Dataset Information

Impact of the Balloon Inflation Time and Pattern on the Coronary Stent Expansion.

ABSTRACT:

Objectives

To assess the expansion pattern of coronary stents by using different balloon inflation times and pressures.

Background

The selection of coronary stent size and its proper deployment is crucial in coronary artery interventions, having an impact on the success of the procedure and further therapy.

Methods

Ten pairs of different stents were deployed under nominal pressure using sequential (5, 5, 10, and 10 seconds of repeated inflations, thus 30 seconds of summarized time) and continuous (30 seconds) deployment pattern. After each given time-point, intraluminal stent measurements were performed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS).

Results

Both in-stent diameters and cross-section areas (CSA) of paired stents measured by OCT at all sequential time-points were significantly smaller compared to given manufacturers charts' values (90% to 94% for diameters and 81% to 88% for CSA, p<0.05). Significant increase of in-stent diameter and CSA was observed across the step-by-step deployment pattern. In-stent lumen measurements were significantly larger when sequential deployment pattern was applied compared to continuous deployment. Additional measurements were also done for overlapping segments of stents, showing smaller in-stent measurements of the latter compared to nonoverlapping segments. Validation of OCT and IVUS measurements using a phantom metallic tube showed perfect reproducibility with OCT and overestimation with IVUS (8% for diameters and 16% for CSA).

Conclusions

Stent diameter after deployment is time-dependent and not only pressure-dependent. Different stent expansion behavior, depending on the applied deployment pattern (sequential and nonsequential), was observed.

SUBMITTER: Skowronski J

PROVIDER: S-EPMC6739786 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Impact of the Balloon Inflation Time and Pattern on the Coronary Stent Expansion.

Skowroński Jarosław J Wolny Rafał R Jastrzębski Jan J Tyczyński Paweł P Szlazak Karol K Pręgowski Jerzy J Mintz Gary S GS Liżewska Karolina K Świeszkowski Wojciech W Chmielak Zbigniew Z Witkowski Adam A

Journal of interventional cardiology 20190321

<h4>Objectives</h4>To assess the expansion pattern of coronary stents by using different balloon inflation times and pressures.<h4>Background</h4>The selection of coronary stent size and its proper deployment is crucial in coronary artery interventions, having an impact on the success of the procedure and further therapy.<h4>Methods</h4>Ten pairs of different stents were deployed under nominal pressure using sequential (5, 5, 10, and 10 seconds of repeated inflations, thus 30 seconds of summariz ...[more]

PMID: 31772543

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Project description:ImportanceDrug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States.ObjectiveTo evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.Design, setting, and participantsAGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023.InterventionsParticipants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon.Main outcomes and measuresThe primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority.ResultsAmong 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively.Conclusions and relevanceAmong patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis.Trial registrationClinicalTrials.gov Identifier: NCT04647253.

Dataset Information

Impact of the Balloon Inflation Time and Pattern on the Coronary Stent Expansion.

Objectives

Background

Methods

Results

Conclusions

Publications

Impact of the Balloon Inflation Time and Pattern on the Coronary Stent Expansion.

Similar Datasets

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