Angiographic Success and Procedural Complications in Patients Undergoing Percutaneous Coronary Chronic Total Occlusion Interventions : A Weighted Meta-Analysis of 18,061 Patients From 65 Studies
TL;DR: CTO PCI carries low risk for procedural complications despite high success rates, according to a meta-analysis of 65 studies published between 2000 and 2011 reporting procedural complications of CTO PCI.
Abstract: Objectives This study sought to perform a weighted meta-analysis of the complication risk during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background The safety profile of CTO PCI has received limited study. Methods We conducted a meta-analysis of 65 studies published between 2000 and 2011 reporting procedural complications of CTO PCI. Data on the frequency of death, emergent coronary artery bypass graft surgery, stroke, myocardial infarction, perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. Results A total of 65 studies with 18,061 patients and 18,941 target CTO vessels were included. Pooled estimates of outcomes were as follows: angiographic success 77% (95% confidence interval [CI]: 74.3% to 79.6%); death 0.2% (95% CI: 0.1% to 0.3%); emergent coronary artery bypass graft surgery 0.1% (95% CI: 0.0% to 0.2%); stroke Conclusions CTO PCI carries low risk for procedural complications despite high success rates.
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TL;DR: CTO PCI is currently performed infrequently in the United States for stable coronary artery disease and is associated with lower procedural success and higher complication rates compared with non-CTO PCI.
Abstract: Objectives The aim of this study was to describe contemporary frequency, predictors, and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in the United States. Background CTO PCI can provide significant clinical benefits, yet there is limited information on its success and safety in unselected patient populations. Methods We analyzed the frequency and outcomes of CTO PCI compared with non-CTO PCI in elective patients, and of successful versus failed CTO PCI between July 1, 2009, and March 31, 2013, in the National Cardiovascular Data Registry CathPCI Registry. Generalized estimating equations logistic regression modeling was used to generate independent variables associated with procedural success and procedural complications. Results During the study period, CTO PCI represented 3.8% of the total PCI volume for stable coronary artery disease (22,365 of 594,510). Overall, patients undergoing CTO PCI required greater contrast volume and longer fluoroscopy time and had lower procedural success (59% vs. 96%, p Conclusions CTO PCI is currently performed infrequently in the United States for stable coronary artery disease and is associated with lower procedural success and higher complication rates compared with non-CTO PCI. Procedural success was associated with several patient factors and operator experience.
380 citations
Cites background from "Angiographic Success and Procedural..."
...A recent systematic review of published studies reported low and decreasing rates of CTO PCI complications over time, despite increasing success rates (31)....
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TL;DR: Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone.
Abstract: Aims The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Method and results Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Conclusion Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. Trial registration NCT01760083.
342 citations
Cites background from "Angiographic Success and Procedural..."
...Non-expert centres would have affected the assessment of the procedural benefit as failed procedures carry a higher complication rate and would bias results in terms of persistence of symptoms.(23) The limitation to expert centres also lead to bias against enrolment of highly symptomatic patients, as the operator was convinced of the benefit of PCI for CTOs based on available clinical evidence....
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TL;DR: The PROGRESS CTO score is a novel useful tool for estimating technical success in CTO PCI performed using the hybrid approach.
Abstract: Objectives This study sought to develop a novel parsimonious score for predicting technical success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) performed using the hybrid approach. Background Predicting technical success of CTO PCI can facilitate clinical decision making and procedural planning. Methods We analyzed clinical and angiographic parameters from 781 CTO PCIs included in PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) using a derivation and validation cohort (2:1 sampling ratio). Variables with strong association with technical success in multivariable analysis were assigned 1 point, and a 4-point score was developed from summing all points. The PROGRESS CTO score was subsequently compared with the J-CTO (Multicenter Chronic Total Occlusion Registry in Japan) score in the validation cohort. Results Technical success was 92.9%. On multivariable analysis, factors associated with technical success included proximal cap ambiguity (beta coefficient [b] = 0.88), moderate/severe tortuosity (b = 1.18), circumflex artery CTO (b = 0.99), and absence of “interventional” collaterals (b = 0.88). The resulting score demonstrated good calibration and discriminatory capacity in the derivation (Hosmer-Lemeshow chi-square = 2.633; p = 0.268, and receiver-operator characteristic [ROC] area = 0.778) and validation (Hosmer-Lemeshow chi-square = 5.333; p = 0.070, and ROC area = 0.720) subset. In the validation cohort, the PROGRESS CTO and J-CTO scores performed similarly in predicting technical success (ROC area 0.720 vs. 0.746, area under the curve difference = 0.026, 95% confidence interval = −0.093 to 0.144). Conclusions The PROGRESS CTO score is a novel useful tool for estimating technical success in CTO PCI performed using the hybrid approach.
