Intravascular Imaging–Guided or Angiography-Guided Complex PCI

Impact of Intravascular Imaging-Guided Stent Optimization According to Clinical Presentation in Patients Undergoing Complex PCI

Key Points• This investigator-initiated, industry-funded, prospective, multicentre, randomized, open-label trial aimed to test the superiority of intravascular imaging-guided percutaneous coronary intervention (PCI) over angiography-guided PCI in patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) undergoing percutaneous treatment of complex coronary artery lesions.Complex coronary artery lesions were defined as: true bifurcation lesions, chronic total occlusions, unprotected left main disease, long lesions, multi-vessel disease, lesions requiring three or more stents, in-stent restenosis, severely calcified lesions, or ostial lesions of major epicardial vessels. 1 • The primary endpoint was target vessel failure (TVF), defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR).Secondary endpoints included the individual components of the primary endpoint, TVF without procedure-related MI, a composite of target vessel MI or cardiac death, and definite stent thrombosis (ST).• A total of 1639 patients with complex coronary artery lesions (mean age, 66 years; 21% female; 51% ACS) were enrolled from May 2018through May 2021 at 20 sites in South Korea and were randomized in a 2:1 ratio to undergo intravascular imaging-guided PCI (n = 1092) or angiography-guided PCI (n = 547).Randomization was stratified based on clinical presentation and participating centre.The choice of intravascular ultrasound (IVUS) or OCT was left at the operators' discretion, and imaging could be used at any time during the PCI procedure but was mandated after stent implantation to guide optimization.Intravascular imaging was performed with IVUS in ∼75% of cases and with OCT in the remaining cases.PCI was performed with the use of standard techniques for coronary lesion preparation and with implantation of everolimus-eluting stents.Clinical follow-up was conducted at 1 month, 6 months, and 12 months and yearly thereafter.• Median follow-up was 2.1 years.The incidence of the primary endpoint was significantly lower in the intravascular imaging-guided PCI group than in the angiography-guided PCI group [cumulative incidence at 3 years, 7.7% vs. 12.3%; hazard ratio (HR), 0.64; 95% confidence interval (CI), 0.45-0.89;P = 0.008].After excluding procedure-related MI events, the incidence of TVF remained lower in the intravascular imaging-guided PCI group than in the angiography-guided PCI group (cumulative incidence, 5.1% vs. 8.7%; HR, 0.59; 95% CI, 0.39-0.90).• The cumulative incidence of cardiac death was lower in the intravascular imaging-guided PCI group than in the angiography-guided PCI group (1.7% vs. 3.8%, HR, 0.47, 95% CI 0.24-0.93),as well as that of TVR (3.4% vs. 5.5%; HR, 0.69; 95% CI, 0.40-1.18)and of the composite endpoint of target-vessel MI or cardiac death (5.3% vs. 8.5%; HR, 0.63; 95% CI, 0.42-0.93).The incidence of definite ST was low (0.3%) in the overall trial population, with a statistically uncertain difference between the two groups (0.1% vs. 0.7%; HR, 0.25; 95% CI, 0.02-2.75).No differences in the incidence of procedure-related safety events (e.g.peri-procedural MI, contrast-induced nephropathy) were observed between the two groups.

Percutaneous coronary intervention (PCI) is increasingly used for revascularization of unprotected left main coronary artery disease. Whether intravascular ultrasonographic (IVUS) guidance during PCI results in better clinical outcomes than conventional angiographic guidance alone is uncertain. In an international, multicenter, open-label trial, we randomly assigned patients with unprotected left main coronary artery disease in a 1:1 ratio to undergo either IVUS-guided PCI or angiography-guided PCI. The primary end point was a patient-oriented composite of any stroke, any myocardial infarction, any revascularization, or death from any cause at the longest follow-up. A total of 806 patients underwent randomization; 401 were assigned to undergo IVUS-guided PCI and 405 to undergo angiography-guided PCI. The mean (±SD) age of the patients was 71.4±10.7 years, 78.4% of the patients were men, and 34.7% had diabetes. At a median follow-up of 2.9 years, a primary end-point event had occurred in 135 patients (33.7%) in the IVUS-guided PCI group and in 125 patients (30.9%) in the angiography-guided PCI group (hazard ratio, 1.11; 95% confidence interval, 0.87 to 1.42; P = 0.40). The incidence of death, myocardial infarction, or revascularization appeared to be similar in the two groups. The percentages of patients with procedure-related and overall safety events also appeared to be similar in the two groups. Among patients with unprotected left main coronary artery disease, IVUS-guided PCI showed no additional benefit over angiography-guided PCI with respect to the incidence of stroke, myocardial infarction, any revascularization, or death from any cause at a median follow-up of 2.9 years. (Funded by Philips Image Guided Therapy Devices and Boston Scientific; OPTIMAL ClinicalTrials.gov number, NCT04111770.).

