Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study.

Abstract

AIMS:

In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up.

METHODS AND RESULTS:

This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%.

CONCLUSIONS:

This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.

• Authors: Giovanni Amoroso, Robert-Jan van Geuns, Christian Spaulding, Stephane Manzo-Silberman, Karl E Hauptmann, René Spaargaren, Héctor M García-García, Patrick W Serruys, Stefan Verheye
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 7 Issue 4 Pg. 428-36 (Aug 2011) ISSN: 1969-6213 [Electronic] France
• PMID: 21764660 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Alloys
• nitinol

Topics

• Adult
• Aged
• Alloys
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation, mortality)
• Coronary Angiography
• Coronary Restenosis (diagnosis, etiology)
• Embolism (diagnosis, etiology)
• Europe
• Feasibility Studies
• Female
• Humans
• Male
• Middle Aged
• Myocardial Infarction (diagnosis, mortality, therapy)
• Prospective Studies
• Prosthesis Design
• Recurrence
• Stents
• Thrombosis (diagnosis, etiology)
• Time Factors
• Tomography, Optical Coherence
• Treatment Outcome
• Ultrasonography, Interventional