Author + information
- Jochen Wöhrle1,
- Jawed Polad2,
- Balbir Singh3,
- Milan Chag4,
- Seung-Woon Rha5,
- Fazila-Tun-Nesa Malik6 and
- Wolfgang Rottbauer1
The Resolute Integrity zotarolimus-eluting stent utilizes novel continuous sinusoid technology (CST). With CST, a single cobalt alloy wire is formed into a repeating sinusoidal pattern, wrapped helically and fused to improve conformability, provide greater flexibility and ease of delivery without compromising other important stent design characteristics like radial and longitudinal strength. The objective of the DELIVER study was to evaluate delivery success as well as in-hospital outcome following use of the Resolute Integrity stent in an all-comers large patient population.
DELIVER is a prospective, multicentre, single arm, open-label, observational study in 163 centers in 33 countries. Patients with coronary artery disease and a lesion of reference vessel diameter of 2.25 to 4.0 mm were eligible for inclusion. Group 1 received the Resolute Integrity stent as the first choice of stent treatment and Group 2 were treated following delivery failure of another stent type. The primary endpoint for the study was delivery success defined as complete passage of the stent across the target lesion with full expansion to the desired diameter at the desired location. Other endpoints are in-hospital clinical outcomes adjudicated by a clinical event committee.
A total of 7740 patients (12165 stents in 10449 lesions) were enrolled between February 2011 and June 2012. Patients suffered from diabetes mellitus in 34.9% and acute myocardial infarction 28.4%. Procedure approach was radial in 46.0%, brachial in 0.6% or femoral in 53.3%. Multiple lesions were treated in 26.9%, pre-dilatation performed in 67.4% and post-dilation in 39.3%. Lesions were de-novo in 94.5% and restenotic in 5.5%. Type B2/C lesions were treated in 58.8%. Reference diameter pre stent implantation was 2.93±0.48mm. The primary endpoint delivery success was high with 98.9% [95% CI 98.7-99.1%] in group I and 98.0% [95% CI 89.1-99.9%] in group 2. Adjudicated in-hospital events were major adverse cardiac events 1.7% (N=128/7740), death 0.3%, clinically driven target-lesion revascularization 0.1% (N=11/7740). Definite and probable stent thrombosis rate according to ARC criteria occurred in 0.1% (N=15/7740).
This largest real-world experience with the new Resolute Integrity stent platform demonstrated a low in-hospital event rate including a low rate of stent thrombosis. Delivery success was high with the Resolute Integrity stent as the first choice of stent as well as after delivery failure of another stent type.
- 2013 American College of Cardiology Foundation