Optical Coherence Tomography-Guided versus Angiography-Guided PCI.

BACKGROUND: Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited. METHODS: In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed. RESULTS: The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group. CONCLUSIONS: Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).

Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial.

BACKGROUND: The optimal antiplatelet regimen after percutaneous coronary intervention (PCI) in patients with peripheral artery disease (PAD) is still debated. This analysis aimed to compare the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients with PAD undergoing PCI. METHODS: In the TWILIGHT trial, patients at high ischemic or bleeding risk that underwent PCI were randomized after 3 months of dual antiplatelet therapy (DAPT) to aspirin or matching placebo in addition to open-label ticagrelor for 12 additional months. In this post-hoc analysis, patient cohorts were examined according to the presence or absence of PAD. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction (MI), or stroke. Endpoints were assessed at 12 months after randomization. RESULTS: Among 7,119 patients, 489 (7%) had PAD and were older, more likely to have comorbidities, and multivessel disease. PAD patients had more bleeding or ischemic complications than no-PAD patients. Ticagrelor monotherapy compared to ticagrelor plus aspirin was associated with less BARC 2, 3, or 5 bleeding in PAD (4.6% vs 8.7%; HR 0.52; 95%CI 0.25-1.07) and no-PAD patients (4.0% vs 7.0%; HR 0.56; 95%CI 0.45-0.69; interaction P-value .830) and a similar risk of death, MI, or stroke in these 2 groups (interaction P-value .446). CONCLUSIONS: Despite their higher ischemic and bleeding risk, patients with PAD undergoing PCI derived a consistent benefit from ticagrelor monotherapy after 3 months of DAPT in terms of bleeding reduction without any relevant increase in ischemic events. CLINICAL TRIAL REGISTRY INFORMATION:: https://www. CLINICALTRIALS: gov/study/NCT02270242.

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.

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.

Optical coherence tomography versus angiography and intravascular ultrasound to guide coronary stent implantation: A systematic review and meta-analysis.

BACKGROUND: Optical coherence tomography (OCT) is an adjunct to angiography-guided coronary stent placement. However, in the absence of dedicated, appropriately powered randomized controlled trials, the impact of OCT on clinical outcomes is unclear. OBJECTIVE: To conduct a systematic review and meta-analysis of all available studies comparing OCT-guided versus angiography-guided and intravascular ultrasound (IVUS)-guided coronary stent implantation. METHODS: MEDLINE and Cochrane Central were queried from their inception through July 2022 for all studies that sought to compare OCT-guided percutaneous coronary intervention (PCI) to angiography-guided and IVUS-guided PCI. The primary endpoint was minimal stent area (MSA) compared between modalities. Clinical endpoints of interest were all-cause and cardiovascular mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). Risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs) were pooled using a random-effects model. RESULTS: Thirteen studies (8 randomized control trials and 5 observational studies) enrolling 6312 participants were included. OCT was associated with a strong trend toward increased MSA compared to angiography (MD = 0.36, p = 0.06). OCT-guided PCI was also associated with a reduction in the incidence of all-cause mortality [RR = 0.59, 95% CI (0.35, 0.97), p = 0.04] and cardiovascular mortality [RR = 0.41, 95% CI (0.21, 0.80), p = 0.009] compared with angiography-guided PCI. Point estimates favored OCT relative to angiography in MACE [RR = 0.75, 95% CI (0.47, 1.20), p = 0.22] and MI [RR = 0.75, 95% CI (0.53, 1.07), p = 0.12]. No differences were detected in ST [RR = 0.71, 95% CI (0.21, 2.44), p = 0.58], TLR [RR = 0.71, 95% CI (0.17, 3.05), p = 0.65], or TVR rates [RR = 0.89, 95% CI (0.46, 1.73), p = 0.73]. Compared with IVUS guidance, OCT guidance was associated with a nonsignificant reduction in the MSA (MD = -0.16, p = 0.27). The rates of all-cause and cardiovascular mortality, MACE, MI, TLR, TVR, or ST were similar between OCT-guided and IVUS-guided PCI. CONCLUSIONS: OCT-guided PCI was associated with reduced all-cause and cardiovascular mortality compared to angiography-guided PCI. These results should be considered hypothesis generating as the mechanisms for the improved outcomes were unclear as no differences were detected in the rates of TLR, TVR, or ST. OCT- and IVUS-guided PCI resulted in similar post-PCI outcomes.

