Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial.

BACKGROUND: Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non-polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent. METHODS AND RESULTS: A total of 1043 patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels were randomized (ACHIEVE n=524; ML PENTA n=519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE n=228; ML PENTA n=214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (P=0.003), stent binary restenosis was 14.9% versus 20.6% (P=0.076), and target-vessel failure was 11.9% versus 14.5% (P=0.12) for ACHIEVE and ML PENTA, respectively. CONCLUSIONS: The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.

Prognostic implications of creatine kinase elevation after primary percutaneous coronary intervention for acute myocardial infarction.

OBJECTIVES: We examined the prognostic implications of the absolute level and rate of increase of creatine kinase (CK) elevation after primary percutaneous coronary intervention (PCI). BACKGROUND: Peak creatine kinase (CK(peak)) and the rate of CK increase are related to reperfusion success and clinical outcomes after thrombolytic therapy for acute myocardial infarction (AMI). The utility of routine serial CK monitoring after primary PCI, in which normal antegrade blood flow is restored in most patients, is unknown. METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 1,529 patients with AMI randomized to either stenting or balloon angioplasty, each with or without abciximab, had CK levels determined at baseline and at 8 +/- 1 h, 16 +/- 1 h, and 24 +/- 1 h after PCI. RESULTS: The CK(peak) occurred at baseline in 3.9% of patients, at 8 +/- 1 h in 69.6%, at 16 +/- 1 h in 20.0%, and at 24 +/- 1 h in 6.5%. The CK levels at all post-procedural time points were significantly higher in patients who died compared with the one-year survivors, as was CK(peak) (mean, 2,865 U/l vs. 1,885 U/l, respectively, p < or = 0.001). By multivariate analysis, CK(peak) was a significant predictor of one-year mortality (hazard ratio = 2.15, p = 0.0002), independent from post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow. Both the improvement in left ventricular ejection fraction from baseline to seven months and its absolute level were inversely correlated with CK(peak) (p < 0.001 for both). In contrast, the time to CK(peak) was not an independent predictor of mortality or myocardial recovery. CONCLUSIONS: The CK(peak) after primary PCI is a powerful predictor of one-year mortality independent of other clinical and angiographic measures.