IVUS-guided Drug-eluting Stent Implantation Research Articles

Use of intravascular ultrasound and long-term cardiac death or myocardial infarction in patients receiving current generation drug-eluting stents

Long-term follow-up data on differential effects of intravascular ultrasound (IVUS) according to lesion complexity are limited in patients undergoing percutaneous coronary intervention (PCI). The current study compared long-term clinical outcomes between IVUS-guided and angiography-guided PCI in patients with second-generation drug-eluting stents (DES). Between February 2008 and December 2015, 5488 patients undergoing PCI with second-generation DES were recruited from an institutional registry of Samsung Medical Center. The primary outcome was a composite of cardiac death or myocardial infarction (MI) during 46 months of median follow-up (interquartile range: 32–102 months). IVUS-guided PCI was performed in 979 patients (17.8%). IVUS-guided PCI was associated with a significantly lower risk of cardiac death or MI compared with angiography-guided PCI (5.7% vs. 12.9%, hazard ratio 0.408, 95% confidence interval 0.284–0.587, p < 0.001). Results were consistent after propensity score matching analysis with 801 matched pairs. In subgroup analysis, there was no significant interaction between lesion complexity (defined by complex procedures, Pinteraction = 0.819, ACC/AHA lesion classification, Pinteraction = 0.401 or SYNTAX score, Pinteraction = 0.149) and use of IVUS for risk of cardiac death or MI. IVUS-guided second-generation DES implantation was associated with a significantly lower long-term risk of cardiac death or MI compared with angiography guidance, regardless of lesion complexity.

Improved 3-Year Cardiac Survival After IVUS-Guided Long DES Implantation: A Patient-Level Analysis From 2 Randomized Trials.

The present study aimed to evaluate long-term cardiac survival benefit for intravascular ultrasound (IVUS)- versus angiography-guided long drug-eluting stent (DES) implantation. Although the long-term benefit of IVUS guidance for DES implantation has been reported from recent randomized trials, this benefit was primarily driven by the reduction in repeat revascularization. Thus, it remains uncertain whether IVUS guidance improved survival during long-term follow-up. We pooled the data of 2 randomized trials (IVUS-XPL [Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions] and ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All-Comers Coronary Lesions]) and compared IVUS guidance versus angiography guidance in 2,577 patients with long lesions treated with an implanted stent length≥28mm. The primary end point was cardiac death at 3 years. A 3-year clinical follow-up was completed in 96%. The primary end point of cardiac death occurred in 12 patients (1.0%) in the IVUS-guided group vs 28 patients (2.2%) in the angiography-guided group (HR: 0.43; 95% CI: 0.22-0.84; P=0.011). In addition, target lesion-related myocardial infarction occurred in 3 patients (0.2%) in the IVUS-guided group and in 9 patients (0.7%) in the angiography-guided group (HR: 0.33; 95%CI: 0.09-1.22; P=0.081), stent thrombosis developed in 3 patients (0.2%) in the IVUS-guided group and 9 patients (0.7%) in the angiography-guided group (HR: 0.33; 95%CI: 0.09-1.23; P=0.082), and ischemia-driven target lesion revascularization was observed in 47 patients (3.8%) in the IVUS-guided group and 80 patients (6.5%) in the angiography-guided group (HR: 0.57; 95%CI: 0.40-0.82; P=0.002). In this post hoc pooled patient-level analysis, the use of IVUS-guided long DES implantation compared with angiography-guided stent implantation improved long-term patient cardiac survival.

Comparison of one-month versus twelve-month dual antiplatelet therapy after implantation of drug-eluting stents guided by either intravascular ultrasound or angiography in patients with acute coronary syndrome: rationale and design of prospective, multicenter, randomized, controlled IVUS-ACS and ULTIMATE-DAPT trial

