BOOM: A novel bifurcation stent technique using optical coherence tomography co-registration.

BACKGROUND/PURPOSE: Bifurcation lesions comprise 20 % of percutaneous coronary interventions (PCI) and are associated with worse long-term outcomes. With an increasing percentage of patients presenting with complex anatomy, including bifurcation disease, there is a need for treatment strategies to optimize PCI outcomes. METHODS/MATERIALS: We retrospectively analyzed 48 patients undergoing OCT guided bifurcation PCI using the 'Bifurcation and Ostial OCT Mapping' (BOOM) technique. The primary efficacy variable studied was stent precision following deployment, defined as the distance of the most proximal stent strut from the true ostium of the target vessel. Additionally, targeted follow-up occurred by phone at 6- and 12-months post procedure, where the frequency of myocardial infarction, target lesion revascularization, target vessel and non-target vessel revascularization, and mortality were collected. RESULTS: A total of 40 (83.3 %) had an ostial lesion that required treatment while the remaining patients had true bifurcation disease. Most target lesions were in either the LAD or its branches (29 lesions (60.3 %)). With respect to stent positioning, the median absolute geographic miss, (i.e., stent protrusion into the main branch or lack of complete ostial stent coverage), was 0.75 mm. At 6 months, one patient required target lesion revascularization with no additional patients at 12 months. CONCLUSIONS: BOOM is a safe and simple strategy that can be a useful technique to optimize precise stent placement for ostial and bifurcation lesions.

Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis.

BACKGROUND: Although use of sirolimus-based analogs has shown superiority over paclitaxel in drug-eluting stents, the relative efficacy of these two agents released from drug-coated balloons (DCB) is unclear. The present meta-analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel-coated balloons (PCB) versus sirolimus-coated balloons (SCB) for either in-stent restenosis or native de novo lesions. METHODS: The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow-up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random-effects models. RESULTS: A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9-12 months of follow-up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75-1.35) between the two groups. On follow-up angiography at 6-9 months, MLD (WMD 0.10, 95% CI 0.02-0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD -0.11, 95% CI -0.23-0.02) and diameter stenosis (WMD -3.33, 95% CI -8.11-1.45). CONCLUSIONS: Among patients undergoing DCB-only PCI, the risk of TLF was similar during 9-12 months of follow-up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow-up angiography.

Intravascular imaging-guided percutaneous coronary intervention for heavily calcified coronary lesions: a systematic review and meta-analysis.

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.

Distinct Challenges of Eruptive and Non-Eruptive Calcified Nodules in Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: To provide a summary of prevalence, pathogenesis, and treatment of coronary calcified nodules (CNs). RECENT FINDINGS: CNs are most frequently detected at the sites of hinge motion of severely calcified lesions such as in the middle segment of right coronary artery and left main coronary bifurcation. On histopathology, CNs exhibit two distinctive morphologies: eruptive and non-eruptive. Eruptive CNs, which have a disrupted fibrous cap with adherent thrombi, are biologically active. Non-eruptive CNs, which have an intact fibrous cap without thrombi, are biologically inactive, representing either healed eruptive CNs or protrusion of calcium due to plaque progression. Recent studies using optical coherence tomography (OCT) have shown a difference in the mechanism of stent failure in the two subtypes, demonstrating early reappearance of eruptive CNs in the stent (at ~ 6 months) as a unique mechanism of stent failure that does not seem to be preventable by simply achieving adequate stent expansion. The cause of CN reappearance in stent is not known and could be due to acute or subacute intrusion or continued growth of the CN. Whether modification of CN is needed, the most effective calcium modification modality and effectiveness of stent implantation in eruptive CNs has not been elucidated. In this review, we discuss pathogenesis of CNs and how intravascular imaging can help diagnose and manage patients with CNs. We also discuss medical and transcatheter therapies beyond conventional stent implantation for effective treatment of eruptive CNs that warrant testing in prospective studies.

Calcified Nodule in Percutaneous Coronary Intervention: Therapeutic Challenges.

Calcified nodules (CNs) are among the most challenging lesions to treat in contemporary percutaneous coronary intervention. CNs may be divided into 2 subtypes, eruptive and noneruptive, which have distinct histopathological and prognostic features. An eruptive CN is a biologically active lesion with a disrupted fibrous cap and possibly adherent thrombus, whereas a noneruptive CN has an intact fibrous cap and no adherent thrombus. The use of intravascular imaging may allow differentiation between the 2 subtypes, thus potentially guiding treatment strategy. Compared with noneruptive CNs, eruptive CNs are more likely to be deformable, resulting in better stent expansion, but are paradoxically associated with worse clinical outcomes, in part because of their frequent initial presentation as an acute coronary syndrome and subsequent reprotrusion of the CN into the vessel lumen through the stent struts. Pending the results of ongoing studies, a tailored therapeutic approach based on the distinct features of the different CNs may be of value.

