Search results

A total of 120 articles were retrieved and screened from the databases. After title and abstract screening, 22 articles were eligible for full-text screening. Finally, a total of seven articles (two RCTs and five observational studies) were finally included in the analysis [10, 14,15,16,17,18,19]. The PRISMA flow chart of the literature search is shown in (Fig. 1).

Fig. 1The alternative text for this image may have been generated using AI.Study characteristics

A total of seven studies comprising 1,766 participants were finally included in the analysis. Four studies (two RCTs followed the VARC-3 definition criteria and two observational studies followed the VARC-2 definition criteria), comprising 948 patients, focused on comparing single Parclose ProGlide with Angio-Seal versus dual Parclose ProGlide. Three observational studies, followed the VARC-2 definition criteria, comprising 818 patients, compared dual Parclose ProGlide with Angio-Seal versus dual Parclose ProGlide. The summary characteristics of the included studies and the baseline characteristics of the patients are shown in (Supplementary Table 4).

Risk of bias assessment

We used ROB-2 for assessing the two included RCTs. Regarding the study by Yeh et al., it showed an overall low risk of bias, while the study by Rheude et al. showed some concerns regarding the randomization process, which resulted in overall some concerns. The summary of ROB-2 is shown in (Fig. 2).

Fig. 2The alternative text for this image may have been generated using AI.

Risk of bias assessment 2 tool (ROB-2)

For the included observational studies, the NOS tool was used, and all studies showed high quality regarding the appropriate selection process, comparability between the two groups, and outcome measurement, as shown in (Supplementary Table 5).

Primary outcomeMajor vascular complications

There was no statistically significant difference between single Parclose ProGlide with Angio-Seal and dual Parclose ProGlide in terms of major vascular complications (OR = 0.86, 95% CI [0.37 to 1.24], p = 0.21). The pooled studies were homogeneous (I² = 0%, p = 0.24), as shown in (Supplementary Fig. 1). Subgroup analysis based on study design showed no significant difference between the two studied groups regarding RCTs (OR = 0.54, 95% CI [0.28 to 1.04], p = 0.07), or observational studies (OR = 2.63, 95% CI [0.49 to 14.20], p = 0.26), as shown in (Fig. 3). A sensitivity analysis excluding the study by Rheude et al. (which used ProStyle or Parclose ProGlide as suture-based closure devices) did not show a significant difference between the two groups (OR = 1.18, 95% CI [0.3 to 4.68], p = 0.82), as shown in (Supplementary Fig. 2).

Fig. 3The alternative text for this image may have been generated using AI.

Forest plot of Major vascular complications according to study design

Dual Parclose ProGlide with Angio-Seal showed no significant difference compared to dual Parclose ProGlide regarding major vascular complications (OR = 0.50, 95% CI [0.20 to 1.26], p = 0.14). The studies were homogenous (I² = 41.18%, p = 0.19), as shown in (Supplementary Fig. 1). A sensitivity analysis excluding the study by Costa et al. (which used either single Prostar or dual Parclose ProGlide as suture-based closure devices) showed no significant difference between the two groups (OR = 0.76, 95% CI [0.38 to 1.51], p = 0.43), as shown in (Supplementary Fig. 2).

Secondary outcomesMajor/life-threatening bleeding

There was no significant difference between Single Parclose ProGlide with Angio-Seal and dual Parclose ProGlide regarding major/life-threatening bleeding (OR = 0.65, 95% CI [0.30 to 1.42, p = 0.28). The studies were homogenous (I² = 24.84%, p = 0.47), as shown in (Supplementary Fig. 3). Subgroup analysis based on study design showed no significant difference between the two studied groups in either RCTs (OR = 0.66, 95% CI [0.25 to 1.74], p = 0.40) or observational studies (OR = 0.67, 95% CI [0.07 to 6.53], p = 0.73), as shown in (Fig. 4). A sensitivity analysis excluding the study by Rheude et al. confirmed that there was no significant difference between the two groups (OR = 1.06, 95% CI [0.42 to 2.68], p = 0.9), as shown in (Supplementary Fig. 4).