Current guidelines recommend administering dual antiplatelet therapy (DAPT) for 12 months to patients with acute coronary syndromes (ACS) and without contraindications after drug-eluting stent (DES) implantation. A recent study reported that 3 months of DAPT followed by ticagrelor monotherapy is effective and safe in ACS patients undergoing DES implantation compared with the standard duration of DAPT. However, it is unclear whether antiplatelet monotherapy with ticagrelor alone versus ticagrelor plus aspirin reduces the incidence of clinically relevant bleeding without increasing the risk of major adverse cardiovascular and cerebrovascular events (MACCEs) in ACS patients undergoing percutaneous coronary intervention (PCI) with DES implantation guided by either intravascular ultrasound (IVUS) or angiography who have completed a 1-month course of DAPT with aspirin plus ticagrelor. The IVUS-ACS and ULTIMATE-DAPT is a prospective, multicenter, randomized, controlled trial designed to determine (1) whether IVUS-guided versus angiography-guided DES implantation in patients with ACS reduces the risk of target vessel failure (TVF) at 12 months and (2) whether ticagrelor alone versus ticagrelor plus aspirin reduces the risk of clinically relevant bleeding without increasing the risk of MACCE 1-12 months after the index PCI in ACS patients undergoing DES implantation guided by either IVUS or angiography. This study will enroll 3486 ACS patients eligible for DES implantation, as confirmed by angiographic studies. The patients who meet the inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 fashion to the IVUS- or angiography-guided group (first randomization). All enrolled patients will complete a 1-month course of DAPT with aspirin plus ticagrelor after the index PCI. Patients with no MACCEs or major bleeding (≥Bleeding Academic Research Consortium (BARC) 3b) within 30 days will be randomized in a 1:1 fashion to either the ticagrelor plus matching placebo (SAPT)group or ticagrelor plus aspirin (DAPT)group for an additional 11 months (second randomization). The primary endpoint of the IVUS-ACS trial is TVF at 12 months, including cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target vessel revascularization (CD-TVR). The primary superiority endpoint of the ULTIMATE-DAPT trial is clinically relevant bleeding, defined as BARC Types 2, 3, or 5 bleeding, and the primary non-inferiority endpoint of the ULTIMATE-DAPT trial is MACCE, defined as cardiac death, myocardial infarction, ischemic stroke, CD-TVR, or definite stent thrombosis occurring 1-12 months in the second randomized population. The IVUS-ACS and ULTIMATE-DAPT trial is designed to test the efficacy and safety of 2 different antiplatelet strategies in ACS patients undergoing PCI with DES implantation guided by either IVUS or angiography. This study will provide novel insights into the optimal DAPT duration in ACS patients undergoing PCI and provide evidence on the clinical benefits of IVUS-guided PCI in ACS patients.

Association between angiographic and intravascular ultrasound optimizations after new-generation drug-eluting stent implantation and clinical outcomes.

Uncertainty remains regarding the associations of angiographic optimization and intravascular ultrasound (IVUS) optimization after new-generation drug-eluting stent (DES) implantation. From four randomized trials comparing outcomes between IVUS and angiography-guidance for long or chronic total occlusion (CTO) lesions, 1396 patients who underwent IVUS-guided new-generation DES implantation were enrolled. Of these, 1112 patients (80%) met angiographic optimization criteria (postprocedural diameter stenosis, ≤20%) and were further classified into the matched (same results for angiographic optimization and IVUS optimization) and the mismatched group (opposite results for angiographic optimization and IVUS optimization) according to the meeting of IVUS optimization criteria (minimal stent area, ≥5.5 mm2 or ≥80% of mean reference lumen area). The major adverse clinical events (MACE) were compared. Of 1112 patients with angiographic optimization, 675 patients met the IVUS optimization criteria (61%; matched), but 437 patients (39%; mismatched) failed to meet IVUS optimization criteria (false-positive rate = 76%). On multivariate analyses, age >60 years, reference vessel diameter ≤2.7 mm, left circumflex artery and lesion length ≥33 mm were significant predictors for the mismatched. When comparing the 12-month MACE rates, the mismatched group (6.8%) showed a significantly higher rate than the matched group (1.5%; hazard ratio = 2.62; 95% confidence interval = 1.20-5.72; P = 0.012), mainly driven by a higher target-vessel revascularization rate (6.4 vs 1.4%; P = 0.021). Despite meeting angiographic optimization criteria in long or CTO lesions, more than one-third of the patients with IVUS-guided new-generation DES implantation failed to meet the IVUS optimization criteria and had worse clinical outcomes. Therefore, IVUS optimization should be considered for patients who had predictors of mismatch.

