Abstract Body: Background and Purpose: External counterpulsation (ECP) is a novel noninvasive method used to improve the perfusion of vital organs, which may benefit ischemic stroke patients. We aimed to test the hypothesis that ECP may improve disability in addition to best medical treatment in atherosclerotic stroke patients within 7 days of symptom onset.
Methods: The trial was a multi-centre, randomized, controlled trial. Patients with cerebral large artery occlusive disease were randomized to 35 one-hour sessions of ECP group or no-ECP control group, in addition to best available evidence-based medical and rehabilitation treatment. Primary outcome was modified Rankin scale (mRS) grade at month 3, defined as a good outcome with a mRS≦2. Secondary outcomes were the scores of National Institutes of Health Stroke Scale (NIHSS) and Barthel index (BI), stroke recurrence, overall mortality and the occurrence of vascular events by 3 months (recurrent stroke, acute coronary syndrome, deep vein thrombosis and hemorrhagic transformation or intracerebral hemorrhage).
Results: In the randomized 189 patients from three hospitals, totally 5 patients were lost to follow-up at month 3. Therefore, 184 patients (97.4%) with moderate neurological deficit (mean NIHSS, 8.2) were included into the intention-to-treat analysis (90 ones in ECP group and 94 ones in No-ECP group, respectively). The groups were balanced in all demographic data. At month 3, there were no significant differences in the proportion of patients with good outcome (ECP 42.2% vs no-ECP 35.1%, P=0.322) and the secondary outcomes, except the incidence of vascular events with a favorable trend (ECP 3.3% vs no-ECP 8.5%, P=0.139). After adjusting for the factors not complying with trail design, a significant lower incidence of vascular events was found in 0.0% of 65 patients in ECP group compared to 9.1% of 88 patients in no-ECP group (P=0.021) at month 3 in per-protocol analysis.
Conclusion: ECP did not statistically significantly improve disability in atherosclerotic stroke within 7 days of symptom onset in the RCT trial. However, per-protocol analysis showed that completion of total 35 one-hour sessions of ECP treatment is beneficial for reducing the incidence of new vascular events in atherosclerotic stroke after 3 months of onset.
Registration number: ChiCTR-TRC-07000706