9-year clinical follow-up of patients with ST-segment elevation myocardial infarction with Genous or TAXUS Liberté stents

<div><p>Objectives</p><p>This matched-cohort retrospective study investigated the long-term (9-year) safety and efficacy outcomes of patients with ST-segment elevation myocardial infarction (STEMI) and primary percutaneous coronary intervention (pPCI) with Genous (n = 102) versus TAXUS Liberté (n = 101) stents in 2006–2008.</p><p>Background</p><p>In the era of off-label use of drug-eluting stents for pPCI in patients with STEMI, the use of first-generation Genous stents (endothelial progenitor cell capture stents that have a passive coating and accelerate re-endothelialization) was proposed.</p><p>Methods</p><p>The primary endpoint was 9-year major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, target vessel revascularization (TVR), and stroke. The secondary endpoints were the separate primary endpoint events at pre-defined time-points (in-hospital, 6 months, and yearly) and stent thrombosis. Time-dependent 9-year composite MACCE, all-cause death, and TVR were compared using Kaplan-Meier estimates and multivariate Cox regression models.</p><p>Results</p><p>Propensity score analysis confirmed the comparability of the groups. Patients in the Genous and TAXUS groups had 7 and 1 acute definitive stent thrombosis events, respectively (p<0.001). There was a trend towards higher in-hospital MACCE in the Genous group (10.8%) versus the TAXUS group (4.0%). Kaplan-Meier analysis showed that 9-year MACCE was significantly worse in the Genous than in the TAXUS group. The in-hospital, 6-month, 1-year, and 9-year mortality rates were 7.8%, 8.8%, 9.8%, and 23.5% in the Genous group and 2.0%, 3.0%, 4.0%, and 16.8% in the TAXUS group.</p><p>Conclusions</p><p>Higher peri-procedural, in-hospital, and short-term mortality led to worse outcomes for first-generation Genous stents versus TAXUS Liberté stents for pPCI in STEMI. TAXUS Liberté stents had more favorable 9-year clinical outcomes.</p></div

Major adverse cardiac and cerebrovascular events (MACCE) in patients with STEMI who received Genous or TAXUS LIBERTÉ stents in primary percutaneous coronary intervention.

<p><b>(A)</b> Primary endpoint: MACCE cumulative 9-year adverse events. <b>(B)</b> and <b>(C)</b> Secondary endpoints death, repeated acute myocardial infarction (re-AMI), target vessel revascularization (TVR), and stroke in patients who received Genous or TAXUS Liberté stents in primary PCI in STEMI. *p<0.05 between the Genous and TAXUS Liberté groups.</p

Main Genous studies.

<p>Main Genous studies.</p

Kaplan-Meier survival analysis in patients with STEMI who received either Genous or TAXUS Liberté stents at the primary percutaneous coronary intervention.

<p><b>(A)</b> Cumulative survival. <b>(B)</b> Forest plot of survival in the indicated subgroups. CI = confidence interval; DM = diabetes mellitus; LAD = left anterior descending coronary artery; Nr = number.</p

Kaplan-Meier major adverse cardiac and cerebrovascular event- (MACCE)-free survival in patients with STEMI who received Genous or TAXUS Liberté stents in primary percutaneous coronary intervention.

<p><b>(A)</b> Cumulative MACCE-free survival. <b>(B)</b> Forest plot of MACCE-free survival in the indicated subgroups. CI = confidence interval; DM = diabetes mellitus; LAD = left anterior descending coronary artery; Nr = number.</p

Kaplan-Meier analysis of target vessel revascularization (TVR)-free survival in patients with STEMI who received Genous or TAXUS Liberté stents in primary percutaneous coronary intervention.

<p>(A) Cumulative TVR-free survival. (B) Forest plot of TVR-free survival in the indicated subgroups. CI = confidence interval; DM = diabetes mellitus; LAD = left anterior descending coronary artery; Nr = number.</p

Demographic and clinical data of the patients with STEMI receiving either Genous or TAXUS Liberté stents in primary percutaneous coronary intervention (pPCI).

<p>Demographic and clinical data of the patients with STEMI receiving either Genous or TAXUS Liberté stents in primary percutaneous coronary intervention (pPCI).</p

Main outcomes of the Genous studies.

<p>Main outcomes of the Genous studies.</p

Angiographic and procedural data of patients with STEMI receiving either Genous or TAXUS Liberté stents in primary percutaneous coronary intervention (pPCI).

<p>Angiographic and procedural data of patients with STEMI receiving either Genous or TAXUS Liberté stents in primary percutaneous coronary intervention (pPCI).</p

List of procedural, in-hospital, 6-month, 1 and 9-year adverse cardiac events in patients with STEMI receiving Genous stents in primary percutaneous coronary intervention (pPCI), with or without prior statin treatment.

<p>Each event has been counted; while cumulative MACCE rate is calculated as one event/ patient.</p