Coronary artery disease
Effect of Gradual Computerized Angioplasty on Outcomes of Patients Undergoing Coronary Stenting

https://doi.org/10.1016/j.amjcard.2009.03.035Get rights and content

Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting. Patients undergoing coronary stenting were eligible and randomized to receive CAPSID or standard manual percutaneous coronary intervention. In the CAPSID group, slow, gradual balloon inflation was performed using a personal computer. Patients with acute ST-elevation myocardial infarction or the need for percutaneous coronary intervention for total occlusions, left main disease, and vein grafts were excluded. Clinical follow-up for major adverse cardiac events, including death, acute myocardial infarction, and TLR, was performed at 12 months. A total of 310 patients were enrolled in the study. No significant differences were found in the clinical characteristics between the CAPSID and control groups. At 1 year of follow-up, the CAPSID group had had a significantly lower rate of major adverse cardiac events (8% vs 18%, p <0.01) driven by significantly lower rates of acute myocardial infarction (1% vs 7%, p <0.01) and TLR (5% vs 12%, p <0.05). In conclusion, gradual computerized balloon inflation using CAPSID as a platform for angioplasty and stenting significantly reduced TLR and major adverse cardiac events at 1 year in patients undergoing coronary stenting. The use of this novel device may improve outcomes in patients undergoing coronary stenting.

Section snippets

Methods

Consecutive patients undergoing PCI at Hadassah-Hebrew University Medical Center were eligible for participation in the present trial. The institutional ethics committee approved the protocol, and all subjects provided informed consent before participation in the study. Patients with a 75% to 99% stenotic lesion after diagnostic angiography who were undergoing stenting were eligible for the present trial. Patients undergoing primary PCI for acute ST-elevation myocardial infarction and patients

Results

A total of 310 patients, with a total of 388 narrowings, were enrolled in the present trial. The baseline characteristics for the patient population are listed in Table 1. No significant differences were found between the control and CAPSID group, except for a greater prevalence of diabetes in the CAPSID group. Table 2 lists the angiographic data, including the quantitative coronary angiography comparison between the 2 groups. No significant difference was found between the groups in lesion

Discussion

The results of the present study have demonstrated that a novel computerized gradual balloon dilation system (CAPSID) reduces clinical events in a population of patients undergoing coronary stenting. This finding presumably resulted from the slower and more gradual balloon inflation using the CAPSID method, which is less traumatic to the vessel wall than standard manual inflation.

The mechanisms underlying early and late complications after angioplasty are complex; however, multiple studies in

Acknowledgment

We gratefully acknowledge Mendel Mendelbaum, MSc, and Avi Licht, MSc, for their help in the design of the CAPSID system.

References (13)

There are more references available in the full text version of this article.

Drs. Katz and Weiss are patent holders for the Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) system.

View full text