Calcific Plaque Modification by Acoustic Shockwaves: Intravascular Lithotripsy in Cardiovascular Interventions.

PURPOSE OF REVIEW: To provide a review of recent literature on the treatment of moderate-to-severe calcification in coronary and peripheral vasculature with intravascular lithotripsy (Shockwave Medical, Santa Clara, CA). RECENT FINDINGS: Moderate-to-severe calcific plaques constitute a significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds and portend lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared to non-calcific plaques. Intravascular lithotripsy (IVL) is a new technique that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. IVL demonstrated high procedural success and low complication rates in the management of moderate-to-severe calcification in coronary and peripheral vascular beds and led to large luminal gain by modification of calcific plaque as assessed by optical coherence tomography. Further studies will determine the role of IVL in an integrated, protocolized approach to the treatment of severely calcified plaques in the coronary and peripheral vascular beds.

Left coronary artery calcification patterns after coronary bypass graft surgery: An in-vivo optical coherence tomography study.

OBJECTIVES: We sought to evaluate the severity and patterns of calcifications in the left main coronary artery (LMCA) and proximal segments of left anterior descending coronary artery (LAD) and left circumflex artery (LCX) using optical coherence tomography (OCT) in patients with and without prior coronary artery bypass grafting (CABG). BACKGROUND: CABG may accelerate upstream calcium development. METHODS: OCT images (n = 76) of the LMCA bifurcation from either the LAD or LCX in 76 patients with at least one patent left coronary graft, on average 7.0 ± 5.6 years post-CABG, were compared with 148 OCT images in propensity-score-matched non-CABG controls. RESULTS: Minimum lumen areas in the LMCA, LAD, and LCX in post-CABG patients were smaller than non-CABG controls. Maximum calcium arc and thickness as well as calcium length were greater in the LMCA and LCX, but not in the LAD in post-CABG patients versus non-CABG controls. Calcium located at the carina of a bifurcation, calcified nodules (CN), thin intimal calcium, and lobulated calcium were more prevalent in post-CABG patients. After adjusting for multiple covariates, prior CABG was an independent predictor of calcification at the carina of a bifurcation (odds ratio [OR] 5.77 [95% confidence interval, CI: 1.5-21.6]), thin intimal calcium (4.7 [1.5-14.4]), and the presence of a CN (15.60 [3.2-76.2]). CONCLUSIONS: Prior CABG is associated with greater amount of calcium in the LMCA and the proximal LCX, as well as higher prevalence of atypical calcium patterns, including CN, thin or lobulated calcium, and calcifications located at the carina of a bifurcation, compared with non-CABG controls.

Therapeutic Approach to Calcified Coronary Lesions: Disruptive Technologies.

PURPOSE OF REVIEW: Moderate or severe calcification is present in approximately one third of coronary lesions in patients with stable ischemic heart disease and acute coronary syndromes and portends unfavorable procedural results and long-term outcomes. In this review, we provide an overview on the state-of-the-art in evaluation and treatment of calcified coronary lesions. RECENT FINDINGS: Intravascular imaging (intravascular ultrasound or optical coherence tomography) can guide percutaneous coronary intervention of severely calcified lesions. New technologies such as orbital atherectomy and intravascular lithotripsy have significantly expanded the range of available techniques to effectively modify coronary calcium and facilitate stent expansion. Calcium fracture improves lesion compliance and is essential to optimize stent implantation. Intravascular imaging allows for detailed assessment of patterns and severity of coronary calcium that are integrated into scoring systems to predict stent expansion, identifying which lesions require atherectomy for lesion modification. Guided by intravascular imaging, older technologies such as rotational atherectomy and excimer laser can be incorporated with newer technologies such as orbital atherectomy and intravascular lithotripsy into an algorithmic approach for the safe and effective treatment of patients with heavily calcified coronary lesions.

Effect of orbital atherectomy in calcified coronary artery lesions as assessed by optical coherence tomography.

