The Effect of Drug-Eluting Stents on Target Lesion Revascularization in Native Coronary Arteries: Results from the NORSTENT Randomized Study

Abstract

Background: The NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS) with 5-year follow-up. No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularizations, which were reduced by DES. We report the occurrence of target lesion revascularization (TLR) in time and across demographic and clinical subgroups in patients with lesions in native coronary arteries (n = 8,782). Results: Clinically driven TLR was performed on 488 (5.6%) of the 8,782 patients during 5 years of follow-up. Male gender, older age, visible thrombus in the lesion, and larger stent diameter were associated with less TLR; multivessel disease and longer stents were associated with a higher risk of TLR. There was a substantial and highly significant reduction of the risk of any TLR after 5 years in the DES group (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.36-0.52], p < 0.001). The effect of DES on TLR was limited in time to the first 2 years in the study with no evidence of a later rebound effect. The reduction in TLR after DES insertion was consistent across subgroups defined by gender, age, diabetes status, renal function, and lesion and stent characteristics. The number needed to treat with DES (vs. BMS) to prevent 1 TLR ranged from 4 to 110 across clinically relevant subgroups. Conclusion: DES have a time-limited effect on the rate of TLR, but with a substantial and highly significant reduction in the first 2 years after the procedure. This effect was found to be consistent across all important clinical subgroups.

Drug-Eluting versus Bare-Metal Stents in Saphenous Vein Grafts Compared to Native Coronary Vessels: The Norwegian Coronary Stent Trial Study

“…This observation is in keeping with previous studies [2, 6-10]. In addition, the only predictor for TLR in vein grafts (recipient vessel) contrasts to what is found in native vessels [4]. Obviously SVG differs in many ways in structure compared to a native vessel [19-21].…”

“…Percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG) is common and has accounted for 5–15% of all PCI procedures [1, 2]. Drug-eluting stent (DES) used in native coronary arteries have consistently shown reduction in the need for repeat revascularization when compared to bare-metal stents (BMS) [3, 4], with no effect on mortality or cardiovascular morbidity. However, the effects of DES compared to BMS when used in SVG, are not established since the results of randomized trials [2, 5-10] and meta-analyses [1, 11-15] of these trials have been inconsistent.…”

“…The Norwegian Coronary Stent Trial (NORSTENT) randomized 9,013 patients with acute or stable coronary lesions in native coronary arteries or vein grafts to PCI with second-generation DES or BMS. There was no significant difference between the treatment arms for the main composite endpoint of all-cause death and non-fatal spontaneous MI [3], but the rate of TLR was lowered from 9.1% with BMS to 4.1% with DES after 5 years [4]. The aim of the present prespecified substudy is to compare the long-term risk of mortality, spontaneous MI, and TLR among patients treated with DES or BMS in SVG compared to patients treated in native coronary arteries.…”

Analyses of Increased Mortality in New and Known Diabetes in Patients with Coronary Disease Enrolled in the NORSTENT Randomized Study

“…We found no interaction between stent type and diabetes on all-cause, cardiac, or noncardiac mortality. Previously we have also reported a lack of interaction between stent type and diabetes concerning TLR [8]. Thus, in our experience, diabetes is not an important factor in the evaluation of when to use DES or BMS, whether the decision is based on mortality or TLR.…”

“…Diabetes has been found to be a risk factor for death and myocardial infarction in many studies of coronary artery disease [1][2][3][4][5][6] to treatment with drug-eluting stents (DES) or bare-metal stents (BMS) (ClinicalTrials.gov number, NCT00811772) [7]. There was no significant difference between DES and BMS for the main composite end point of death of any cause and nonfatal spontaneous myocardial infarction [7] but a consistent effect of DES on reducing the rate of target lesion revascularization (TLR) [8]. In the main study, 5,512 patients had fasting glucose level or percent glycated hemoglobin (HbA1c) measured and recorded at the index procedure and constitute the population for this study.…”