3-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation

The aim of this study was to explore the difference in target vessel failure (TVF) 3 years after intravascular ultrasound (IVUS) guidance versus angiographic guidance among all comers undergoing second-generation drug-eluting stent (DES) implantation. The multicenter randomized ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions) trial showed a lower incidence of 1-year TVF after IVUS-guided DES implantation among all comers compared with angiographic guidance. However, the 3-year clinical outcomes of the ULTIMATE trial remain unknown. A total of 1,448 all comers undergoing DES implantation who were randomly assigned to either IVUS guidance or angiographic guidance in the ULTIMATE trial were followed for 3 years. The primary endpoint was the risk for TVF at 3 years. The safety endpoint was definite or probable stent thrombosis (ST). At 3 years, TVF occurred in 47 patients (6.6%) in the IVUS-guided group and in 76 patients (10.7%) in the angiography-guided group (p = 0.01), driven mainly by the decrease in clinically driven target vessel revascularization (4.5% vs. 6.9%; p = 0.05). The rate of definite or probable ST was 0.1% in the IVUS-guided group and 1.1% in the angiography-guided group (p = 0.02). Notably, the IVUS-defined optimal procedure was associated with a significant reduction in 3-year TVF relative to that with the suboptimal procedure. IVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during 3-year follow-up among all comers, particularly those who underwent the IVUS-defined optimal procedure compared with those with angiographic guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions; NCT02215915)

844 Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: A Health Economic Analysis

There is increasing evidence that use of intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) is associated with improved clinical outcomes compared with angiography alone. However, concern regarding the cost-effectiveness of IVUS has limited use of this technology worldwide. In this study, we aimed to evaluate the cost-effectiveness of IVUS-guided PCI compared with angiography-guided PCI in patients undergoing drug-eluting stent (DES) implantation. A Markov model was constructed to compare the cost-effectiveness of IVUS-guided to angiography-guided DES implantation from the Australian healthcare system perspective. Procedure-related morbidity and mortality were estimated from the published literature. Costs were obtained from Australian sources. Outcomes of interest included costs, life-expectancy and quality-adjusted life years (QALYs). In the base case analysis, the population of interest was all-comers undergoing PCI. In sensitivity analyses, we explored whether lesion subtype affected cost-effectiveness. In the base case, IVUS-guided DES implantation was cost-effective compared to angiography-guided DES implantation. With 5% annual discounting, IVUS was associated with increased lifetime costs of AUD$799 per person and benefits of 0.10 life-years and 0.11 QALYs compared to angiography, yielding an incremental cost-effectiveness ratio of AUD$9,280/QALY gained. Analysis by lesion subtype revealed greater cost-effectiveness among patients with left main and complex coronary lesions. Results were robust to sensitivity analyses, with IVUS being cost-effective in 98% of 10,000 Monte Carlo iterations assuming a willingness-to-pay threshold of $AUD50,000/QALY gained. Use of IVUS guidance during PCI is likely to be cost-effective compared with angiography guidance alone among patients undergoing DES implantation.

Prognostic value of post-intervention fractional flow reserve after intravascular ultrasound-guided second-generation drug-eluting coronary stenting.

The aim of this study was to investigate the prognostic value of fractional flow reserve (FFR) and a novel index (the D-index) of residual diffuse disease after intravascular ultrasound (IVUS)-guided second-generation drug-eluting stent (DES) implantation. We evaluated 201 patients (201 lesions) who underwent IVUS-guided second-generation DES implantation in the left anterior descending artery with pre- and post-intervention physiological evaluations. Post-intervention hyperaemic pullback pressure recording was used to quantify residual diffuse disease using the novel D-index, defined as the difference between the distal stent and the far distal FFR values divided by distance. Clinical outcomes were assessed by vessel-oriented composite endpoints (VOCE) and major adverse cardiac events (MACE). The incremental discriminant and reclassification abilities of far distal FFR or D-index for VOCE and MACE were compared. Post intervention, far distal FFR and D-indices were significantly lower in vessels with VOCE. The optimal far distal FFR and D-index cut-off values for VOCE and MACE were 0.86 and 0.017 cm, respectively. Although both indices remained significant predictors of VOCE, only the D-index proved to be a significant predictor of MACE and significantly improved the incremental reclassification ability for MACE. Residual diffuse disease assessed by the D-index after IVUS-guided second-generation DES implantation can help to predict both VOCE and MACE, while far distal FFR can help to predict VOCE specifically.

