Standard Percutaneous Coronary Intervention Research Articles

Safety, feasibility, and incremental value of ultralow and zero contrast PCI in an all-comers registry.

Patients with chronic kidney disease and CAD have been denied revascularization because of fear of precipitating acute renal failure from contrast exposure. Skepticism on whether Ultra-Low contrast percutaneous coronary intervention (PCI) or Zero contrast PCI (ULC/ZC PCI) can be safely performed has limited its adoption. This observational registry enrolled 200 consecutive patients referred for elective PCI at a single center from June 2021 to December 2022. The study investigated whether the clinical outcomes of PCI performed with UL/ZC-PCI (n-48) were comparable to outcomes following standard PCI (n-152). Both groups were well matched in baseline and procedural characteristics. The groups had a highly statistical difference in the use of CV. Mean CV was 19.17 ± 7.29 cc in the ULC/ZC-group and 147.14 ± 73.55 cc in the control arm. The principal findings of the study were that the incidence of ontrast-induced acute kidney injury (AKI) was eightfold lower in patients receiving UL/ZC compared to the control group that received standard PCI. The incidence of all-cause mortality, myocardial infarction and major bleeding were similar in both groups. At 6 months, the decrement in renal function was lower in the group that received lower volumes of contrast. This single center observational registry demonstrated that UL-C/ZC-PCI is safe and effective in a broad spectrum of complex lesions. The skillsets needed to perform this are teachable, widely applicable and do not require a large upgrade of capital equipment. AKI rates and decrement in renal function at 6 months were both significantly lower in the UL-ZC group.

Electroacupuncture for slow flow/no-reflow phenomenon in patients with acute myocardial infarction undergoing percutaneous coronary intervention: protocol for a pilot randomized controlled trial.

Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI. This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure. This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials. ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.

Association between cholesterol crystals and 6-month prognosis in patients with acute coronary syndrome: an optical coherence tomography study

Abstract Background Optical coherence tomography (OCT) guided percutaneous coronary intervention (PCI) has been demonstrated to improve short and long-term outcomes compared with standard angiography-guided PCI. However, little is known about the impact of cholesterol crystals on the prognosis of patients with acute coronary syndrome (ACS) in the setting of receiving OCT-guided PCI. Purpose This study aims to investigate the association between cholesterol crystals and 6-month outcomes in ACS patients who underwent OCT-guided PCI. Methods Patients with ACS who underwent OCT-guided PCI in a high-volume PCI center between July 2020 and June 2022 were retrospectively enrolled and were further divided into two groups according to the presence or absence of cholesterol crystals. OCT imaging characteristics including plaque morphology before the PCI procedure in target lesions were assessed. The primary outcome was a composite of all-cause death, ischemia-driven revascularization, or readmission for heart failure in a 6-month follow-up period. The association between cholesterol crystals and 6-month outcomes was evaluated using Kaplan-Meier curves. Independent predictors for cholesterol crystals and 6-month outcomes were evaluated by the logistic regression and Cox proportional hazards regression analyses, respectively. Results 403 patients were enrolled in this study. The mean age was 61 years old and 79.4% were men. Cholesterol crystals were presented in 224 (55.6%) target lesions in patients with ACS. Baseline characteristics were not statistically different between the two groups in age, sex, smoke, previous hyperlipidemia, and other clinical features, except for diabetes, multivessel disease, and ACS classification (p <0.05). In the multivariable logistic regression analysis, cholesterol crystals were associated with diabetes, plaque rupture, lipid length, calcification, macrophage infiltration, and thin-capped fibroatheroma (all p <0.05). Patients with cholesterol crystals had higher risks of poor 6-month composite outcomes when compared to those without cholesterol crystals (13.4% vs. 6.7%, HR 2.09, 95%CI 1.07-4.09, p = 0.031), even after confounders adjustment for age, sex, diabetes, multivessel disease and ACS classification using inverse probability of treatment weighting (p = 0.027). Subgroup analysis showed significant interactions between cholesterol crystals and 6-month outcomes with respect to the male (HR 2.82, 95%CI 1.22-6.51, p = 0.015), target lesions in LAD (HR 4.47, 95%CI 1.29-15.44, p = 0.018), and incomplete revascularization (HR 3.08, 95%CI 1.04-8.98, p = 0.042). The Cox regression analysis identified cholesterol crystal as an independent predictor for 6-month composite outcomes (HR 2.12, 95%CI 1.08-4.19, p = 0.030). Conclusions The presence of cholesterol crystals was associated with a poor 6-month prognosis in patients with ACS, even in the setting of receiving OCT-guided PCI.

