Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Abstract

S tent implantation constitutes the default strategy during coronary interventions.1,2 Drug-eluting stents (DES) are widely used because of their unique ability to inhibit neointimal proliferation and reduce the restenosis risk.1,2 However, although rare, in-stent restenosis (ISR) still occurs after DES implantation. 3,4 Of concern, several studies have suggested that treatment Background-Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results-A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-ElutingBalloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at followup remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. Conclusions-This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EESprovide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940. Current address for A. of patients with DES-ISR is more challenging than treatment of patients with bare-metal stent (BMS) ISR. 5-9 Indeed, long-term clinical and angiographic results of patients treated for DES-ISR are significantly poorer than those seen in patients treated for BMS-ISR. [5][6][7][8][9] These findings have been demonstrated in patients with ISR treated with first-generation DES. 5,6 Recent studies suggest that drug-eluting balloons (DEB), another well-established therapy in this scenario, are also associated with poorer long-term clinical and ang...

The characteristics and risk factors of in-stent restenosis in patients with percutaneous coronary intervention: what can we do

“…The mechanism of ISR has not been fully elucidated, the results of study have found that the hypertension, diabetes, number of coronary artery lesions ≥ 2 arteries, LDL-C ≥ 1.9 mmol/L, unstable angina, left anterior descending artery, diameter of stent ≥ 3 mm, the length of stent > 20 mm were independent risk factors for ISR in patients with PCI, targeted preventions should be conducted based on those factors. PCI is currently the main effective treatment option for CHD, especially drug-coated stents have greatly improved the efficacy and prognosis of patients with CHD [10]. Although drugcoated stents can significantly reduce the risk of ISR, the risk of acute heart disease events such as progressive angina or acute myocardial infarction caused by ISR still exists, which seriously affects the outcome after PCI [11].…”

Prognostic Value of Plasma Long Noncoding RNA ANRIL for In-Stent Restenosis

“…Serial coronary angiography was performed at baseline (before and after intervention) and within 36 months’ follow-up. ISR was defined as >50% diameter stenosis at follow-up [ 9 ].…”

Diagnosis and management challenges of in-stent restenosis in coronary arteries

“…A recently published pooled analysis of the RIBS V and RIBS IV compared the efficacy of EES in patients with BMS-ISR and DES-ISR[ 79 - 82 ]. The study detected clinical and morphological differences of ISR in BMS vs DES, including for the later more focal ISR pattern and delayed onset of presentation.…”