A meta-analysis conducted by Shah and his colleagues published in JAMA cardiology demonstrated that in patients with high bleeding risk, coronary interventions with drug-eluting stents (DES) optimized for biocompatibility were preferable over those with bare-metal stents (BMS) in terms of both safety and efficacy, in patients with only 1 month of Dual Antiplatelet therapy (DAPT).
Clinical practice guideline recommendations currently support the use of BMSs followed by 1 month of dual- antiplatelet therapy (DAPT) in patients at high bleeding risk (HBR) or those who are uncertain candidates for DAPT. Indeed, DESs receive a class III (harmful) recommendation for patients who are unlikely to tolerate or comply with prolonged DAPT and for those in whom this cannot be determined prior to stent implantation. It is a fact that a significant number of patients receive bare-metal stents (BMS) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT). However, 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. Shah et al. raised the question regarding the optimal stent strategy for coronary intervention in patients with high risk of bleeding in whom a short course of dual antiplatelet therapy was preferred. In order to evaluate the efficacy and safety of DESs compared with BMSs for coronary intervention with a single month of DAPT, they conducted a meta-analysis using human studies found in PubMed, the Cochrane databases through April 2018, and reference lists of selected articles.
“Our meta-analysis suggests that DESs are not only safe but more efficacious compared with BMSs with a single month of DAPT. It also shows that DESs not only improved soft outcomes (ie, revascularization) compared with BMSs but also hard outcomes, such as MI, with this shorter duration of DAPT. The risk of stent thrombosis was lower with DESs in this meta-analysis, but this did not reach statistical significance in random-effects models, most likely because of a type II error (lack of power).”- Dr. Rahman Shah, M.D.
The investigators included randomized clinical trials if patients underwent percutaneous coronary intervention and randomly assigned each patient to treatment with either DESs or BMSs. The data were independently extracted by two reviewers. Odds ratios (ORs) were calculated using random-effects models. The efficacy endpoints 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 included stent thrombosis and bleeding complications. The 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). The investigators reported that 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. Moreover, 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.
The investigators concluded that coronary intervention with drug-eluting stents decreased the risk for myocardial infarction, target vessel revascularization, ischemia-driven target lesion revascularization, and stent thrombosis compared with bare-metal stents used with 1 month of dual antiplatelet therapy. The study reflected how in patients with high bleeding risk, coronary interventions with drug-eluting stents optimized for biocompatibility were preferable over those with bare-metal stents. Highlighting the take-home message, Shah and his colleagues wrote, “These results suggest that guidelines recommendations regarding the routine use of BMSs for patients with high bleeding risk or those who are uncertain candidates for DAPT (with the sole goal of shortening DAPT duration) are no longer warranted with the availability of current-generation DES, particularly those optimized for biocompatibility.” While they acknowledged the specific limitations of their analysis, including the lack of patient-level data, potential for type 2 error because of the limited number of trials, variable definitions for HBR, and lack of contemporary durable polymer DESs, they added, “Our meta-analysis suggests that DESs are not only safe but more efficacious compared with BMSs with a single month of DAPT. It also shows that DESs not only improved soft outcomes (ie, revascularization) compared with BMSs but also hard outcomes, such as MI, with this shorter duration of DAPT. The risk of stent thrombosis was lower with DESs in this meta-analysis, but this did not reach statistical significance in random-effects models, most likely because of a type II error (lack of power).” In an accompanying editorial titled ‘The Myths of the Bare-Metal Stent,’ Dr. Dean J. Kereiakes reinforced the importance of the study saying, “Shah et al. succinctly and elegantly develop the concept of cumulative risk following BMS because restenosis is not benign and may be associated with TLR and MI. Indeed, requiring even nonemergent, uncomplicated TLR (largely restenting) has been associated with increased rates of MI and death compared with not requiring TLR, which may reflect the hazard of multiple metal layers.”
“There are still very rarely occurring clinical scenarios (eg, active severe bleeding, need for expedited surgical procedures, or incontrovertible evidence of an inability to take medications for a month) that may require DAPT durations even shorter than 1 month. Whether percutaneous coronary intervention is indicated at all in these scenarios is always a legitimate question, but for the very short term (until newer DES data and/or device approvals emerge), I personally would grant a respite to the extremely rare case of BMS implantation that might occur in these extreme scenarios.”- Dr. Ajay J. Kirtane, M.D.
Thus, based on these findings, in patients whose adherence to DAPT beyond 30 days is uncertain, specific DES models optimized for biocompatibility should be considered as the default therapy rather than BMSs. These data are also suggestive of the fact that current guidelines recommendations regarding the use of BMSs should be revisited. Scrutinizing the publication and its accompanying editorial, Dr. Ajay J. Kirtane, Chief Academic Officer of the Center for Interventional Vascular Therapy, New York-Presbyterian, Columbia, stated, “While both articles are supportive of the evolving dominance of DES use over BMS use, even with shorter durations of DAPT, they also highlight the need for additional (and currently ongoing) prospective and randomized data clearly establishing the safety of shorter durations of DAPT with current-generation DES devices.” Speaking of the implications of the findings on his own clinical practice, he added, “There are still very rarely occurring clinical scenarios (eg, active severe bleeding, need for expedited surgical procedures, or incontrovertible evidence of an inability to take medications for a month) that may require DAPT durations even shorter than 1 month. Whether percutaneous coronary intervention is indicated at all in these scenarios is always a legitimate question, but for the very short term (until newer DES data and/or device approvals emerge), I personally would grant a respite to the extremely rare case of BMS implantation that might occur in these extreme scenarios.”
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