Comparison of mid-term mortality after surgical, supported or unsupported percutaneous revascularization in patients with severely reduced ejection fraction: A direct and network meta-analysis of adjusted observational studies and randomized-controlled

IntroductionThe optimal revascularization strategy in patients with heart failure with reduced ejection fraction (HFrEF) remains to be elucidated. The aim of this paper is to compare the mid-term mortality rate among patients with severely reduced ejection fraction (EF) and complex coronary artery disease who underwent coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) with Impella support, or without. MethodsRandomized control trials and propensity-adjusted observational studies including patients with ischemic cardiomyopathy (ICM) and severe EF reduction undergoing revascularization were selected. Different revascularization strategies (CABG, supported PCI, and PCI without Impella) were compared in pairwise and network meta-analysis. The primary endpoint was mid-term mortality (within the first year after revascularization). ResultsFifteen studies, mostly observational (17,841 patients; 6779 patients treated with CABG, 8478 treated with PCI without Impella, and 2584 treated with Impella-supported PCI) were included in this analysis. The median age was 67.8 years (IQR 65–70.1), 21.2% (IQR 16.4–26%) of patients were female sex, and a high prevalence of cardiovascular risk factors was noted across the entire population. At pairwise analysis, CABG and PCI without Impella showed similar one-year all-cause mortality (10.6% [IQR 7.5–12.6%] vs 12% [IQR 8.4–11.5%]) RR 0.85 CI 0.67–1.09, while supported PCI reduced one-year all-cause mortality compared to PCI without Impella (9.4% [IQR 5.7–12.5%] vs 10.6% [IQR 8.9–10.7%]) RR 0.77 CI 0.6–0.89. At network meta-analysis, supported PCI showed better results (RR 0.75, 95% CI 0.59–0.94) compared to CABG. ConclusionOur analysis found that supported PCI may have a benefit over standard PCI in patients in direct comparison, and over CABG from indirect comparison, and with HFrEF undergoing revascularization. Further RCTs are needed to confirm this result. (PROSPERO CRD42023425667).

Safety and Long-Term Outcomes of Rotablation in Patients with Reduced (

Clinical outcomes in patients with reduced left ventricular systolic function undergoing rotational atherectomy (RA) for percutaneous coronary intervention (PCI) remain understudied. Our study sought to evaluate the impact of RA-PCI in patients with LV systolic dysfunction on long-term outcomes. Between 2015 and 2019, 4941 patients with reduced LV function (rEF) undergoing PCI (with or without RA) were included in the hospital database. The primary endpoint was in-hospital major adverse cardiovascular and cerebral events (MACCE). The secondary endpoint was 3-year MACCE. In-hospital MACCE rates were significantly higher in RA-PCI compared to standard PCI without RA (PCI) (7.6% vs. 3.9%, p = 0.0009). However, 3-years MACCE rates were similar in RA-PCI and PCI (26.40% vs. 26.6%, p = 0.948). In conclusion, RA-PCI in patients with rEF is feasible, safe, and shows similar long-term results to PCI.

A Single-Center Study Using IVUS to Guide Rotational Atherectomy for Chronic Renal Disease's Calcified Coronary Artery.

