Efficacy and Safety of Drug-Eluting Stents Optimized for Biocompatibility vs Bare-Metal Stents With a Single Month of Dual Antiplatelet Therapy: A Meta-analysis

Abstract

Importance: A significant number of patients receive bare-metal stents (BMSs) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT). Emerging evidence suggests that new-generation DESs, particularly those optimized for biocompatibility, may be more efficacious and safer than BMSs, even with a single month of DAPT after stent implantation.

Objective: To evaluate the efficacy and safety of DESs compared with BMSs for coronary intervention with a single month of DAPT.

Data sources: Human studies found in PubMed, the Cochrane databases through April 2018, and reference lists of selected articles.

Study selection: Randomized clinical trials were included if they enrolled patients undergoing percutaneous coronary intervention and randomly assigned each patient to treatment with either DESs or BMSs. The additional inclusion criterion was use of only 1 month of DAPT poststent implantation.

Data extraction and synthesis: Two reviewers independently extracted the data. Odds ratios (ORs) were calculated using random-effects models.

Main outcomes and measures: The efficacy end points were major adverse cardiac events, myocardial infarction, target vessel revascularization, ischemia-driven target lesion revascularization, cardiac mortality, and all-cause mortality at 1 year. The safety outcomes were stent thrombosis and bleeding complications.

Results: Data from 3 randomized clinical trials involving 3943 patients were included (2457 men [62.3%]; mean [SD] age ranging from 75.7 [9.3] years to 81.4 [4.3] years per trial subgroup). Coronary intervention with DESs reduced the rates for major adverse cardiac events (OR, 0.68 [95% CI, 0.57-0.82]; P < .001), target lesion revascularization (OR, 0.38 [95% CI, 0.22-0.67]; P = .001), target vessel revascularization (OR, 0.50 [95% CI, 0.38-0.65]; P < .001), and myocardial infarction (OR, 0.51 [95% CI, 0.31-0.83]; P = .01) compared with BMSs at 1 year. The incidence of stent thrombosis was also lower with DESs compared with BMSs (1.8% vs 2.8%), but this difference was not statistically significant in the random-effects model. Additionally, the 2 stent types did not differ in the risks of all-cause mortality, cardiac mortality, and bleeding.

Conclusions and relevance: In the limited number of randomized clinical trials comparing DESs with BMSs with shortened DAPT durations in patients who have high bleeding risk or are uncertain candidates for prolonged DAPT, coronary intervention with specific DESs optimized for biocompatibility is not only safe but also efficacious, even with only 1 month of DAPT.

Figure 1.. Efficacy End Points of Major Adverse Cardiac Events, Target Lesion Revascularization, and Target Vessel Revascularization

The odds ratio estimate of each study is indicated with a square. The size of the square represents the weight of the corresponding study in the meta-analysis.

Figure 2.. Efficacy End Points of Myocardial Infarction, All-Cause Mortality, and Cardiac Mortality

The odds ratio estimate of each study is indicated by a square whose size represents the weight that the corresponding study had in the meta-analysis.

Figure 3.. Safety End Points

Individual and pooled odds ratios for stent thrombosis and bleeding complications. The odds ratio estimate of each study is indicated by a square whose size represents the weight that the corresponding study had in the meta-analysis. BARC bleeding indicates bleeding at Bleeding Academic Research Consortium categories 2 through 5.