Fig. 4The alternative text for this image may have been generated using AI.

Forest plot of major/life threatening bleeding according to study design

Dual Parclose ProGlide with Angio-Seal was associated with a lower risk of major/life-threatening bleeding than dual Parclose ProGlide (OR = 0.43, 95% CI [0.21 to 0.92], p = 0.03). The studies were homogenous (I² = 11.71%, p = 0.36), as shown in (Supplementary Fig. 3). A sensitivity analysis excluding the study conducted by Costa et al. showed no significant difference between the two groups (OR = 0.56, 95% CI [0.26 to 1.21], p = 0.14), as shown in (Supplementary Fig. 4).

Additional vascular closure device

The pooled OR favored single Parclose ProGlide with Angio-Seal over dual Parclose ProGlide (OR of 0.11, 95% CI [0.06 to 0.19], p < 0.01). The studies were homogenous (I² = 0%, p = 0.49), as shown in (Supplementary Fig. 5). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (3.7% vs. 36.99%), corresponding to an absolute risk reduction of 33.29%. Subgroup analysis based on study design showed the superiority of a single Parclose ProGlide with Angio-Seal in RCTs (OR = 0.11, 95% CI [0.05, 0.24], p = p < 0.01). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (3.56% vs. 33.24%), corresponding to an absolute risk reduction of 29.68%. Also, the single Perclose ProGlide with Angio-Seal group was superior to the dual Parclose ProGlide in observational study (OR = 0.08, 95% CI [0.02, 0.34], p = p < 0.01), as shown in (Fig. 5). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (5% vs. 65.2%), corresponding to an absolute risk reduction of 60.22%. A sensitivity analysis excluding the study by Rheude et al. showed a significant reduction in the use of additional VCD in single Parclose ProGlide with Angio-Seal (OR = 0.06, 95% CI [0.02, 0.20], p < 0.01), as shown in (Supplementary Fig. 6). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (1.71% vs. 31.55%), corresponding to an absolute risk reduction of 29.84%.

Fig. 5The alternative text for this image may have been generated using AI.

Forest plot of additional VCD according to study design

Minor vascular complications

Single Parclose ProGlide with Angio-Seal was associated with reduced minor vascular complications compared to dual Parclose ProGlide (OR = 0.53, 95% CI [0.39 to 0.72], p < 0.01). The studies were homogenous (I² = 0%, p = 0.87), as shown in (Supplementary Fig. 7). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (16.24% vs. 32.28%), corresponding to an absolute risk reduction of 16.04%. Subgroup analysis based on study design indicated the superiority of single Parclose ProGlide with Angio-Seal over dual Parclose ProGlide in RCTs (OR = 0.52, 95% CI [0.38, 0.72], p = p < 0.01). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (19.45% vs. 37.86%), corresponding to an absolute risk reduction of 18.41%. There was no significant difference between the two groups in observational studies (OR = 0.56, 95% CI [0.23, 1.38], p = 0.21), as shown in (Supplementary Fig. 8). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (7.86% vs. 12.37%), corresponding to an absolute risk reduction of 4.51%. After excluding the study by Rheude et al., the pooled OR did not reach significance (OR = 0.59, 95% CI [0.35, 1.01], p = 0.06), as shown in (Supplementary Fig. 9). The absolute event rates were lower in the single Perclose ProGlide with Angio-Seal group (10.18% vs. 16.89%), corresponding to an absolute risk reduction of 6.71%.

There was no significant difference between dual Parclose ProGlide with Angio-Seal and dual Parclose ProGlide in terms of minor vascular complications (OR = 0.84, 95% CI [0.37 to 1.90], p = 0.67). The studies were heterogeneous (I² = 59.88%, p = 0.09), as shown in (Supplementary Fig. 7). The absolute event rates were lower in the dual Perclose ProGlide with Angio-Seal group (10.61% vs. 12.47%), corresponding to an absolute risk reduction of 1.86%. A leave-one-out analysis confirmed that no single study had a disproportionate effect on the pooled OR. Excluding the study by Rheude et al. did not significantly change the results significantly (OR = 1.09, 95% CI [0.46, 2.58], p = 0.85), as shown in (Supplementary Fig. 10). The absolute event rates were nearly the same between the two groups (14.57% vs. 14.47%), corresponding to an absolute risk reduction of 0.1%.