OBJECTIVES: We sought to assess plaque modification and stent expansion following orbital atherectomy (OA) for calcified lesions using optical coherence tomography (OCT). BACKGROUND: The efficacy of OA for treating calcified lesions is not well studied, especially using intravascular imaging in vivo. METHODS: OCT was performed preprocedure, post-OA, and post-stent (n = 58). Calcium modification after OA was defined as a round, concave, polished calcium surface. Calcium fracture was complete discontinuity of calcium. RESULTS: Comparing pre- vs post-OA OCT (n = 29), calcium area was significantly decreased post-OA (from 3.4 mm2 [2.4-4.7] to 2.9 mm2 [1.9-3.9], P < 0.001). Poststent percent calcium fracture (calcium fracture length/calcium length) correlated with post-OA percent calcium modification (calcium modification length/calcium length) (r = 0.31, P = 0.01). Among 75 calcium fractures in 35 lesions, maximum calcium thickness at the fracture site was greater with vs without calcium modification (0.58 mm [0.50-0.66] vs 0.45 mm [0.38-0.52], P = 0.003). Final optimal stent expansion, defined as minimum stent area ≥6.1 mm2 or stent expansion ≥90% (medians of this cohort) at the maximum calcium angle site, was observed in 41 lesions. Larger post-OA lumen area (odds ratio 2.64; 95% CI 1.21-5.76; P = 0.02) and the presence of calcium fracture (odds ratio 6.77; 95% CI 1.25-36.6; P = 0.03) were independent predictors for optimal stent expansion. CONCLUSIONS: Calcium modification by OA facilitates poststent calcium fracture even in thick calcium. Greater calcium modification correlated with greater calcium fracture, in turn resulting in better stent expansion.

A prospective, single-center, randomized study to assess whether automated coregistration of optical coherence tomography with angiography can reduce geographic miss.

OBJECTIVE: We sought to evaluate whether automated coregistration of optical coherence tomography (OCT) with angiography reduces geographic miss (GM) during coronary stenting. BACKGROUND: Previous intravascular ultrasound or OCT studies have showed that residual disease at the stent edge or stent edge dissection was associated with stent thrombosis or edge restenosis. This has been termed GM. METHODS: Two hundred de novo coronary lesions were randomized in a 1:1 ratio to OCT-guided percutaneous coronary intervention (PCI) with versus without automated coregistration of OCT with angiography. GM, the primary endpoint, was defined as angiographic ≥type B dissection or diameter stenosis >50% or OCT minimum lumen area <4.0 mm2 with significant residual disease or dissection (dissection flap >60°) within 5 mm from the stent edge. RESULTS: The prevalence of GM was not different comparing OCT-guided PCI with versus without automated coregistration (27.6% vs 34.0%, P = 0.33). However, there was a trend toward a reduced prevalence of significant distal stent edge dissection in lesions with automated coregistration (11.1% vs 20.8%, P = 0.07). The discrepancy in the distance between planned versus actual implanted stent location with automated coregistration was significantly shorter than without coregistration (1.9 ± 1.6 mm vs 2.6 ± 2.7 mm, P = 0.03), especially the prevalence of ≥5 mm discrepancy that was less frequent with automated coregistration. CONCLUSIONS: Automated coregistration of OCT with angiography did not reduce the primary endpoint of GM after stent implantation.

Utility of intracoronary imaging in the cardiac catheterization laboratory: comprehensive evaluation with intravascular ultrasound and optical coherence tomography.

Background: Intracoronary imaging is an important tool for guiding decision making in the cardiac catheterization laboratory. Sources of data: We have reviewed the latest available evidence in the field to highlight the various potential benefits of intravascular imaging. Areas of agreement: Coronary angiography has been considered the gold standard test to appropriately diagnose and manage patients with coronary artery disease, but it has the inherent limitation of being a 2-dimensional x-ray lumenogram of a complex 3-dimensional vascular structure. Areas of controversy: There is well-established inter- and intra-observer variability in reporting coronary angiograms leading to potential variability in various management strategies. Intracoronary imaging improves the diagnostic accuracy while optimizing the results of an intervention. Utilization of intracoronary imaging modalities in routine practice however remains low worldwide. Increased costs, resources, time and expertise have been cited as explanations for low incorporation of these techniques. Growing points: Intracoronary imaging supplements and enhances an operator's decision-making ability based on detailed and objective lesion assessment rather than a subjective visual estimation. The benefits of intravascular imaging are becoming more profound as the complexity of cases suitable for revascularization increases. Areas timely for developing research: While the clinical benefits of intravascular ultrasound have been well validated, optical coherence tomography in comparison is a newer technology, with robust clinical trials assessing its clinical benefit are underway.