Prevalence and anatomical factors associated with stent under-expansion in non-severely calcified lesions.

BACKGROUND: Stent underexpansion, typically related to lesion calcification, is the strongest predictor of adverse events after percutaneous coronary intervention (PCI). Although uncommon, underexpansion may also occur in non-severely calcified lesions. AIM: We sought to identify the prevalence and anatomical characteristics of underexpansion in non-severely calcified lesions. METHODS: We included 993 patients who underwent optical coherence tomography-guided PCI of 1051 de novo lesions with maximum calcium arc <180°. Negative remodeling (NR) was the smallest lesion site external elastic lamina diameter that was also smaller than the distal reference. Stent expansion was evaluated using a linear regression model accounting for vessel tapering; underexpansion required both stent expansion <70% and stent area <4.5mm2. RESULTS: Underexpansion was observed in 3.6% of non-heavily calcified lesions (38/1051). Pre-stent maximum calcium arc and thickness were greater in lesions with versus without underexpansion (median 119° vs. 85°, p = 0.002; median 0.95 mm vs. 0.78 mm, p = 0.008). NR was also more common in lesions with underexpansion (44.7% vs. 24.5%, p = 0.007). In the multivariable logistic regression model, larger and thicker eccentric calcium, mid left anterior descending artery (LAD) location, and NR were associated with underexpansion in non-severely calcified lesions. The rate of underexpansion was especially high (30.7%) in lesions exhibiting all three morphologies. Two-year TLF tended to be higher in underexpanded versus non-underexpanded stents (9.7% vs. 3.7%, unadjusted hazard ratio [95% confidence interval] = 3.02 [0.92, 9.58], p = 0.06). CONCLUSION: Although underexpansion in the absence of severe calcium (<180°) is uncommon, mid-LAD lesions with NR and large and thick eccentric calcium were associated with underexpansion.

Coronary intravascular lithotripsy for severe coronary artery calcification: The Disrupt CAD I-IV trials.

Coronary artery calcification (CAC) severity is associated with increased vessel inflammation, atherosclerosis, stent failure, and risk of percutaneous coronary intervention-related complications. Current modalities for CAC modification include atherectomy techniques (rotational, orbital, and laser) and balloon modification (cutting and scoring). However, these methods are limited by their risk of slow flow/no reflow, coronary dissection, perforation, and myocardial infarction. Intravascular lithotripsy (IVL) emits high-energy sonic waves that induce calcium fractures within a target lesion to improve vessel compliance for stent placement. Low rates of major cardiac adverse events (MACE) and high rates of procedural and angiographic success were observed with IVL in the Disrupt CAD I-IV trials. Optical coherence tomography sub-studies identified calcium fracture as the likely etiology of improved vessel compliance and increased luminal diameter post-IVL. Rates of MACE, procedural, and angiographic success were consistent across the Disrupt CAD trials, suggesting IVL is less operator-dependent compared to other calcium-modifying techniques. Coronary IVL offers interventional cardiologists a safe and effective method of severe CAC modification, while providing reproducible outcomes.

Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial.

BACKGROUND: Percutaneous coronary intervention (PCI) of calcified lesions remains challenging for interventionalists. AIMS: We aimed to investigate whether combining rotational atherectomy (RA) with cutting balloon angioplasty (RA+CBA) results in more optimal stent expansion compared with RA followed by non-compliant balloon angioplasty (RA+NCBA). METHODS: ROTA-CUT is a prospective, multicentre, randomised trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomised 1:1 to either RA+CBA or RA+NCBA. The primary endpoint was the minimum stent area on intravascular ultrasound (IVUS). Secondary endpoints included minimum lumen area and stent expansion assessed by IVUS and acute lumen gain, final residual diameter stenosis and minimum lumen diameter assessed by angiography. Clinical endpoints were obtained at 30 days. RESULTS: The mean age was 71.1±9.4 years, and 22% were women. The procedural details of RA were similar between groups, as were procedure duration and contrast use. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm2 vs 6.9±1.8 mm2; p=0.685). Furthermore, there were no significant differences regarding the other IVUS and angiographic endpoints. Procedural complications were rare, and 30-day clinical events included 2 myocardial infarctions and 1 target vessel revascularisation in the RA+CBA group and 1 myocardial infarction in the RA+NCBA group. CONCLUSIONS: Combining RA with CBA resulted in a similar minimum stent area compared with RA followed by NCBA in patients undergoing PCI of moderately or severely calcified lesions. RA followed by CBA was safe with rare procedural complications and few clinical adverse events at 30 days.

