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.

Unintended Deformation of Stents During Bifurcation PCI: An OCTOBER Trial Substudy.

BACKGROUND: Unintended deformation of implanted coronary stents can lead to loss of coronary access, stent thrombosis and coronary events during follow-up. The incidence, mechanisms and clinical outcomes of unintended stent deformations (USD) during complex bifurcation stenting are not well characterized. OBJECTIVES: In a prespecified analysis of the OCTOBER (European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction) trial, we aimed to: 1) determine the incidence and characterize mechanisms of USD identified by optical coherence tomography (OCT); and 2) evaluate physician's detection and correction of accidental abluminal rewiring and USD. METHODS: OCT scans were analyzed for accidental abluminal rewiring and USD. When USD was identified, the plausible mechanism was determined by analysis of all procedural OCT scans and the corresponding angiograms. RESULTS: USD was identified by the core lab in 9.3% (55/589) of OCT-guided cases. Accidental abluminal rewiring was the cause in 44% (24/55), and guide catheter collision was the cause in 40% (22/55) of cases. USD was found in 18.5% of all cases with left main bifurcation percutaneous coronary intervention. The total incidence of abluminal rewiring was 33 in 32 OCT-guided cases (5.4%) and was corrected by physicians in 18 of 33 appearances (54.5%). The 2-year major adverse cardiac event rate for patients with untreated USD (n = 30) was 23.3%, whereas patients with confirmed or possibly corrected USD (n = 25) had no events during follow-up. CONCLUSIONS: USD was associated with adverse procedural complications and cardiac events during follow-up when not identified and corrected. The predominant mechanisms were undetected abluminal rewiring and guide catheter collision. Left main bifurcation percutaneous coronary intervention was a particular risk with USD detected in 18.5% of cases.

Symptoms as a Predictor of the Placebo-Controlled Efficacy of PCI in Stable Coronary Artery Disease.

BACKGROUND: Placebo-controlled evidence from ORBITA-2 found that percutaneous cutaneous intervention (PCI) in stable coronary artery disease with little or no antianginal medication relieved angina, but residual symptoms persisted in many. The reason for this was unclear. OBJECTIVES: ; This ORBITA-2 secondary analysis investigates the relationship between presenting symptoms and disease severity (anatomic, non-invasive, and invasive ischemia) and the ability of symptoms to predict the placebo-controlled efficacy of PCI. METHODS: Pre-randomization symptom severity and nature were assessed using the ORBITA smartphone application and symptom and quality of life questionnaires including the Rose angina questionnaire. Disease severity was assessed using quantitative coronary angiography (QCA), stress echocardiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR). Bayesian ordinal regression was used. RESULTS: At pre-randomization, the median number of daily angina episodes was 0.8 (0.4-1.6), 64% had Rose angina, QCA diameter stenosis 61 (49-74), stress echocardiography score 1.0 (0.0-2.7), FFR 0.63 (0.49-0.75), and iFR 0.78 (0.55-0.87). There was little relationship between symptom severity and nature and disease severity: angina symptom score with QCA ordinal correlation coefficient 0.06 (95% CrI 0.00 to 0.08); stress echocardiography 0.09 (95% CrI 0.02 to 0.10); FFR 0.04 (95% CrI -0.03 to 0.07); and iFR 0.04 (95% CrI -0.01 to 0.07). However, Rose angina and guideline-based typical angina were strong predictors of placebo-controlled PCI efficacy (angina symptom score: OR 1.9, 95% CrI 1.6 to 2.1, Pr(Interaction)=99.9% and OR 1.8, 95% CrI 1.6 to 2.1, Pr(Interaction)=99.9%, respectively). CONCLUSIONS: Although symptom severity and nature were poorly associated with disease severity, the nature of symptoms powerfully predicted the placebo-controlled efficacy of PCI.

Impact of Anatomical and Viability-guided Completeness of Revascularization on Clinical Outcomes in Ischemic Cardiomyopathy.

