Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Drug-eluting stents (DES) may increase late stent thrombosis (ST) risk compared to bare metal stents (BMS).
• An increased rate of death and myocardial infarction (MI) has not been consistently observed with DES.
• Hypothesis: Prevention of restenosis by DES may offset the excess risk from ST.

Purpose of the Study:

• To evaluate the safety and efficacy of paclitaxel-eluting stents versus BMS.
• To compare the incidence of death, MI, and target lesion revascularization (TLR) between stent types.
• To determine if the benefits of DES in preventing restenosis outweigh the risks associated with ST.

Main Methods:

• Pooled analysis of patient-level data from 4 prospective, double-blind trials.
• 3445 patients randomized to paclitaxel-eluting stents or BMS.
• Median follow-up of 3.2 years; assessment of death/MI within 7 days of ST or TLR.

Main Results:

• ST occurred in 1.0% of patients (34 total), with 91.1% experiencing death or MI within 7 days.
• TLR occurred in 12.3% of patients (425 total), with 3.5% experiencing death or MI within 7 days.
• ST resulted in 12 deaths/MIs with BMS and 19 with DES; TLR resulted in 11 deaths/MIs with BMS and 4 with DES.

Conclusions:

• ST is infrequent but carries a high risk of death and MI.
• TLR is more frequent but associated with a lower risk of death and MI.
• The significant reduction in restenosis with DES may counterbalance the potential excess risk of late ST.