Accuracy and limitation of plaque detection by coronary CTA: a section-to-section comparison with optical coherence tomography.

Plaques identified by Coronary CT angiography (CCTA) are important in clinical diagnosis and primary prevention. High-risk plaque features by CCTA have been extensively validated using optical coherence tomography (OCT). However, since their general diagnostic performance and limitations have not been fully investigated, we sought to compare CCTA with OCT among consecutive vessel sections. We retrospectively compared 188 consecutive plaques and 84 normal sections in 41 vessels from 40 consecutive patients referred for chest pain evaluation who had both CCTA and OCT with a median time lapse of 1 day. The distance to reference points were used to co-register between the modalities and the diagnostic performance of CCTA was evaluated against OCT. Plaque categories evaluated by CT were calcified, non-calcified and mixed. The diagnostic performance of CCTA was excellent for detecting any plaque identified by OCT with the sensitivity, specificity, negative and positive predictive values and accuracy of 92%, 98%, 99%, 84% and 93%, respectively. The lower than expected negative predictive value was due to failure of detecting sub-millimeter calcified (≤ 0.25 mm2) (N = 12) and non-calcified plaques (N = 4). Misclassification of plaque type accounted for majority of false negative findings (25/41, 61%) which was most prevalent among the mixed plaque (19/41, 46%). There was calcification within mixed plaques (N = 5) seen by CCTA but missed by OCT. Our findings suggest that CCTA is excellent at identifying coronary plaques except those sub-millimeter in size which likely represent very early atherosclerosis, although the clinical implication of very mild atherosclerosis is yet to be determined.

Utility of optical coherence tomography in acute coronary syndromes.

Studies utilizing intravascular imaging have replicated the findings of histopathological studies, identifying the most common substrates for acute coronary syndromes (ACS) as plaque rupture, erosion, and calcified nodule, with spontaneous coronary artery dissection, coronary artery spasm, and coronary embolism constituting the less common etiologies. The purpose of this review is to summarize the data from clinical studies that have used high-resolution intravascular optical coherence tomography (OCT) to assess culprit plaque morphology in ACS. In addition, we discuss the utility of intravascular OCT for effective treatment of patients presenting with ACS, including the possibility of culprit lesion-based treatment by percutaneous coronary intervention.

Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting.

BACKGROUND: Whether an eruptive or noneruptive target lesion calcified nodule (CN) portends worse acute and long-term clinical outcomes after stenting has not been established. OBJECTIVES: The authors sought to compare acute and long-term clinical outcomes in eruptive CN vs noneruptive CN morphology. METHODS: Using optical coherence tomography, an eruptive CN was defined as an accumulation of small calcium fragments protruding and disrupting the overlying fibrous cap, typically with small amount of thrombus. A noneruptive CN was defined as an accumulation of small calcium fragments with a smooth intact fibrous cap without an overlying thrombus. The primary endpoint was target lesion failure (TLF) including cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization in patients with ≥6-month follow-up. RESULTS: Among 3,231 patients with evaluable pre- and postintervention OCT, 236 patients had lesions with CNs (7.3%). After eliminating 4 secondary lesions and 6 patients without ≥6-month follow-up, 126 (54.8%) lesions with eruptive CNs and 104 (45.2%) lesions with noneruptive CNs formed the current report. Compared with noneruptive CNs, eruptive CNs were independently associated with greater stent expansion (89.2% ± 18.7% vs. 81.5% ± 18.9%; P = 0.003) after adjusting for morphologic and procedural factors. At 2 years, eruptive CNs trended toward more TLF compared with noneruptive CNs (Kaplan-Meier estimates, 19.8% vs 12.5%; P = 0.11) and significantly more target lesion revascularization (18.3% vs 9.6%; P = 0.04). In the adjusted model, eruptive CNs were independently associated with 2-year TLF (HR: 2.07; 95% CI: 1.01-4.50; P = 0.048). CONCLUSIONS: Compared with noneruptive CN morphology, lesions with an eruptive CN appearance on optical coherence tomography had a worse poststent long-term clinical outcome despite better acute stent expansion.

Optical Coherence Tomography-Guided Percutaneous Coronary Intervention: Practical Application.

Optical coherence tomography (OCT) provides high-resolution imaging of coronary arteries and can be used to optimize percutaneous coronary intervention (PCI). Intracoronary OCT, however, has had limited adoption in clinical practice. Novelty and relative complexity of OCT interpretation compared with the more established intravascular ultrasound, lack of a standardized algorithm for PCI guidance, paucity of data from randomized trials, and lack of rebate for intravascular imaging have contributed to the modest practical adoption of OCT. We provide a practical step-by-step guide on how to use OCT in PCI, including device set-up, simplified image interpretation, and an algorithmic approach for PCI. optimization.