BACKGROUND: Complete revascularization of coronary disease has been linked to improved outcomes in patients with preserved left ventricular (LV) function. OBJECTIVES: To identify the impact of complete revascularization in patients with severe LV dysfunction. METHODS: Patients enrolled in the REVIVED-BCIS2 trial were eligible if baseline/procedural angiograms and viability studies were available for analysis by independent core laboratories. Anatomical and viability-guided completeness of revascularization were measured by the coronary and myocardial revascularization indices (RIcoro and RImyo) respectively, where RIcoro=[change in BCIS Jeopardy Score (BCIS-JS)] / [baseline BCIS-JS] and RImyo=[number of revascularized viable segments] / [ number of viable segments supplied by diseased vessels]. The PCI group was classified as having complete or incomplete revascularization by median RIcoro and RImyo. The primary outcome was death or hospitalization for heart failure. RESULTS: Of 700 randomized patients, 670 were included. The baseline BCIS-JS and SYNTAX scores were 8 (6 to 10) and 22 (15 to 29) respectively. In those assigned to PCI, median RIcoro and RImyo values were 67% and 85%. Compared to the group assigned to optimal medical therapy alone, there was no difference in the likelihood of the primary outcome in those receiving complete anatomical or viability-guided revascularization (HR 0.90, 95% CI 0.62-1.32 and HR 0.95, 95% CI 0.66-1.35 respectively). A sensitivity analysis by residual SYNTAX score showed no association with outcome. CONCLUSIONS: In patients with severe left ventricular dysfunction, neither complete anatomical nor viability-guided revascularization were associated with improved event-free survival compared to incomplete revascularization or treatment with medical therapy alone.

Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial.

BACKGROUND: The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. METHODS: ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. FINDINGS: Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77-1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI -0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group. INTERPRETATION: ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease. FUNDING: Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary's Coronary Flow Trust, British Heart Foundation.

SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR (Colchicine and spironolactone in patients with myocardial infarction) SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia-driven target vessel revascularization within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention for STEMI based on the Thrombectomy vs percutaneous coronary intervention alone in STEMI (TOTAL) trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%. Overall, 733 patients were enrolled from 8 countries with a mean age 60 years, 19.4% diabetes mellitus, 41.3% anterior MI, and median door-to-balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2 to 6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI, or target vessel revascularization were 2.7%, 1.9%, 1.0%, respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4%, and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared with the performance goal based on previous trials.

A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina.

BACKGROUND: Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina. RESULTS: A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group. CONCLUSIONS: Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).

The everolimus eluting Synergy MegatronTM drug-eluting stent platform: Early outcomes from the European Synergy MegatronTM Implanters' Registry.

BACKGROUND: The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels. AIMS: To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry. METHODS: This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation. RESULTS: Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%.  At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001). CONCLUSIONS: Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.

The safety and feasibility of live-stream proctoring for CTO procedures.

OBJECTIVE: To assess the technical feasibility of a new method of educational training, based on audio-video (AV) communication between an interventional cardiologist and the cath lab staff members in one location and a remote expert proctor. METHODS: Overall, 9 patients underwent a percutaneous coronary intervention (PCI) targeting a chronic total occlusion (CTO) between June 2021 and January 2022 at a single Belgian center using the virtual proctoring approach. For this assessment, the strategic planning of the CTO PCI and all the decisions throughout the intervention were the responsibility of the proctor. The operator was guided via an AV link, by the proctor throughout the procedure. RESULTS: The operator performed each procedural step, guided by the remote proctor, who had continuous access to all relevant interventional details. No major adverse cardiac events (MACE) occurred during the index hospitalization or within 6 months follow-up. CONCLUSIONS: A new method of virtual proctoring based on live AV communication is feasible, even in the case of highly complex CTO PCI procedures. This strategy also appears safe and may provide the patient the benefit of incremental expertise. This approach is facilitated by advances in AV communication and allows physicians to share expertise irrespective of location. It could increase global interaction between colleagues and facilitate sharing of knowledge, which are both key aspects in the development of CTO PCI. This preliminary experience could serve as a basis for future large studies to study the potential role and benefits of virtual proctoring for complex CTO PCI procedures.

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

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

External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries.

BACKGROUND: Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed. RESULTS: Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p < 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p < 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p < 0.001), proximal cap ambiguity (52% vs. 34%, p < 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72-0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5). CONCLUSION: Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI.

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.

Sex Differences in Clinical Profile and Outcome After Percutaneous Coronary Intervention for Chronic Total Occlusion.