To assess the effectiveness and safety of an IVUS-guided rotational atherectomy (RA) percutaneous coronary intervention (PCI) in chronic renal patients with complex coronary calcification who are at risk for contrast-related acute kidney injury (AKI). From October 2018 to October 2021, 48 patients with chronic renal disease who were receiving PCI with RA at the General Hospital of NingXia Medical University were informed for data collection for this research. They were randomly assigned to the IVUS-guided RA group and the Standard RA group, which did not use IVUS. According to a clinical expert consensus document on rotational atherectomy in China, both PCI procedures were performed. The intravascular ultrasound (IVUS) results from the study group were used to describe the morphology of the lesion and to guide the selection of burrs, balloons, and stents. IVUS and angiography were used to evaluate the outcome in the end. IVUS-guided RA PCI and Standard RA PCI groups' effects and results were contrasted. There were no appreciable differences in the clinical baseline characteristics between the IVUS-guided RA PCI group and the Standard RA PCI group. The average estimated glomerular filtration rate (eGFR) of two groups was (81.42 ± 20.22 vs 82.34 ± 22.19) mL/min/1.73 m2. Most of them (45.8% vs 54.2%) was in stage 60-90 mL/min/1.73m2. When compared to the standard RA PCI group, RA in IVUS-Guided group was more performed electively (87.5% vs 58.3%; p = 0.02). The IVUS-guided RA PCI group was associated with shorter fluoroscopy time (20.6 ± 8.4 vs 36 ± 22; p<0.01) and less contrast amount (32 ±16 vs 184 ±116mL; p<0.01) than Standard-RA group. Five patients in the Standard RA PCI group developed contrast-induced nephropathy, which was 5 times than the IVUS-guided RA PCI group (20.8% VS 4.1%; p=0.19). In chronic renal patients with complex coronary calcification, an IVUS-guided RA PCI technique is effective and safe. It can also lower the volume of contrast and perhaps the incidence of contrast-related AKI.

The relationship between chronic kidney disease and "complex" percutaneous coronary intervention: Uncovering the details.

Key Points It remains unclear whether the complexity level of coronary interventions affects cardiovascular outcomes in patients with chronic kidney disease (CKD). This study showed that “complex” percutaneous coronary intervention (PCI) is associated with a greater risk of adverse cardiovascular events than standard PCI in both patients with or without CKD. However, the complexity of PCI appeared to have a greater effect on all‐cause mortality and bleeding in patients with CKD than in those without CKD. The data presented confirm the predicted effect of CKD on outcomes after complex PCI. However, the similar effect of complex PCI observed in patients with or without CKD suggests that some patients with CKD have an acceptable risk profile to undergo complex intervention. The reported findings should be interpreted with caution; making a patient‐specific decision before PCI is key in this patient population.

Abstract 10566: Hypothermia as an Adjunctive Therapy to Percutaneous Intervention in St-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Control Trials

Introduction: In the setting of acute ST-elevation myocardial infarction (STEMI), several randomized control trials (RCTs) suggested a potential benefit with the use of Therapeutic hypothermia (TH). However, results from previous studies are contradictory. Method: We performed a comprehensive literature search for studies that evaluated the efficacy and safety of adjunctive TH compared to the standard percutaneous coronary intervention (PCI) in awake patients with STEMI. The primary outcome was the infarct size (IS) and microvascular obstruction (MVO) assessed by cardiac imaging at the end of follow-up. The secondary outcomes were major adverse cardiovascular events (MACE), procedure-related complications, and door to balloon time. Relative risk (RR) or the mean difference (MD) and corresponding 95% confidence intervals (CIs) were calculated using the random-effects model. Results: A total of 10 RCTs, including 706 patients (mean age: 58±9.6 years, 364 patients managed with adjunctive TH vs. 342 with standard PCI), were included. As compared to standard PCI, TH was not associated with a statistically significant improvement in the IS (MD: -0.87 %, 95%CI: -2.97, 1.23; P = 0.42) or in the MVO (MD: 0.11 %, 95%CI: -0.06, 0.27; P = 0.21). MACE and its individual components were comparable between the two groups. However, the TH approach was associated with an increased risk of infection and prolonged door to balloon time. Furthermore, there was a trend in the TH group toward an increased incidence of stent thrombosis and paroxysmal atrial fibrillation. Conclusions: According to our meta-analysis of published RCTs, the benefit of TH in STEMI patients is modest, with a marginal safety profile and potential for care delays. Larger-scale RCTs are needed to further clarify our results.

