This study confirmed that risk factor control after stroke or TIA remained unsatisfactory in our local setting of routine care. Shortly after the index event, patients are obviously motivated to participate in a structured support program. The results after implementation of such a secondary prevention support program suggest that risk factor control can clearly be improved compared to usual care. Intensity of this support relates to the interval until targets are met. However, attendance rates indicate that significant efforts are necessary to keep patients in the program.
Our findings about quality of secondary prevention in usual care are in accordance with previous findings both at a national
[24] and international
[13],
[25],
[26] level. A very similar percentage (54.5%) of patients with blood pressure >140/90 mmHg was found at baseline in the Reduction of Atherothrombosis for Continued Health (REACH) Registry
[26].
Most studies investigating routine stroke aftercare have reported proportions of medication adherence for different preventive strategies during follow-up so far
[13],
[27],
[28]. Based on the outpatient appointments, we focused on risk factor measurements and achieved target values.
The support program for intensified secondary prevention promises a major reduction of recurrent events when taking into account the high risk for ischemic re-events in acute stroke
[29] and TIA patients
[9],
[30] and the given evidence for risk reduction via blood pressure control
[31], LDL-lowering
[7] and antithrombotic treatments
[3].
The results of our intervention are in accordance with other studies on prevention programs: Supported control of blood pressure was investigated in the Home Blood Pressure study
[32] in hypertensive patients. The combination of blood pressure focused website training and regular pharmacist care management including modification of lifestyle yielded superior blood pressure control and improved compliance to pharmaceutical therapy compared to usual care. As a shortcoming of the study, the observation period was one year only and vascular events were therefore not reported as endpoints. Another exemplary randomized study in patients after acute coronary syndrome or stroke showed that risk factors were better controlled under intensive disease management and risk factor modification
[33]. A reduction of subsequent vascular events was also suggested within one year.
In this context, it seems of crucial importance that secondary prevention is carried out at an early stage. The EXPRESS study demonstrated successfully that an early and aggressive deployment of combined secondary prevention measures effectively reduces the re-event rate of TIA and minor stroke
[11]. It was shown that the 90 days re-event rate both of TIA and minor stroke could be reduced significantly by immediate start of antithrombotic therapy, blood pressure lowering and reduction of cholesterol and, if necessary, initiating carotid endarterectomy. It can be concluded that an improved and early start of secondary prevention is necessary and effective after TIA and minor stroke.
In long-term followed-up patients (mean follow-up 8 years) with type 2 diabetes mellitus, intensive treatment, with a stepwise implementation of behavior modification and pharmacologic therapy that targeted hyperglycemia, hypertension, dyslipidemia, and microalbuminuria, along with secondary prevention of cardiovascular disease with aspirin reduced the risk of cardiovascular and microvascular events by about 50 percent
[15].
Our study has several limitations: First, the comparison between usual care and support program was conducted in consecutive but not simultaneous cohorts. We cannot rule out, therefore, that the improved achievement of secondary prevention targets in the support program was at least partially contaminated by an increased awareness about the crucial role of adherence to guidelines both by patients and their family doctors as both studies were performed in the same setting. Second, follow-up data could not be collected in about 20% of patients in both cohorts because we restricted follow-up assessments to those patients who attended the outpatient appointments at six months. Although attendance rates are usually lower than follow-up rates, this mitigates the validity of our results. Third, with the different intervals of outpatient appointments in the two groups, vascular event rates are difficult to compare. Fourth, in contrast to high standard randomized controlled trials, our patient groups, patient characteristics and the way of documentation between both cohorts may differ not only in observed but also in unobserved baseline parameters. The differences in the way of documentation between both cohorts and also in the patient characteristics were not addressed using multivariable analyses. Finally, follow-up was not performed in a blinded manner. In order to minimize selection bias, we only compared patients (usual care cohort) who assured that they would participate in a secondary prevention program with patients in the intervention cohort. Patients who are willing to participate in a supported secondary prevention program are probably more concerned about their health than the general stroke population and more prone to adhere to vascular risk control recommendation.
Conclusion
The results of our study suggest that the support program leads to a major improvement of secondary prevention. We are going to investigate the effects of this support program on reduction of recurrent coronary and cerebrovascular events in an appropriately powered randomized controlled trial (clinicaltrials.gov: NCT01586702).