Intravascular ultrasound guidance reduces cardiac death and coronary revascularization in patients undergoing drug-eluting stent implantation: results from a meta-analysis of 9 randomized trials and 4724 patients.

Intravascular ultrasound (IVUS) guidance is not routinely performed in real-word clinical practice partly because the benefit of IVUS guidance is not well established. This updated meta-analysis aims to compare IVUS-guided and angiography-guided drug-eluting stent (DES) implantation, simultaneously stressing the value of an optimal IVUS-defined procedure. Medline, Scopus, Google Scholar, and Cochrane Controlled Trials Registry were searched for the randomized trials comparing IVUS-guided and angiography-guided DES implantation. Nine eligible randomized trials including 4,724 patients were identified. At a mean follow-up of 16.7 months, IVUS guidance was associated with a significant lower risk of major adverse cardiovascular events (MACE) [5.4% vs. 9.0%; relative risks (RR): 0.61, 95% confident interval (CI) 0.49-0.74, p < 0.001], cardiac death (0.6% vs. 1.2%; RR: 0.49, 95% CI 0.26-0.92, p = 0.03), target vessel revascularization (3.5% vs .6.1%; RR: 0.58, 95% CI 0.42-0.80, p = 0.001), target lesion revascularization (3.1% vs. 5.2%; RR: 0.59, 95% CI 0.44-0.80, p = 0.001), and definite/probable stent thrombosis (0.5% vs .1.1%; RR: 0.45, 95% CI 0.23-0.87, p = 0.02) compared with angiography guidance. No significant differences in all cause death and myocardial infarction were noted between the two groups. Subgroup analysis showed that patients who met the optimal criteria had a lower rate of MACE than those with IVUS-defined suboptimal procedure (RR: 0.33, 95% CI 0.06-0.60, p = 0.02). The present meta-analysis with the largest sample size to date demonstrates that IVUS-guided DES implantation significantly reduces cardiac death, coronary revascularization and stent thrombosis, particularly for patients with IVUS-defined optimal procedures compared with angiography guidance.

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

Objective:Intravascular ultrasound (IVUS) is not routinely performed in the real-world practice, and the benefits of IVUS-guided drug-eluting stent (DES) implantation in patients with complex coronary lesions remains unclear. This updated meta-analysis attempts to evaluate the clinical outcomes of the IVUS guidance in these patients.Methods:We searched potential eligible citations from the PubMed, EMBASE, Medline, and other internet sources. The primary endpoint were major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). The risk of definite/probable stent thrombosis (ST) was chosen as the safety endpoint.Results:Nine randomized trials including a total of 3,612 patients with complex coronary lesions were finally analyzed. Compared to angiography guidance, IVUS-guided DES implantation was associated with significantly lower incidence of MACE [odds ratios (OR) 0.57, 95% confidence intervals (CI): 0.45–0.72, p<0.001; I2=0.0%, p=0.674], cardiac death (OR 0.42, 95%CI:0.21–0.82, p=0.010; I2=0.0%, p=0.961), MI (OR 0.65, 95%CI:0.44–0.95, p=0.027; I2=41.8%, p=0.089), TVR (OR 0.55, 95%CI:0.38–0.79, p=0.001; I2=0.0%, p=0.916), target lesion revascularization (TLR) (OR 0.58, 95%CI:0.41–0.82, p=0.002; I2=0.0%, p=0.888), and ST (OR 0.48, 95%CI:0.24–0.93, p=0.029; I2=0.0%, p=0.733).Conclusion:The updated meta-analysis demonstrates that DES implantation under IVUS guidance leads to a significant reduction in MACE, cardiac death, MI, TVR, TLR, and ST among patients with complex coronary lesions.

Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial

BackgroundIntravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation is associated with fewer major adverse cardiovascular events compared with angiography guidance for patients with individual lesion subset. However, the beneficial effect on major adverse cardiovascular event outcome of IVUS guidance over angiography guidance in all-comers who undergo DES implantation still remains understudied. ObjectivesThis study aimed to determine the benefits of IVUS guidance over angiography guidance during DES implantation in all-comer patients. MethodsA total of 1,448 all-comer patients who required DES implantation were randomly assigned (1:1 ratio) to either an IVUS guidance or angiography guidance group. The primary endpoint was target-vessel failure (TVF) at 12 months, including cardiac death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization (TVR). The procedure was defined as a success if all IVUS-defined optimal criteria were met. ResultsAt 12 months follow-up, 60 TVFs (4.2%) occurred, with 21 (2.9%) in the IVUS group and 39 (5.4%) in the angiography group (hazard ratio [HR]: 0.530; 95% confidence interval [CI]: 0.312 to 0.901; p = 0.019). In the IVUS group, TVF was recorded in 1.6% of patients with successful procedures, compared with 4.4% in patients who failed to achieve all optimal criteria (HR: 0.349; 95% CI: 0.135 to 0.898; p = 0.029). The significant reduction of clinically driven target-lesion revascularization or definite stent thrombosis (HR: 0.407; 95% CI: 0.188 to 0.880; p = 0.018) based on lesion-level analysis by IVUS guidance was not achieved when the patient-level analysis was performed. ConclusionsThe present study demonstrates that IVUS-guided DES implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions [ULTIMATE]; NCT02215915)

Meta-analysis and systematic review of intravascular ultrasound versus angiography-guided drug eluting stent implantation in left main coronary disease in 4592 patients

BackgroundAlthough several meta-analyses have demonstrated the utility of intravascular ultrasound (IVUS) in guiding drug-eluting stent (DES) implantation compared to angiography-guidance, there has been a dearth of evidence in the left main coronary artery (LMCA) lesion subset.MethodsWe performed a meta-analysis to compare clinical outcomes of IVUS versus conventional angiography guidance during implantation of DES for patients with LMCA disease. Pubmed, Cochrane Library, Embase were searched.ResultsA total of 1002 publications were reviewed; and finally, seven clinical studies - one prospective randomized controlled trial and six observational studies with 4592 patients (1907 IVUS-guided and 2685 angiography-guided) - were included in the meta-analysis. IVUS guidance was associated with a significant reduction in major adverse cardiac events (relative ratio [RR] 95% CI 0.61; 95% confidence interval [CI] 0.53 to 0.70; P < 0.001), all-cause death (RR 0.55; 95% CI 0.42 to 0.71; P < 0.001), cardiac death (RR 0.45; 95% CI 0.32 to 0.62; P < 0.001), myocardial infarction (RR 0.66; 95% CI 0.55 to 0.80; P < 0.001), and stent thrombosis (RR 0.48; 95% CI 0.27 to 0.84; P = 0.01) compared with angiographic guidance. However, there was no significant difference regarding target lesion revascularization (RR 0.60; 95% CI 0.31 to 1.18; P = 0.099) and target vessel revascularization (RR 0.64; 95% CI 0.26 to 1.56; P = 0. 322).ConclusionsCompared to angiographic guidance, IVUS-guided DES implantation was associated with better clinical outcomes for patients with LMCA lesions, especially hard endpoints of death, myocardial infarction, and stent thrombosis.

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

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 in drug-eluting stents implantation: a meta-analysis and trial sequential analysis of randomized controlled trials.

ObjectivePrevious evidence suggested that intravascular ultrasound (IVUS) guidance could improve outcomes after drug-eluting stents (DES) placement, largely driven by data from observational studies. We, therefore, performed a meta-analysis and trial sequential analysis of randomized controlled trials to overcome this limitation.ResultsThe retrieval process yielded 7 RCTs with 3,192 patients. Compared to the angiography guidance, IVUS-guided DES implantation was associated with a significant reduction in the major adverse cardiac events (MACE) (OR 0.60, 95% CI 0.46-0.78; P < 0.001), target vessel revascularization (OR 0.60, 95% CI 0.40-0.91; P = 0.02) and target lesion revascularization (OR 0.60, 95% CI 0.42-0.85; P = 0.004). IVUS and conventional angiography guidance showed similar incidence of stent thrombosis (ST) (OR 0.56, 95% CI 0.25-1.23; P = 0.15), cardiac death (OR 0.47, 95% CI 0.19-1.15; P = 0.10) and myocardial infarction (OR 0.85, 95% CI 0.45-1.61; P = 0.62). Trial sequential analysis revealed a definite reduction in MACE with IVUS guidance without solid evidence for ST.Materials and MethodsA systematical literature search was performed in the databases of PubMed, the Cochrane Library and ClinicalTrials.gov, complemented with reference screening from relevant articles. Primary endpoints were MACE and ST.ConclusionsIVUS-guided DES implantation is associated with a lower risk of MACE and revascularization without conclusive benefits for ST.

