PCI Poses Risk for Patients with Stable Ischemic Heart Disease

Gregg Stone, MD

Results a new analysis from Mount Sinai Hospital could prove useful to cardiologists.

An analysis of patient-level data from more than a dozen randomized coronary stent trials has found patients with stable ischemic heart disease had a substantial risk for long-term major adverse cardiovascular events (MACE) following revascularization with percutaneous coronary intervention, even with newer drug-eluting stents (DES).

With the goal of further evaluating whether revascularization might improve prognosis in this patient population, investigators—led by Gregg Stone, MD, of Mount Sinai Hospital—conducted the current study to examine the long-term outcomes of revascularization. The primary objectives of the analysis were to assess rates and creditors for long-term adverse events in these patients.

The primary endpoint of the study was MACE, which was defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization. The study also had multiple secondary endpoints including target lesion failure (TLF), which was defined as a composite of cardiac death, target vessel MI, or ischemia-driven target lesion revascularization.

A wide variety of stents were included from the 19 trials used by investigators in the current analysis. Stent types were defined as bare-metal stents (BMS) or first or second-generation drug-eluting stents (DES1 or DES2). Among the stents included in the analysis were sirolimus-eluting stents, paclitaxel-eluting stents, everolimus-eluting stents, fast-release zotarolimus-eluting stents, slow-release zotarolimus-eluting stents, and biolimus-eluting stents with a bioabsorbable polymer coating. Investigators pointed out sirolimus-eluting stents and paclitaxel-eluting stents were considered DES1 while all others were considered DES2.

From the 19 trials included by investigators, a cohort of 10,987 patients was identified—this group included 1550 who received BMS, 2776 who received DES1, and 6661 who received DES2. Of note, 89.6% of patients in the DES1 group received paclitaxel-eluting stents and 41.2% of the DES2 group received everolimus-eluting stents. The mean follow-up duration for the study was 4.9 years.

At 1-year, rates of MACE and TLF were 7.9% and 7.5%, respectively, but investigates noted a progressive reduction in rates with more contemporary stents. In all, relative risk for MACE at 1-year was lower with DES1 (RR, 0.46; 95% CI, 0.38—0.55; P <.0001) and DES2 (RR, 0.28; 95% CI, 0.24—0.32; P <.0001) compared with BMS. Additionally, MACE frequency declined with DES2 compared to DES1 (RR, 0.61; 95% CI, 0.51— 0.71; P <.0001).

When examining 5-year outcomes, the overall rates of MACE was 16.1%. Compared with BMS, 5-year MACE rates were lower with DES1 (RR, 0.68; 95% CI, 0.60—0.78; P <.0001) and DES2 (RR, 0.48; 95% CI, 0.43—0.55; P <.0001) and again with DES2 compared with DES1 (RR, 0.72; 95% CI, 0.64—0.81; P <.0001).

Investigators also performed an analysis of very late clinical outcomes, defined as those taking place between the end of year 1 and year 5. When examining rates of MACE during this period, results indicated risk for very late MACE was higher with DES1 than with BMS (RR, 1.39; 95% CI, 1.09—1.56; P=0.009) and DES2 (RR, 1.18; 95% CI, 1.00–1.39; P=.05).

In an editorial, Eric Bates, MD, of the Cardiovascular Center at the University of Michigan, writes the current results underscore the debate over the role of percutaneous coronary intervention in this patient population. Bates notes its sue should only be considered for obstructive coronary artery stenosis.

“This report again reinforces the long-accepted conclusion that newer generation DES are superior to bare metal stents or first-generation DES but does not address the impact of PCI on prognosis in patients with stable ischemic heart disease,” Bates wrote.

This study, “Long-Term Outcomes After Revascularization for Stable Ischemic Heart Disease,” was published in Circulations: Interventions.