Guidance Of Percutaneous Coronary Intervention Research Articles

Clinical outcomes with intravascular ultrasound guidance of percutaneous coronary interventions: a targeted literature review of randomized controlled trials

Clinical outcomes with intravascular ultrasound guidance of percutaneous coronary interventions: a targeted literature review of randomized controlled trials

Optical coherence tomography (OCT) - versus angiography-guided strategy for percutaneous coronary intervention: a meta-analysis of randomized trials

BackgroundOptical coherence tomography (OCT) guidance in percutaneous coronary intervention (PCI) has been shown to improve procedural outcomes. However, evidence supporting its superiority over angiography-guided PCI in terms of clinical outcomes is still emerging and limited. This study aimed to compare the efficacy and safety of OCT-guided PCI versus angiography‐guided PCI in patients with coronary artery disease (CAD).MethodsA systematic search of electronic databases was conducted to identify randomized control trials (RCTs) comparing the clinical outcomes of OCT-guided and angiography‐guided PCI in patients with CAD. Clinical endpoints including all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis and major adverse cardiac events (MACE) were assessed.ResultsEleven RCTs, comprising 2,699 patients in the OCT-guided group and 2,968 patients in the angiography-guided group met inclusion criteria. OCT-guided PCI was associated with significantly lower rates of cardiovascular death(RR 0.56; 95%CI: 0.32–0.98; p = 0.04; I2 = 0%), stent thrombosis(RR 0.56; 95%CI: 0.33–0.95; p = 0.03; I2 = 0%), and MACE (RR 0.79; 95%CI: 0.66–0.95; p = 0.01; I2 = 5%). The incidence of all-cause death (RR 0.71; 95%CI: 0.49–1.02; p = 0.06; I2 = 0%), myocardial infarction (RR 0.86; 95%CI: 0.67–1.10; p = 0.22; I2 = 0%) and TLR (RR 0.98; 95%CI: 0.73–1.33; p = 0.91; I2 = 0%) was non-significantly lower in the OCT-guided group.ConclusionsAmong patients undergoing PCI, OCT-guided PCI was associated with lower incidences of cardiovascular death, stent thrombosis and MACE compared to angiography-guided PCI.Trial registrationPROSPERO registration number: CRD42023484342.

Intracoronary imaging to guide percutaneous coronary intervention: from evidence to guidelines.

Despite notable advances in devices and techniques, percutaneous coronary intervention (PCI) is still affected by a substantial number of complications and failure rates. Over the years, the use of intracoronary imaging (ICI) has dramatically improved the understanding of mechanical and technical factors related to successful and failed PCI, becoming a mainstay in complex trans-catheter interventions. However, ICI modalities are invasive, time-consuming, and costly, and a net clinical benefit needs to be shown in order to recommend their routine use in clinical practice. In the past, the lack of evidence from randomized trials has been reflected in the scepticism shown by international guidelines. The recent publication of large randomized clinical trials conducted worldwide has provided new evidence regarding the clinical usefulness of ICI guidance in PCI. The consistent reduction of adverse events achieved in these trials, also demonstrated in an updated meta-analysis, suggested that the use of ICI in PCI is compelling to achieve optimal technical results and better outcomes, especially in complex high-risk interventions. Also considering the burden of information provided by ICI on coronary artery disease, looking from the inside seems today an opportunity that modern cardiology cannot ignore anymore.

Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies.

Intravascular Imaging in Patients With Complex Coronary Lesions and Chronic Kidney Disease

