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

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

Study Question: The investigators sought to examine the effect of intravenous beta-blockers administered before primary percutaneous coronary intervention (PCI) on survival and myocardial recovery after acute myocardial infarction (AMI). Methods: The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial randomized 2082 AMI patients to either stenting or balloon angioplasty, each ⫾ abciximab. In accordance with the protocol, intravenous beta-blockers were administered before PCI in the absence of contraindications. Results: A total of 1136 patients (54.5%, BB⫹ group) received beta-blockers before PCI, whereas 946 (45.5%, BB⫺ group) did not. The 30-day mortality was significantly lower in the BB⫹ group than in the BB⫺ group (1.5% vs. 2.8%, p⫽0.03), an effect entirely limited to patients who had not been receiving beta-blockers before admission (1.2% vs. 2.9%, p⫽0.007). In contrast, no survival benefit with pre-procedural beta-blockers was observed in patients receiving beta-blockers at home (3.3% vs. 1.9%, respectively, p⫽0.47). By multivariate analysis, pre-procedural beta-blocker use was an independent predictor of lower 30-day mortality among patients without previous betablocker therapy (relative risk ⫽0.38 [95% confidence interval, 0.17– 0.87], p⫽0.02). The improvement in left ventricular ejection fraction from baseline to 7 months was also greater after intravenous beta-blockers (3.8% vs. 1.3%, p⫽0.01), an effect limited to patients not receiving oral beta-blockers before admission. Conclusions: The authors concluded that in patients with AMI undergoing primary PCI, myocardial recovery is enhanced and 30-day mortality is reduced with pre-procedural intravenous beta-blockade among patients untreated with oral beta-blocker medication before admission. Perspective: The present study supports the routine administration of intravenous beta-blocker therapy in patients with AMI not maintained on oral beta-blockers before primary PCI, in the absence of absolute contraindications. Beta-blockers are frequently under-prescribed in the periinfarct period and the present study demonstrates that intravenous beta-blocker administration was safe without increases in adverse events such as bradyarrhythmias or severe hypotension. This safety profile, coupled with the potential benefits of enhanced survival and myocardial recovery, reinforce the importance of the administration of pre-procedural intravenous beta-blockers to most patients with AMI before primary PCI, especially those not maintained on oral beta-blocker therapy at the time of admission. DM

Lansky AJ, Costa RA, Mintz GS, et al, for the DELIVER Clinical Trial Investigators. Circulation 2004;109:1948 –54. Study Question: Paclitaxel has been shown to inhibit smooth muscle cell proliferation and migration. The investigators report the angiographic outcomes of the non–polymerbased, paclitaxel-coated ACHIEVE stent evaluated in the DELIVER clinical trial. Methods: 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. A total of 1043 patients with focal de novo coronary lesions, ⬍25 mm in length, in 2.5– 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). Results: 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 vs. 0.98 mm (p⫽0.003), stent binary restenosis was 14.9% vs. 20.6% (p⫽0.076) and targetvessel failure was 11.9% vs. 14.5% (p⫽0.12) for ACHIEVE and ML PENTA, respectively. Conclusions: The authors concluded that 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. Perspective: The primary finding of this study is that the benefit of a nonpolymeric paclitaxel-coated stent was significantly less than that observed in other polymer-based, drug-eluting stent programs with paclitaxel or sirolimus and did not translate into clinically meaningful reductions in angiographic or clinical restenosis. Polymer-based, drugeluting stents should be considered the standard of care for stent implantation at this time. DM

Impact of Intravenous Beta-Blockade Before Primary Angioplasty on Survival in Patients Undergoing Mechanical Reperfusion Therapy for Acute Myocardial Infarction

Temporal Trends in Percutaneous Mitral Commissurotomy Over a 15-Year Period

Halkin A, Grines CL, Cox DA, et al. J Am Coll Cardiol 2004;43: 1780 –7.

Iung B, Nicoud-Houel A, Fondard O, et al. Eur Heart J 2004;25: 701–7.

ACC CURRENT JOURNAL REVIEW Jul 2004

44