BACKGROUND: There are limited data around sex differences in the risk profile, treatments and outcomes of percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) lesions in contemporary interventional practice. We investigated the impact of sex on clinical and procedural characteristics, complications and clinical outcomes in a national cohort. METHODS & RESULTS: We created a longitudinal cohort (2006-2018, n = 30,605) of patients with stable angina who underwent CTO PCI in the British Cardiovascular Intervention Society (BCIS) database. Clinical, demographic, procedural and outcome data were analysed in two groups stratified by sex: male (n = 24,651), female (n = 5954). Female patients were older (68 vs 64 years, P < 0.001), had higher prevalence of diabetes mellitus (DM), hypertension (HTN) and prior stroke. Utilization of intravascular ultrasound (IVUS), drug eluting stents (DES), radial or dual access and enabling strategies during CTO PCI were higher in male compared to female patients. Following multivariable analysis, there was no significant difference in in-patient mortality (adjusted odds ratio (OR):1.40, 95 % CI: 0.75-2.61, P = 0.29) and major cardiovascular and cerebrovascular events (MACCE) (adjusted OR: 1.01, 95 % CI: 0.78-1.29, P = 0.96). The crude and adjusted rates of procedural complications (adjusted OR: 1.37, 95 % CI: 1.23-1.52, P < 0.001), coronary artery perforation (adjusted OR: 1.60, 95 % CI: 1.26-2.04, P < 0.001) and major bleeding (adjusted OR: 2.06, 95 % CI: 1.62-2.61, P < 0.001) were higher in women compared with men. CONCLUSION: Female patients treated by CTO PCI were older, underwent lesser complex procedures, but had higher adjusted risk of procedural complications with a similar adjusted risk of mortality and MACCE compared with male patients.

External validation of the PROGRESS-CTO complication risk scores: Individual patient data pooled analysis of 3 registries.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with a considerable risk of complications, and risk stratification is of utmost importance. AIMS: To assess the clinical usefulness of the recently developed PROGRESS-CTO (NCT02061436) complication risk scores in an independent cohort. METHODS: Individual patient data pooled analysis of 3 registries was performed. RESULTS: Of the 4569 patients who underwent CTO PCI, 102 (2.2%) had major adverse cardiovascular events (MACE). Patients with MACE were older (69 ± 11 vs. 65 ± 10, p < 0.001), more likely to have a history of prior coronary artery bypass graft surgery, and unfavorable angiographic characteristics J-CTO score (2.4 ± 1.2 vs. 2.1 ± 1.3, p = 0.007), including blunt stump (59% vs. 49%, p = 0.047). Technical success was lower in patients with MACE (59% vs. 86%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO complication risk models were as follows: MACE 0.72 (95% confidence interval [CI], 0.67-0.76), mortality 0.73 (95% CI, 0.61-0.85), and pericardiocentesis 0.69 (95% CI, 0.62-0.77) in the validation dataset. The observed complication rates increased with higher PROGRESS-CTO complication scores. The PROGRESS-CTO MACE score showed good calibration in this external cohort, with MACE rates similar to the original study: 0.7% (score 0-1), 1.5% (score 2), 2.2% (score 3), 3.8% (score 4), 4.9% (score 5), 5.8% (score 6-7). CONCLUSION: Given the good discriminative performance, calibration, and ease of calculation, the PROGRESS-CTO complication scores could help assess the risk of complications in patients undergoing CTO PCI.

Validation of the OPEN-CLEAN Chronic Total Occlusion Percutaneous Coronary Intervention Perforation Score in a Multicenter Registry.

Coronary artery perforation is one of the most common and feared complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We evaluated the utility of the recently presented OPEN-CLEAN (Coronary artery bypass graft, Length of occlusion, Ejection fraction, Age, calcificatioN) perforation score in an independent multicenter CTO PCI dataset. Of the 2,270 patients who underwent CTO PCI at 7 centers, 150 (6.6%) suffered coronary artery perforation. Patients with perforations were older (69 ± 10 vs 65 ± 10, p <0.001), more likely to be women (89% vs 82%, p = 0.010), more likely to have history of previous coronary artery bypass graft (38% vs 20%, p <0.001), and unfavorable angiographic characteristics such as blunt stump (64% vs 42%, p <0.001), proximal cap ambiguity (51% vs 33%, p <0.001), and moderate-severe calcification (57% vs 43%, p = 0.001). Technical success was lower in patients with perforations (69% vs 85%, p <0.001). The area under the receiver operating characteristic curve of the OPEN-CLEAN perforation risk model was 0.74 (95% confidence interval 0.68 to 0.79), with good calibration (Hosmer-Lemeshow p = 0.72). We found that the CTO PCI perforation risk increased with higher OPEN-CLEAN scores: 3.5% (score 0 to 1), 3.1% (score 2), 5.3% (score 3), 7.1% (score 4), 11.5% (score 5), 19.8% (score 6 to 7). In conclusion, given its good performance and ease of preprocedural calculation, the OPEN-CLEAN perforation score appears to be useful for quantifying the perforation risk for patients who underwent CTO PCI.

