Drug-eluting Stents Research Articles

Differential properties of drug-eluting stents and bioresorbable scaffolds in photon-counting computed tomography.

Differential properties of drug-eluting stents and bioresorbable scaffolds in photon-counting computed tomography.

A Case of Coronary Artery Aneurysm Occurring After Drug-Coated Balloon Intervention for De Novo Chronic Total Occlusion

AbstractDrug-coated balloons (DCBs) have been proposed as a viable alternative to drug-eluting stents (DES) for managing chronic total occlusion (CTO), reducing adverse reactions associated with DES. However, adverse events after DCB treatment are rarely reported. We present a case of coronary artery aneurysm (CAA) formation after DCB treatment. A 55-year-old active smoker presented with exertional chest pain and positive ischemic response on the exercise stress test. Diagnostic coronary angiography revealed CTO in the mid-left anterior descending (mid-LAD) coronary artery with collateral circulation arising from the contralateral side. The patient underwent DCB treatment using a paclitaxel-coated balloon after predilatation with a noncutting balloon and a semi-compliant balloon. The final angiogram showed minimal recoil, type B coronary dissection nonflow limiting, and thrombolysis in myocardial infarction (TIMI) grade 3 flow. A follow-up coronary angiogram at 6 months revealed a fusiform aneurysm at the treated lesion with DCB. Despite the asymptomatic nature of the patient, good distal flow in the LAD, and the patient achieving a TIMI grade 3 flow, a decision was made to observe and closely monitor the patient. Despite potential risks, DCB remains a viable alternative to DES in CTO cases. Our case suggests that, although CAA occurred, it did not lead to significant adverse cardiac events. Further research is needed to understand the predictors and long-term outcomes of CAA.

A Prospective, Randomized Trial of Bioresorbable Polymer Drug-Eluting Stents Versus Fully Bioresorbable Scaffolds in Patients Undergoing Coronary Stenting

Background: The performance of an everolimus-eluting bioresorbable scaffold (BRS) was inferior to an everolimus-eluting metallic drug-eluting stent (DES) with permanent polymer, mainly due the mechanical features of BRS technology. The performance of BRS as compared to metallic DES with bioresorbable polymers remains unstudied. Methods: This prospective, randomized, multicenter, clinical trial enrolled patients who underwent coronary stenting for de novo coronary lesions. Patients were randomly assigned to bioresorbable polymer everolimus-eluting stents (BP-EES) or everolimus-eluting BRS. The primary endpoint was percentage diameter stenosis (in-device) at 6- to 8-month angiographic surveillance. The main secondary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death/target vessel-myocardial infarction/target lesion revascularization assessed after 12 months and 5 years. Results: The trial was prematurely terminated after the enrollment of 117 of 230 patients (BP-EES, n = 60; BRS, n = 57) due to safety issues associated with BRS technology. The primary endpoint of in-device diameter stenosis at angiographic surveillance was 12.5 ± 7.7% with BP-EES versus 19.3 ± 16.5% with BRS (p = 0.01). The DOCE occurred in 5.0% in the BP-EES group versus 12.3% of patients in the BRS group (hazard ratio [HR] 2.48, 95% confidence interval [CI] 0.64–9.58, p = 0.19) after 12 months and in 11.7% in the BP-EES group versus 26.4% of patients in the BRS group (HR 2.38, 95% CI 0.97–5.84, p = 0.06) after 5 years. Conclusions: BP-EES showed superior mid-term angiographic performance compared with BRS. Clinical event rates did not differ significantly between the groups up to 5 years of follow-up. These results should be interpreted with caution in view of the premature discontinuation of the study.

Successful Coronary Interventions with the Ingenious Vector\(\circledR\) Balloon in Chronic Total Occlusion (CTO): A Preliminary Study

Aims: To assess the safety and plausibility of successful coronary interventions in Chronic Total Occlusion (CTO) with the innovative Vector\(\circledR\) balloon through balloon-assisted crossing technique. Study Design: Observational, prospective study. Place and Duration of Study: Department of Cardiology, King Edward Memorial Hospital and Seth G. S. Medical College, Mumbai. The study was carried out between the months of March and June, 2024. Methodology: A total of 20 patients were included in the study. All patients with chronic coronary syndrome were being planned for Percutaneous Coronary Intervention (PCI) for CTO. During PCI, the standard protocol of intervening CTO lesions was followed. When the operator was not able to cross the lesion with standard CTO guidewires, Vector\(\circledR\) balloon-assisted crossing was planned. This technique was used in a total of seven (35%) patents. Success was defined as the possibility of advancing the guidewire further to the target lesion and being able to deploy a drug eluting stent. Safety was assessed as reporting complications like kinking or rupture of the balloon shaft, loss of balloon inside the guide or the coronary artery and the balloon burst rate after inflation exceeding the Rated Burst Pressure (RBP) according to the manufacturer’s reference table. Results: The mean age of the patients was 58.1 ± 3.6 years. The balloon-assisted crossing was successful in all seven patients. The most commonly used diameter of the balloon was 1.25 mm (42.85%). Conclusion: The novel Vector\(\circledR\) balloon catheter showed excellent result when deployed to treat the CTO after the usual strategy of guidewire escalation had failed. The proximal shaft with polytetrafluoroethylene (PTFE) coating brings the flexibility to navigate complex and tortuous vascular pathways with ease due to its laser welded core-wire. A study with a larger sample size and a comparator arm would rather clarify if such a balloon-assisted crossing technique in CTO would decrease the need of costly devices like double lumen microcatheters.

