Dataset Information

Long-term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention: an observational single-centre registry follow-up.

ABSTRACT:

Objectives

There are few data evaluating the long-term effect of femoral vascular closure devices (FCDs) on patients' clinical outcome. We aim to evaluate the incidence of peripheral vascular disease (PVD) in patients who received FCD following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures.

Design and setting

Observational study of a single-centre registry.

Participants

From June 2000 to September 2004, 265 patients who received FCD after coronary angiography and PCIs were enrolled on the study.

Outcome measures

Clinical follow-up (using Rutherford's categories of claudication), ankle brachial index (ABI) and duplex ultrasound of femoral arteries (using the non-accessed side as control) were performed to evaluate the presence of PVD.

Results

The mean follow-up interval was 3320±628 days. 1 patient (0.4%) suffered from grade 2 claudication and another (0.4%) suffered from grade 1 claudication. The mean ABIs of the accessed side and non-accessed side were 1.06±0.13 and 1.08±0.11, respectively (p=0.17). For duplex ultrasound, the mean common femoral artery peak systolic velocities of the accessed side and non-accessed side were 87.4±22.3 and 87.7±22.1 cm/s, respectively (p=0.73); the mean superficial femoral artery peak systolic velocities of the accessed side and non-accessed side were 81.4±20.1 and 81.31±17.8 cm/s, respectively (p=0.19).

Conclusions

The use of FCD after a coronary angiogram and PCI is safe and does not increase the long-term risk of PVD.

SUBMITTER: Lee SW

PROVIDER: S-EPMC4067826 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Publications

Long-term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention: an observational single-centre registry follow-up.

Lee Stephen Wai-Luen SW Tam Chor-Cheung CC Wong Ka-Lam KL Kong Shun-Ling SL Yung See-Yue SY Wong Yiu-Tung YT Chiu Suk-Yee SY Lam Cheung-Chi CC Chan Ki-Wan KW Chan Hon-Wah HW

BMJ open 20140612 6

<h4>Objectives</h4>There are few data evaluating the long-term effect of femoral vascular closure devices (FCDs) on patients' clinical outcome. We aim to evaluate the incidence of peripheral vascular disease (PVD) in patients who received FCD following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures.<h4>Design and setting</h4>Observational study of a single-centre registry.<h4>Participants</h4>From June 2000 to September 2004, 265 patients who recei ...[more]

PMID: 24928591

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Project description:Background The effectiveness of vascular closure devices (VCDs) to reduce bleeding after transfemoral percutaneous coronary intervention remains unsettled. Methods and Results Participants in the REGULATE-PCI (Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention) trial who underwent transfemoral percutaneous coronary intervention with VCD implantation were compared with those who underwent manual compression. The primary effectiveness end point was type 2, 3, or 5 Bleeding Academic Research Consortium access site bleeding at day 3. Univariate and multivariate analyses were adjusted by the inverse probability weighting method using propensity score. Time to hemostasis and time to ambulation were compared between groups. Of the 1580 patients who underwent transfemoral percutaneous coronary intervention, 1004 (63.5%) underwent VCD implantation and 576 (36.5%) had manual compression. The primary effectiveness end point occurred in 64 (6.4%) participants in the VCD group and in 38 (6.6%) participants in the manual compression group (inverse probability weighting-adjusted odds ratio, 1.02 [95% CI, 0.77-1.36]; P=0.89). There were statistically significant 2-way interactions between VCD use and female sex, chronic kidney disease, and use of high-potency P2Y12 inhibition (ticagrelor or prasugrel) (P<0.05 for all) with less bleeding with VCD use in these high-risk subgroups. Median time to hemostasis and time to ambulation were shorter in the VCD versus the manual compression group (P<0.01 for both). Conclusions Following transfemoral percutaneous coronary intervention, VCD use is associated with a shorter time to hemostasis and time to ambulation but not less bleeding. Further study of patients with high-bleeding risk is required, including women, patients with chronic kidney disease, and those using high-potency P2Y12 inhibitors. Registration URL: https://clinicaltrials.gov/ct2/show/NCT01848106; Unique identifier: NCT01848106.

Project description:ImportanceDiagnostic coronary angiography in asymptomatic patients may lead to inappropriate percutaneous coronary intervention (PCI) due to a diagnostic-therapeutic cascade. Understanding the association between patient selection for coronary angiography and PCI appropriateness may inform strategies to minimize inappropriate procedures.ObjectiveTo determine if hospitals that frequently perform coronary angiography in asymptomatic patients, a clinical scenario in which the benefit of angiography is less clear, are more likely to perform inappropriate PCI.Design, setting, and participantsMulticenter observational study of 544 hospitals participating in the CathPCI Registry between July 1, 2009, and September 30, 2013.Main outcomes and measuresHospital proportion of asymptomatic patients at diagnostic coronary angiography and hospital rate of inappropriate PCI as defined by 2012 appropriate use criteria for coronary revascularization.ResultsOf 1 225 562 patients who underwent elective coronary angiography, 308 083 (25.1%) were asymptomatic. The hospital proportion of angiography among asymptomatic patients ranged from 1.0% to 73.6% (median, 24.7%; interquartile range, 15.9%-35.9%). By hospital quartile of asymptomatic patients at angiography, hospitals with higher rates of asymptomatic patients at angiography had higher median rates of inappropriate PCI (14.8% vs 20.2% vs 24.0 vs 29.4% from lowest to highest quartile, P < .001 for trend). This outcome was attributable to more frequent use of inappropriate PCI in asymptomatic patients at hospitals with higher rates of angiography in asymptomatic patients (5.4% vs 9.9% vs 14.7% vs 21.6% from lowest to highest quartile, P < .001 for trend). Hospitals with higher rates of asymptomatic patients at angiography also had lower rates of appropriate PCI (38.7% vs 33.0% vs 32.3% vs 32.9% from lowest to highest quartile, P < .001 for trend).Conclusions and relevanceIn a national sample of hospitals, performance of coronary angiography in asymptomatic patients was associated with higher rates of inappropriate PCI and lower rates of appropriate PCI. Improving preprocedural risk stratification and thresholds for coronary angiography may be one strategy to improve the appropriateness of PCI.

Dataset Information

Long-term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention: an observational single-centre registry follow-up.

Objectives

Design and setting

Participants

Outcome measures

Results

Conclusions

Publications

Long-term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention: an observational single-centre registry follow-up.

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