As patients with chronic kidney disease (CKD) are more likely to have complex coronary lesions, intravascular imaging guidance in percutaneous coronary intervention (PCI) for this population could be potentially beneficial. To investigate whether the outcomes of intravascular imaging-guided procedural optimization would be different according to the presence of CKD. This was a prespecified substudy of RENOVATE-COMPLEX-PCI, a recently published multicenter randomized clinical trial in Korea studying the benefits of intravascular imaging for complex coronary lesions. Patients with complex coronary lesions, with or without CKD, were enrolled between May 2018 and May 2021. Data were analyzed from January to June 2023. PCI in each group was done either under the guidance of intravascular imaging or angiography alone. The primary end point was target vessel failure (TVF) at the 3-year point, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. A total of 1639 patients (1300 male [79.3%]) treated with PCI for complex coronary lesions were stratified into CKD (296 participants) and non-CKD (1343 participants) groups. The mean (SD) age of each group was 70.3 (9.4) and 64.5 (10.1) years, and mean (SD) estimated serum creatinine was 2.9 (5.3) and 0.8 (0.2) mg/dL for CKD and non-CKD groups, respectively. Intravascular imaging-guided revascularization was associated with significantly lower incidence of the primary end point compared with angiography-guided revascularization in both CKD (13.3% vs 23.3%; hazard ratio [HR], 0.51; 95% CI, 0.27-0.93; P = .03) and non-CKD (6.4% vs 9.9%; HR, 0.66; 95% CI, 0.44-0.99; P = .05) groups. The significantly lower incidence of the primary end point was mainly associated with the lower risk of cardiac death or target vessel-related myocardial infarction (9.4% vs 22.2%; HR, 0.39; 95% CI, 0.20-0.76; P = .006) in the CKD group and by target vessel revascularization (3.0% vs 5.5%; HR, 0.55; 95% CI, 0.30-0.99; P = .05) in the non-CKD group. Those with a glomerular filtration rate of at least 30 mL/min/1.73m2 and less than 60 ml/kg/1.73m2 showed the greatest benefit from imaging-guided complex PCI (8.8% vs 21.2%; HR, 0.28; 95% CI, 0.11-0.68; P = .02). In this prespecified cohort substudy of the Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention trial, intravascular imaging guidance showed clinical benefit over angiography guidance in reducing the risk of TVF, regardless of the presence of CKD. The greatest benefits of imaging-guided complex PCI were observed in stage 3 CKD. ClinicalTrials.gov Identifier: NCT03381872.

Remote guidance of percutaneous coronary intervention: A pilot study.

The safety and effectiveness of remote guidance of percutaneous coronary interventions (PCI) have not been fully appraised in controlled studies. We hereby presented the results of a study on remote guidance (vs on-site guidance) of PCI to explore its feasibility, safety, and effectiveness. Patients were recruited from those who received PCI procedures from January 2018 to June 2019 in a secondary hospital (Jincheng, Shanxi, China), in collaboration with a tertiary medical center (Beijing, China) approximately 680 km away. According to the type of guidance during the procedure, the patients were assigned to two groups: the remote guidance group and the on-site guidance group. Remote guidance was assisted with an advanced commercial telemedicine system. Interventional strategies, procedural success rate, peri-procedural complications, procedural duration, radiation doses, and the amount of contrast medium were compared between the two groups. A total of 352 patients were included in this study, with a total of 411 PCI procedures and 446 target lesions. The baseline clinical characteristics, as well as the distribution and characteristics of coronary artery lesions, did not differ significantly between the two groups. No significant differences were noticed in procedural success rate, peri-procedural complications, procedural duration, radiation dose, and in-hospital major adverse cardiovascular events. However, the amount of contrast medium was slightly higher in the remote guidance group. The results of the present pilot study showed the feasibility of remotely guided PCI, with safety and effectiveness measures at acceptable levels comparable to the traditional on-site guidance. Randomized studies with long-term follow-up are warranted to further confirm our findings.

Outcomes With Intravascular Ultrasound and Optical Coherence Tomography Guidance in Percutaneous Coronary Intervention

Intracoronary imaging has become an important tool in the treatment of complex lesions with percutaneous coronary intervention (PCI). This retrospective cohort study identified 1,118,475 patients with PCI from the Nationwide Readmissions Database from 2017 to 2019. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were identified with appropriate International Classification of Diseases, Tenth Revision codes. The primary outcome was major adverse cardiac events. The secondary outcomes include net adverse clinical events (NACEs), all-cause mortality, myocardial infarction (MI) readmission, admission for stroke, and emergency revascularization. The multivariate Cox proportional hazard regression was used to adjust for demographic and co-morbid confounders. Of 1,118,475 PCIs, 86,140 (7.7%) used IVUS guidance and 5,617 (0.5%) used OCT guidance. The median follow-up time was 184days. The primary outcome of major adverse cardiac events was significantly lower for the IVUS (6.5% vs 7.6%; hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.86 to 0.91, p <0.001) and OCT (4.4% vs 7.6%; HR 0.69, 95% CI 0.61 to 0.79, p <0.001) groups. IVUS was associated with significantly lower rates of NACEs (8.4% vs 9.4%; HR 0.92, 95% CI 0.89 to 0.94, p <0.001), all-cause mortality (3.5% vs 4.3%; HR 0.85, 95% CI 0.82 to 0.88, p <0.001), readmission for MI (2.7% vs 3.0%; HR 0.95, 95% CI 0.91 to 0.99, p=0.012), and admission for stroke (0.5% vs 0.6%; HR 0.86, 95% CI 0.78 to 0.95, p=0.002). OCT was associated with significantly lower rates of NACEs (6.6% vs 9.4%; HR 0.81, 95% CI 0.73 to 0.89, p <0.001) and all-cause mortality (1.8% vs 4.3%; HR 0.51, 95% CI 0.42 to 0.63, p <0.001). Emergency revascularization was not significantly different with IVUS guidance. Readmission for MI, stroke, and emergency revascularization were not significantly different with OCT guidance. A subgroup analysis of patients with ST-elevation MI and non-ST-elevation MI showed similar results. In conclusion, the use of IVUS and OCT guidance with PCI were associated with significantly lower rates of morbidity and mortality in real-world practice.