The recurrences of acute coronary syndrome (ACS) and target vessel failure after percutaneous coronary intervention (PCI) remain clinical concerns. Intravascular imaging, such as optical coherence tomography (OCT) or intravascular ultrasound (IVUS), has demonstrated clinical benefits in patients with stable coronary disease; however, the benefits of its use remains unclear in patients with ACS. This study aimed to investigate the benefit of imaging-guided PCI in patients with ACS on the recurrence of ACS using a nationwide database in Japan. This retrospective observational study used records from the National Database between April 2014 and March 2021. We included patients hospitalised with ACS aged ≥20 years who had undergone first-time PCI and divided them into imaging-guided PCI (OCT or IVUS) and angiography-guided PCI groups. The primary outcome was ACS recurrence during a 3-year follow-up period. We analysed the association between intravascular imaging and the outcome using inverse probability of treatment weighting. Among the patients with ACS, angiography-guided PCI, OCT-guided PCI, and IVUS-guided PCI were performed in 32,044, 22,748, and 297,944 patients, respectively. During the study period, both OCT- and IVUS-guided PCI rates increased, from 4.7% to 6.9% and from 77.0% to 87.9%, respectively. OCT-guided PCI was associated with a lower risk of ACS recurrence (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.71-0.91; p<0.001); IVUS-guided PCI was also associated with a lower risk of ACS recurrence (HR 0.76, 95% CI: 0.71-0.82; p<0.001). In real-world clinical practice, the rates of both OCT- and IVUS-guided PCI have increased and have been associated with a lower risk of ACS recurrence compared with angiography-guided PCI in patients with ACS.

Although multiple randomized clinical trials (RCTs) have shown that intravascular imaging (IVI)-guided percutaneous coronary intervention (PCI) is associated with improved clinical outcomes compared with angiography-guided PCI, its benefits specifically in calcified coronary lesions is unclear due to the small number of patients included in individual trials. We performed a meta-analysis of RCTs to investigate benefits of IVI-guided PCI compared with angiography-guided PCI in heavily calcified coronary lesions. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, target-vessel or target-lesion myocardial infarction, and target-vessel or target lesion revascularization. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated by using a random-effects meta-analysis based on the restricted maximum likelihood method. A search PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified 4 trials that randomized 1319 patients with angiographically moderate or severe or severe coronary calcification to IVI-guided (n = 702) vs. angiography-guided PCI (n = 617). IVI-guided PCI resulted in a significantly lower odds of MACE (OR 0.57, 95% CI 0.40-0.80) compared with angiography-guided PCI at a weighted median follow-up duration of 27.3 months. There was no evidence of heterogeneity among the studies (I2 = 0.0%), and included trials were judged to be low risk of bias. Compared with angiography-guided PCI, IVI-guided PCI was associated with a significantly lower MACE in angiographically heavily calcified coronary lesions.

Intravascular Imaging-guided Percutaneous Coronary Intervention in Patients With and Without Diabetes: A Meta-analysis of Randomized Trials.

Intravascular imaging-guided percutaneous coronary intervention for acute myocardial infarction according to ACC/AHA lesion classification.

