Context Arterial puncture closing devices (APCDs) were developed to replace
standard compression at the puncture site and to shorten bed rest following
percutaneous coronary intervention.
Objective To assess the safety and efficacy of APCDs (Angioseal, Vasoseal, Duett,
Perclose, Techstar, Prostar) compared with standard manual compression in
patients undergoing coronary angiography or percutaneous vascular interventions.
Data Sources A systematic literature search of MEDLINE (1966-January 2003), EMBASE
(1989-January 2003), PASCAL (1996-January 2003), BIOSIS (1990-January 2003),
and CINHAL (1982-January 2003) databases and the Cochrane Central Register
of Controlled Trials for relevant articles in any language.
Study Selection Included randomized controlled trials reporting vascular complications
at the puncture site (hematoma, bleeding, arteriovenous fistula, pseudoaneurysm)
and efficacy (time to hemostasis, time to ambulation, time to discharge from
Data Extraction Two reviewers abstracted the data independently and in duplicate. Disagreements
were resolved by discussion among at least 3 reviewers. The most important
criteria were adequacy of allocation concealment, whether the analysis was
according to the intention-to-treat principle, and if person assessing the
outcome was blinded to intervention group. Random-effects models were used
to pool the data.
Data Synthesis Thirty trials met the selection criteria and included up to 4000 patients.
When comparing any APCD with standard compression, the relative risk (RR)
of groin hematoma was 1.14 (95% confidence interval [CI], 0.86-1.51; P = .35); bleeding, 1.48 (95% CI, 0.88-2.48; P = .14); developing an arteriovenous fistula, 0.83 (95% CI, 0.23-2.94; P = .77); and developing a pseudoaneurysm at the puncture
site, 1.19 (95% CI, 0.75-1.88; P = .46). Time to
hemostasis was shorter in the group with APCD compared with standard compression
(mean difference, 17 minutes; range, 14-19 minutes), but there was a high
degree of heterogeneity among studies. Only 2 studies explicitly reported
allocation concealment, blinded outcome assessment, and intention-to-treat
analysis. When limiting analyses to only trials that used explicit intention-to-treat
approaches, APCDs were associated with a higher risk of hematoma (RR, 1.89;
95% CI, 1.13-3.15) and a higher risk of pseudoaneurysm (RR, 5.40; 95% CI,
Conclusions Based on this meta-analysis of 30 randomized trials, many of poor methodological
quality, there is only marginal evidence that APCDs are effective and there
is reason for concern that these devices may increase the risk of hematoma