Hypothermia as an Adjunctive Therapy to Percutaneous Intervention in ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Control Trials

IntroductionIn the setting of acute ST-elevation myocardial infarction (STEMI), several randomized control trials (RCTs) suggested a potential benefit with the use of therapeutic hypothermia (TH). However, results from previous studies are contradictory. MethodWe performed a comprehensive literature search for studies that evaluated the efficacy and safety of adjunctive TH compared to the standard percutaneous coronary intervention (PCI) in awake patients with STEMI. The primary outcomes were the infarct size (IS) and microvascular obstruction (MVO) assessed by cardiac imaging at the end of follow-up. The secondary outcomes were major adverse cardiovascular events (MACE), procedure-related complications, and door-to-balloon time. Relative risk (RR) or the mean difference (MD) and corresponding 95 % confidence intervals (CIs) were calculated using the random-effects model. ResultsA total of 10 RCTs, including 706 patients were included. As compared to standard PCI, TH was not associated with a statistically significant improvement in the IS (MD: -0.87 %, 95%CI: −2.97, 1.23; P = 0.42) or in the MVO (MD: 0.11 %, 95%CI: −0.06, 0.27; P = 0.21). MACE and its components were comparable between the two groups. However, the TH approach was associated with an increased risk of infection and prolonged door-to-balloon time. Furthermore, there was a trend in the TH group toward an increased incidence of stent thrombosis and paroxysmal atrial fibrillation. ConclusionsAccording to our meta-analysis of published RCTs, TH is not beneficial in awake patients with STEMI and has a marginal safety profile with potential for care delays. Larger-scale RCTs are needed to further clarify our results.

Cardiac Magnetic Resonance Shows Improved Outcomes in Patients with an ST-Segment Elevation Myocardial Infarction and a High Thrombus Burden Treated with Adjuvant Aspiration Thrombectomy.

There is a discrepancy between epicardial vessel patency and microcirculation perfusion in a third of patients treated with percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Optimization with aspiration thrombectomy (AT) may reduce distal embolization and microvascular obstruction. The effect of AT in the treatment of STEMI is debatable. The purpose of this study was to use cardiac magnetic resonance (CMR) to determine whether AT influences microvascular obstruction (MVO), infarct size and left ventricular (LV) remodelling in STEMI patients. Sixty STEMI patients with a thrombus-occluded coronary artery were randomized in a 2:1 fashion to receive PCI proceeded by AT (AT + PCI group), or PCI only. MVO, myocardial infarct size and LV remodelling were assessed by CMR during the index hospitalization and 6 months thereafter. The majority of patients had a large thrombus burden (TIMI thrombus grade 5 in over 70% of patients). PCI and AT were effective in all cases. There were no periprocedural strokes. CMR showed that the addition of AT to standard PCI was associated with lesser MVO when indexed to the infarct size and larger infarct size reduction. There were less patients with left ventricle remodelling in the AT + PCI vs. the PCI only group. To conclude, in STEMI patients with a high thrombus burden, AT added to PCI is effective in reducing infarct size, MVO and LV remodelling.

First-in-Human Evaluation of the Safety and Efficacy of a Novel Stent Positioning Assistance System for Precise Positioning of Coronary Stents.