Safety and efficacy of the next generation Resolute Onyx zotarolimus-eluting stent: Primary outcome of the RESOLUTE ONYX core trial.

OBJECTIVES: To assess the safety and efficacy of the novel Resolute (R-) Onyx drug-eluting stent (DES). BACKGROUND: The R-Onyx DES consists of a composite wire with an outer shell of cobalt chromium alloy and a platinum-iridium inner core to enhance radiopacity, with thinner, swaged struts and modified stent geometry compared with the predicate Resolute DES, resulting in a slightly lower total drug load in most sizes. METHODS: This was a prospective, single-arm non-inferiority trial compared with a historical control. Patients with stable angina/ischemia and up to 2 de novo target lesions ≤35 mm long with reference vessel diameter (RVD) of 2.25-4.2 mm were enrolled. The primary endpoint was late lumen loss at 8-month follow-up. Propensity-score adjusted outcomes from the single-arm RESOLUTE-US trial served as the control. RESULTS: Seventy-five patients (85 lesions) were enrolled. Mean patient age was 66 ± 9 years, 73% were male, and 32% had diabetes. Mean lesion length was 14.28 ± 6.68 mm, mean RVD was 2.57 ± 0.48 mm, and 86% of lesions were class B2/C. In-stent late lumen loss at 8 months was 0.24 ± 0.39 mm with R-Onyx DES compared with 0.36 ± 0.52 mm with Resolute DES (P < 0.001 for noninferiority, P = 0.029 for superiority). At 8 months, clinically driven target lesion revascularization occurred in 3 patients (4.0%) and target lesion failure occurred in 5 patients (6.7%). CONCLUSIONS: In-stent late lumen loss is non-inferior, and appears to be superior, with the thin-strut novel composite wire R-Onyx DES compared with Resolute DES. Continued evolution of stent design can improve angiographic outcomes in complex lesions, even in the current era of next-generation DES.

Impact of diabetes mellitus on procedural and one year clinical outcomes following treatment of severely calcified coronary lesions with the orbital atherectomy system: A subanalysis of the ORBIT II study.

OBJECTIVES: The goal of the study was to investigate the safety and efficacy of the coronary orbital atherectomy system to treat severe coronary artery calcification (CAC) prior to stent placement in diabetic and non-diabetic patients. BACKGROUND: The ORBIT II study reported the safety and efficacy of orbital atherectomy treatment in 443 patients with severe CAC. Percutaneous coronary intervention in diabetic patients is associated with an increased risk of major adverse cardiac events (MACE) compared with non-diabetics. The outcomes of diabetic patients who undergo orbital atherectomy are unknown. METHODS: Patients were sub-grouped as either diabetic (160/443, 36.1%) or non-diabetic (283/443, 63.9%). The MACE rate, defined as cardiac death, myocardial infarction (MI; CK-MB > 3X ULN), and target vessel revascularization, was examined at 30 days and 1 year after treatment. RESULTS: Procedural success was similar in the diabetic and non-diabetic groups (89.3 vs. 88.6%, P = 0.88). There was no significant difference in the 30-day and 1-year MACE rates between the diabetic and non-diabetic groups (30 day: 8.8 vs. 11.3%; P = 0.40; 1 year: 17.1 vs. 16.7%, P = 0.97). The individual components of cardiac death (3.9 vs. 2.9%, P = 0.58), MI (9.4 vs. 11.3%, P = 0.52), and target vessel revascularization (5.9 vs. 5.8%, P = 0.99) were also similar in both groups at 1 year. CONCLUSIONS: The rates of adverse clinical events in diabetic patients who underwent orbital atherectomy were low and similar to non-diabetic patients. This study suggests orbital atherectomy is a reasonable treatment strategy for diabetic patients with severe CAC.

Phenotype of Same-Day-Discharge Patients After Percutaneous Coronary Intervention.

