Dataset Information

Development and Validation of a Scoring System for Predicting Periprocedural Complications During Percutaneous Coronary Interventions of Chronic Total Occlusions: The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) Complications Score.

ABSTRACT:

Background

High success rates are achievable for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the hybrid approach, but periprocedural complications remain of concern. Although scores estimating success and efficiency in CTO PCI have been developed, there is currently no available score for estimation of the risk for periprocedural complications. We sought to develop a scoring tool for prediction of periprocedural complications during CTO PCI.

Methods and results

We analyzed data from 1569 CTO PCIs in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) using a derivation and validation sampling ratio of 2:1. Variables independently associated with periprocedural complications in multivariable analysis in the derivation set were assigned points based on their respective odds ratios. Forty-four (2.8%) patients experienced complications. Three factors were independent predictors of complications and were included in the score: patient age >65 years, +3 points (odds ratio, OR=4.85, CI 1.82-16.77); lesion length ?23 mm, +2 points (OR=3.22, CI 1.08-13.89); and use of the retrograde approach +1 point (OR=2.41, CI 1.04-6.05). The resulting score showed good calibration and discriminatory capacity in the derivation (Hosmer-Lemeshow ?² 6.271, P=0.281, receiver-operating characteristic [ROC] area=0.758) and validation (Hosmer-Lemeshow ?² 4.551, P=0.473, ROC area=0.793) sets. Score values of 0 to 2, 3 to 4, and ?5 were defined as low, intermediate, and high risk of complications (derivation cohort 0.4%, 1.8%, 6.5%, P<0.001; validation cohort 0.0%, 2.5%, 6.8%, P<0.001).

Conclusions

The PROGRESS CTO complication score is a useful tool for prediction of periprocedural complications in CTO PCI.

Clinical trial registration

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02061436.

SUBMITTER: Danek BA

PROVIDER: S-EPMC5121521 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Publications

Development and Validation of a Scoring System for Predicting Periprocedural Complications During Percutaneous Coronary Interventions of Chronic Total Occlusions: The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) Complications Score.

Danek Barbara Anna BA Karatasakis Aris A Karmpaliotis Dimitri D Alaswad Khaldoon K Yeh Robert W RW Jaffer Farouc A FA Patel Mitul P MP Mahmud Ehtisham E Lombardi William L WL Wyman Michael R MR Grantham J Aaron JA Doing Anthony A Kandzari David E DE Lembo Nicholas J NJ Garcia Santiago S Toma Catalin C Moses Jeffrey W JW Kirtane Ajay J AJ Parikh Manish A MA Ali Ziad A ZA Karacsonyi Judit J Rangan Bavana V BV Thompson Craig A CA Banerjee Subhash S Brilakis Emmanouil S ES

Journal of the American Heart Association 20161011 10

<h4>Background</h4>High success rates are achievable for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the hybrid approach, but periprocedural complications remain of concern. Although scores estimating success and efficiency in CTO PCI have been developed, there is currently no available score for estimation of the risk for periprocedural complications. We sought to develop a scoring tool for prediction of periprocedural complications during CTO PCI.<h4>Methods an ...[more]

PMID: 27729332

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Project description:BackgroundThe COMET-CTO trial was a randomized prospective study that assessed long-term follow-up in patients with chronic total occlusion (CTO) in coronary arteries treated with percutaneous coronary intervention (PCI) or with optimal medical therapy (OMT). During the 9-month follow-up, the incidence of major adverse cardiac events (MACE) did not differ between the two groups; no death or myocardial infarction (MI) was observed. There was a significant difference in quality of life (QoL), assessed by the Seattle Angina Questionnaire (SAQ), in favor of the PCI group. Here we report long-term follow-up results (56 ± 12 months).MethodsBetween October 2015 and May 2017, a total of 100 patients with CTO were randomized into two groups of 50 patients: PCI CTO or OMT group. The primary endpoint of the current study was the incidence of MACE defined as cardiac death, MI, and revascularization [PCI or coronary artery bypass graft (CABG)]. As the secondary exploratory outcome, we analyzed all the cause-mortality rate.ResultsOut of 100 randomized patients, 92 were available for long-term follow-up (44 in the PCI group and 48 in the OMT group). The incidence of MACE did not differ significantly between the two groups (p = 0.363). Individual components of MACE were distributed, respectively: cardiac death (OMT vs. PCI group, 6 vs. 3, p = 0.489), MI (OMT vs. PCI group, 1 vs. 0, p = 1), and revascularization (PCI: OMT vs. PCI group, 2 vs. 2, p = 1; CABG: OMT vs. PCI group, 1 vs. 1, p = 1). There was no significant difference between the two groups regarding the individual component of MACE. Six patients died from non-cardiac causes [five deaths were reported in the OMT group and one death in the PCI group (p = 0.206)]. Kaplan-Meier survival curves for MACE did not differ significantly between the study groups (log-rank 0.804, p = 0.370). Regarding the secondary exploratory outcome, a total of 15 patients died at 56 ± 12 months (11 in the OMT and 4 in the PCI group) (p = 0.093). The Kaplan-Meier survival curves for all-cause mortality rates did not differ significantly between the two groups (log rank 3.404, p = 0.065). There were no statistically significant differences between OMT and PCI groups in all five SAQ domains. There was a significant improvement in three SAQ domains in the PCI group: PL (p < 0.001), AF (p = 0.007), and QoL (p = 0.001).ConclusionAfter 56 ± 12 months of follow-up, the incidence of MACE, as well as QoL measured by SAQ, did not differ significantly between the PCI and OMT groups.

Project description:Percutaneous coronary intervention (PCI) is widely used in patients with chronic total occlusion (CTO), but its benefit in improving long-term outcomes is controversial. We aimed to develop a prediction score for grading "survival advantage" conferred by successful results of CTO-PCI and a scoring system for prediction of the influence of CTO-PCI results on major adverse cardiac and cerebrovascular events (MACCEs). Follow-up data of 2625 patients who underwent CTO-PCI at 65 Japanese centers were analyzed. An integer scoring system was developed by including statistical effect modifiers on the association between successful CTO-PCI and one-year mortality. Follow-up at 12 months was completed in 2034 patients. During follow-up, 76 deaths (3.7%) occurred. Patients with successful CTO-PCI had a better one-year survival than patients with failed CTO-PCI (log rank P = 0.016). Effect modifiers for the association between successful procedure and one-year mortality included diabetes (P interaction = 0.043), multivessel disease (P interaction = 0.175), Canadian Cardiovascular Society class ≥2 (P interaction = 0.088), and prior myocardial infarction (MI) (P interaction = 0.117). Each component was assigned a single point and summed to develop the scoring system. The patients were then categorized to specify the prediction of survival advantage by successful PCI: ≤2 (normal) and ≥3 (distinct). The differences in one-year mortality between patients with successful and failed treatment were -0.7% and 11.3% for normal and distinct score categories, respectively. In the scoring system for MACCE, score components were prior MI (P interaction = 0.19), left anterior descending artery (LAD)-CTO (P interaction = 0.079), and reattempt of CTO-PCI (P interaction = 0.18). The differences in one-year MACCEs between successful and failed patients for each score category (0, 1, and ≥2) were -1.7%, 7.5%, and 15.1%, respectively. The novel scoring system assessing the advantage of successful PCI can be easily applied in patients with CTO. It is a valid instrument for clinical decision-making while assessing the survival advantage of CTO-PCI and the influence of procedural results on MACCEs.

Dataset Information

Development and Validation of a Scoring System for Predicting Periprocedural Complications During Percutaneous Coronary Interventions of Chronic Total Occlusions: The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) Complications Score.

Background

Methods and results

Conclusions

Clinical trial registration

Publications

Development and Validation of a Scoring System for Predicting Periprocedural Complications During Percutaneous Coronary Interventions of Chronic Total Occlusions: The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) Complications Score.

Similar Datasets

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