Distal protection devices in primary percutaneous coronary intervention of native coronary artery lesions: a meta-analysis of randomized controlled trials

Abstract

Objective:

The use of embolic protection devices to decrease major adverse cardiac events (MACEs) in patients with saphenous vein graft lesions is considered class I therapy by the recent practice guidelines. However, the benefits of adjunctive protection devices to prevent distal embolization in patients with native coronary artery lesions are still a matter of debate. Therefore, we performed the meta-analysis to determine whether the use of distal protection devices during revascularization can improve myocardial perfusion and reduce the occurrence of MACEs compared with primary percutaneous coronary intervention (PCI) alone.

Methods and results:

Studies were identified in English-language articles by search of Medline and Embase database (inception to December 2011). A total of 15 prospective randomized controlled trials involving 2783 patients were included for analysis (1378 patients in the distal protection device group and 1405 cases in the control group). Overall, adjunctive embolic protection was associated with significantly improved postprocedural TIMI 3 (thrombolysis in myocardial infarction 3) flow (OR 1.71; 95% CI 1.13–2.57; P = 0.01) and MBG 3 (myocardial blush grade 3) (OR 1.50; 95% CI 1.09–2.07; P = 0.01), whereas the overall MACEs analysis demonstrated that a nonsignificant trend was observed toward better clinical outcomes associated with adjunctive protection devices at 1 month (OR 0.80; 95% CI 0.55–1.15; P = 0.23) and at 6 months (OR 0.80; 95% CI 0.55–1.17; P = 0.24). When stratified by MACEs, no statistical differences were found among mortality, reinfarction, and target vessel revascularization (TVR), respectively.

Conclusions:

The meta-analysis indicated an improvement of myocardial perfusion in AMI patients treated with adjunctive protection devices. However, a nonsignificant trend was observed toward a lower risk of MACEs in the distal protection device group when compared with the control group.

Key words::

• Distal protection
• Meta-analysis
• Myocardial infarction
• Percutaneous coronary intervention
• Randomized controlled trials

Transparency

Declaration of funding

This study was supported in part by grants from Doctoral Fund of Ministry of Education (200803351042) and Medical Scientific Research Foundation of Zhejiang Province in China (2009A11).

Bo Jin^{a, †}

Xue-Hong Dong^{b, †}

Chao Zhang^{c, †}

Yong Li^a

Hai-Ming Shi^a

Declaration of financial/other relationships

B.J., X.-H.D., C.Z., Y.L., and H.-M.S. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

We would like to thank Dr. Ying Shan for her editorial suggestions. The principal investigator had full access to all of the data in the study and takes responsibility for the accuracy of the data analysis.