Intravascular ultrasound-guided drug-eluting stent implantation for patients with unprotected left main coronary artery lesions: a single-center randomized trial

Abstract

Objective: Intravascular ultrasound (IVUS) has developed as a preferable choice for optimizing the stenting procedures mainly because it will have good access to vessel size, lesion length, or severity accurately. However, it still remains unclear about the benefits of IVUS guidance in drug-eluting stent (DES) implantation for patients with unprotected left main coronary artery (ULMCA) stenosis. The aim of the present study was to evaluate the clinical outcomes with respect to IVUS-guided DES implantation for these patients. Methods: A total of 336 consecutive patients from December 2010 to December 2015 were enrolled in the study. The patients were then randomly assigned into two groups: IVUS-guided group (n=167) and control group (n=169). The primary endpoint was the incidence of composite major adverse cardiac events (MACEs), including cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). The risk of stent thrombosis (ST) was chosen as the safety endpoint. Results: After a 1-year follow-up, the occurrence of composite MACE in the IVUS-guided group was significantly lower than that in the control group (13.2% vs. 21.9%, p=0.031), which might mainly result from the significant reduction in the risk of cardiac death (1.8% vs. 5.9%, p=0.048). Dramatically, the risk of MI did not differ significantly between the two groups (11.4% vs. 13.6%, p=0.478), though a tended reduction in TVR was observed under IVUS guidance (4.2% vs. 8.9%, p=0.068). There was no statistical significance between the two groups with respect to the risk of target lesion revascularization (IVUS-guided vs. control: 1.2% vs. 3.0%, p=0.239) and ST (IVUS-guided vs. control: 1.2% vs. 3.0%, p=0.246). Conclusion: The possible feasibility of IVUS-guided DES implantation for patients with ULMCA stenosis was supported by the present study. Larger and more powerful randomized trials were still warranted to research the whole benefits of IVUS guidance for these patients.

Intravascular Ultrasound-Guidance Is Associated With Lower Cardiovascular Mortality and Myocardial Infarction for Drug-Eluting Stent Implantation ― Insights From an Updated Meta-Analysis of Randomized Trials ―

“…[5][6][7] A total of 10 randomized trials with 5,060 patients (2,526 in the IVUS-guided group and 2,534 in the angiographyguided group) were included (Table). [5][6][7][8][9][10][11][12][13][14] Most of the included trials evaluated the effect of IVUS on complex lesions (e.g., long lesions, chronic total occlusion, left main disease), except for the ULTIMATE trial, which enrolled all-comers. In the ULTIMATE trial, 5 the mean lesion length was 34.5 mm, 66.9% were Type B2/C lesions, and 8.9% were chronic total occlusions.…”

Intravascular ultrasound versus angiography-guided drug eluting stent implantation in patients with complex coronary lesions: an updated meta-analysis of 9 randomized clinical trials

“…This updated meta-analysis extended the superior results from our prior citation (11), among which a new RCT (16) focusing on exploring the efficacy of the IVUS guidance in patients suffering from unpro- (16). In fact, the large ULTIMATE trial (6) (intravascular ultrasound-guided versus angiography-guided implantation of drug-eluting stent in all-comers) has indicated that DES implantation under IVUS guidance could significantly reduce the TVF by analyzing the largest sample size (IVUS guidance vs. angiography guidance, 724 vs. 724, respectively), which will make the dominant position of IVUS guidance in all-comer patients well established.…”

“…1). Among these included citations, there were two trials in each subset, including long lesions (9, 15), CTO (10,21), unprotected LM disease (16,22), or complex coronary lesions (13,14). Only 1 paper was for a de novo lesion in a small vessel (diameter 2.25-2.75 mm) (23).…”

“…Characteristics of the past medical histories among the included RCTsData are recorded as intravascular ultrasound guidance vs. angiography guidance.LVEF -left ventricular ejection fraction; MI -myocardial infarction; NA -not available; PCI -percutaneous coronary intervention21,23) reported TVR data, seven trials(9,10,13,14,16,21,22) reported TLR data, and eight trials(9, 10, 13-16, 21, 22) reported ST results. No significant heterogeneity was observed, and the fixed-effects model with the Mantel-Haenszel method was applied for all result analyzes.…”

Intravascular ultrasound versus angiogram guided drug eluting stent implantation. A systematic review and updated meta-analysis with trial sequential analysis

“…We included 11 RCTs comparing IVUS versus angiogram guided DES implantation [3,4,[9], [10], [11], [12], [13], [14], [15], [16], [17]]. The PRISMA flow diagram is shown in Supplementary Fig.…”