Incidence and mechanisms of longitudinal stent deformation associated with Biomatrix, Resolute, Element, and Xience stents: Angiographic and case-by-case review of 1,800 PCIs

Catheter Cardiovasc Interv. 2015 Nov 15;86(6):1002-11. doi: 10.1002/ccd.25790. Epub 2015 Apr 24.

Abstract

Background: There is conflicting evidence regarding the incidence of longitudinal stent deformation (LSD) in contemporary practice.

Methods and results: To assess the incidence and mechanism of LSD across commonly used DES platforms, we performed a case-by-case review of 1,800 PCI cases involving 450 consecutive procedures using Biomatrix Flex, Resolute Integrity, Promus Element, and Xience V stents, respectively, between January 2009 and December 2011. LSD was detected in a higher proportion with Promus Element [15 (3.1%)] compared with other platforms (Xience V [4 (0.9%)], Biomatrix [3 (0.7%)], Resolute [3 (0.7%)]; P = 0.002). LSD was characterized as guide catheter/guide extension induced, or as impact from secondary devices such as postdilatation balloons or IVUS catheters. The incidence of guide catheter/guide extension LSD was similar across platforms; (Promus Element [5 (1.1%)], Xience V [4 (0.9%)], Biomatrix [3 (0.7%)], Resolute [3 (0.7%)]; P = 0.85). Secondary device LSD occurred exclusively with Promus Element (9/450 cases [2%] (P < 0.0001). Re-entering the deformed stent was more difficult in cases of secondary device LSD (6/9 compared with 0/12 treated cases; P < 0.001). Univariate predictors of LSD were previous CABG, culprit vessel, ostial involvement, and lesion tortuosity. Multivariate predictors of LSD were the Promus Element stent (OR 5.53 CI[1.54-19.85]), Guideliner use (OR 22.09 CI[4.73-103]), postdilation balloons (OR 5.47 CI[1.31-22.81]) and number of stents deployed (OR 2.06 CI[1.45-2.9].

Conclusion: LSD is more common than previously reported. LSD by a guide catheter/guide extension occurred equally with all platforms, however, LSD associated with secondary devices only occurred with the Element stent. These findings have important implications regarding current and future stent designs.

Keywords: drug-eluting stents; longitudinal stent deformation; percutaneous coronary intervention.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Analysis of Variance
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / methods*
  • Chi-Square Distribution
  • Cohort Studies
  • Coronary Angiography / methods
  • Coronary Disease / diagnostic imaging*
  • Coronary Disease / therapy*
  • Databases, Factual
  • Equipment Failure Analysis / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / instrumentation
  • Predictive Value of Tests
  • Prosthesis Design
  • Prosthesis Failure*
  • Retrospective Studies
  • Statistics, Nonparametric
  • Stents / adverse effects*
  • Treatment Outcome
  • United Kingdom