Randomized prospective study comparing the everolimus-eluting polymer-coated stent versus a biodegradable polymer with biolimus coated stent. While the use of first generation DES effectively reduces restenosis and reintervention rates, several meta-analyzes have shown a higher rate of late events of thrombotic origin associated with inflammatory phenomena and delayed reendothelialization at the site of implantation compared...
COMFORTABLE AMI: A randomized trial comparing a coated stent with biodegradable biolimus polymer (Biomatrix) with an uncoated stent (Gazelle) in patients with AMI with ST segment elevation.
Randomized trial (n = 1161 patients in 16 centers) comparing a coated stent with biodegradable biolimus polymer (Biomatrix) versus uncoated stent (Gazelle) in patients with AMI with ST segment elevation. While there is no doubt about the effectiveness of first generation SF to reduce the rate of reoperations compared with non-drug eluting stents, there is...
DESolve I FIM: Evaluation of a FIM trial results of a bioabsorbable stent (15 patients).
This trial is a prospective evaluation of DESolveTM bioabsorbable coronary stent implantation in a 15 patient cohort enrolled in New Zealand and Belgium. At 6 months follow up, late lumen loss was 0,19 mm, binary restenosis was 0% and thrombosis was absent. OCT evaluation showed excellent stent apposition, and 98% of evaluated struts were covered...
TROFI: Minimal intra-stent flow area in STEMI patients post primary PCI with or without manual thrombus aspiration.
Professor Serruys presented the results of the TROFI trial that compares the minimal intra-stent flow area in STEMI patients post primary PCI with or without manual thrombus aspiration. The minimal intra-stent flow area helps assess thrombus burden and is defined as: (stent area + incomplete stent apposition area) – (intralulminal defect area attached to the...
PROTECT: A comparison of thrombosis incidence between the drug-eluting stents sirolimus and zotarolimus.
Summary: Randomized, open, pragmatic essay PROTECT (patient related outcomes of Endeavor versus Cypher stenting trial) compared two drug-eluting stents with different behaviors, (Cypher ® and Endeavor ®), in the reendothelialization degree and antiproliferative potency. Cypher has a permanent sirolimus-eluting polymer which generates a potent antiproliferative effect and a suboptimal healing (or reendothelialization). Furthermore, Endeavor has...
XIMA: Randomized prospective study comparing everolimus eluting stents versus conventional stent implantation in octogenarians.
Background: Octogenarian patients represent an increasingly growing population. In addition, this age group has a higher proportion of co-morbidities with more extensive and complex coronary disease. However, they have often been excluded from major studies, whose average age is usually 60 years. Despite having a more complex coronary anatomy, the role of pharmacological stent (DES)...
ISAR-DESIRE 3: A paclitaxel eluting balloon versus Taxus in the treatment of eluting stent restenosis.
Fundamentals. Background: Although we’ve had more than a decade of experience with implanting drug-eluting stents, (DES), the best treatment for restenosis on these devices remains unknown. The drug-eluting balloons are a promising alternative which avoid the possibility of a new layer of metal on the restenotic injury. This study compared the performance of these balls...
ISAR-LEFT MAIN 2: Everolimus-eluting stents versus Zotarolimus eluting stents in the treatment of the unprotected left coronary trunk.
Summary: Second-generation drug-eluting stents have shown better results than their predecessors. In this study we compare two second-generation drug stents in patients with unprotected left coronary trunk injuries. Methods and results: 650 patients with unprotected trunk injury were randomized to either XIENCE V (everolimus eluting) or RESOLUTE (zotarolimus eluting) stents. The primary endpoint was the...
MASTER Trial: Prospective, multicentre, randomized trial evaluating the MGuard stent in the treatment of patients with acute myocardial infarction with ST segment elevation (STEMI).
Foreword: The EPS MGUARD stent (embolic protection stent) has a fine metal structure covered by a thin polyethylene fiber mesh with pores of 5 microns wrapping the stent that might prevent distal embolization during primary angioplasty and would therefore be particularly attractive during primary angioplasty. Methods and Results: We included 432 patients referred for primary...
NEXT trial looked at a non-inferiority degradable polymer stent versus a second-generation permanent polymer stent.
Previous studies of non-inferiority (SORT-OUT III and V) compared the biodegradable polymer biolimus-eluting stent (BES) with permanent polymer stent and sirolimus-eluting stent (SES) or everolimus-eluting stent (EES), showing no differences, although the data is still contradictory. The aim of this study was to evaluate whether the recently approved BES is not inferior to EES in...