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

BackgroundImaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.MethodsWe conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.ResultsWe assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.ConclusionsAmong patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)

Applied coronary physiology for planning and guidance of percutaneous coronary interventions. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology.

The clinical value of fractional flow reserve and non-hyperaemic pressure ratios are well established in determining an indication for percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD). In addition, over the last 5 years we have witnessed a shift towards the use of physiology to enhance procedural planning, assess post-PCI functional results, and guide PCI optimisation. In this regard, clinical studies have reported compelling data supporting the use of longitudinal vessel analysis, obtained with pressure guidewire pullbacks, to better understand how obstructive CAD contributes to myocardial ischaemia, to establish the likelihood of functionally successful PCI, to identify the presence and location of residual flow-limiting stenoses and to predict long-term outcomes. The introduction of new functional coronary angiography tools, which merge angiographic information with fluid dynamic equations to deliver information equivalent to intracoronary pressure measurements, are now available and potentially also applicable to these endeavours. Furthermore, the ability of longitudinal vessel analysis to predict the functional results of stenting has played an integral role in the evolving field of simulated PCI. Nevertheless, it is important to have an awareness of the value and challenges of physiology-guided PCI in specific clinical and anatomical contexts. The main aim of this European Association of Percutaneous Cardiovascular Interventions clinical consensus statement is to offer up-to-date evidence and expert opinion on the use of applied coronary physiology for procedural PCI planning, disease pattern recognition and post-PCI optimisation.

Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging

BackgroundPatients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging. MethodsThe Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups. ResultsAmong the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar. ConclusionDespite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653). Non-standard abbreviations and acronymsBARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy.

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry

BackgroundOptical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. MethodsThis multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm2 MSA for non-left main and 3.5 mm2 for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. ResultsFive hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm2) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm2). The average MSA (with expansion ≥80% cutoff) was 6.63 mm2 and 4.74 mm2 with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm2 and 3.95 mm2, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. ConclusionPCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

Ultrassonografia intravascular para guiar a intervenção coronária percutânea: resultados do registro nacional português

Introdução: As diretrizes atuais recomendam o uso da ultrassonografia intravascular de coronárias como ferramenta adjuvante em situações difíceis. Objetivo: Caracterizar a utilização da ultrassonografia intravascular em Portugal e comparar os desfechos após intervenção coronária percutânea no tronco da coronária esquerda, guiada ou não por ultrassonografia intravascular. Métodos: Estudo observacional retrospectivo multicêntrico, que analisou pacientes submetidos à intervenção coronária percutânea entre janeiro de 2012 e dezembro de 2018, incluídos no Portuguese Registry on Interventional Cardiology da Sociedade Portuguesa de Cardiologia. Valor de p bicaudal &lt;0,05 foi considerado estatisticamente significativo. Resultados: Este estudo demonstrou variação significativa na utilização da ultrassonografia intravascular em Portugal (valor de p qui-quadrado para tendência &lt;0,001). O ano com maior utilização foi 2016 (2,4%). Houve aumento progressivo, nos últimos 7 anos, na utilização da ultrassonografia intravascular na intervenção coronária percutânea do tronco da coronária esquerda (valor de p qui-quadrado para tendência &lt;0,001), com importantes diferenças regionais. A população submetida à intervenção coronária percutânea do tronco da coronária esquerda guiada por ultrassonografia intravascular era mais jovem, mas tinha maior prevalência de fatores de risco cardiovascular, disfunção sistólica ventricular e lesões coronárias complexas. Além disso, esse grupo de pacientes teve menor prevalência do desfecho primário intra-hospitalar (1,4% versus 3,9%; p=0,024). Porém, após análise multivariada ajustada para fatores de confusão, este estudo não demonstrou impacto significativo da utilização da ultrassonografia intravascular no desfecho intra-hospitalar. Conclusão: A utilização da ultrassonografia intravascular na intervenção coronária percutânea do tronco da coronária esquerda vem aumentando lentamente nos últimos 7 anos em Portugal. Neste estudo, a utilização desse método não teve impacto estatístico nos desfechos intra-hospitalares.

