Higher Rates Of Target Lesion Failure Research Articles

Abstract 4120583: Long term Safety and Efficacy of Ultrathin Bioabsorbable polymer sirolimus eluting Stents Versus Thin Durable polymer everolimus eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A systematic review and meta analysis

Background: First generation drug eluting stents (DES) with thick polymers may contribute to local vascular inflammation and late stent thrombosis. Thinner-strut DES (ultrathin), particularly those with biodegradable polymers, aim to reduce this risk by minimizing flow disturbance and vascular injury. However, the long-term safety and efficacy of ultrathin biodegradable polymer sirolimus eluting stents (BP-SES) compared to durable polymer everolimus eluting stents (DP-EES) are still uncertain. Thus, we performed a meta analysis to compare outcomes of these two stents. Methods: Inclusion criteria comprised randomized controlled trials comparing ultrathin BP SES and thin DP EES in patients undergoing percutaneous coronary interventions with long term follow-up of at least 3 years. We excluded cohort studies, case reports, editorials, conference abstracts, and animal studies. Primary outcomes were target lesion failure (TLF), cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). We systematically searched PubMed, Cochrane CENTRAL, and Scopus. Cochrane’s ROB 2.0 tool assessed trial quality, and RevMan software (5.4) performed the meta-analysis. Results: Our analysis included ten RCTs, totaling 16,216 patients, with 9,108 in the BP SES group and 7,108 in the DP EES group. TLF occurred in 905 patients (9.94%) in the BP-SES group and 821 patients (11.55%) in the DP-EES group, with no statistically significant differences between the groups (RR = 0.92, 95% CI = 0.85 to 1.01, p = 0.08). Additionally, there were no significant differences in cardiac death (RR = 1.00, 95% CI = 0.84 to 1.19, p = 1.00), TV-MI (RR = 0.91, 95% CI = 0.78 to 1.05, p = 0.19), and CI-TLR (RR = 0.88, 95% CI = 0.78 to 1.01, p = 0.06) between the two groups. Conclusion: The use of BP-SES did not result in higher rates of TLF, CD, TV-MI, or CI-TLR compared to DP-DES. These findings suggest that both BP-SES and DP-DES are viable options for PCI procedures, with comparable long-term safety profiles. However, some trials used strut thicknesses exceeding 70µm in cases requiring wider diameters, similar to the strut thickness in the DP-EES group. This makes it challenging to assess whether, in addition to biodegradable polymers, lower strut thickness contributes to reducing target lesion-related events. Further research may be needed to explore other relevant outcomes and to confirm these findings in diverse patient populations.

Latest generation stents: is it time to revive the bioresorbable scaffold?

Bioresorbable scaffolds (BRS) have been introduced in the last decade in percutaneous coronary interventions. Despite several advantages being postulated, the negative results from the mid-term follow-up of the Absorb trials have tempered enthusiasm for these innovative devices. The Absorb scaffold was associated with higher rates of target-lesion failure and scaffold thrombosis when compared to current metallic stents, and for this reason was withdrawn from the market. This failure has to be considered multifactorial, involving technical and technological aspects. Continuous engineering refinements in BRS technology, means newer-generation devices are available in clinical practice, and several more are under preclinical and clinical assessment. Thinner and smaller struts, associated with a faster resorption and reendothelialization process, are at the basis of promising preclinical results for new BRS. In this review we summarize the Absorb scaffold experience and focus on the latest evidence concerning emerging new BRS, to explore if a "BRS revival" is conceivable.

One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry

The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

Angiographic complexity of coronary artery disease according to SYNTAX score and clinical outcomes after revascularisation with newer-generation drug-eluting stents: a substudy of the BIOSCIENCE trial.

We sought to assess the performance of drug-eluting stents combining an ultrathin cobalt-chromium platform with a biodegradable polymer across categories of increasing SYNTAX score (SS). Patients included in the BIOSCIENCE trial and randomly allocated to treatment with biodegradable polymer sirolimus-eluting stents (BP-SES) or durable polymer everolimus-eluting stents (DP-EES) were categorised according to SS tertiles (low <8, medium 8-15, high >15). The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation. The patient-oriented endpoint (POCE) included death, myocardial infarction, or any repeat revascularisation. The SS was available in 2,041 out of 2,119 patients (96.3%). At two-year follow-up, patients with an SS >15 experienced higher rates of both TLF and POCE as compared to patients with medium and low SS (14.5% vs. 8.1% and vs. 5.9%, p<0.001; 22.7% vs. 14.9% and vs. 12.4%; p<0.001), respectively. Comparable rates of the composite endpoints were documented for both stent types in each category of SS. Increasing lesion complexity as assessed by SS was associated with higher rates of TLF and POCE in a contemporary PCI population with minimal exclusion criteria. BP-SES and DP-EES showed comparable performance across the entire spectrum of CAD severity.

Everolimus-eluting versus sirolimus-eluting coronary stents in patients with and without diabetes mellitus

Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention (PCI). This study aimed to elucidate the relative efficacy of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) according to diabetic status. Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. Among a total of 6,524 patients, 2,404 (36.8%) had diabetes mellitus. Patients with diabetes were shown to have a higher rate of TLF after PCI, which was mainly driven by differences in cardiac death and myocardial infarction, while the rate of repeat revascularisation and stent thrombosis did not differ significantly. TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status (interaction p=0.384). In addition, no significant interactions were present with regard to any pre-specified clinical endpoints. The results were corroborated by analysis with inverse probability of treatment weighting (interaction p=0.329). We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI. Despite the recent advances in drug-eluting stent technology, diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus. Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI.

EVEROLIMUS–ELUTING VERSUS SIROLIMUS–ELUTING CORONARY STENTS IN PATIENTS WITH AND WITHOUT DIABETES MELLITUS

AIMS Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention (PCI). This study aimed to elucidate the relative efficacy of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) according to diabetic status. METHODS AND RESULTS Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. Among a total of 6,524 patients, 2,404 (36.8%) had diabetes mellitus. Patients with diabetes were shown to have a higher rate of TLF after PCI, which was mainly driven by differences in cardiac death and myocardial infarction, while the rate of repeat revascularisation and stent thrombosis did not differ significantly. TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status (interaction p=0.384). In addition, no significant interactions were present with regard to any pre-specified clinical endpoints. The results were corroborated by analysis with inverse probability of treatment weighting (interaction p=0.329). We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI. CONCLUSIONS Despite the recent advances in drug-eluting stent technology, diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus. Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI.