Placebo-Controlled Efficacy of Percutaneous Coronary Intervention for Focal and Diffuse Patterns of Stable Coronary Artery Disease.
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ABSTRACT:
SUBMITTER: Rajkumar CA
PROVIDER: S-EPMC8366766 | biostudies-literature | 2021 Aug
REPOSITORIES: biostudies-literature
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Placebo-Controlled Efficacy of Percutaneous Coronary Intervention for Focal and Diffuse Patterns of Stable Coronary Artery Disease.
Rajkumar Christopher A CA Shun-Shin Matthew M Seligman Henry H Ahmad Yousif Y Warisawa Takayuki T Cook Christopher M CM Howard James P JP Ganesananthan Sashiananthan S Amarin Laura L Khan Caitlin C Ahmed Ayesha A Nowbar Alexandra A Foley Michael M Assomull Ravi R Keenan Niall G NG Sehmi Joban J Keeble Thomas R TR Davies John R JR Tang Kare H KH Gerber Robert R Cole Graham G O'Kane Peter P Sharp Andrew S P ASP Khamis Ramzi R Kanaganayagam Gajen G Petraco Ricardo R Ruparelia Neil N Malik Iqbal S IS Nijjer Sukhjinder S Sen Sayan S Francis Darrel P DP Al-Lamee Rasha R
Circulation. Cardiovascular interventions 20210803 8
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Project description:Background Coronary artery disease (CAD) patterns play an essential role in the decision-making process about revascularization. The pullback pressure gradient (PPG) quantifies CAD patterns as either focal or diffuse based on fractional flow reserve (FFR) pullbacks. The objective of this study was to evaluate the impact of CAD patterns on acute percutaneous coronary intervention (PCI) results considered surrogates of clinical outcomes. Methods and Results This was a prospective, multicenter study of patients with hemodynamically significant CAD undergoing PCI. Motorized FFR pullbacks and optical coherence tomography (OCT) were performed before and after PCI. Post-PCI FFR >0.90 was considered an optimal result. Focal disease was defined as PPG >0.73 (highest PPG tertile). Overall, 113 patients (116 vessels) were included. Patients with focal disease were younger than those with diffuse CAD (61.4±9.9 versus 65.1±8.7 years, P=0.042). PCI in vessels with high PPG (focal CAD) resulted in higher post-PCI FFR (0.91±0.07 in the focal group versus 0.86±0.05 in the diffuse group, P<0.001) and larger minimal stent area (6.3±2.3 mm2 in focal versus 5.3±1.8 mm2 in diffuse CAD, P=0.015) compared withvessels with low PPG (diffuse CAD). The PPG was associated with the change in FFR after PCI (R2=0.51, P<0.001). The PPG significantly improved the capacity to predict optimal PCI results compared with an angiographic assessment of CAD patterns (area under the curvePPG 0.81 [95% CI, 0.73-0.88] versus area under the curveangio 0.51 [95% CI, 0.42-0.60]; P<0.001). Conclusions PCI in vessels with focal disease defined by the PPG resulted in greater improvement in epicardial conductance and larger minimal stent area compared with diffuse disease. PPG, but not angiographically defined CAD patterns, distinguished patients attaining superior procedural outcomes. Registration URL: https://clinicaltrials.gov/ct2/show/NCT03782688.
| S-EPMC9851458 | biostudies-literature
Project description:BackgroundDyspnea is a frequent symptom in patients with stable coronary artery disease (CAD) and is recognized as a possible angina equivalent.ObjectivesThis study was to assess the impact of percutaneous coronary intervention (PCI) on dyspnea, quality of life, and angina pectoris in patients with stable CAD.MethodsThe prospective, multi-center PLA-pCi-EBO-pilot trial included 144 patients with symptomatic stable CAD and successful PCI. The prespecified endpoints angina pectoris (Seattle Angina Questionnaire-SAQ) and dyspnea (NYHA scale) were assessed 6 months after PCI. Predictors for symptomatic improvement were assessed with uni- and multivariable logistic regression analyses.ResultsPatients with concomitant dyspnea had worse SAQ physical limitation scores at baseline (49.5 ± 21.0 vs 58.9 ± 22.0, p = 0.013) but showed no difference for angina frequency or quality of life. Overall, symptomatic burden of angina pectoris and dyspnea was alleviated by PCI. However, patients with concomitant dyspnea had markedly worse scores for physical limitation (78.9 ± 25.0 vs 94.3 ± 10.6, p < 0.001), angina frequency (77.9 ± 22.8 vs 91.1 ± 12.4, p < 0.001), and quality of life (69.4 ± 24.1 vs 82.5 ± 14.4, p < 0.001) after PCI. The prevalence of dyspnea (NYHA class ≥ 2) declined from 73% before PCI to 54%. Of 95 initially dyspneic patients, 57 (60%) improved at least one NYHA class 6 months after PCI. In a multivariable logistic regression analysis, "atypical angina pectoris" was associated with improved NYHA class, whereas "diabetes mellitus" had a negative association.ConclusionPCI effectively reduced dyspnea, which is a frequent and demanding symptom in patients with CAD. The German Clinical Trials Register registration number is DRKS0001752 ( www.drks.de ).
