In patients with isolated proximal left anterior descending (LAD) disease, PCI with Cordis' Cypher sirolimus-eluting stent is not inferior to minimally invasive direct CABG at one-year follow up with respect to major adverse cardiac events (MACE), according to a randomized trial published in the June 23 issue of the Journal of American College of Cardiology.
The authors noted that bare-metal stenting (BMS) is inferior to minimally invasive CABG in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. However, the investigators undertook the study because Cypher has shown to be effective in restenosis reduction.
Holger Thiele, MD, from the department of internal medicine and cardiology, Heart Center at University of Leipzig in Germany, and colleagues randomized a total of 130 patients with significant proximal LAD coronary artery disease to either Cypher (65 patients) or minimally invasive CABG (65 patients). The primary clinical endpoint was noninferiority in freedom from MACE, such as cardiac death, MI and the need for target vessel revascularization within 12 months. Follow-up was completed for all patients.
The researchers found that MACE occurred in 7.7 percent of patients after stenting, as compared with 7.7 percent after surgery (p = 0.03 for noninferiority). The individual components of the combined endpoint revealed mixed results.
Although noninferiority was revealed for the difference in death and MI (1.5 vs. 7.7 percent), noninferiority was not established for the difference in target vessel revascularization (6.2 versus 0 percent), according to the investigators.
Thiele and colleagues found that clinical symptoms improved significantly in both treatment groups in comparison with baseline, and the percentage of patients free from angina after 12 months was 81 versus 74 percent (p = 0.49).
The authors noted that stent thrombosis is a potentially important limitation of drug-eluting stents. "This persistent, potentially prothrombotic substrate necessitates prolonged dual-antiplatelet medication for at least 12 months as recommended in the current trial," they wrote.
Thiele and colleagues also said that minimally invasive CABG is associated with a small but consistent rate of perioperative complications, like in conventional surgery. "Perioperative complications occurred significantly more often after surgery and had substantial impact on hospital resources. However, these complications did not influence quality of life at 12-month follow up and the overall rate of MACE," they wrote.
The authors also noted a patient preference for stenting.
This work was supported by an unrestricted grant from Cordis of New Brunswick, N.J.