OBJECTIVES: The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated proximal left anterior descending (LAD) coronary artery disease. BACKGROUND:Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction. METHODS: A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. RESULTS: Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). 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% (p = 0.49). CONCLUSIONS: In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms.
RCT Entities:
OBJECTIVES: The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated proximal left anterior descending (LAD) coronary artery disease. BACKGROUND: Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction. METHODS: A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. RESULTS: Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). 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% (p = 0.49). CONCLUSIONS: In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms.
Authors: Ralf E Harskamp; Judson B Williams; Michael E Halkos; Renato D Lopes; Jan G P Tijssen; T Bruce Ferguson; Robbert J de Winter Journal: J Thorac Cardiovasc Surg Date: 2014-03-20 Impact factor: 5.209
Authors: Mario Gaudino; Irbaz Hameed; Michael E Farkouh; Mohamed Rahouma; Ajita Naik; N Bryce Robinson; Yongle Ruan; Michelle Demetres; Giuseppe Biondi-Zoccai; Dominick J Angiolillo; Emilia Bagiella; Mary E Charlson; Umberto Benedetto; Marc Ruel; David P Taggart; Leonard N Girardi; Deepak L Bhatt; Stephen E Fremes Journal: JAMA Intern Med Date: 2020-12-01 Impact factor: 21.873