registry

Journal

CIRCULATION-CARDIOVASCULAR INTERVENTIONS
Volume 3, Issue 4, Pages 327-334

Publisher

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1161/CIRCINTERVENTIONS.110.946939

Keywords

restenosis; drug-eluting stents; percutaneous coronary intervention; risk assessment

Funding

  1. Volcano Corporation
  2. Terumo
  3. Amylin Pharmaceuticals
  4. Medicines Company
  5. Boston Scientific
  6. Schering Plough
  7. Cordis Corporation
  8. BMS-Sanofi
  9. Harvard Clinical Research Institute
  10. Abbott Vascular
  11. Medtronic Vascular
  12. Eli Lilly
  13. Daiichi Sankyo
  14. Bristol Myers Squibb
  15. Sanofi-Aventis
  16. Edwards Lifesciences
  17. MedRad
  18. Merck/Schering-Plough
  19. Eli Lilly-Daiichi Sankyo
  20. Millennium Pharmaceuticals
  21. Schering Plough Inc.

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Background-Prediction of restenosis after percutaneous coronary intervention (PCI) remains challenging, and existing risk assessment algorithms were developed before the widespread adoption of drug-eluting stents (DES). Methods and Results-We used data from the EVENT registry to develop a risk model for predicting target lesion revascularization (TLR) in 8829 unselected patients undergoing DES implantation between 2004 and 2007. Using a split-sample validation technique, predictors of TLR at 1 year were identified from two thirds of the subjects (derivation cohort) using multiple logistic regression. Integer point values were created for each predictor, and the summed risk score (range, 0 to 10) was applied to the remaining sample (validation cohort). At 1 year, TLR occurred in 4.2% of patients, and after excluding stent thrombosis and early mechanical complications, the incidence of late TLR (more likely representing restenosis-related TLR) was 3.6%. Predictors of TLR were age <60, prior PCI, unprotected left main PCI, saphenous vein graft PCI, minimum stent diameter <= 2.5 mm, and total stent length >= 40 mm. Comparison of observed versus predicted rates of TLR according to risk score demonstrated good model fit in the validation set. There was more than a 3-fold difference in TLR rates between the lowest risk category (score = 0; TLR rate, 2.2%) and the highest risk category (score >= 5; TLR rate, 7.5%). Conclusions-The overall incidence of TLR remains low among unselected patients receiving DES in routine clinical practice. A simple risk model incorporating 6 readily available clinical and angiographic variables helps identify individuals at extremely low (<2%) and modestly increased (>7%) risk of TLR after DES implantation. (Circ Cardiovasc Interv. 2010; 3: 327-334.)

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