Prior skeleton based online deep reinforcement learning for coronary artery centerline extraction.

Coronary centerline extraction is an essential technique for X-ray coronary angiography (XCA) image analysis, which provides qualitative and quantitative guidance for percutaneous coronary intervention (PCI). In this paper, an online deep reinforcement learning method for coronary centerline extraction is proposed based on the prior vascular skeleton. Firstly, with XCA image preprocessing (foreground extraction and vessel segmentation) results, the improved ZhangSuen image thinning algorithm is used to rapidly extract the preliminary vascular skeleton network. On this basis, according to the spatial-temporal and morphological continuity of the angiography image sequence, the connectivity of different branches is determined using k-means clustering, and the vessel segments are then grouped, screened, and reconnected to obtain the aorta and its major branches. Finally, using the previous results as prior information, an online Deep Q-Network (DQN) reinforcement learning method is proposed to optimize each branch simultaneously. It comprehensively considers grayscale intensity and eigenvector continuity to achieve the combination of data-driven and model-driven without pre-training. Experimental results on clinical images and the third-party dataset demonstrate that the proposed method can accurately extract, restructure, and optimize the centerline of XCA images with a higher overall accuracy than the existing state-of-the-art methods.

Coronary Physiology: Modern Concepts for the Guidance of Percutaneous Coronary Interventions and Medical Therapy.

Recent evidence on ischemia, rather than coronary artery disease (CAD), representing a major determinant of outcomes, has led to a progressive shift in the management of patients with ischemic heart disease. According to most recent guidelines, myocardial revascularization strategies based on anatomical findings should be progressively abandoned in favor of functional criteria for the guidance of PCI. Thus, emerging importance has been assigned to the assessment of coronary physiology in order to determine the ischemic significance of coronary stenoses. However, despite several indexes and tools that have been developed so far, the existence of technical and clinical conditions potentially biasing the functional evaluation of the coronary tree still cause debates regarding the strategy of choice. The present review provides an overview of the available methods and the most recent acquirements for the invasive assessment of ischemia, focusing on the most widely available indexes, fractional flow reserve (FFR) and instant-wave free ratio (iFR), in addition to emerging examples, as new approaches to coronary flow reserve (CFR) and microvascular resistance, aiming at promoting the knowledge and application of those "full physiology" principles, which are generally advocated to allow a tailored treatment and the achievement of the largest prognostic benefits.

Abstract 9349: Procedural Characteristics of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention and Their Clinical Implications

Introduction: Despite the clinical benefits to intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI), most patients with coronary artery disease undergo angiography-guided PCI alone in real world. Hypothesis: We sought to investigate the procedural characteristics of IVUS-guided PCI and their clinical outcomes, as compared with angiography-guided PCI. Methods: This was a cohort study using patient-level data from IVUS-XPL and ULTIMATE clinical trials. A total of 2,848 patients with 3,872 native coronary lesions were included and procedural characteristics assessed by quantitative coronary angiography (QCA) were compared between IVUS and angiography guidance. Results: Stent-to-reference vessel diameter ratio (i.e., QCA stent sizing) was greater (1.11±0.16 vs 1.07±0.14, p&lt;0.001) and high-pressure post-dilation was more frequently performed (83.7% vs 75.4%, p&lt;0.001) with IVUS guidance, whereas residual stent edge dissections were more frequent in lesions treated with IVUS guidance (4.6% vs 0.7%, p&lt;0.001). Given the dissection risk, optimal QCA stent sizing for IVUS guidance was a stent-to-QCA reference vessel diameter ratio ≥1.1 to &lt;1.3. Among 1,424 patients (1,969 lesions) treated with angiography guidance, QCA stent sizing &lt;1.0 was observed in 651 (33.1%) lesions while QCA stent sizing ≥1.1 to &lt;1.3 was observed in only 526 (26.7%) lesions. Under angiography guidance, patients with both QCA stent sizing ≥1.1 to &lt;1.3 and high-pressure post-dilation (235/1,424, 16.5%) had a lower risk of 3-year target lesion failure compared with others (hazard ratio=0.532, 95% confidence interval=0.293-0.966, p=0.038). Conclusions: IVUS-guided PCI resulted in larger QCA-assessed stent sizing and more frequent post-dilation with high-pressure inflations. These procedures may further improve long-term clinical outcomes in patients undergoing PCI without IVUS.