Minor bleeding and unplanned surgical intervention

There was no significant difference between single Parclose ProGlide with Angio-Seal and dual Parclose ProGlide regarding minor bleeding (OR = 1.28, 95% CI [0.89, 1.84], p = 0.18), or unplanned surgical intervention (OR = 0.66, 95% CI [0.38, 1.16], p = 0.15), as shown in (Supplementary Figs. 11, 12). The studies on minor bleeding and unplanned surgical intervention were homogenous (I² = 0%, p = 0.67) and (I² = 0%, p = 0.99), respectively. Subgroup analysis based on study design revealed no significant differences between the two studied groups in minor bleeding (RCTs: OR = 1.38, 95% CI [0.93, 2.04], p = 0.11; observational studies: OR = 0.77, 95% CI [0.27, 2.15], p = 0.61) or unplanned surgical intervention (RCTs: OR = 0.66, 95% CI [0.37, 1.18], p = 0.16; observational studies: OR = 0.67, 95% CI [0.07, 6.53], p = 0.73), as shown in (Supplementary Figs. 13, 14). A sensitivity analysis excluding Rheude et al. indicated that there was no significant difference between single Parclose ProGlide with Angio-Seal and dual Parclose ProGlide for both minor bleeding (OR = 1.09, 95% CI [0.65, 1.81], p = 0.75) and unplanned surgical intervention (OR = 0.66, 95% CI [0.38, 1.15], p = 0.14). ), as shown in (Supplementary Figs. 15, 16).

Dual Parclose ProGlide with Angio-Seal did not significantly reduce minor bleeding (OR = 0.95, 95% CI [0.44, 2.05], p = 0.90), or unplanned surgical intervention (OR = 0.74, 95% CI [0.29, 1.92], p = 0.54) compared to dual Parclose ProGlide, as shown in (Supplementary Figs. 11, 12). The studies on minor bleeding and unplanned surgical intervention were homogenous (I² = 37.74%, p = 0.21) and (I² = 0%, p = 0.88), respectively. Excluding the study by Costa et al. did not significantly change the results for unplanned surgical intervention (OR = 0.80, 95% CI [0.29, 2.25], p = 0.67), as shown in (Supplementary Fig. 16).

Mortality

There was no significant difference in mortality between single Parclose ProGlide with Angio-Seal and dual Parclose ProGlide (OR = 0.76, 95% CI [0.22 to 2.64], p = 0.67). The studies were homogeneous (I² = 0%, p = 0.37). Similarly, dual Parclose ProGlide with Angio-Seal did not show significance over dual Parclose ProGlide regarding mortality (OR = 0.71, 95% CI [0.31 to 1.62], p = 0.41), as shown in Supplementary Fig. 17. After excluding the study by Costa et al., the pooled OR remained non-significant (OR = 0.79, 95% CI [0.30 to 2.02], p = 0.62), as shown in Supplementary Fig. 18.

Hematoma, pseudoaneurysm, and dissection

The was no significant difference between dual Parclose ProGlide with Angio-Seal and dual Parclose ProGlide regarding hematoma (OR = 1.62, 95% CI [0.42 to 6.27], p = 0.48), pseudoaneurysm (OR = 0.48, 95% CI [0.18 to 1.26], p = 0.14), and dissection (OR = 1.26, 95% CI [0.63 to 2.53], p = 0.52), as shown in Supplementary Fig. 19–21. The studies assessing hematoma were heterogenous (I² = 71.7%, p = 0.48), while those assessing pseudoaneurysm and dissection were homogenous (I² = 0%, p = 0.88) and (I² = 0%, p = 0.37), respectively.