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Articles by G Guagliumi
Total Records ( 2 ) for G Guagliumi
  A Maehara , G. S Mintz , A. J Lansky , B Witzenbichler , G Guagliumi , B Brodie , M. A Kellett , H Parise , R Mehran and G. W. Stone
 

Background— Vascular responses to drug-eluting stents in ST-segment elevation myocardial infarction are unknown. In the prospective, multicenter Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset were randomized 3:1 to TAXUS EXPRESS paclitaxel-eluting stents (PES) or EXPRESS bare metal stents (BMS).

Methods and Results— A formal intravascular ultrasound substudy enrolled 464 patients with baseline and 13-month follow-up imaging at 36 centers. Overall, 446 lesions in 402 patients were suitable for standard qualitative and quantitative analyses, which were performed at an independent blinded core laboratory. The primary prespecified end point was the in-stent percent net volume obstruction at follow-up. Median stent length measured 23.4 mm (first and third quartiles, 18.5 and 31.9 mm). PES compared with BMS significantly reduced 13-month percent net volume obstruction (6.5% [first and third quartiles, 2.2% and 10.8%] versus 15.6% [first and third quartiles, 7.2% and 28.8%]; P<0.0001). PES compared with BMS also resulted in more late-acquired stent malapposition (29.6% versus 7.9%; P=0.0005) resulting from positive vessel remodeling. Plaque and/or thrombus protrusion through stent struts was initially present in 70.4% of PES and 64.8% of BMS; all resolved during follow-up. New aneurysm formation, stent fracture, and subclinical thrombus were uncommon, although seen only in PES.

Conclusions— PES compared with BMS significantly reduce neointimal hyperplasia in patients with ST-segment elevation myocardial infarction but also result in a high frequency of late-acquired stent malapposition as a result of positive vessel remodeling. Ongoing long-term follow-up is required to establish the clinical significance of these findings.

Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

  G Guagliumi , V Sirbu , G Musumeci , H. G Bezerra , A Aprile , H Kyono , L Fiocca , A Matiashvili , N Lortkipanidze , A Vassileva , J. J Popma , D. J Allocco , K. D Dawkins , O Valsecchi and M. A. Costa
  Background—

Polymer-coated drug-eluting stents are effective in preventing restenosis but have been associated with delayed healing and incomplete strut coverage. It is unknown whether paclitaxel-eluting stents (PES) with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia. Using optical coherence tomography (OCT) as a primary imaging modality, we assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (<1 µm) biodegradable abluminal polymers.

Methods and Results—

In this pilot trial, 60 patients with de novo lesions (≤25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberté PES or JACTAX PES, a Liberté stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 µg each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 µg each). OCT follow-up occurred at 6 months with clinical follow-up through 1 year. The primary end point was percent uncovered struts by OCT. An independent core laboratory blinded to stent assignment analyzed images. The 6-month rate of uncovered struts per patient was 5.3±14.7% for TAXUS Liberté, 7.0±12.2% for JACTAX HD, and 4.6±7.3% for JACTAX LD (P=0.81); percent malapposed struts was 1.4±4.4%, 0.8±1.9%, and 1.1±2.8%, respectively (P=0.86). Strut-level intimal thickness was 0.20±0.10, 0.22±0.15, and 0.24±0.15 mm (P=0.64); percent volume obstruction by OCT was 22.2±12.8, 22.5±16.2, and 25.8±15.2 (P=0.69). There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year.

Conclusions—

JACTAX PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with TAXUS Liberté.

Clinical Trial Registration—

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.

 
 
 
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