PCI Deferral Based on Fractional Flow Reserve or Optical Coherence Tomography: Two-Year Results of the Forza Trial

Backgroud: The “FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty” (FORZA) trial showed that in patients with angiographically intermediate coronary lesions (AICLs), optical coherence tomography (OCT) guidance of percutaneous coronary intervention (PCI) reduced the occurrence of the composite endpoint of major adverse cardiac events (MACE) or significant angina at 13 months, while fractional flow reserve (FFR) guidance was associated with a higher rate of medical management and with lower costs. Safety of PCI deferral when FFR &gt;0.80 is known, while data on clinical outcomes using an OCT guidance are lacking. We assessed the safety of PCI deferral based on OCT findings. Methods: This is a subgroups analysis of the FORZA Trial focusing on the clinical outcome of patients in whom PCI was originally deferred. In details, patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was deferred if FFR was &gt;0.80 while in the OCT arm in the absence of any of the following conditions: area stenosis &gt;75%, or 50% to 75% with minimum lumen area &lt;2.5 mm2 or plaque rupture. Angina status (evaluated using the Seattle Angina Questionnaire, SAQ), MACE (death, myocardial infarction, target vessel revascularization) and rate of patients treated with optimal medical therapy alone were assessed at 24 months. Results: From a total of 350 patients with 446 AICLs enrolled in the trial (176 randomized to FFR and 174 to OCT), based on the predefined FFR and OCT criteria, PCI was deferred in 119 patients (67.6%) in the FFR arm, and in 82 patients (47.1%) in the OCT arm. At 24-months follow-up, significant residual angina (defined as a value &lt;90 on the angina frequency scale) was observed in 6 patients (5.0%) in the FFR arm, and in 6 patients (7.3%) in the OCT arm (p = 0.55). Rate of MACE was 10.9% in the FFR arm and 6.1% in the OCT arm (p = 0.32). The number of patients managed by optimal medical therapy alone was still significantly higher using FFR than OCT guidance also at 24 months (60.2% vs 44.2%, p = 0.0038). Conclusions: PCI-deferral based on OCT (using the FORZA trial criteria) is safe and associated with numerically less events at 24-months follow up. FFR guidance is still associated with a higher number of patients managed by optimal medical therapy alone.

Intravascular imaging for left main stem assessment: An update on the most recent clinical data.

Left main (LM) stem has different structural and anatomical characteristics compared to all of the other segments of the coronary tree, thus its management through percutaneous coronary intervention (PCI) is a challenge and is associated with worse clinical outcome and higher need for revascularization as compared to other lesion settings. Intravascular imaging, by means of intravascular ultrasound (IVUS) or optical coherence tomography (OCT), is an important tool for LM PCI guidance, aiming at improving the immediate performance and the long term outcome of this procedure. Following current guidelines and recent scientific findings, IVUS becomes important to firstly assess, and finally evaluate the result of LM stenting, according to the experience and preferences of the operator. The role of OCT still remains to be defined, but recent data is shedding light also on this imaging technique. The aim of this review is to highlight the latest scientific advancements regarding intravascular imaging in LM coronary artery disease.

Comparison of Six Different Percutaneous Coronary Intervention Guidance Modalities.

Background: New randomized trials and modalities in guiding percutaneous coronary intervention (PCI) have become available. Objective: We aimed to compare the clinical outcomes of coronary angiography (CAG), intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and optical frequency domain imaging (OFDI)-guided PCI. Methods: A network meta-analysis was performed to compare different PCI guidance modalities. The clinical outcomes included major adverse cardiovascular events (MACE), all-cause death, myocardial infarction (MI), and target vessel/lesion revascularization (TVR/TLR). Odds ratio (OR) and corresponding 95% credible interval (CrI) were calculated. Results: Thirty-six randomized trials, including 19,042 patients, were included. In comparison with CAG, IVUS significantly reduced MACE (OR: 0.71; 95% CrI: 0.57 to 0.86) and TVR/TLR (OR: 0.53; 95% CrI: 0.43 to 0.66). MACE (OR: 1.44; 95% CrI: 1.02 to 2.08) and TVR/TLR (OR: 1.87; 95% CrI: 1.04 to 3.71) were significantly increased in the FFR group, compared with IVUS group. There were no significant differences in MACE or TVR/TLR among the left guidance modality comparisons. Differences in all-cause death or MI were not observed in any comparisons. Conclusions: IVUS could reduce MACE and TVR/TLR, compared with CAG or FFR. Therefore, IVUS may be the optimal modality in guiding PCI.

