One-Year Clinical Outcomes of Patients Presenting With ST-Segment Elevation Myocardial Infarction Caused by Bifurcation Culprit Lesions Treated With the Stentys Self-Apposing Coronary Stent: Results From the APPOSITION III Study.

Abstract

OBJECTIVE:

To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions.

BACKGROUND:

The nitinol, self-expanding Stentys was initially developed as a dedicated bifurcation stent. The stent facilitates a provisional strategy by accommodating its diameter to both the proximal and distal reference diameters and offering an opportunity to "disconnect" the interconnectors, opening the stent toward the side branch.

METHODS:

The APPOSITION (a post-market registry to assess the Stentys self-expanding coronary stent in acute myocardial infarction) III study was a prospective, multicenter, international, observational study including STEMI patients undergoing primary percutaneous coronary intervention (PCI) with the Stentys SAS. Clinical endpoints were evaluated and stratified by bifurcation vs non-bifurcation culprit lesions.

RESULTS:

From 965 patients included, a total of 123 (13%) were documented as having a bifurcation lesion. Target-vessel revascularization (TVR) rates were higher in the bifurcation subgroup (16.4% vs 10.0%; P=.04). Although not statistically significant, other endpoints were numerically higher in the bifurcation subgroup: major adverse cardiac events (MACE; 12.7% vs 8.8%), myocardial infarction (MI; 3.4% vs 1.8%), and definite/probable stent thrombosis (ST; 5.8% vs 3.1%). However, when postdilation was performed, clinical endpoints were similar between bifurcation and non-bifurcation lesions: MACE (8.7% vs 8.4%), MI (1.2% vs 0.7%), and definite/probable ST (3.7% vs 2.4%).

CONCLUSIONS:

The use of the Stentys SAS was safe and feasible for the treatment of bifurcation lesions in the setting of primary PCI for STEMI treatment with acceptable 1-year cardiovascular event rates, which improved when postdilation was performed.

• Authors: Maik J Grundeken, Huangling Lu, Nicola Vos, Alexander IJsselmuiden, Robert-Jan van Geuns, Rainer Wessely, Thomas Dengler, Alessio La Manna, Johanne Silvain, Gilles Montalescot, René Spaargaren, Jan G P Tijssen, Robbert J de Winter, Joanna J Wykrzykowska, Giovanni Amoroso, Karel T Koch
• Journal: The Journal of invasive cardiology (J Invasive Cardiol) Vol. 29 Issue 8 Pg. 253-258 (Aug 2017) ISSN: 1557-2501 [Electronic] United States
• PMID: 28756418 (Publication Type: Journal Article, Multicenter Study, Observational Study)

Chemical References

• Alloys
• nitinol

Topics

• Aged
• Alloys (therapeutic use)
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation, methods)
• Coronary Angiography (methods)
• Coronary Vessels (diagnostic imaging, pathology, surgery)
• Female
• Humans
• Male
• Middle Aged
• Outcome and Process Assessment, Health Care
• Postoperative Complications (epidemiology, etiology)
• Product Surveillance, Postmarketing
• ST Elevation Myocardial Infarction (diagnosis, surgery)
• Self Expandable Metallic Stents (adverse effects, statistics & numerical data)