243 citations
TL;DR: High procedure and patient success rates, combined with a low event rate and improved procedural characteristics, support further use of the hybrid algorithm for a broad community of appropriately trained CTO operators.
224 citations
Additional excerpts
...Proximal cap ambiguity 447 (36) 353 (33) 94 (53) <0....
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...ch 488 (39) 366 (38) 31 (35) 91 (44) 447 (36) 290 (30) 32 (36) 125 (60)...
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University of Missouri–Kansas City1, Beth Israel Deaconess Medical Center2, Loyola University Chicago3, University of Washington4, NewYork–Presbyterian Hospital5, York Hospital6, Good Samaritan Medical Center7, Providence Sacred Heart Medical Center and Children's Hospital8, Boston Scientific Corporation9, Research Medical Center10
TL;DR: Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTOPCI can more effectively share in the decision to pursue this or other therapeutic options.
Abstract: Objectives This study sought to accurately describe the success rate, risks, and patient-reported benefits of contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background In light of the evolving techniques to successfully revascularize CTO lesions, there remains a compelling need to more accurately quantify the success rates, risks, and benefits of these complex procedures. Methods Using a uniquely comprehensive, core-lab adjudicated, single-arm, multicenter registry of 1,000 consecutive patients undergoing CTO PCI by the hybrid approach, we evaluated the technical success rates, complication rates, and raw and adjusted health status benefits at 1 month among successfully as compared to unsuccessfully treated patients. Results Technical success was high (86%). In-hospital and 1-month mortality was 0.9% and 1.3%, respectively, and perforations requiring treatment occurred in 48 patients (4.8%). Among those who survived and completed the 1-month interview (n = 947), mean ± SEM Seattle Angina Questionnaire quality of life scores improved from 49.4 ± 0.9 to 75.0 ± 0.7 (p Conclusions Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTO PCI can more effectively share in the decision to pursue this or other therapeutic options.
217 citations
Cites background from "Angiographic Success and Procedural..."
...The risks of CTO PCI are reported to be decreasing over time (23) and similar to non-CTO PCI....
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...Nonetheless, the frequency of perforation and clinical perforation is higher than previously reported by both hybrid and nonhybrid operators (23)....
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References
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TL;DR: Moher et al. as mentioned in this paper introduce PRISMA, an update of the QUOROM guidelines for reporting systematic reviews and meta-analyses, which is used in this paper.
Abstract: David Moher and colleagues introduce PRISMA, an update of the QUOROM guidelines for reporting systematic reviews and meta-analyses
62,157 citations
Journal Article•
TL;DR: The QUOROM Statement (QUality Of Reporting Of Meta-analyses) as mentioned in this paper was developed to address the suboptimal reporting of systematic reviews and meta-analysis of randomized controlled trials.
Abstract: Systematic reviews and meta-analyses have become increasingly important in health care. Clinicians read them to keep up to date with their field,1,2 and they are often used as a starting point for developing clinical practice guidelines. Granting agencies may require a systematic review to ensure there is justification for further research,3 and some health care journals are moving in this direction.4 As with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting. As with other publications, the reporting quality of systematic reviews varies, limiting readers' ability to assess the strengths and weaknesses of those reviews.
Several early studies evaluated the quality of review reports. In 1987, Mulrow examined 50 review articles published in 4 leading medical journals in 1985 and 1986 and found that none met all 8 explicit scientific criteria, such as a quality assessment of included studies.5 In 1987, Sacks and colleagues6 evaluated the adequacy of reporting of 83 meta-analyses on 23 characteristics in 6 domains. Reporting was generally poor; between 1 and 14 characteristics were adequately reported (mean = 7.7; standard deviation = 2.7). A 1996 update of this study found little improvement.7
In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM Statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomized controlled trials.8 In this article, we summarize a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews (Box 1).
Box 1
Conceptual issues in the evolution from QUOROM to PRISMA
46,935 citations
TL;DR: This paper examines eight published reviews each reporting results from several related trials in order to evaluate the efficacy of a certain treatment for a specified medical condition and suggests a simple noniterative procedure for characterizing the distribution of treatment effects in a series of studies.
33,234 citations
"Angiographic Success and Procedural..." refers methods in this paper
...Due to its conservative or “worst-case scenario” estimates, a randomeffects model as described by DerSimonian and Laird (8) was used to obtain a summary estimate and 95% confidence intervals (CI)....
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TL;DR: A structured summary is provided including, as applicable, background, objectives, data sources, study eligibility criteria, participants, interventions, study appraisal and synthesis methods, results, limitations, conclusions and implications of key findings.
31,379 citations
TL;DR: An Explanation and Elaboration of the PRISMA Statement is presented and updated guidelines for the reporting of systematic reviews and meta-analyses are presented.
Abstract: Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.
Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.
The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
25,711 citations