One score and 4 years after the first PTA for treatment of intracranial atherostenosis I did the first in man WINGSPAN-procedure for intracranial atherosclerotic disease (ICAD)

One score and 4 years after the first PTA for treatment of intracranial atherostenosis I did the first in man WINGSPAN-procedure for intracranial atherosclerotic disease (ICAD). This was the beginning of an encouraging trial known as WINGSPAN trial (HDE-Trial). Target patients had symptomatic ICAD and had failed antithrombotic therapy. Technical success rate was 100% and the 30-day composite ipsilateral stroke/death rate was 4.5% (1). On the other hand the SAMMPRIS trial the first randomized trial comparing endovascular therapy (EVT) with optimized medical therapy for symptomatic IACD was stopped, because the rate of periprocedural stroke in the EVT group was higher than expected and the rate of stroke in the medical-management group was lower than estimated (2). What are the implications and possible criticisms of these contradictionary findings? In the SAMMPRIS trial patients with recent transient ischemic attack or stroke related to 70–99% stenosis of a major intracranial artery were randomly assigned to EVT. So inclusion criterion was well beyond the level required so far in clinical practice before intracranial stent angioplasty is performed. Usually intracranial stenosis is only be treated if the patient despite medical therapy is symptomatic or there is a hemodynamic compromise by one high-grade intracranial stenosis. SAMMPRIS did not follow the current HDE indication for use of the Wingspan Stent system; it focused on studying the treatment of severe ICAD early in the treatment lifecycle and with an aggressive drug treatment regimen. The Wingspan Stent System is for patients who are refractory to medical therapy. In the SAMMPRIS trial, it was not required for patients to be refractory to medical therapy. Regardless these criteria the SAMMPRIS study attempted a significant extension of the indication to establish stent angioplasty as a first-line therapy. The sample size calculations and expected values for the SAMMPRIS trial based primarily on data from the HDE study a technical safety and feasibility study with predominantly simple lesions. To compare both studies in terms of periprocedural complications is problematic. Results from multicenter registries (3, 4) reflect more the real world scenario and showed higher technical and procedural complication rates. On the other hand, if one compares the morbidity and mortality rate of 10.7% in the historical control data of the WASID study, the MM-rate in the endovascular arm of SAMMPRIS with 14.7% is only moderately increased. The majority of these strokes in SAMMPRIS occurred within one day after the procedure and therefore might correctly …