BACKGROUND: Overnight observation is the standard of care for uncomplicated elective percutaneous coronary intervention (PCI). However, same-day discharge (SDD) is reportedly safe using predetermined criteria and patient risk categories. Characteristics of patients with SDD have not yet been described. OBJECTIVE: The purpose of this study was to describe the phenotype of patients appropriate for SDD after PCI without predetermined criteria and patient risk categories. METHODS: Analysis of PCI registry data was conducted on patients (n = 2174) who underwent elective and nonelective PCI between January 2012 and June 2014. Preliminary analysis included descriptive statistics, t tests, and χ tests. All variables were analyzed using random forest plot to determine importance of predictors of SDD followed by confirmatory logistic regression. RESULTS: Random forest plot indicated 6 predictors of SDD. Confirmatory logistic regression using a model with all 6 predictors indicated that the model was able to distinguish between patients with SDD and overnight observation after PCI and was statistically significant (χ(7.12, N = 2174) = 511.12, P < .005). Strongest predictors of SDD were stable angina (odds ratio, 5.93 [95% confidence interval, 1.316-26.712]; P = .020) followed by non-ST elevation myocardial infarction/high-risk unstable angina (odds ratio, 1.66 [95% confidence interval, 1.239-2.225]; P = .001). Readmission within 24 hours of SDD after PCI was low at 0.91%. CONCLUSIONS: Age, access site, complexity, and number of lesions stented did not preclude SDD. A broader range of patients, particularly patients in higher risk categories (non-ST elevation myocardial infarction and unstable angina), are candidates for SDD.

Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial.

BACKGROUND: Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. METHODS: In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm2), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586. FINDINGS: Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm2 (IQR 4·54-7·34) with OCT guidance, 5·89 mm2 (4·67-7·80) with IVUS guidance, and 5·49 mm2 (4·39-6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI -0·70 mm2; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). INTERPRETATION: OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. FUNDING: St Jude Medical.

ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System.

OBJECTIVES: To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function. BACKGROUND: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized. METHODS: ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization. RESULTS: Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR < 90 ml/min/1.73 m2 and 108 patients had eGFR ≥ 90 ml/min/1.73 m2 . The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m2 and eGFR ≥ 90 ml/min/1.73 m2 groups was 65.0 ± 0.9 ml/min/1.73 m2 and 109.1 ± 2.0 ml/min/1.73 m2 , respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m2 group at 30 days (87.4% vs. 96.3%, P = 0.02) and 1-year (80.6% vs. 90.7%, P = 0.02). CONCLUSIONS: Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m2 and eGFR ≥ 90 ml/min/1.73 m2 . Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions. © 2016 Wiley Periodicals, Inc.

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy.

OBJECTIVES: We evaluated the clinical outcomes of elderly patients who underwent orbital atherectomy for the treatment of severe coronary artery calcification (CAC) prior to stenting. BACKGROUND: Percutaneous coronary intervention (PCI) of severe CAC is associated with worse clinical outcomes including death, myocardial infarction (MI), and target vessel revascularization (TVR). The elderly represents a high-risk group of patients, often have more comorbid conditions, and have worse outcomes after PCI compared to younger patients. Clinical trials and a large multicenter registry have demonstrated the safety and efficacy of orbital atherectomy for the treatment of severe CAC. Clinical outcomes of elderly patients who undergo orbital atherectomy are unknown. METHODS: Of the 458 patients, 229 were ≥75 years old (elderly) and 229 were <75 years old (younger). The primary endpoint was rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), comprised of cardiac death, MI, TVR, and stroke. RESULTS: The primary endpoint was similar in the elderly and younger groups (2.2% vs. 2.2%, P = 1), as were the individual endpoints of death (2.2% vs. 0.4%, P = 0.1), MI (0.9% vs. 1.3%, P = 0.65), TVR (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P = 0.32). The rates of angiographic complications and stent thrombosis were similarly low in both groups. CONCLUSIONS: The elderly represented a sizeable number of patients who underwent orbital atherectomy. It is a safe and effective treatment strategy for elderly patients with severe CAC as the clinical outcomes were similar to their younger counterparts. A randomized trial should further clarify the role of orbital atherectomy in these patients.

Safety of orbital atherectomy in patients with left ventricular systolic dysfunction.