Objectives This study was planned for evaluating the safety and efficacy of SPAS (stent positioning assistance system) device in first-in-human procedures. Background SPAS is a novel device that can be used for improved positioning of coronary stents. Methods Consecutive patients underwent percutaneous coronary intervention (PCI) with the SPAS device. Device-related adverse and serious adverse events were evaluated in addition to a dedicated questionnaire completed by operators immediately after using SPAS. Results The SPAS device was deployed in 55 PCI procedures, comprising of heavily calcified lesions (33.3%), totally occluded (7.4%), and severely tortuous vessels (7.4%). In these procedures, nonbifurcation and nonostial (53.7%), bifurcation (22.2%), and edge-to-edge (24.1%) stenting techniques were employed. Analysis of the pooled scores for the five satisfaction-related questions gave an average score of 5.6 ± 1.5, with 40 (75.5%) operators providing an average satisfaction grade of >5; the average operator-rated SPAS device accuracy performance scores exceeded 6 out of 7 (on visual analog score). The time spent for positioning the stent with the SPAS device averaged 41 ± 68.0 seconds. The SPAS device was rated as easy to use (6.1 ± 1.6) and reliable (6.1 ± 1.7). No device-related adverse events were reported. Conclusion This stent positioning device was evaluated in a consecutive cohort of standard and complex PCI procedures. The device was shown to be safe, easy, and precise to use, both in standard and complex cases.

A multi-center, international, randomized, 2-year, parallel-group study to assess the superiority of IVUS-guided PCI versus qualitative angio-guided PCI in unprotected left main coronary artery (ULMCA) disease: Study protocol for OPTIMAL trial.

Percutaneous coronary intervention (PCI) is used increasingly for revascularization of unprotected left main coronary artery (LMCA) disease. Observational studies and subgroup analyses from clinical trials, have suggested a possible benefit from the use of intravascular ultrasound (IVUS) guidance when performing unprotected LMCA PCI. However, the value of imaging with IVUS has never been proven in an appropriately powered randomized clinical trial. The OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound (OPTIMAL) trial has been designed to establish whether IVUS-guided PCI optimization on LMCA is associated with superior clinical outcomes when compared with standard qualitative angiography-guided PCI. The OPTIMAL trial is a randomized, multicenter, international study designed to enroll a total of 800 patients undergoing PCI for unprotected LMCA disease. Patients will be randomized in a 1:1 fashion to IVUS-guided PCI versus angiogram-guided PCI. In patients allocated to the angiogram-guided arm, use of IVUS is discouraged, unless there are safety concerns. In patients allocated to the IVUS guidance arm, pre-procedural IVUS assessment is highly recommended, whilst post-procedural IVUS assessment is mandatory to confirm appropriate stenting result and/or to guide stent result optimization, according to predefined criteria. Patients will be followed up to 2 years after the index procedure. The primary outcome measure is the Academic Research Consortium (ARC) patient-oriented composite endpoint (PoCE) which includes all-cause death, any stroke, any myocardial infarction and any repeat revascularization at 2 years follow-up. The OPTIMAL trial aims to provide definitive evidence about the clinical impact of IVUS-guidance during PCI to an unprotected LMCA. It is anticipated by the investigators, that an IVUS-guided strategy will be associated with less clinical events compared to a strategy guided by angiogram alone. ClinicalTrials.gov: NCT04111770. Registered on October 1, 2019.

Radial versus femoral approach for rotational atherectomy – technical aspects and procedural outcomes