The future of individualized cardiovascular care: how wearables could be integrated to improve outcomes.

Personalized medicine is a concept all clinicians must strive to deliver. Recent advances in technology increasingly offer new opportunities to personalize care, not least in cardiovascular medicine. Health trackers and wearables are technologies in an explosive phase of development. They allow accurate and continuous measurement of bio-data, recorded and analysed using apps and mobile devices. However, although there is huge potential, most physicians and healthcare organizations are yet to realize the value of integrating wearables into routine clinical practice. We discuss how this state-of-the-art technology can support patients in making meaningful lifestyle changes and revolutionize the future of cardiovascular medicine.

Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction.

BACKGROUND: Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown. METHODS: We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores. RESULTS: A total of 700 patients underwent randomization - 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P = 0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, -1.6 percentage points; 95% CI, -3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, -1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months. CONCLUSIONS: Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure. (Funded by the National Institute for Health and Care Research Health Technology Assessment Program; REVIVED-BCIS2 ClinicalTrials.gov number, NCT01920048.).

Defining Percutaneous Coronary Intervention Complexity and Risk: An Analysis of the United Kingdom BCIS Database 2006-2016.

OBJECTIVES: The authors used the BCIS (British Cardiovascular Intervention Society) database to define the factors associated with percutaneous coronary intervention (PCI) procedural complexity. BACKGROUND: Complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly defined. METHODS: The BCIS (British Cardiovascular Intervention Society) database was used to study all PCI procedures in the United Kingdom 2006-2016. A multiple logistic regression model was developed to identify variables associated with in-hospital major adverse cardiac or cerebrovascular events (MACCE) and to construct a CHIP score. The cumulative effect of this score on patient outcomes was examined. RESULTS: A total of 313,054 patients were included. Seven patient factors (age ≥80 years, female sex, previous stroke, previous myocardial infarction, peripheral vascular disease, ejection fraction <30%, and chronic renal disease) and 6 procedural factors (rotational atherectomy, left main PCI, 3-vessel PCI, dual arterial access, left ventricular mechanical support, and total lesion length >60 mm) were associated with increased in-hospital MACCE and defined as CHIP factors. The mean CHIP score/case for all PCIs increased significantly from 1.06 ± 1.32 in 2006 to 1.49 ± 1.58 in 2016 (P < 0.001 for trend). A CHIP score of 5 or more was present in 2.5% of procedures in 2006 increasing to 5.3% in 2016 (P < 0.001 for trend). Overall in-hospital MACCE was 0.6% when the CHIP score was 0 compared with 1.2% with any CHIP factor present (P < 0.001). As the CHIP score increased, an exponential increase in-hospital MACCE was observed. The cumulative MACCE for procedures associated with a CHIP score 4+ or above was 3.2%, and for a CHIP score 5+ was 4.4%. All other adverse clinical outcomes were more likely as the CHIP score increased. CONCLUSIONS: Seven patient factors and 6 procedural factors were associated with adverse in-hospital MACCE and defined as CHIP factors. Use of a CHIP score might be a future target for risk modification.

Outcomes of successful vs. failed contemporary chronic total occlusion percutaneous coronary intervention.

BACKGROUND: There are limited contemporary data on the impact of success vs. failure on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We conducted a systematic review and a meta-analysis of contemporary studies that compared the outcomes in patients who underwent successful vs. failed contemporary (2010 onwards) CTO PCI. We performed a sensitivity analysis limited to studies that started enrollment after the publication of the hybrid algorithm in 2012. RESULTS: We included five studies with a total of 6,084 patients (successful CTO PCI n = 4,861, failed CTO PCI n = 1,223). During a median follow-up time of 12 months (range 6-60 months), successful CTO PCI was associated with a lower risk of major adverse cardiovascular events [OR: 0.61, 95% CI (0.41, 0.92), p = 0.02, I2 = 63%] and all-cause death [OR: 0.57, 95% CI (0.33, 0.99), p = 0.05, I2 = 60%]. Both groups had similar risk of myocardial infarction (MI) [OR 0.69, 95% CI (0.43, 1.10), p = 0.38, I2 = 80%], target vessel revascularization (TVR) [OR: 0.56, 95% CI (0.25, 1.27), p = 0.17, I2 = 80%], and stroke [OR: 0.52, 95% CI (0.14, 1.91), p = 0.33, I2 = 0%]. CONCLUSION: In contemporary practice, successful CTO PCI was associated with a lower incidence of MACE driven by lower all-cause mortality compared with failed CTO PCI at a median follow-up of 1 year.