Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study

Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1141-50. doi: 10.1002/ccd.25610. Epub 2015 Sep 22.

Abstract

Objectives: We studied coronary vasomotion in patients treated with the Mistent(®) absorbable polymer sirolimus-eluting stent (APSES) and in patients implanted with the Endeavor(®) zotarolimus-eluting stent (ZES).

Background: First generation (1st-gen) drug-eluting stents (DES) induce persistent vasomotor dysfunction in the treated coronary artery. It is unknown whether and to what extent the implantation of an absorbable polymer DES impairs coronary vasomotion.

Methods: This sub-study of the DESSOLVE II trial included 19 APSES Mistent(®) and 10 ZES Endeavor(®) patients. Incremental atrial pacing and quantitative coronary angiography were used to assess vasomotion proximal and distal to the stent and in a reference segment at 9 months after implantation. Percent changes in vessel diameter with pacing versus baseline were calculated and compared. Vasomotor response of the APSES group was also compared with changes observed in a historical group of 17 patients implanted with a 1st-gen sirolimus-eluting stent (SES).

Results: Normal vasomotion (vasodilatation) was preserved and of comparable magnitude in the APSES and in the ZES group both proximally (P = 0.34) and distally (P = 0.38) to the stent. This finding was not observed in the 1st-gen SES group showing marked pacing-induced vasoconstriction at both stent edges (P < 0.05 vs. APSES). The results were practically unchanged after excluding patients with absolute changes in vessel diameter <3% between baseline and maximal pacing.

Conclusions: The implantation of an absorbable polymer sirolimus-eluting stent is associated with preserved coronary vasomotion, comparable to that observed after implantation of the Endeavor(®) ZES, and distinct from 1st-gen SES which induce coronary vasomotor dysfunction.

Trial registration: ClinicalTrials.gov NCT01294748.

Keywords: coronary angiography; coronary stenting; endothelial function.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants*
  • Aged
  • Cardiac Pacing, Artificial
  • Cardiovascular Agents / administration & dosage*
  • Coronary Angiography
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / therapy*
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / physiopathology*
  • Drug-Eluting Stents*
  • Europe
  • Female
  • Historically Controlled Study
  • Humans
  • Male
  • Middle Aged
  • New Zealand
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Polymers*
  • Prospective Studies
  • Single-Blind Method
  • Sirolimus / administration & dosage*
  • Sirolimus / analogs & derivatives
  • Time Factors
  • Treatment Outcome
  • Vasoconstriction
  • Vasodilation*

Substances

  • Cardiovascular Agents
  • Polymers
  • zotarolimus
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT01294748