Abstract Background Rotational atherectomy (RA) is a well-established therapy for the treatment of heavily calcified coronary lesions. While the radial approach has evolved into the gold-standard for standard percutaneous coronary intervention (PCI), RA is still often performed via a femoral approach. Concerns over guiding size, sheath size, the delivery of the burr as well as the need for a temporary pacemaker play a role in that decision. Methods This retrospective analysis includes all patients undergoing RA from 03/2013 to 06/2019 at one institution. We sought to investigate the procedural outcome and the influence of the percutaneous approach. Results A total of 228 patients were planned to undergo RA. Based on operator preference, RA was attempted via the radial approach (RAD) in 78 (34.2%) patients and via the femoral approach (FEM) in 150 (65.8%) patients. The procedure failed in 2.6% (RAD 1.3% vs. FEM 3.3%, p=0.359) due to crossing failure of either the RotaWire (n=5) or the burr (n=1). The left anterior descending was the most frequently treated vessel in the radial group and significantly more often targeted in comparison to the femoral group (LAD: RAD 44.6% vs. FEM 26.5%, p=0.004). All other vessels were similarly often treated in both groups (LM: RAD 13.3% vs. FEM 17.3%, p=0.414; LCX: RAD 15.7% vs. FEM 23.5%, p=0.155; RCA: RAD 25.3% vs. FEM 31.5%, p=0.315; Bypass: RAD 1.2% vs. FEM 1.2%, p=0.984). RAD-RA was significantly more often performed with a 6F sheath in comparison to FEM-RA (RAD 47.4% vs. FEM 16.7%, p&amp;lt;0.001). A 7F sheath was used in 52.6% of the cases for RAD-RA (men: 85.4%, women: 14.6%, p=0.176) and is therefore the most frequently chosen sheath size within that group. A 7F or 8F sheath was used in 75.3%, respectively 8.0% of the cases in the FEM group (7F: p&amp;lt;0.001; 8F: p=0.010 compared to RAD). There were no significant differences regarding the burr sizes (RAD 1.43±0.17mm vs FEM 1.41±0.18mm, p=0.442). Whereas the placement of a temporary pacemaker was equal in both groups (RAD 20.8% vs. FEM 30.8%, p=0.110), the femoral group showed a higher number of patients with any back-up pacing, permanent or temporary (RAD 24.7% vs. FEM 39.0%, p=0.031). There were no significant differences in terms of fluoroscopy time (RAD 00:24:65±00:12:48 vs. FEM 00:28:33±00:17:05, p=0.180) and the volume of contrast medium (RAD 217.2±96.3ml vs. FEM 192.9±86.0ml, p=0.118). Moreover, procedural complications (RAD 17.9% vs. FEM 18.0%, p=0.992) and access site related complications (RAD 6.4% vs. FEM 10.0%, p=0.363) occurred equivalently in both groups. Conclusion This analysis shows that RA via radial access is as safe and successful as via femoral access. Despite the more frequent use of 6F sheaths, burr sizes did not differ. Additionally, neither fluoroscopy time nor contrast volume indicated a higher complexity of the RAD approach. Funding Acknowledgement Type of funding sources: None.

Safety and feasibility of robotic assisted percutaneous coronary intervention compared to standard percutaneous coronary intervention- a systematic review and meta-analysis

ObjectiveRobotically assisted PCI offers a great alternative to S–PCI. This has gained even more relevance during the COVID-19 pandemic era however safety of R–PCI compared to S–PCI has not been studied well. This study explores the safety and efficacy of robotically assisted PCI (R–PCI) compared to standard PCI (S–PCI) for the treatment of coronary artery disease (CAD). MethodsPubMed, Scopus, Ovid, and Google scholar databases were searched for studies comparing R–PCI to S–PCI. Outcomes included clinical success, procedure time, fluoroscopy time, contrast use and radiation exposure. ResultsTheauthors included 5 studies comprising 1555 patients in this meta-analysis. Clinical success was comparable in both arms (p = 0.91). Procedure time was significantly longer in R–PCI group (risk ratio: 5.52, 95% confidence interval: 1.85 to 9.91, p = 0.003). Compared to S–PCI, patients in R–PCI group had lower contrast use (meandifference: −19.88, 95% confidence interval: −21.43 to −18.33, p < 0.001), fluoroscopy time (mean difference:-1.82, 95% confidence interval: −3.64 to −0.00, p = 0.05) and radiation exposure (mean difference:-457.8, 95% confidence interval: −707.14 to −208.14, p < 0.001). ConclusionR–PCI can achieve similar success as S–PCI at the expense of longer procedural times. However, radiation exposure and contrast exposure were lower in the R–PCI arm.

Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.

To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. Mean glomerular filtration rate was 32 ± 17ml/min/1.73m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.

