Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study

Abstract

Introduction. Carotid artery stenting (CAS) using conventional (single-layer) stents is associated with worse clinical outcomes in diabetes mellitus (DM) vs. non-DM patients: an effect driven largely by lesion-related adverse events. CAS outcomes with MicroNet-covered stents (MCS) in diabetic patients have not been evaluated. Aim. To compare short- and long-term clinical outcomes and restenosis rate in DM vs. non-DM patients with carotid stenosis treated using MCS. Materials and Methods. In a prospective study in all-comer symptomatic and increased-stroke-risk asymptomatic carotid stenosis, 101 consecutive patients (age 51-86 years, 41% diabetics) underwent 106 MCS-CAS. Clinical outcomes and duplex ultrasound velocities were assessed periprocedurally and at 30 days/12 months. Results. Baseline characteristics of DM vs. non-DM patients were similar except for a higher prevalence of recent cerebral symptoms in DM. Type 1 and type 1+2 plaques were more prevalent in DM patients (26.7% vs. 9.8%, p = 0.02 ; 62.2% vs. 37.7%, p = 0.01 ). Proximal embolic protection was more prevalent in DM (60% vs. 36%; p = 0.015 ). 30-day clinical complications were limited to a single periprocedural minor stroke in DM (2.4% vs. 0%, p = 0.22 ). 12-month in-stent velocities and clinical outcomes were not different (death rate 4.8% vs. 3.3%; p = 0.69 ; no new strokes). Restenosis rate was not different (0% vs. 1.7%, p = 0.22 ). Conclusions. MCS may offset the adverse impact of DM on periprocedural, 30-day, and 12-month clinical complications of CAS and minimize the risk of in-stent restenosis. In this increased-stroke-risk cohort, adverse event rate was low both in DM and non-DM. Further larger-scale clinical datasets including extended follow-ups are warranted.

Carotid Stenosis and Stroke: Medicines, Stents, Surgery—“Wait-and-See” or Protect?

“…2. It is unclear why some of these have made it into clinical guidelines 37,59 while others have not. An update may be appropriate in this respect, to encourage clinical decision making that takes into consideration the totality of evidence.…”

“…2 Notably, carotid stenosis is more prevalent in patients with diabetes (that is also an idependent risk factor for the lesion symptomatic transformation), coronary artery disease (CAD), and peripheral artery disease. 2,8,20,[32][33][34][35][36][37] Contemporary clinical data from vascular clinics following patients with known vascular disease, show a yearly stroke rate of 2.5% in reallife cohorts, including patients on maximal (by today's criteria) medical therapy (MMT). 20,[38][39][40] This exceeds the annual stroke risk of 2.1% per year associated with paroxysmal AFib 41 that has been the main focus of stroke prevention.…”

“…20,51 Pharmacomanagement: The Pillar of Therapy to Reduce the Stroke Risk in Patients with Atherosclerotic Carotid Artery Stenosis Medical therapy reduces stroke risk in ASxCS, but the residual risk remains substantial, particularly in patients with vascular comorbidities or diabetes. 20,[35][36][37][38][39][40]52 The progress in pharmacologic prevention in cardiovascular medicine over the last two decades, including the use (and currently high penetration) of statins, antiplatelet agents, and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, has likely led to some reduction in the statistical stroke risk in patients with ASxCS. Subgroup analyses of pharmacologic trials suggest a stroke reduction benefit in ASxCS patients treated with the above medications.…”

“…Note that the presence of PAD or CAD increases the risk of CS while diabetes (patient I) is an important risk factor for stroke in CS. [35][36][37] Patient III was not revascularized due to a wide-spread belief (despite lack of data) in a sufficient MMT protection against CS-related stroke (see text for references). After the stroke, patients I and III were no longer suitable for carotid revascularization due to major loss of cerebral tissue with a mRS 3, resulting in a high risk-to-benefit ratio for intervention.…”