Clinical Impact of Intravascular Ultrasound–Guided Chronic Total Occlusion Intervention With Zotarolimus-Eluting Versus Biolimus-Eluting Stent Implantation

Abstract

P ercutaneous coronary intervention (PCI) for chronic total occlusion (CTO) is still challenging, and there are unmet needs even with the availability of drug-eluting stents (DESs). [1][2][3][4] Despite the development of novel techniques and technologies for CTO intervention, the increased clinical and angiographic risk factors accompanying more complex procedures have been associated with worse clinical outcomes. [3][4][5][6] The use of intravascular ultrasound (IVUS) has been recommended as 1 way to improve overall PCI clinical outcomes; however, few studies have evaluated its use during CTO intervention, and no randomized study has compared IVUS-guided CTO intervention with conventional angiography-guided intervention. 7-9Background-There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. Methods and Results-After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUSguided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). Conclusions-Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01563952. Kim et al Clinical Impact of IVUS-Guided CTO InterventionTherefore, we conducted a prospective, multicenter, randomized trial designed t...

Intravascular ultrasound in percutanous coronary intervention for chronic total occlusions: predictors of use, indications and in-hospital outcome

“…However, in two randomized trials, IVUS use was not associated with a reduction of contrast load [18,19]. Although in our study, less contrast was required in IVUS guided CTO PCI attempts, this did not result in lower incidence of contrast induced nephropathy.…”

“…In a randomized trial, Kim et al [19] compared the mid-term outcome of 201 CTO patients who underwent IVUS-guided versus angiography-guided stenting. At 12 months, the incidence of MACE (composite of cardiac death, MI, or target vessel revascularization) was lower in the IVUS-guided group (2.6% vs. 7.1%; p=0.035) [19]. However, this latter study was underpowered because of low events rate observed in both groups.…”

“…Recently, the interest in IVUS use during percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) has dramatically increased [4][5][6]. Indeed, IVUS has various potential roles in the recanalization of CTOs, some specific to wire crossing, others in common with other complex long calcified lesions such as optimal sizing and expansion of the stents [7].…”

Optical coherence tomography- vs. intravascular ultrasound-guided percutaneous coronary intervention

“…Intravascular imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT) represent two techniques that provide essential information on preprocedural lesion characteristics (i.e., lesion severity, landing zone, and plaque composition) and the result after stent implantation (i.e., stent expansion and eccentricity, strut apposition, lesion coverage, tissue protrusion, and dissections). A total of 11 randomized controlled trials investigated the effect of IVUS-guided PCI with mixed results (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11). Of note, studies including patients with an increased complexity [i.e., chronic total occlusion (CTO) or lesion length >28 mm] demonstrated a consistent benefit of IVUS-guided PCI as compared with angiography, mainly driven by a reduction of repeat revascularization for restenosis (MACE at 1 year: CTO-IVUS, 2.6% vs. 7.1%, P=0.035; IVUS-XPL, 2.9% vs. 5.8%, P=0.007) (1,2).…”

“…A total of 11 randomized controlled trials investigated the effect of IVUS-guided PCI with mixed results (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11). Of note, studies including patients with an increased complexity [i.e., chronic total occlusion (CTO) or lesion length >28 mm] demonstrated a consistent benefit of IVUS-guided PCI as compared with angiography, mainly driven by a reduction of repeat revascularization for restenosis (MACE at 1 year: CTO-IVUS, 2.6% vs. 7.1%, P=0.035; IVUS-XPL, 2.9% vs. 5.8%, P=0.007) (1,2). In addition, IVUS was instrumental in guiding left main stem PCI in the recent EXCEL and NOBLE left main trials in more than 70% of patients, although these studies were not designed to investigate effects of intracoronary-guided imaging (12,13).…”