OBJECTIVES: We evaluated the angiographic and clinical outcomes in patients with severely calcified lesions and systolic dysfunction who underwent orbital atherectomy (OA). We hypothesized that OA would provide similar outcomes in patients with systolic dysfunction compared with patients with preserved systolic function. BACKGROUND: Systolic dysfunction is associated with an increased risk of adverse clinical events after percutaneous coronary intervention (PCI). The effects of OA in patients with systolic dysfunction are unknown. METHODS: Our analysis retrospectively analyzed 438 patients (n = 69 with EF ≤ 40%) who underwent OA. The primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days. RESULTS: There were no significant differences between patients with preserved versus reduced systolic function in terms of dissections (0.9% vs. 1.6%, P = 0.51), perforation (0.3% vs. 3.2%, P = 0.07), or no reflow (0.3% vs. 3.2%, P = 0.07). Patients with systolic dysfunction had higher rates of the composite of 30-day MACCE (1.1% vs. 8.7%, P = 0.002) and the individual end points of death (0.3% vs. 7.2%, P < 0.001), and myocardial infarction (0.5% vs. 4.3%, P = 0.03). The rates of target vessel revascularization (0% vs. 0%, P = 1), stroke (0.3% vs. 0%, P > 0.9), and stent thrombosis (0.8% vs. 1.4%, P = 0.5) were low in both groups and did not differ. CONCLUSION: Plaque modification with OA was safe and well tolerated in patients with systolic dysfunction. In this high-risk cohort, adverse clinical outcomes occurred more frequently than in a lower risk population.

Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight from the ORBIT II trial.

OBJECTIVES: We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type. BACKGROUND: The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions. METHODS: ORBIT II was a single-arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30-day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first-generation drug-eluting stent [DES], or second-generation DES). The 2-year MACE rate and its components were compared between groups. RESULTS: In the ORBIT II study cohort, 2-year rates of MACE, cardiac death, and target vessel revascularization were 19.4%, 4.3%, and 8.1%, respectively. Two year data were available in 419 of 443 patients (94.6%) with median follow up time of 25.1 months. Stent-type data were available in 435 of the 443 patients (98.2%). Six patients received stents of more than one type and were excluded from the stent type comparisons. Among the 429 patients included in the stent comparison analyses, 43 patients (10.0%) received BMS, 74 (17.2%) received first-generation DES, and 312 (72.7%) received second-generation DES. The 1 and 2-year target lesion revascularization rates were lower among patients receiving first-generation (1.4% and 6.3%) and second-generation (3.9% and 5.0%) DES compared to patients receiving BMS (15.3% and 15.3%), respectively (1 year: P = 0.007; 2 year: P = 0.047). Higher diameter stenosis and the use of BMS were independently associated with the occurrence of MACE and TVR at 2 years. CONCLUSIONS: OAS remained safe and effective for patients with de novo, severely calcified lesions at 2 years in the ORBIT II study. Adverse ischemic events were significantly higher with BMS compared with DES. © 2016 Wiley Periodicals, Inc.

Outcomes in Diabetic Patients Undergoing Orbital Atherectomy System.

OBJECTIVES: We evaluated the angiographic and clinical outcomes of orbital atherectomy to treat severely calcified coronary lesions in diabetic and non-diabetic patients. BACKGROUND: Diabetics have increased risk for death, myocardial infarction, and target vessel revascularization after percutaneous coronary intervention. Severely calcified coronary lesions are associated with increased cardiac events. Orbital atherectomy facilitates stent delivery and optimizes stent expansion by modifying severely calcified plaque. Outcomes in diabetic patients who undergo orbital atherectomy have not been reported. METHODS: Our retrospective multicenter registry included 458 consecutive real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events at 30 days. RESULTS: Diabetics represented 42.1% (193/458) of the entire cohort. The primary endpoint was similar in diabetics and non-diabetics (1.0% vs. 3.0%%, P = 0.20), as were 30-day rates of death (0.5% vs. 1.9%, P = 0.41), myocardial infarction (0.5% vs. 1.5%, P = 0.40), target vessel revascularization (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P > 0.9). Angiographic complications and stent thrombosis rate were low and did not differ between the 2 groups. CONCLUSION: Diabetics represented a sizeable portion of patients who underwent orbital atherectomy. Diabetics who had severely calcified coronary arteries and underwent orbital atherectomy had low event rates that were similar to non-diabetics. Orbital atherectomy appears to be a viable treatment strategy for diabetic patients. Randomized trials with longer-term follow-up are needed to determine the ideal treatment strategy for diabetics.