Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.

Iliac artery angioplasty with stenting is an effective alternative treatment modality for aortoiliac occlusive diseases. Few randomized controlled trials have compared the efficacy and safety between self-expandable stent (SES) and balloon-expandable stent (BES) in atherosclerotic iliac artery disease. In this randomized, multicenter study, patients with common or external iliac artery occlusive disease were randomly assigned in a 1:1 ratio to either BES or SES. The primary end point was the 1-year clinical patency, defined as freedom from any surgical or percutaneous intervention due to restenosis of the target lesion after the index procedure. The secondary end point was a composite event from major adverse clinical events at 1 year. A total of 201 patients were enrolled from 17 major cardiovascular intervention centers in South Korea. The mean age of the enrolled patients was 66.8 ± 8.5 years and 86.2% of the participants were male. The frequency of critical limb ischemia was 15.4%, and the most common target lesion was in the common iliac artery (75.1%). As the primary end point, the 1-year clinical patency as primary end point was 99% in the BES group and 99% in the SES group (p > 0.99). The rate of repeat revascularization at 1 year was 7.8% in the BES group and 7.0% in the SES group (p = 0.985; confidence interval, 1.011 [0.341-2.995]). In our randomized study, the treatment of iliac artery occlusive disease with self-expandable versus balloon-expandable stent was comparable in 12-month clinical outcomes without differences in the procedural success or geographic miss rate regardless of the deployment method in the distal aortoiliac occlusive lesion (ClinicalTrials.gov, NCT01834495).

The Current Status of Intervention for Intermediate Coronary Stenosis in the Korean Percutaneous Coronary Intervention (K-PCI) Registry.

BACKGROUND AND OBJECTIVES: Intermediate coronary lesion that can be under- or over-estimated by visual estimation frequently results in stenting of functionally nonsignificant lesions or deferral of percutaneous coronary intervention (PCI) of significant lesions inappropriately. We evaluated current status of PCI for intermediate lesions from a standardized database in Korea. METHODS: We analyzed the Korean percutaneous coronary intervention (K-PCI) registry data which collected a standardized PCI database of the participating hospitals throughout the country from January 1, 2014, through December 31, 2014. Intermediate lesion was defined as a luminal narrowing between 50% and 70% by visual estimation and then compared whether the invasive physiologic or imaging study was performed or not. RESULTS: Physiology-guided PCI for intermediate lesions was performed in 16.8% for left anterior descending artery (LAD), 9.8% for left circumflex artery (LCX), 13.2% for right coronary artery (RCA). PCI was more frequently performed using intravascular ultrasound (IVUS) than using fractional flow reserve (FFR) for coronary artery segments (27.7% vs. 13.9% for LAD, 32.9% vs. 8.1% for LCX, and 33.8% vs. 10.8% for RCA). In accordance with or without FFR, PCI for intermediate lesions was more frequently performed in the hospitals with available FFR device than without FFR, especially in left main artery (LM), proximal LAD lesion (40.9% vs. 5.9% for LM, 24.6% vs 7.6% for proximal LAD). CONCLUSIONS: These data provide the current PCI practice pattern with the use of FFR and IVUS in intermediate lesion. More common use of FFR for intermediate lesion should be encouraged.

Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

BACKGROUND: The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. METHODS/DESIGN: The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. DISCUSSION: The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. TRIAL REGISTRATION: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial): study protocol for a randomized controlled trial.

BACKGROUND: There have been few randomized control trials comparing the incidence of stent fracture and primary patency among different self-expanding nitinol stents to date. The SMART™ CONTROL stent (Cordis Corp, Miami Lakes, Florida, United States) has a peak-to-valley bridge and inline interconnection, whereas the COMPLETE™-SE stent (Medtronic Vascular, Santa Rosa, California, United States) crowns have been configured to minimize crown-to-crown interaction, increasing the stent's flexibility without compromising radial strength. Further, the 2011 ESC (European society of cardiology) guidelines recommend that dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel should be administered for at least one month after infrainguinal bare metal stent implantation. Cilostazol has been reported to reduce intimal hyperplasia and subsequent repeat revascularization. To date, there has been no randomized study comparing the safety and efficacy of two different antiplatelet regimens, clopidogrel and cilostazol, following successful femoropopliteal stenting. METHODS/DESIGN: The primary purpose of our study is to examine the incidence of stent fracture and primary patency between two different major representative self-expanding nitinol stents (SMART™ CONTROL versus COMPLETE™-SE) in stenotic or occlusive femoropopliteal arterial lesion. The secondary purpose is to examine whether there is any difference in efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol for one month following stent implantation in femoropopliteal lesions. This is a prospective, randomized, multicenter trial to assess the efficacy of the COMPLETE™-SE versus SMART™ CONTROL stent for provisional stenting after balloon angioplasty in femoropopliteal arterial lesions. The study design is a 2x2 randomization design and a total of 346 patients will be enrolled. The primary endpoint of this study is the rate of binary restenosis in the treated segment at 12 months after intervention as determined by catheter angiography or duplex ultrasound. DISCUSSION: This trial will provide powerful insight into whether the design of the COMPLETE™-SE stent is more fracture-resistant or effective in preventing restenosis compared with the SMART™ CONTROL stent. Also, it will determine the efficacy and safety of aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions. TRIAL REGISTRATION: Registered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT01570803).

Assessment of left ventricular asynchrony using volume-time curves of 16 segments by real-time 3 dimensional echocardiography: comparison with tissue Doppler imaging.

BACKGROUND: Recent technical developments with high-resolution real-time 3 dimensional echocardiography (RT3DE) facilitate the acquisition of high quality images and the analysis of segmental volume-time curves (VTCs). AIMS: To assess left ventricular (LV) asynchrony using the VTCs of 16 segments by RT3DE, and to evaluate accuracy compared to tissue Doppler imaging (TDI). METHODS: Twenty-three heart failure (HF) patients (LVEF: 25+/-6%, age: 60+/-13 years) and 16 normal controls underwent TDI and RT3DE. The standard deviation (SD3) of the end systolic time reaching minimal systolic volume for the 16 segments on VTCs was obtained by RT3DE. The standard deviation (SD2) of the electromechanical coupling time for the 8 segments was measured using TDI. RESULTS: SD3 was markedly higher in HF patients than in controls (7.7+/-2.5 vs 1.5+/-1.0%, P<0.01) and increased as LVEF decreased (r=-0.85, P<0.01). SD2 was also significantly higher in HF patients (27.0+/-8.6 vs 12.6+/-5.0 ms, P<0.01) and had a good negative correlation with LVEF (r=-0.72, P<0.01). SD3 was well correlated to SD2 (r=0.66, P<0.01). CONCLUSIONS: We suggest that analysis of VTCs in 16 segments using RT3DE may be a useful alternative to TDI for the evaluation of LV asynchrony.