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Published on: September 15, 2023
Randomized comparison of percutaneous coronary intervention with sirolimus-eluting stents versus coronary artery
Enno Boudriot1, Holger Thiele, Thomas Walther
1Department of Internal Medicine/Cardiology, University of Leipzig-Heart Center, Germany.
Insights
Sirolimus-eluting stents did not prove noninferior to coronary artery bypass grafting for unprotected left main disease due to higher repeat revascularization rates. However, hard endpoints like death and heart attack were comparable between treatments.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Cardiac Surgery
Background:
- Coronary artery bypass grafting (CABG) is the standard for unprotected left main (ULM) disease.
- Drug-eluting stents (DES) offer potential alternatives, but comparative data are limited.
- Randomized trials are needed to establish the efficacy of percutaneous coronary intervention (PCI) with DES versus CABG.
Purpose of the Study:
- To compare sirolimus-eluting stenting versus CABG in patients with ULM coronary artery disease.
- To assess noninferiority of PCI with DES compared to CABG.
- To evaluate major adverse cardiac events (MACE) at 12-month follow-up.
Main Methods:
- A prospective, multicenter, randomized trial involving 201 patients with ULM disease.
- Patients were assigned to either sirolimus-eluting stenting (n=100) or CABG (n=101) using predominantly arterial grafts.
- The primary endpoint was freedom from MACE (cardiac death, myocardial infarction, target vessel revascularization) at 12 months.
Main Results:
- The primary endpoint occurred in 19.0% of PCI patients versus 13.9% of CABG patients (p=0.19 for noninferiority).
- Rates of death and myocardial infarction were similar (5.0% vs. 7.9%; p<0.001 for noninferiority).
- PCI was inferior for repeat revascularization (14.0% vs. 5.9%; p=0.35 for noninferiority), while perioperative strokes were higher with CABG (30% vs. 4%; p<0.001).
Conclusions:
- Sirolimus-eluting stents did not achieve noninferiority to CABG for ULM disease at 12 months, primarily due to higher revascularization rates.
- For hard endpoints (death, MI), PCI demonstrated favorable results.
- Longer follow-up is necessary to fully assess the long-term outcomes of both treatment strategies.
Objectives:
The purpose of this randomized study was to compare sirolimus-eluting stenting with coronary artery bypass grafting (CABG) for patients with unprotected left main (ULM) coronary artery disease.
Background:
CABG is considered the standard of care for treatment of ULM. Improvements in percutaneous coronary intervention (PCI) with use of drug-eluting stents might lead to similar results. The effectiveness of drug-eluting stenting versus surgery has not been established in a randomized trial.
Methods:
In this prospective, multicenter, randomized trial, 201 patients with ULM disease were randomly assigned to undergo sirolimus-eluting stenting (n = 100) or CABG using predominantly arterial grafts (n = 101). The primary clinical end point was noninferiority in freedom from major adverse cardiac events, such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months.
Results:
The combined primary end point was reached in 13.9% of patients after surgery, as opposed to 19.0% after PCI (p = 0.19 for noninferiority). The combined rates for death and myocardial infarction were comparable (surgery, 7.9% vs. stenting, 5.0%; noninferiority p < 0.001), but stenting was inferior to surgery for repeat revascularization (5.9% vs. 14.0%; noninferiority p = 0.35). Perioperative complications including 2 strokes were higher after surgery (4% vs. 30%; p < 0.001). Freedom from angina was similar between groups (p = 0.33).
Conclusions:
In patients with ULM stenosis, PCI with sirolimus-eluting stents did not show noninferiority [corrected] to CABG at 12-month follow-up with respect to freedom from major adverse cardiac events, which is mainly influenced by repeated revascularization, whereas for hard endpoints, [corrected] PCI results are favorable. A longer follow-up is warranted. [corrected]
