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Contemporary DES show low 1-year stent thrombosis risk; scaffolds confer increased risk vs. certain DES
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In patients undergoing PCI, contemporary drug-eluting stents confer a low risk for definite or probable stent thrombosis at 1 year, whereas drug-eluting bioresorbable vascular scaffolds demonstrate an increased risk for device thrombosis compared with cobalt-chromium everolimus-eluting, platinum-chromium everolimus-eluting and hybrid sirolimus-eluting stents, according to study results published in JACC: Cardiovascular Interventions.
In the systematic review and meta-analysis, researchers conducted an electronic search for randomized controlled trials that compared the safety of two or more coronary stents or scaffolds in patients undergoing PCI. The researchers focused on studies evaluating the following stents: bare-metal stents; paclitaxel-eluting stents (PES); sirolimus-eluting stents (SES); zotarolimus-eluting stents (ZES; Endeavor, Medtronic); cobalt-chromium everolimus-eluting stents (CoCr-EES); platinum-chromium (PtCR)-EES; biodegradable polymer (BP)-EES; R-ZES (Resolute, Medtronic); biolimus A9-eluting stents (BP-BES); hybrid SES (O-SES; Orsiro, Biotronik); polymer-free sirolimus- and probucol-eluting stents; and bioresorbable vascular scaffolds (BVS).
The researchers identified 147 randomized trials (n = 126,526) for inclusion in the analysis.
The primary safety endpoint was definite or probable stent thrombosis or device thrombosis according to the Academic Research Consortium (ARC) criteria at 1 year. Other safety endpoints included early stent thrombosis, late stent thrombosis, definite stent thrombosis, all-cause mortality, cardiac mortality and MI. Target vessel revascularization and target lesion revascularization were defined as efficacy endpoints. Outcomes to 1 year were evaluated.
In the 110 studies (n = 111,088) for which the primary endpoint of definite or probable 1-year stent thrombosis was available, all DES except for PES and BVS demonstrated superiority over BMS in terms of this endpoint. All other DES, with the exception of BVS and E-ZES, demonstrated superiority over PES. CoCr-EES, O-SES and PtCr-EES were linked to a significantly lower stent thrombosis risk vs. BVS and E-ZES. Moreover, CoCr-EES and O-SES showed significant superiority over SES and BP-BES. In terms of definite stent thrombosis, this outcome was available in 107 studies (n = 106,543). In these studies, BP-BES, SES, R-ZES, O-SES, CoCr-EES and PtCr-EES yielded superior results vs. PES. Additionally, CoCr-EES was correlated with a lower risk for stent thrombosis than E-ZES, BP-BES and SES, the researchers wrote.
No significant differences were found in comparisons of study stents in terms of all-cause mortality or cardiac mortality.
According to the researchers, 1-year MI risk was significantly lower with SES, R-ZES, BP-BES, E-ZES, PtCr-EES, CoCr-EES and O-SES vs. BMS, whereas SES, BP-BES, E-ZES, PtCr-EES, CoCr-EES and O-SES showed significantly lower risk of MI vs. PES. PtCr-EES was found to be superior to SES, and O-SES was superior to BVS.
All DES and BVS had low rates of TVR and TLR.
“Contemporary DES showed excellent safety profiles in terms of definite or probable [stent thrombosis] at 1 year. However, BVS was associated with a significantly increased risk of device thrombosis when compared to CoCr-EES, PtCr-EES and Orsiro hybrid polymer SES,” the researchers wrote. “The benefit of BVS may emerge after 1 year, as complete degradation of the BVS is achieved in 1 to 4 years post-implantation. Extended follow-up of ongoing clinical trials would shed more light on the safety of this device.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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