Abstract
BackgroundImproved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial.MethodsIn a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan–Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.ResultsA total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76–1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63–1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40–1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72–1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41–2.52).ConclusionsIn patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent.Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008
Highlights
Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary interven‐ tion remain an unmet clinical need
In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucoleluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent
Lesion, and procedural characteristics and angiographic outcomes Of a total of 3002 patients enrolled in the ISAR-TEST 5 trial, 870 patients with diabetes mellitus were identified: 575 patients were assigned to treatment with polymer-free sirolimus- and probucol-eluting stent and 295 to durable polymer zotarolimus-eluting stent (Fig. 1)
Summary
Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary interven‐ tion remain an unmet clinical need. Persistent inflammatory response to durable polymer coatings of DES is recognized as a leading cause of delayed arterial healing and one of the key factors underlying late stent failure in patients who undergo DES implantation [5, 6]. This issue is of particular relevance in the setting of diabetic patients with high atherothrombotic risk [2, 7]. The efficacy and safety of polymer-free DES compared with durable polymer-based second-generation DES in diabetic patients are poorly defined and very long-term outcomes are underexplored with data almost exclusively deriving from comparison with outdated first-generation polymer-based DES [9]
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