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ESC Congress 2003: 6 months result of a non-polymeric paclitaxel eluting stent in high-risk lesions

September 01, 2003

IMPORTANT: This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2003. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology

ESC Congress 2003: Hot Line II - Acute coronary syndromes / percutaneous coronary intervention

The Deliver II trial is a prospective, non-randomized controlled trial; 1533 patients were included in 86 sites across Europe, Middle East and Africa. Patients were followed for six months and a subset of 500 patients will have a long-term follow-up. Only patients with coronary lesions with a high risk of revascularization were included.

The primary goal of the study was to identify the factors that lead to an increased relative risk of revascularization when implanted with a non-polymeric paclitaxel eluting stent, and therefore to help physicians decide in which patients and which lesions those stents would receive the greatest benefit. The goal of the study was not to assess the efficacy of the non-polymeric paclitaxel eluting stent in this population, as no control group was included.

The primary endpoint was Target Lesion Revascularization (TLR) in order to reflect clinical practice and clinical impact on patients, instead of the more traditional vessel angiographic outcome as we felt that what matters more in everyday practice is patient outcome as opposed to coronary imaging.

The population included lesions with chronic total or sub-total occlusion, small vessels, bifurcated lesions, long lesions, multivessel disease, and restenotic lesions (including in-stent restenosis).
At six months, the TLR rate in the overall population was 10.5%, and the hierarchical MACE rate (death, Q-wave MI, non-Q-wave MI and TLR) was 15.7%. Univariate analysis identified the following lesion risk factors as the ones contributing the most to TLR: small vessel (?2.75 mm), left anterior descending (LAD) artery, restenotic lesion and total stent length (p<0.05). The following patient risk factors were pointing to worsened prognosis: angina and number of diseased vessels. Multivariate analysis identified the following factors to be at higher risk of revascularization: post-procedure minimum lumen diameter, LAD, restenotic lesion, total stent length and number of diseased vessels. Deliver II indicates that patients receiving non-polymeric paclitaxel eluting stents that have one or more of these risk factors should be followed up more extensively and care should taken to avoid negative clinical consequences.

Further developments of stent platforms, polymers and drugs are needed to address higher risk lesions, and further improve patient outcome.

Eberhard Grube
Krankenhaus Siegburg GmbH, Siegburg
Germany

European Society of Cardiology (ESC)