| S-EPMC10449717 | biostudies-literature
Project description:BackgroundPercutaneous 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.MethodsWe 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.ResultsA 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.ConclusionsAmong 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.).
| S-EPMC7615400 | biostudies-literature
Project description:BackgroundIt is unclear whether beta-blocker treatment is advantageous in patients with stable coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). We evaluated the clinical impact of long-term beta-blocker maintenance in patients with stable CAD after PCI with drug-eluting stent (DES).MethodsFrom a nationwide cohort database, we identified the stable CAD patients without current or prior history of myocardial infarction or heart failure who underwent DES implantation. An intention-to-treat principle was used to analyze the impact of beta-blocker treatment on long-term outcomes of major adverse cardiovascular events (MACE) composed of cardiovascular death, myocardial infarction, and hospitalization with heart failure.ResultsAfter stabilized inverse probability of treatment weighting, a total of 78,380 patients with stable CAD was enrolled; 45,746 patients with and 32,634 without beta-blocker treatment. At 5 years after PCI with a 6-month quarantine period, the adjusted incidence of MACE was significantly higher in patients treated with beta-blockers [10.0 vs. 9.1%; hazard ratio (HR) 1.11, 95% CI 1.06-1.16, p < 0.001] in an intention-to-treat analysis. There was no significant difference in all-cause death between patients treated with and without beta-blockers (8.1 vs. 8.2%; HR 0.99, 95% CI 0.94-1.04, p = 0.62). Statistical analysis with a time-varying Cox regression and rank-preserving structure failure time model revealed similar results to the intention-to-treat analysis.ConclusionsAmong patients with stable CAD undergoing DES implantation, long-term maintenance with beta-blocker treatment might not be associated with clinical outcome improvement.Trial registrationClinicalTrial.gov (NCT04715594).
| S-EPMC9152083 | biostudies-literature
Project description:BackgroundRecently, sclerostin, a bone-derived protein, has been shown to play a key role in atherosclerosis progression. However, few studies have investigated the influence of sclerostin on cardiovascular disease prognosis. We investigated the relationship between serum sclerostin levels and adverse outcomes in elderly patients with stable coronary artery disease (SCAD) who were undergoing percutaneous coronary intervention (PCI).MethodsWe enrolled 310 elderly SCAD patients who underwent PCI in this study and followed them 3 years. According to the median serum sclerostin levels, subjects were stratified into a low sclerostin (low scl) group (n = 144) and a high sclerostin (high scl) group (n = 166). Time-to-event analyses were performed with the Kaplan-Meier method. Associations between sclerostin levels and main adverse cardiovascular and cerebrovascular events (MACCEs) and mortality were evaluated by Cox multivariate regression analysis. The prognostic power of predictive models was verified by the concordance index and receiver operating characteristic curve analysis.ResultsThe high scl group had a significantly higher MACCE-free rate and better survival than the low scl group. Serum sclerostin was an independent predictor and could improve the prognostic power for adverse outcomes. In addition, serum sclerostin levels were significantly associated with bone turnover markers, a lower presence of multivessel disease and a lower CCS angina class.ConclusionsSerum sclerostin is a prognostic parameter for predicting and intervening in the adverse outcomes of elderly SCAD patients undergoing PCI, which may be explained by its potential role in the bone-vascular axis.
| S-EPMC7532957 | biostudies-literature
Project description:ObjectivesTo assess the perceptions of patients with stable coronary artery disease of the urgency and benefits of elective percutaneous coronary intervention and to examine how they vary across centers and by providers.DesignCross sectional study.Setting10 US academic and community hospitals performing percutaneous coronary interventions between 2009 and 2011.Participants991 patients with stable coronary artery disease undergoing elective percutaneous coronary intervention.Main outcome measuresPatients' perceptions of the urgency and benefits of percutaneous coronary intervention, assessed by interview. Multilevel hierarchical logistic regression models examined the variation in patients' understanding across centers and operators after adjusting for patient characteristics, using median odds ratios.ResultsThe most common reported benefits from percutaneous coronary intervention were to extend life (90%, n=892; site range 80-97%) and to prevent future heart attacks (88%, n=872; site range 79-97%). Although nearly two thirds of patients (n=661) reported improvement of symptoms as a benefit of percutaneous coronary intervention (site range 52-87%), only 1% (n=9) identified this as the only benefit. Substantial variability was noted in the ways informed consent was obtained at each site. After adjusting for patient and operator characteristics, the median odds ratios showed significant variation in patients' perceptions of percutaneous coronary intervention across sites (range 1.4-3.1) but not across operators within a site.ConclusionPatients have a poor understanding of the benefits of elective percutaneous coronary intervention, with significant variation across sites. No sites had a high proportion of patients accurately understanding the benefits. Coupled with the wide variability in the ways in which hospitals obtain informed consent, these findings suggest that hospital level interventions into the structure and processes of obtaining informed consent for percutaneous coronary intervention might improve patient comprehension and understanding.
