Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery: Rationale and design of the multicenter, randomized PROCTOR trial.

BACKGROUND: Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. METHODS: PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). CONCLUSION: PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.

Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial.

BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.

Clinical Outcomes and OCT Analysis After Culotte Stenting With 2nd- and 3rd-Generation Everolimus-Eluting Stents: Two-Year Follow-Up of the CELTIC Bifurcation Study.

PURPOSE: The aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing. METHODS: A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up. RESULTS: After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years. OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents. CONCLUSIONS: The first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

BACKGROUND: Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). AIMS: The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. METHODS: This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. RESULTS: Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). CONCLUSIONS: In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

Intravascular lithotripsy for treatment of calcific coronary lesions in ST elevation myocardial infarction.

AIMS: To describe the utility and safety of intravascular lithotripsy (IVL) in the setting of primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). METHODS AND RESULTS: We performed a retrospective analysis, across six UK sites of all patients in whom IVL was used for coronary calcium modification of the culprit lesion during primary PCI for STEMI. The 72 patients were included. IVL was used in de-novo culprit lesions in 57 (79%) of cases and culprit in-stent restenoses in 11 (15%) of cases. In four cases (6%) it was used in a newly deployed stent when this was under-expanded due to inadequate calcium modification. Of the 30 cases in which intracoronary imaging was available for stent analysis, the average stent expansion was 104%. Intra-procedural stent thrombosis occurred in one case (1%), and no-reflow in three cases (4%). The 30 day MACE rates were 18%. CONCLUSION: IVL appears to be feasible and safe for use in the treatment of calcific coronary artery disease in the setting of STEMI.

Acute Treatment and 5-Year Follow-up of Longitudinal Deformation of a Bioresorbable Scaffold.

A 46-year-old man with type 1 diabetes underwent percutaneous coronary intervention with bioresorbable scaffold implantation for a long segment of physiologically significant left anterior descending coronary artery disease. The procedure was complicated by longitudinal stent deformation (LSD). The images carry several important educational messages for clinicians. First, as with all stents, LSD is possible in extreme circumstances. Second, as the device is not seen angiographically, it is imperative that optical coherence tomography be performed to confirm LSD. When recognized and treated, the procedural and long-term outcomes are good for this complication.

Safety and efficacy of the NovaCross microcatheter in facilitating crossing of chronic total occlusion coronary lesions: a multicenter, single-arm clinical trial.

BACKGROUND: The aim of this study was to evaluate the safety and efficacy of the novel NovaCross microcatheter system in patients with ischemic heart disease due to coronary chronic total occlusions (CTO). METHODS: A total of 191 subjects between the ages of 25-80 years were recruited in 10 investigational sites. Each subject underwent a percutaneous coronary intervention (PCI) of a CTO lesion using the NovaCross microcatheter, equipped with expandable nitinol scaffolds to enhance guidewire penetration and crossing of the CTO lesion. The primary safety endpoint was procedural major adverse cardiac events [composite of death, myocardial infarction (MI), or urgent target vessel revascularization]. The primary efficacy endpoint was to assess the ability of the NovaCross microcatheter to successfully facilitate the placement of a guidewire beyond a native coronary CTO in the true vessel lumen. After the PCI, subjects remained in hospital until a 12-lead ECG and blood tests for cardiac biomarkers were taken at 3-6 h and 8-16 h post-procedure. RESULTS: No deaths, urgent revascularization, or urgent coronary artery bypass surgery were reported. The reported MI rate according to the protocol definition was 12.3%, and technical success was achieved in 75.3% of the subjects regardless of CTO procedure technique. In 89.2% of the subjects, the NovaCross succeeded in penetrating the proximal CTO cap, and in 25.8% of the subjects, the extendable portion of the NovaCross crossed the full length of the CTO lesion. CONCLUSIONS: The NovaCross met both the primary safety endpoint and the primary efficacy endpoint. We, therefore, conclude that the device is well tolerated, effective, and could be easily adopted by interventional cardiologists.

Intravascular Healing Is Not Affected by Approaches in Contemporary CTO PCI: The CONSISTENT CTO Study.

OBJECTIVES: The aim of this study was to assess angiographic, imaging, and clinical outcomes following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with dissection and re-entry techniques (DART) and subintimal (SI) stenting compared with intimal techniques. BACKGROUND: Reliable procedural success and safety in CTO PCI require the use of DART to treat the most complex patients. Potential concerns regarding the durability of DART with SI stenting still need to be addressed. METHODS: This was a prospective, multicenter, single-arm trial of patients with appropriate indications for CTO PCI. RESULTS: Successful CTO PCI was performed in 210 of 231 patients (91% success). At 1 year, the primary endpoint of target vessel failure (cardiac death, myocardial infarction related to the target vessel, or any ischemia-driven revascularization) occurred in 5.7% of patients, meeting the pre-set performance goal. Major adverse cardiovascular events (all-cause mortality, myocardial infarction, or target vessel revascularization) occurred in 10% at 1 year and 17% by 2 years and was not influenced by DART. Quality-of-life measures significantly improved from baseline to 12 months. There was no difference in intravascular healing assessed using optical coherence tomography at 12 months for patients treated with DART and SI stenting compared with intimal strategies. CONCLUSIONS: Contemporary CTO PCI is associated with medium-term clinical outcomes comparable with those achieved in other complex PCI cohorts and significant improvements in quality of life. The use of DART with SI stenting does not adversely affect intravascular healing at 12 months or medium-term major adverse cardiovascular events. (Consistent CTO Trial; NCT02227771).