Previous studies have demonstrated that use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) was associated with lower incidence of death, myocardial infarction, and target vessel revascularization. Recently, optical coherence tomography (OCT) has emerged as an alternative intravascular imaging device with better resolution. The aim of this study was to investigate frequency and prognostic impact of IVUS or OCT-guided PCI during urgent revascularization for acute myocardial infarction diagnosed by the universal definition. A total of 2788 patients who underwent urgent PCI were selected from a multicenter, Japanese registry of acute myocardial infarction diagnosed by universal definition (J-MINUET). Frequency, clinical characteristics and prognostic impact of the IVUS-, or OCT- guided PCI were investigated. Clinical endpoint was in-hospital death. Angiography-, IVUS-, and OCT-guided urgent PCI were performed in 689 (24.7%), 1947 (69.8%), and 152 (5.5%) patients. In-hospital death in each group was 10.4%, 5.1%, and 3.3%, respectively (P < 0.01). By univariate and multivariate logistic regression analysis, IVUS-guided PCI (vs. angiography-guided PCI, OR 0.49, 95% CI 0.30-0.81, P = 0.006) was a significant independent predictor of in-hospital death. Intravascular imaging guided-PCI was frequently adopted during urgent PCI for acute myocardial infarction diagnosed by universal definition and was associated with better in-hospital survival.

Background Intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) has potential benefits. This meta-analysis aimed to explore whether IVUS-guided PCI had better short- and long-term prognoses than angiography-guided PCI. Methods We retrieved studies from PubMed, Embase, and Cochrane Library. Clinical trials including retrospective and randomized controlled trials (RCTs) that compared IVUS-guided PCI with angiography-guided PCI were included. The patients were followed up after operation at 30 days, 1 year, 2 years, and 3 years. The clinical outcomes were target lesion revascularization (TLR), target vessel revascularization (TVR), and MACEs, including stent thrombosis (ST), myocardial infarction (MI), cardiac death, and all-cause death. The study population included patients with MI, coronary bifurcation lesions, short or long lesions, and unprotected left main coronary artery stenosis (ULMCA). The quality of retrospective trials was evaluated using the Newcastle–Ottawa Scale, and the quality of randomized controlled trials was evaluated using the Jadad score. A total of 20 clinical trials met the criteria. Three trials were randomized controlled trials, while 17 were retrospective trials. Results A total of 24,783 patients were included. In observational trials, the OR of MACEs was 0.49 (95% CI: 0.38–0.62) in 30 days, 0.65 (95% CI: 0.58–0.73) in one year, 0.51 (95% CI: 0.36–0.71) in two years, and 0.45 (95% CI: 0.31–0.65) in three years. In patients with long coronary lesions, the OR of MACEs in 1 year was 0.64 (95% CI: 0.28–1.50). In patients with left main artery disease, the OR of MACEs in 3 years was 0.42 (95% CI: 0.26–0.67). Compared with angiography-guided PCI, IVUS-guided PCI was associated with a lower incidence of MACEs during the same following period. Conclusion Compared with angiography-guided PCI, IVUS-guided PCI has better performance in reducing the occurrence of MACEs.

Editorial: Rotational Atherectomy Followed by Drug-Coated Balloons in Calcified Coronary De Novo Lesions – An Alternative to Stent Implantation?

Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention: Outcomes From the Pan-London PCI Cohort

The prognosis of unrevascularized non-culprit lesions (NCLs) and the benefits of non-culprit percutaneous coronary intervention (PCI) may depend on their functional significance and location in patients with acute myocardial infarction (AMI) and multivessel coronary disease (MVD). We investigated the differential outcomes of fractional flow reserve (FFR) versus angiography-guided PCI for NCL between the left anterior descending artery (LAD) and non-LAD arteries. This was a prespecified post hoc analysis of the FRAME-AMI trial. The primary endpoint, a composite of time to death, myocardial infarction, or repeat revascularization, was matched between the two strategies according to the NCL location. Among 562 patients, the proportions of NCL in the LAD and non-LAD groups were 55.0% and 45.0%, respectively. PCI rates (82.2% vs. 78.3%; p=0.242) and the primary outcome (9.4% vs. 11.5%; p=0.421) were comparable between the two groups. In the non-culprit LAD group, FFR-guided PCI was associated with a lower rate of the primary outcome compared to angiography-guided PCI (5.7% vs. 14.3%, p=0.010). In the non-culprit non-LAD group, the outcome rate did not significantly differ between FFR- and angiography-guided PCI (7.4% vs. 14.5%, p=0.081). Nevertheless, the interaction between the non-culprit location and FFR- or angiography-guided PCI did not affect the primary outcome (p=0.667). The NCL location did not affect the favorable outcomes of FFR-guided PCI over angiography-guided PCI in patients with AMI and MVD.