Case Report: Role of Rotational Atherectomy in Complex PCI

Background : One in three patients undergoing percutaneous coronary intervention (PCI) exhibits moderate or severe coronary artery calcification. Coronary calcification remains a major independent predictor of PCI failure and adverse outcomes. PCI of calcified coronary lesions remains challenging, despite significant improvements in the available tools and techniques. Rotational Atherectomy (RA) is a critical component to improve PCI success in these situations by producing lumen enlargement by physical removal of plaque and reduction in plaque rigidity, thus facilitating dilation Case Illustration: A 73-year-old man with exertional angina was referred to our hospital, with a history of hypertension, diabetes mellitus, ex-smoker and dyslipidemia. Physical exam, electrocardiogram, chest x-rays, and laboratory findings were unremarkable, but transthoracic echocardiogram revealed anterior wall hypokinesis. History of cardiac catheterization outside of our center with angiographic result of left anterior descending (LAD) lesion, highly calcified, non-dilatable on first several POBA attempts. Coronary angiography at our center, revealed diffuse calcification from proximal to distal of the LAD artery with about 90% maximum stenosis in mid LAD. RA (Rotablator, Boston) was then performed with A 1.50 mm burr gradually advanced at 150,000 rpm to passed the lesion. After deployments of stents, final angiogram showed well positioned stents with good distal run-off flow. The patient was uneventful during the procedure and was discharged following day. Discussion: In experienced hands, RA is as safe as standard PCI. RA is as a tool to make PCI possible in complex lesions with moderate or severe calcification when clinical variables make PCI appropriate. Rotablator is a catheter-based interventional cardiology procedure using a high-speed rotational device designed to ablate atherosclerotic plaque and restore luminal patency. This help to facilitate stent delivery, avoiding the barotrauma caused by repeated high-pressure balloon inflations that can lead to vessel dissection or perforation. Atherectomy can be performed safely with optimal burr selection and proper ablation techniques, and as a result, complication rates have been significantly minimized, with few changes in the acute complications reported in contemporary studies.

Antithrombotic Therapy in Chronic Total Occlusion Interventions

Chronic total occlusion (CTO) recanalization is among the most complex subsets of coronary interventions. Hence, optimum peri- and post-procedural anticoagulation and antiplatelet therapy is key for the achievement of successful revascularization and reduction of major adverse cardiovascular outcomes in patients undergoing CTO percutaneous coronary intervention (PCI). Unfractionated heparin is still considered the gold standard anticoagulant because its action can be reversed by protamine administration, with bivalirudin being reserved mainly for patients with heparin-induced thrombocytopenia. However, small studies comparing unfractionated heparin with bivalirudin in CTO interventions have shown similar outcomes. Glycoprotein IIb/IIIa inhibitors should, in general, be avoided. Aspirin in combination with clopidogrel for 6–12 months is the standard post CTO PCI dual antiplatelet regimen. For the most complex cases, clopidogrel can be substituted by a more potent P2Y12 inhibitor, namely ticagrelor or prasugrel.

Use of enhanced stent visualisation compared to angiography alone to guide percutaneous coronary intervention

ObjectiveWe aimed to assess the use of enhanced stent visualisation (ESV) on outcomes, after PCI with overlapping stents, specifically using CLEARstent technology. BackgroundStent underexpansion and overlap are both significant risk factors for restenosis and stent thrombosis. Enhanced stent visualisation (e.g. CLEARstent) systems could provide important data to reduce under-expansion and stent overlap. MethodsThis was a cohort study based on this institution's percutaneous coronary intervention (PCI) registry. A total of 2614 patients who had PCI for stable angina or acute coronary syndromes (ACS, excluding cardiogenic shock) with overlapping 2nd generation drug eluting stents (DES) in the same vessel between May 2015 and January 2018 were included in the analysis. Patients were divided into ESV (n = 1354) and no ESV guided intervention (n = 1260). The primary end-point was major adverse cardiovascular events (MACE: target vessel revascularisation, target vessel myocardial infarction and all-cause mortality) recorded at a median follow up of 2.4 years. ResultsGroups were comparable for patient characteristics (age, diabetes mellitus, ACS presentation). A significant difference in MACE was observed between patients who underwent ESV-guided PCI (9.5%) compared with patients who underwent Standard PCI (14.4%, p = .018). This difference was mainly driven by reduced rates of target vessel revascularisation and recurrent myocardial infarction. Overall this difference persisted after multivariate Cox analysis (HR 0.86, 95% CI: 0.73–0.98) and propensity matching (HR = 0.88, 95% CI: 0.69–0.99). ConclusionWe suggest that routine clinical use of ESV technology during PCI can be useful, and is associated with better medium-term angiographic and clinical outcomes. Further study is required to build on this promising signal.

