Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents.

We designed a randomized trial exploiting optical coherence tomography (OCT) to assess coverage and apposition of overlapping bare-metal stents (BMS) and drug-eluting stents (DES) in human coronary arteries. Overlapping DES impair healing in animals. Optical coherence tomography allows accurate in vivo assessment of stent strut coverage and apposition. Seventy-seven patients with long coronary stenoses were randomized to overlapping sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), or BMS. The primary goal of the study was to determine the rate of uncovered/malapposed struts in overlap versus nonoverlap segments, according to stent type, at 6-month follow-up with OCT. A total of 53,047 struts were analyzed. The rate of uncovered/malapposed struts was 1.5 +/- 3.4% and 0.6 +/- 2.7% in overlap versus nonoverlap BMS (p = NS), respectively, and 4.3 +/- 11% and 3.6 +/- 8% in overlap versus nonoverlap DES (p = NS), respectively. There were no differences in the rates of uncovered/malapposed struts between overlapping BMS and DES, likely due to low frequency of uncovered/malapposed struts in ZES (0.1 +/- 0.4%), which offset the higher rates observed in SES (6.7 +/- 9.6%) and PES (6.7 +/- 16.5%, p < 0.05). Overlap segments showed greater neointimal volume obstruction versus nonoverlap segments in all DES (p < 0.05 for all DES types). Strut-level neointimal thickness at overlap and nonoverlap segments were lowest in SES (0.16 +/- 0.1 mm and 0.12 +/- 0.1 mm, respectively) compared with PES (0.27 +/- 0.1 mm and 0.20 +/- 0.1 mm, respectively), ZES (0.40 +/- 0.16 mm and 0.33 +/- 0.13 mm, respectively), and BMS (0.55 +/- 0.31 mm and 0.53 +/- 0.25 mm, respectively, p < 0.05). As assessed by OCT the impact of DES on vascular healing was similar at overlapping and nonoverlapping sites. However, strut malapposition, coverage pattern, and neointimal hyperplasia differ significantly according to DES type. (Optical Coherence Tomography for Drug Eluting Stent Safety [ODESSA]; NCT00693030).

Guagliumi G ，Musumeci G ，Sirbu V ，Bezerra HG ，Suzuki N ，Fiocca L ，Matiashvili A ，Lortkipanidze N ，Trivisonno A ，Valsecchi O ，Biondi-Zoccai G ，Costa MA ，ODESSA Trial Investigators ... -  《-》

Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study.

Using optical coherence tomography, we assessed the proportion of uncovered struts at 6-month follow-up in zotarolimus-eluting stents (ZES), specifically Endeavor (Medtronic CardioVascular, Santa Rosa, California) stents, and identical bare-metal stents (BMS) implanted in patients with ST-segment elevation myocardial infarction (STEMI). Sirolimus- and paclitaxel-eluting stents implanted in STEMI have been associated with delayed healing and incomplete strut coverage. ZES are associated with a more complete and uniform strut coverage in stable patients, but whether this holds true also after STEMI is unknown. Forty-four patients with STEMI who underwent primary PCI were randomized to ZES or BMS (3:1 randomization). Angiographic, intravascular ultrasound, and optical coherence tomography follow-up was conducted at 6 months and clinical follow-up at 1 year. All images were analyzed by an independent core laboratory that was blind to stent assignments. There were no differences between ZES and BMS in percentage of uncovered struts (median: 0.00% [interquartile range (IQR): 0.00% to 1.78%] vs. 1.98% [IQR: 0.21% to 7.33%], p = 0.13), maximum length of uncovered segments (0.00 [IQR: 0.00 to 1.19] mm vs. 1.38 [IQR: 0.65 to 3.30] mm, p = 0.10), percentage of malapposed struts (0.00% [IQR: 0.00% to 0.23%] vs. 0.15% [IQR: 0.00% to 5.81%], p = 0.16), and maximum length of malapposed segments (0.00 [IQR: 0.00 to 0.67] mm vs. 0.33 [IQR: 0.00 to 2.55] mm, p = 0.20). Neointimal response was similar between ZES and BMS (332 [IQR: 240 to 429] microm vs. 186 [IQR: 136 to 348] microm, p = 0.99) and evenly distributed. No late acquired malapposition was observed in both groups. There were no deaths, myocardial infarction, or stent thromboses at 1 year. This optical coherence tomography study found no difference in strut coverage and similar vessel response to ZES, when compared with identical BMS, implanted during primary percutaneous coronary intervention in STEMI patients. (Six-Month Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography [OCTAMI]; NCT00704561).

Guagliumi G ，Sirbu V ，Bezerra H ，Biondi-Zoccai G ，Fiocca L ，Musumeci G ，Matiashvili A ，Lortkipanidze N ，Tahara S ，Valsecchi O ，Costa M ... -  《-》

Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.

In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found. Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. http://www.clinicaltrials.gov. Unique identifier: NCT01056744.

Poerner TC ，Otto S ，Gassdorf J ，Nitsche K ，Janiak F ，Scheller B ，Goebel B ，Jung C ，Figulla HR ... -  《-》

Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial.

Kim JS ，Jang IK ，Fan C ，Kim TH ，Kim JS ，Park SM ，Choi EY ，Lee SH ，Ko YG ，Choi D ，Hong MK ，Jang Y ... -  《-》

A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclita

Poerner TC ，Otto S ，Gassdorf J ，Janiak F ，Danzer C ，Ferrari M ，Figulla HR ... -  《-》