The outcomes of intravascular ultrasound-guided drug-eluting stent implantation among patients with complex coronary lesions: a comprehensive meta-analysis of 15 clinical trials and 8,084 patients.

Objective:The effects of intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation in patients with complex coronary artery lesions remains to be controversial. This study sought to evaluate the outcomes of IVUS guidance in these patients.Methods:The EMBASE, Medline, and other internet sources were searched for relevant articles. The primary endpoint was major adverse cardiac events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularization (TVR). The incidence of definite/probable stent thrombosis (ST) was analyzed as the safety endpoint.Results:Fifteen clinical trials involving 8.084 patients were analyzed. MACE risk was significantly decreased following IVUS-guided DES implantation compared with coronary angiography (CAG) guidance (odds ratio [OR] 0.63, 95% confidence intervals [CI]: 0.53–0.73, p<0.001), which might mainly result from the lower all-cause mortality risk (OR 0.52, 95% CI: 0.40–0.67, p<0.001), MI (OR 0.70, 95% CI: 0.56–0.86, p=0.001), and TVR (OR 0.53, 95% CI: 0.40–0.70, p<0.001). The subgroup analyses indicated better outcomes of IVUS guidance in DES implantation for these patients with left main disease or bifurcation lesions.Conclusion:IVUS guidance in DES implantation is associated with a significant reduction in MACE risk in patients with complex lesions, particularly those with left main disease or bifurcation lesions. More large and powerful randomized trials are still warranted to guide stenting decision making. (Anatol J Cardiol 2017; 17: 258-68)

Intravascular ultrasound-guided drug-eluting stent implantation

Intravascular ultrasound (IVUS) is a reliable imaging tool to guide percutaneous coronary intervention. There has been increasing evidence supporting the clinical utility of IVUS-guided drug-eluting stent (DES) implantation, including randomized trials, observational studies, and meta-analyses of both. IVUS provides cross-sectional views of the coronary artery wall, and allows us to assess stenosis severity, identify plaque morphology, optimize stent implantation, and understand mechanism of stent failure. IVUS guidance can increase DES efficacy and decrease clinical events. In this review article, we summarize available evidence on IVUS-guided DES implantation.

Effects of Intravascular Ultrasound-GuidedVersus Angiography-Guided New-Generation Drug-Eluting Stent Implantation: Meta-Analysis With Individual Patient-Level DataFrom2,345Randomized Patients.

The aim of this study was to evaluate the clinical usefulness of intravascular ultrasound (IVUS)-guided new-generation drug-eluting stent (DES) implantation using a meta-analysis of individual patient-level data from randomized trials. Published randomized trials that compare IVUS-guided versus angiography-guided new-generation DES implantation are scarce. Searches of the MEDLINE, Embase, and Cochrane databases were performed to find randomized trials that compared IVUS-guided versus angiography-guided new-generation DES implantation. A total of 2,345 patients from 3randomized trials were identified, and all patients were treated for long lesions or chronic total occlusions. Individual patient-level data were obtained. The primary endpoint was a major adverse cardiac event, a composite of cardiac death, myocardial infarction, or stent thrombosis. An intention-to-treat analysis and per protocol analysis were performed. By 1 year post-procedure, major adverse cardiac events had occurred in 0.4% of the patients who underwent IVUS-guided DES implantation versus 1.2% of those who underwent angiography-guided DES implantation (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.99; p= 0.040). For the IVUS-guided group, favorable clinical outcomes were observed for myocardial infarction (0% vs. 0.4%; HR: 0.09; p= 0.026). In addition, the clinical benefit of IVUS guidance was stronger in the per protocol analysis (HR: 0.32; 95% CI: 0.12 to 0.89; p= 0.021). Compared with angiographic guidance, IVUS-guided new-generation DES implantation was associated with favorable outcomes in terms of major adverse cardiac events, the composite of cardiac death, myocardial infarction, or stent thrombosis. These findings must be interpreted only for complex lesions, because all identified patients had long lesions or chronic total occlusions.