2-Year Outcomes of Angiographic Quantitative Flow Ratio-Guided Coronary Interventions

BackgroundIn the multicenter, randomized, sham-controlled FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, quantitative flow ratio (QFR)–based lesion selection improved 1-year clinical outcomes compared with conventional angiographic guidance for percutaneous coronary intervention (PCI). ObjectivesThe purpose of this study was to determine whether the benefits of QFR guidance persist at 2 years, particularly for patients in whom QFR changed the revascularization strategy. MethodsEligible patients were randomized to a QFR-guided strategy (PCI performed only if QFR ≤0.80) or a standard angiography-guided strategy. Major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization occurring within 2 years were analyzed in the intention-to-treat population. ResultsAmong 3,825 randomized participants, 2-year MACE occurred in 161 of 1,913 (8.5%) patients in the QFR-guided group and in 237 of 1,912 (12.5%) patients in the angiography-guided group (HR: 0.66; 95% CI: 0.54-0.81; P < 0.0001), driven by fewer MIs (4.0% vs 6.8%; HR: 0.58; 95% CI: 0.44-0.77; P = 0.0002) and ischemia-driven revascularizations (4.2% vs 5.8%; HR: 0.71; 95% CI: 0.53-0.95; P = 0.02) in the QFR-guided group. Landmark analysis showed consistent results within the first year and between 1-2 years (Pint = 0.99). Although the 2-year MACE rate was lower in the QFR-guided group in both patients with and without revascularization strategy changes, the extent of outcome improvement was greater (Pint = 0.009) among those patients in whom the preplanned PCI strategy was modified by QFR. ConclusionsQFR-guided lesion selection improved 2-year clinical outcomes compared with standard angiography guidance. The benefits were most pronounced among patients in whom QFR assessment altered the planned revascularization strategy. (FAVOR III China Study [The Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease] NCT03656848)

Procedural Characteristics of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention and Their Clinical Implications.

Background Despite the clinical benefits to intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI), most patients with coronary artery disease undergo angiography-guided PCI alone in the real-world setting. We sought to investigate the procedural characteristics of IVUS-guided PCI and their clinical outcomes, as compared with angiography-guided PCI. Methods and Results This was a cohort study using patient-level data from the 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) clinical trials. A total of 2848 patients with 3872 native coronary lesions were included and procedural characteristics assessed by quantitative coronary angiography (QCA) were compared between IVUS and angiography guidance. Stent-to-reference vessel diameter ratio (ie, QCA stent sizing) was greater (1.11±0.16 versus 1.07±0.14, P<0.001) and high-pressure postdilation was more frequently performed (83.7% versus 75.4%, P<0.001) with IVUS guidance, whereas residual stent edge dissections were more frequent in lesions treated with IVUS guidance (4.6% versus 0.7%, P<0.001). Given the dissection risk, optimal QCA stent sizing for IVUS guidance was a stent-to-QCA reference vessel diameter ratio ≥1.1 to <1.3. Among 1424 patients (1969 lesions) treated with angiography guidance, QCA stent sizing <1.0 was observed in 651 (33.1%) lesions, while QCA stent sizing ≥1.1 to <1.3 was observed in only 526 (26.7%) lesions. Under angiography guidance, patients with both QCA stent sizing ≥1.1 to <1.3 and high-pressure postdilation (235 of 1424, 16.5%) had a lower risk of 3-year target lesion failure compared with others (hazard ratio, 0.532; 95% CI, 0.293-0.966 [P=0.038]). Conclusions IVUS-guided PCI resulted in larger QCA-assessed stent sizing and more frequent postdilation with high-pressure inflations. These procedures may further improve long-term clinical outcomes in patients undergoing PCI without IVUS. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01308281 (IVUS-XPL); NCT02215915 (ULTIMATE).