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Project description:Concomitant percutaneous transluminal angioplasty (PTA) at the time of percutaneous coronary intervention (PCI) is often performed because lower extremity artery disease (LEAD) commonly coincides with coronary artery disease. We investigated the impact of concomitant PTA on both cardiovascular and limb outcomes in the Korean National Health Insurance Service registry. Among 78,185 patients undergoing PCI, 6563 patients with stable LEAD without limb ischemia were included. After 1:5 propensity score matching was conducted, 279 patients in the PTA + PCI group and 1385 patients in the PCI group were compared. Multivariate Cox proportional hazard models showed that the risk of all-cause death was higher in the PTA + PCI group than in the PCI group, whereas the risks of myocardial infarction, repeat revascularization, stroke, cardiovascular death and bleeding events were not different between the 2 groups. In contrast, the risks of end-stage renal disease and unfavorable limb outcomes were higher in the PTA + PCI group. Mediation analyses revealed that amputation and PTA after discharge significantly mediated the association between concomitant PTA and all-cause death. Concomitant PTA was not associated with an increased risk of cardiovascular events but may increase the risk of all-cause death mediated by unfavorable renal and limb outcomes in patients with stable LEAD.
| S-EPMC9338082 | biostudies-literature
Project description:BackgroundInterpretation of recent alterations to the guideline priority of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for multivessel disease contests historical data and practice. To reevaluate contemporary outcomes, a large contemporary analysis was conducted comparing CABG with multivessel PCI among Medicare beneficiaries.MethodsThe United States Centers for Medicare and Medicaid Services database was evaluated all beneficiaries with acute coronary syndrome undergoing isolated CABG or multivessel PCI (2018-2020). Risk adjustment was performed using multilevel regression analysis, Cox proportional hazards time to event models, and inverse probability of treatment weighting propensity scores.ResultsA total of 104,127 beneficiaries were identified undergoing CABG (n = 51,389) or multivessel PCI (n = 52,738). Before risk adjustment, compared with PCI, CABG patients were associated with younger age (72.9 vs 75.2 years, P < .001), higher Elixhauser Comorbidity Index (5.0 vs 4.2, P < .001), more diabetes (48.5% vs 42.2%, P < .001), higher cost ($54,154 vs $33,484, P < .001), and longer length of stay (11.9 vs 5.8 days, P < .001). After inverse probability of treatment weighting propensity score adjustment, compared with PCI, CABG was associated with lower hospital mortality (odds ratio, 0.74; P < .001), fewer hospital readmissions at 3 years (odds ratio, 0.85; P < .001), fewer coronary reinterventions (hazard ratio, 0.37; P < .001), and improved 3-year survival (hazard ratio, 0.51; P < .001).ConclusionsContemporary real-world data from Medicare patients with multivessel disease reveal that CABG outcomes were superior to PCI, providing important longitudinal data to guide patient care and policy development.
| S-EPMC10739562 | biostudies-literature
Project description: Not available
| S-EPMC514212 | biostudies-literature
Project description:Background:There is a strong association between chronic ischemia and autonomic imbalance. Percutaneous coronary intervention (PCI) may restore autonomic balance in patients with stable coronary artery disease (SCAD), which is characterized by increased heart rate variability (HRV). Anxiety is often found in patients who are going to undergo invasive procedures and has been identified to induce autonomic imbalance. The aim of our study is to identify the impact of preprocedural anxiety on increased HRV following an elective PCI. Methods:Our study was a pretest and post-test correlation study involving 44 SCAD patients who underwent elective PCI at Cipto Mangunkusumo National Hospital. The HRV was measured before and after PCI. Anxiety symptoms were evaluated using Hospital Anxiety Depression Score (HADS) questionnaires. Results:We found a higher increase on HRV parameter following the PCI of subjects in the nonanxiety group compared with the anxiety group (median?=?9.11 vs. 2.83; U?=?154.00; p=0.043). Conclusions:Preprocedural anxiety may inhibit HRV increase following PCI procedure.
| S-EPMC7024083 | biostudies-literature