Ultrasound vs Angiography for Drug-Eluting Stent Implantation—Reply

In comparing the IVUS-guided with the angiography-guided strategy for drug-eluting stent optimization, different end points and methods of vessel diameter measurement were used, as noted by Dr Hoffer, due to the intrinsic difficulty in defining common optimization criteria for both groups. We think these differences are unlikely to explain the results. Previous studies, such as the Angiography Vs IVUS Optimization (AVIO) trial1 and a meta-analysis,2 also reported larger postintervention minimal lumen diameter and lesser residual stenosis with IVUS-guided drug-eluting stent implantation. However, in the AVIO trial, the greater minimal lumen diameter in the IVUS-guided group failed to lead to better clinical outcomes, unlike in our IVUS-XPL trial.

Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.

Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents. To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions. The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent ≥28 mm in length) between October 2010 and July 2014 at 20 centers in Korea. Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat. One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% [95% CI, -5.14% to -0.79%]) (hazard ratio [HR], 0.48 [95% CI, 0.28 to 0.83], P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 [95% CI, 0.14 to 2.52], P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32). Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization. clinicaltrials.gov Identifier: NCT01308281.

Rationale and design: Impact of intravascular ultrasound guidance on long-term clinical outcomes of everolimus-eluting stents in long coronary lesions

BackgroundAlthough the use of drug-eluting stents (DESs) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization, treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis. Intravascular ultrasound (IVUS) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention. However, it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes. HypothesisWe hypothesize that the long-term clinical outcomes of IVUS-guided DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions. Study designThis study is a randomized, prospective, multi-center trial comparing the long-term clinical outcomes of IVUS-guided and angiography-guided everolimus-eluting stent implantation in patients with long coronary lesions (implanted stent ≥28mm in length). The primary end point is a composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or target lesion revascularization at 1year following intervention. A total of 1,400 patients will be required to be enrolled according to sample size calculations. ConclusionThis study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance.

Intravascular Ultrasound-Guided Implantation of Drug-Eluting Stents to Improve Outcome: A Meta-Analysis

The aim of this study was to systematically review and perform a meta-analysis of randomized trials and observational studies of intravascular ultrasound (IVUS)-guided versus angiography-guided implantation of drug-eluting stents (DES). Although studies in the bare-metal stents era suggested that there were clinical benefits to IVUS guidance, it is still controversial whether percutaneous coronary intervention (PCI) with DES guided by IVUS leads to better clinical outcomes. Relevant studies published through March 31, 2013, were searched for and identified in the electronic databases. Summary estimates were obtained using a random-effects model. From 138 initial citations, 3 randomized trials and 12 observational studies with 24,849 patients (11,793 IVUS-guided and 13,056 angiography-guided) were included in this study. Comparison of IVUS- versus angiography-guided PCI disclosed odds ratios (ORs) for major adverse cardiac events of 0.79 (95% confidence interval [CI]: 0.69 to 0.91; p= 0.001). IVUS-guided PCI was also associated with significantly lower rates of all-cause mortality (OR: 0.64; 95% CI: 0.51 to 0.81; p< 0.001), myocardial infarction (OR: 0.57; 95% CI: 0.42 to 0.78; p < 0.001), target vessel revascularization (OR: 0.81; 95% CI: 0.68 to 0.95; p= 0.01), and stent thrombosis (OR: 0.59; 95% CI: 0.42 to 0.82; p= 0.002). Ameta-analysis of propensity-matched studies demonstrated similar results in terms of clinical outcomes, but not repeat revascularization. IVUS-guided DES implantation is associated with significantly lower rates of adverse clinical events compared with angiography guidance. Further study is needed to clarify which subgroups of subjects with IVUS guidance will have greater benefit.