Key result
Resolute Onyx with 1-month DAPT shows comparable cardiac death or MI in small vs larger vessels.
Why the study?
Randomized studies evaluating coronary stenting versus balloon angioplasty in small coronary vessels had yielded controversial results.
Does small vessel disease (reference vessel diameter ≤2.5 mm) increase the risk of cardiac death or myocardial infarction compared to larger vessel disease in high-bleeding-risk patients treated with Resolute Onyx zotarolimus-eluting stents and 1-month DAPT?
Observational (n=1,490)
Nonrandomized
Yes
Does small vessel disease (reference vessel diameter ≤2.5 mm) increase the risk of cardiac death or myocardial infarction compared to larger vessel disease in high-bleeding-risk patients treated with Resolute Onyx zotarolimus-eluting stents and 1-month DAPT?
In high-bleeding-risk patients treated with Resolute Onyx zotarolimus-eluting stents followed by 1-month DAPT, clinical outcomes including cardiac death, MI, and stent thrombosis in patients with small vessel disease (RVD ≤2.5 mm) were favorable and comparable to those with larger vessels.
Comparable cardiac death/MI rates support short-DAPT feasibility in small vessels; leaves open dedicated randomized confirmation in high-bleeding-risk cohorts.
Objectives A meta-analysis of 11 randomized trials was done to compare stenting versus balloon angioplasty (BA) in small coronary vessels. Background Randomized studies on coronary stenting (CS) in small vessels have yielded controversial results. Methods Eleven randomized trials on CS versus BA in small vessels, including angiographic re-evaluation at six months, were analyzed. Results The BeStent (Medtronic Instent, Minneapolis, Minnesota) was used in four studies, the Multi-Link (Guidant, Advanced Cardiovascular Systems Inc., Santa Clara, California) in three trials, and the NIR (Boston Scientific Corp., Boston, Massachusetts), JoStent (Jomed International AB, Helsingborg, Sweden), Tenax (Biotronik, Berlin, Germany), and BioDivysio (Abbott Vascular Devices, Redwood City, California) in the remaining four trials. Overall, 3,541 patients were included (1,672 allocated to BA and 1,869 to stent). The rate of cross-over from balloon to stent in the pooled population was 19%, and unsuccessful stent deployment occurred in 2% of the patients allocated to stent. The pooled rates of restenosis were 25.8% and 34.2% in patients allocated to stent and balloon, respectively (p = 0.003) (risk ratio [RR] 0.77; 95% confidence interval [CI] 0.65 to 0.92). A smaller reference vessel diameter at baseline was associated with a higher risk reduction in the restenosis rate (y = -3.551 + 1.826 [x]; p = 0.012). Patients allocated to stent had lower rates of major adverse cardiac events (15.0% vs. 21.8%, p = 0.002; RR 0.70; 95% CI 0.57 to 0.87) and new target vessel revascularizations (12.5% vs. 17.0%, p = 0.004; RR 0.75, 95% CI 0.61 to 0.91). Conclusions Elective stenting is superior to provisional stenting in small coronary arteries. This benefit is more evident in smaller coronary arteries.
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Moreno et al. (2004) conducted an observational in Small vessel coronary artery disease in patients at high bleeding risk (n=1,490). PCI of small vessel disease (reference vessel diameter ≤2.5 mm) with Resolute Onyx zotarolimus-eluting stent and 1-month DAPT vs. PCI of non-small vessel disease (all lesions with reference vessel diameter >2.5 mm) with Resolute Onyx zotarolimus-eluting stent and 1-month DAPT was evaluated on Composite of cardiac death (CD) or myocardial infarction (MI) between 1 and 12 months (HR 1.106, 95% CI 0.735-1.665, p=0.63). Small vessel disease (RVD ≤2.5 mm) treated with Resolute Onyx stents and 1-month DAPT had comparable 1-to-12-month cardiac death or MI rates to larger vessels (8.5% vs 6.8%; HR 1.106, P=0.63).
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