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

ObjectivesThis study aimed to determine the effect on long-term survival of using optical coherence tomography (OCT) during percutaneous coronary intervention (PCI). BackgroundAngiographic guidance for PCI has substantial limitations. The superior spatial resolution of OCT could translate into meaningful clinical benefits, although limited data exist to date about their effect on clinical endpoints. MethodsThis was a cohort study based on the Pan-London (United Kingdom) PCI registry, which includes 123,764 patients who underwent PCI in National Health Service hospitals in London between 2005 and 2015. Patients undergoing primary PCI or pressure wire use were excluded leaving 87,166 patients in the study. The primary endpoint was all-cause mortality at a median of 4.8 years. ResultsOCT was used in 1,149 (1.3%) patients, intravascular ultrasound (IVUS) was used in 10,971 (12.6%) patients, and angiography alone in the remaining 75,046 patients. Overall OCT rates increased over time (p < 0.0001), with variation in rates between centers (p = 0.002). The mean stent length was shortest in the angiography-guided group, longer in the IVUS-guided group, and longest in the OCT-guided group. OCT-guided procedures were associated with greater procedural success rates and reduced in-hospital MACE rates. A significant difference in mortality was observed between patients who underwent OCT-guided PCI (7.7%) compared with patients who underwent either IVUS-guided (12.2%) or angiography-guided (15.7%; p < 0.0001) PCI, with differences seen for both elective (p < 0.0001) and acute coronary syndrome subgroups (p = 0.0024). Overall this difference persisted after multivariate Cox analysis (hazard ratio [HR]: 0.48; 95% confidence interval [CI]: 0.26 to 0.81; p = 0.001) and propensity matching (hazard ratio: 0.39; 95% CI: 0.21 to 0.77; p = 0.0008; OCT vs. angiography-alone cohort), with no difference in matched OCT and IVUS cohorts (HR: 0.88; 95% CI: 0.61 to 1.38; p = 0.43). ConclusionsIn this large observational study, OCT-guided PCI was associated with improved procedural outcomes, in-hospital events, and long-term survival compared with standard angiography-guided PCI.

Impact of Selective Aspiration Thrombectomy on Mortality in Patients With ST-Segment Elevation Myocardial Infarction

Although routine aspiration thrombectomy (AT) is not recommended by the current American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guideline, for selected cases, a class IIb indication is given because of lack of data. We studied the impact of selective AT on mortality in patients with ST-segment elevation myocardial infarction using a prospective registry. We analyzed data of 1,255 patients, of whom 535 underwent AT based on operator's decision. Separate propensity score matching procedures were performed including all patients and only those with initial TIMI (Thrombolysis In Myocardial Infarction) 0 to 1 flow, indicating the highest thrombus burden. Primary outcome measure was time to all-cause death at 1 year. Both studies were sufficiently powered to detect the hazard ratio (HR) of 0.52 seen in the TAPAS (Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study) trial. In the study with open inclusion criteria, 1-year mortality rates were 15.5% and 14.5% in the AT and conventional percutaneous coronary intervention arm, respectively (p = 0.77). The unadjusted HR was 1.05 (95% CI 0.73 to 1.51), p = 0.80, whereas the adjusted HR was 0.97 (95% CI 0.66 to 1.41), p = 0.87. In patients with initial TIMI 0 to 1 flow, mortality rate at 1 year was 15.6% in the AT and 16.7% in the standard percutaneous coronary intervention group (p = 0.76). The unadjusted and adjusted HRs were similar: 0.91 (95% CI 0.62 to 1.34), p = 0.65 and 0.93 (95% CI 0.62 to 1.37), p = 0.70, respectively. In conclusion, selective AT based on operator's discretion offers no mortality benefit of the magnitude detected in the TAPAS trial, even for patients with initial TIMI 0 to 1 flow grade.