Intravascular ultrasound to guide left main stem intervention: a NOBLE trial substudy.

AIMS: We aimed to investigate the association between the use and findings of IVUS with clinical outcomes in the PCI arm of a randomised trial of LMS PCI. METHODS AND RESULTS: The NOBLE trial randomised patients with LMS disease to treatment by PCI or CABG. Of 603 patients treated by PCI, 435 (72%) underwent post-PCI IVUS assessment, 224 of which were analysed in a core laboratory. At five years, the composite of MACCE was 18.9% if post-PCI IVUS was performed versus 25.0% if it was not performed (p=0.45, after adjustment). Overall repeat revascularisation was not reduced (10.6% vs 16.5%, p=0.11); however, LMS TLR was (5.1% vs 11.6%, p=0.01) if IVUS was used. For comparison of stent expansion, LMS MSA was split into tertiles. We found no significant difference in MACCE, death, myocardial infarction or stent thrombosis between tertiles. There was a significant difference between the lower and upper tertiles for repeat revascularisation (17.6% vs 5.2%, p=0.02) and LMS TLR (12.2% vs 0%, p=0.002). CONCLUSIONS: Post-PCI IVUS assessment and adequate stent expansion are not associated with reduced MACCE; however, there is an association with reduced LMS TLR. The use of intracoronary imaging to prevent stent underexpansion in LMS PCI is likely to improve outcomes.

Incidence of "shocktopics" and asynchronous cardiac pacing in patients undergoing coronary intravascular lithotripsy.

AIMS: Coronary intravascular lithotripsy (IVL) is a novel approach to vascular calcium modification that restores vessel compliance allowing effective lesion expansion. In this study we report the capacity for coronary IVL to precipitate ventricular ectopics ("shocktopics") and asynchronous cardiac pacing. METHODS AND RESULTS: This was a retrospective review of all cases of coronary IVL (n=54) undertaken in the Royal Victoria Hospital, Belfast, between September 2018 and March 2019. The indication for PCI was chronic stable angina in 46.1% (n=26), non-ST-elevation acute coronary syndrome (NSTEACS) in 33.3% (n=18) and ST-elevation myocardial infarction (STEMI) in 18.5% (n=10) of patients. The incidence of coronary IVL-provoked ventricular capture was 77.8% (n=42). Multivariable logistic regression analysis identified heart rate as the only independent predictor of an increased risk of IVL-induced ventricular capture. Patients with a heart rate <65 bpm prior to IVL were sixteen-fold more likely (OR 16.3 [2.4-110.8], p=0.004) to experience events compared to patients with a heart rate ≥65 bpm. "Shocktopic" beat morphology was largely uniform in each patient and appeared dependent on the target lesion location, in keeping with mechano-electric coupling through activation of local stretch-activated cardiomyocyte channels. No adverse clinical events occurred as a result of coronary IVL-induced capture. CONCLUSIONS: Coronary IVL with the Shockwave Medical system is associated with a high incidence of "shocktopics" and asynchronous cardiac pacing that is largely dependent on the resting heart rate. There have been no clinical events associated with this phenomenon, but further systematic evaluation is warranted.

A Technical Focus on Antegrade Dissection and Re-entry for Coronary Chronic Total Occlusions: a Practice Update for 2019.

Coronary chronic total occlusions (CTOs) are a commonly encountered lesion. These present in a diverse patient population with variable anatomy. Technical success rates of ~90% are achievable for CTO lesions in centers with appropriate expertise. Many lesions can be crossed with wire-based techniques. However, the most anatomically complex and technically challenging lesions will often require more advanced approaches such as retrograde access and/or the application of blunt dissection techniques in the vessel to safely navigate long and/or ambiguous CTO segments. Retrograde dissection and re-entry (RDR) and antegrade dissection and re-entry (ADR) strategies are often needed to treat such lesions. In many circumstances, ADR offers a safe and efficient means to successfully cross a CTO lesion. Therefore, operators must remain cognizant of the risks and benefits of differing technical approaches during CTO percutaneous coronary intervention, particularly when both ADR and RDR are feasible. This article provides an overview of the ADR technique in addition to updated approaches in contemporary clinical practice.

Erratum to: Common and Uncommon CTO complications.

[This corrects the article DOI: 10.15420/icr.2018.10.2.].

Saphenous Vein Graft Sacrifice Following Native Vessel PCI is Safe and Associated with Favourable Longer-Term Outcomes.

