Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial.

INTRODUCTION: The COVID-19 pandemic has presented challenges to managing vascular risk factors with in-person follow-up of patients with asymptomatic carotid stenosis enrolled in the CREST2 trial. CREST2 is comparing intensive medical management alone versus intensive medical management plus revascularization with endarterectomy or stenting. We performed a study to evaluate the feasibility of a home-based program for testing blood pressure (BP) and low-density lipoprotein (LDL) in CREST2. METHODS: This study involved 45 patients at 10 sites in the CREST2 trial. The initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL > 90 mg/dl, or both. If a patient at the site declined participation, another was substituted. All patients who agreed to participate were sent a BP monitoring device and a commercially available at-home lipid test kit that uses a self-performed finger-stick blood sample that was resulted to the patient. Training on the use of the equipment and obtaining the risk factor results was done by the study coordinator by telephone. RESULTS: Ten of the 130 currently active CREST2 sites participated, 8 in the LDL portion and 5 in the BP portion (3 sites did both). Twenty-six BP devices and 23 lipid tests were sent to patients. Of the 26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3. Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4. CONCLUSION: This study established the feasibility of at-home monitoring of BP and LDL in a clinical trial and identified implementation challenges prior to widespread use in the trial. (ClinicalTrials.gov number NCT02089217).

Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital.

OBJECTIVE: Carotid endarterectomy (CEA) is effective in reducing the risk of stroke in individuals with more than 60% carotid stenosis. Carotid angioplasty and stenting (CAS) has been proffered as effective and used in treating individuals with asymptomatic carotid stenosis despite the absence of proven clinical equivalency. This randomized trial was designed to explore the hypothesis that CAS is equivalent to CEA for treating asymptomatic carotid stenosis. METHODS: A total of 85 individuals presenting with asymptomatic carotid stenosis of more than 80% were selected randomly for CAS or CEA and followed up for 48 months. RESULTS: Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique, as determined by carotid ultrasonography. No major complications such as cerebral ischemia or death occurred. Procedural complications associated with CAS (n = 5) were hypotension and/or bradycardia; those concomitant with CEA (n = 3) were cervical nerve injury or complications related to general anesthesia (n = 4). Both procedures were well tolerated in the context of pain and discomfort. Hospital stay was similar in the two groups (mean, 1.1 versus 1.2 d). The occurrence of complications associated with CAS or CEA prolonged hospitalization by 3 days (mean, 4.0 versus 4.5 d). Return to full activity was achieved within 1 week by more than 85% of patients; all returned to their usual lifestyle by 2 weeks. Although hospital charges were slightly higher for CAS, costs were similar. CONCLUSION: CAS and CEA may be equally effective and safe in treating individuals with asymptomatic carotid stenosis.

Carotid angioplasty with stenting versus endarterectomy: 10-year randomized trial in a community hospital.

OBJECTIVES: This single-center, randomized, clinical trial was designed to determine the 10-year comparative efficacy and durability of carotid angioplasty and stenting (CAS) versus carotid endarterectomy (CEA) in preventing ipsilateral ischemic stroke in symptomatic and asymptomatic patients with high-grade carotid artery stenosis. BACKGROUND: Modern clinical trials with short-term follow-up indicate CAS and CEA are equivalent in reducing the risk for ipsilateral ischemic stroke secondary to carotid stenosis. A paucity of data exists regarding long-term outcomes. METHODS: Patients of all surgical risks with symptomatic and asymptomatic carotid stenosis (>70%) were randomly selected for CEA or CAS and followed a minimum of 10 years. RESULTS: Long-term follow-up was achieved in 173 patients (91%). Eighty-seven (50.2%) died within this period, most commonly of nonvascular causes. No difference in the risk of stroke ipsilateral to the treated artery was noted among treatment groups (p > 0.05). Restenosis determined by sequential ultrasound was assessed only in the CAS group (3.3%) and remained asymptomatic. The combined risk of fatal or nonfatal heart attack over the 10-year period was highest in individuals with symptomatic versus asymptomatic stenosis (27.5% vs. 11.0%; hazard ratio [HR]: 2.32, 95% confidence interval [CI]: 1.298 to 4.146, p = 0.005) and was higher in all patients treated with CEA (HR: 2.27, 95% CI: 1.35 to 3.816, p = 0.002). CONCLUSIONS: Long-term protection against ipsilateral stroke provided by CAS and CEA did not differ in this trial. The 10-year risk of fatal/nonfatal myocardial infarction was highest in all patients harboring symptomatic carotid stenosis at enrollment. The risk of fatal/nonfatal heart attack was significantly more prevalent in those symptomatic or asymptomatic patients randomized to CEA.