Background Complete revascularization either angiography-guided or fractional flow reserve (FFR)-guided can improve the clinical outcomes in patients with acute myocardial infarction (AMI) and multivessel disease. However, there is concern that angiography-guided percutaneous coronary intervention (PCI) may result in unnecessary PCI of non-infarct related artery (IRA) and its long-term prognosis is still unclear. Purpose We sought to evaluate clinical outcomes after non-IRA PCI according to quantitative flow ratio (QFR). Methods We performed post-hoc QFR analysis of non-IRA lesions of AMI patients who enrolled in the FRAME-AMI trial which randomly allocated patients into either FFR-guided PCI (FFR≤0.80) or angiography-guided PCI (diameter stenosis of &amp;gt;50%) for non-IRA lesions. Patients were classified by non-IRA QFR values into the QFR≤0.80 and QFR&amp;gt;0.80 groups. The primary end point was a major adverse cardiac event (MACE), a composite of cardiac death, MI, and repeat revascularization. Results A total of 443 patients (552 lesions) were eligible for the QFR analysis. Of 209 patients in the angiography-guided PCI group, 30.0% (N=60) underwent non-IRA PCI despite having QFR&amp;gt;0.80 in non-IRA. Conversely, only 2.7% (N=4) among 209 patients in the FFR-guided PCI group had QFR&amp;gt;0.80 in non-IRA. At a median follow-up of 3.5 years (interquartile range 2.7 to 4.1 years), the rate of MACE was significantly higher among patients with non-IRA PCI despite QFR&amp;gt;0.80 than patients with deferred PCI for non-IRA lesions (12.9% vs. 3.1%; HR=4.13, 95% CI 1.10-15.57, P=0.036). Non-IRA PCI despite QFR&amp;gt;0.80 was associated with higher risk of non-IRA MACE than patients with deferred PCI for non-IRA lesions (12.9% vs. 2.1%; HR 5.44, 95% CI 1.13-26.19, P=0.035). Conclusions In AMI patients with multivessel disease, 30.0% of angiography-guided PCI resulted in unnecessary PCI for non-IRA with QFR&amp;gt;0.80, which was significantly associated with the increased risk of MACE than those with deferred PCI for non-IRA lesions.

Early vascular healing after drug-eluting stent (DES) implantation is associated with better outcomes and lower incidence of in-stent thrombosis. To examine vascular healing response in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) guided by optical coherence tomography (OCT) versus angiography alone. Sixty patients were randomized 1:1:1 to OCT-guided PCI with 3-month OCT follow-up (O3 group, n = 20), angiography-guided PCI with 3-month OCT follow-up (A3 group, n = 20), or angiography-guided PCI with 6-month OCT follow-up (A6 group, n = 20). The primary endpoint was the proportion of covered struts at 3- or 6-month follow-up. The proportion of covered struts in the O3 group was significantly higher than in the A3 group (95.2% vs. 92.3%, p < 0.001), but lower than in the A6 group (95.2% vs. 97.4%, p < 0.001). The O3 group had a lower proportion of incomplete strut apposition (ISA) than the A3 group (0.46% vs. 0.76%, p = 0.006), and higher than the A6 group (0.46% vs. 0.27%, p = 0.018) at follow-up. The optimal cut-off value of ISA after implantation of DES for predicting stent coverage at 3 and 6-month follow-up was 200μm and 308μm, respectively. Only one patient experienced target lesion revascularization in the A3 group during a 3-year clinical follow-up. In patients with NSTE-ACS undergoing PCI with DES, OCT guidance achieved higher strut coverage compared with angiography guidance at 3-month follow-up. However, the difference in the strut coverage between the OCT-guided group and the angiography-guided group at 6 months indicates that the degree of endothelialization may be more time-dependent instead of invasive device guidance.

There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point. Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. ClinicalTrials.gov Identifier: NCT03381872.