BACKGROUND: Competitive flow from saphenous vein grafts (SVG) that remain patent following percutaneous coronary intervention (PCI) of the native vessel may compromise durability of the reconstructed vessel. SVG sacrifice has been advocated, but the safety and longer-term outcomes of this are unknown. METHODS: We retrospectively reviewed all post-bypass patients who following successful PCI of the native vessel underwent attempted saphenous vein graft (SVG) closure between January 2014 and July 2018 in two institutions. The co-primary end-points of interest were safety and target lesion failure (TLF), defined as a composite of cardiac death, target vessel recurrent myocardial infarction or clinically driven target lesion revascularisation (TLR). RESULTS: Of the 33 consecutive patients included, the reconstructed native vessel was a chronic total occlusion (CTO) in 93.9% of patients (n = 31) with a mean J-CTO score of 3.2 (±1.1) SVG closure was successful in 97.0% of patients (n = 32). Amplatzer Vascular Plugs (AVP; Abbott Vascular) were used in all patients with most grafts closed by a single plug (72.7%). The average procedure time was 20.1 min with evidence of a short learning curve. Over a mean follow up of 602 (±393) days from the date of SVG closure, the incidence of TLF was 9.1% (n = 3). There was an additional case of targe vessel failure (TVF) due to progression of native vessel disease not treated at the index procedure. SVG closure resulted in only 1 episode of "slow flow" that was transient and self-resolving. There were no other associated peri-procedural or in-hospital complications. CONCLUSION: Following native vessel PCI, SVG sacrifice may be considered to terminate the potentially deleterious effects of residual competitive flow. In selected cases, this approach achieves high success rate and favourable longer-term outcomes.

Algorithmic solutions to common problems encountered during chronic total occlusion angioplasty: The algorithms within the algorithm.

Improved technical equipment, dissemination of best practices, and the importance of complete coronary revascularization have led to a renewed interest in coronary chronic total occlusion (CTO) PCI. In particular, the hybrid algorithm has been associated with increasing procedural success rates in the US. However, the hybrid algorithm only covers overarching strategies in the overall approach to these lesions. Several technical challenges can occur during execution of these approaches, each of which has several potential solutions. A systematic or algorithmic approach to dealing with these challenges could contribute to improved procedural efficiency and higher procedural success. While there have been isolated attempts in the past to codify approaches to each of these situations, there has not been a contemporary, comprehensive review of the potential solutions to these problems. We present 10 common problems encountered during CTO PCI and a consensus hierarchical approach to them.

Recovery of myocardial perfusion after percutaneous coronary intervention of chronic total occlusions is comparable to hemodynamically significant non-occlusive lesions.

BACKGROUND: The benefits of chronic coronary total occlusion (CTO) percutaneous coronary intervention (PCI) are being questioned. The aim of this study was to assess the effects of CTO PCI on absolute myocardial perfusion, as compared with PCI of hemodynamically significant non-CTO lesions. METHODS: Consecutive patients with a preserved left ventricular ejection fraction (≥50%) and a CTO or non-CTO lesion, in whom [15 O]H2 O positron emission tomography was performed prior and after successful PCI, were included. Change in quantitative (hyperemic) myocardial blood flow (MBF), coronary flow reserve (CFR) and perfusion defect size (in myocardial segments) were compared between CTOs and non-CTO lesions. RESULTS: In total 92 patients with a CTO and 31 patients with a non-CTO lesion were included. CTOs induced larger perfusion defect sizes (4.51 ± 1.69 vs. 3.23 ± 2.38 segments, P < 0.01) with lower hyperemic MBF (1.30 ± 0.37 vs. 1.58 ± 0.62 mL·min-1 ·g-1 , P < 0.01) and similarly impaired CFR (1.66 ± 0.75 vs. 1.89 ± 0.77, P = 0.17) compared with non-CTO lesions. After PCI both hyperemic MBF and CFR increased similarly between groups (P = 0.57 and 0.35) to normal ranges with higher hyperemic MBF values in non-CTO compared with CTO (2.89 ± 0.94 vs. 2.48 ± 0.73 mL·min-1 ·g-1 , P = 0.03). Perfusion defect sizes decreased similarly after CTO PCI and non-CTO PCI (P = 0.14), leading to small residual defect sizes in both groups (1.15 ± 1.44 vs. 0.61 ± 1.45 segments, P = 0.054). CONCLUSIONS: Myocardial perfusion findings are slightly more hampered in patients with a CTO before and after PCI. Percutaneous revascularization of CTOs, however, improves absolute myocardial perfusion similarly to PCI of hemodynamically significant non-CTO lesions, leading to satisfying results.

Common and Uncommon CTO Complications.

Despite the ongoing development of technical skills, increasing operator experience and improvements in medical devices, percutaneous coronary interventions (PCI) for chronic total occlusions (CTO) are still the most challenging procedures in interventional cardiology for coronary artery disease. Due to the complexity of the procedures, there is an increased complication rate compared with PCIs for the treatment of non-occlusive disease. This may significantly increase procedural morbidity and potentially mortality. CTO-PCI related complications include all the usual complications that are seen in routine PCI in addition to unique issues such as inadvertent occlusion of donor vessels or injury of collateral channels causing haemodynamic instability or ischaemia. To minimise the morbidity associated with these procedures, it is important to be aware of potential complications and recognise them in a timely fashion. Should they arise, operators should be able to deal with them in a safe and efficient manner.