PROVISIONAL STENTING IN LEFT MAIN STEM DISEASE: LONG-TERM OUTCOMES AND IMPACT ON SIDE BRANCH PERFUSION

Left main stem disease (LMSD) is a severe form of coronary artery disease (CAD) that involves a significant risk of mortality if not treated effectively. Traditionally, coronary artery bypass grafting (CABG) has been the primary method for revascularization in LMSD. However, percutaneous coronary intervention (PCI), especially provisional stenting using drug-eluting stents (DES), has gained popularity for its minimal invasiveness and comparable clinical outcomes. Provisional stenting allows treatment of the main vessel with additional side branch stenting only when needed, reducing complications and stent usage. Objective: The primary objective of this study is to evaluate the long-term outcomes of provisional stenting in patients with LMSD, focusing on its impact on side branch perfusion, in-stent restenosis (ISR), and major adverse cardiac events (MACE). Methods: This retrospective cohort study was conducted at a tertiary care hospital specializing in cardiology between January 2023 and December 2023. A total of 284 patients who underwent provisional stenting for LMSD were included. Fractional flow reserve (FFR) and quantitative coronary angiography (QCA) were used to assess side branch perfusion, with follow-up data including clinical outcomes such as ISR, MACE, and survival rates. Multivariate regression analysis was used to identify predictors of poor outcomes, and Kaplan-Meier survival curves were generated to compare outcomes based on side branch perfusion status. Results: The study found that 77.5% of patients achieved adequate side branch perfusion (FFR > 0.80) after provisional stenting, while 22.5% had impaired perfusion (FFR ≤ 0.80). The incidence of MACE was 10.6%, and ISR was reported in 7.0% of patients during the one-year follow-up period. Kaplan-Meier analysis showed a significant survival benefit for patients with adequate side branch perfusion (Log-Rank p < 0.001). Age and diabetes mellitus were significant predictors of MACE. Conclusion: Provisional stenting in LMSD provides favourable long-term outcomes, particularly in terms of side branch perfusion and reduced MACE. However, a subset of patients, particularly those with diabetes, may require additional interventions. Future studies should focus on improving outcomes in patients with impaired side branch perfusion and exploring the role of advanced imaging techniques in optimizing stenting strategies.

One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial.

We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR). Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated. Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y12 inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study. We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, p = 0.61), or any of the hemorrhagic and ischemic secondary endpoints. This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR.

Randomized Comparison of NovelLow-Dose Sirolimus-Eluting Biodegradable Polymer Stent vsSecond-Generation DES: TARGET-IV NA Trial.

Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs. We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs. The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss). A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). Atotal of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5%CI: 2.03, Pnoninferiority< 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263mm for BP-SES and 0.327 ± 0.463mm for control (least squares mean difference:-0.178; 90%CI:-0.2943 to-0.0632; Pnoninferiority< 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13months (Pnoninferiority=0.01). The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532).

Comparison of Clinical Outcomes between Drug-Eluting Balloons and Drug-Eluting Stents in Patients with Small Coronary Artery Disease

Background/Aims: Drug-eluting balloons (DEBs) represent a novel therapeutic approach for patients with small coronary artery disease. However, further studies are needed to compare the clinical efficacy of DEBs versus drug-eluting stents (DESs).Methods: In total, 492 patients (age, 67.9 ± 11.0 years; 339 men) with small coronary artery lesions (diameter &lt; 2.75 mm) were randomly assigned to group I (DEB) (n = 104; age, 67.2 ± 10.7 years; 83 men) and group II (DES) (n = 388; age, 68.0 ± 11.1 years; 254 men). For inverse probability of treatment weighting (IPTW) analysis, the study population was stratified into groups I (n = 269) and II (n = 280). We compared the incidences of major adverse cardiac events (MACE) between the two groups during 12 months of clinical follow-up.Results: Group I had shorter device lengths (22.4 ± 5.8 mm) compared with group II (27.4 ± 9.3 mm; p &lt; 0.001). Additionally, devices in group I were smaller in diameter (2.4 ± 0.1 mm) compared with those in group II (2.6 ± 0.1 mm; p &lt; 0.001). Left ventricular ejection fraction (LVEF) was lower in group I (53.8% ± 12.6%) than in group II (58.6% ± 11.9%; p &lt; 0.001). After IPTW, no significant differences in LVEF were observed between groups I and II. During 12 months of follow-up, the incidence of total MACE did not differ between the two groups.Conclusions: No significant differences were observed in clinical efficacy between DEB and DES for the treatment of small coronary artery disease. Therefore, DEB can be considered a viable alternative to DES in patients with small coronary artery disease.

TCT-449 Long-Term Outcomes of Drug-Coated Balloons vs Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease

TCT-449 Long-Term Outcomes of Drug-Coated Balloons vs Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease

Ten-year clinical outcomes after drug-eluting stents implantation according to clinical presentation-Insights from the DECADE cooperation.

Investigations of very long-term outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) according to clinical presentation are scarce. Here, we investigated the 10-year clinical outcomes of patients undergoing DES-PCI according to clinical presentation. Patient-level data from five randomized trials with 10-year follow-up after DES-PCI were pooled. Patients were dichotomized into acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) groups as per clinical presentation. The primary outcome was all-cause death. Secondary outcomes were cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST) and repeat revascularization involving the target lesion (TLR), target vessel (TVR) or non-target vessel (nTVR). Of the 9700 patients included in this analysis, 4557 presented with ACS and 5143 with CCS. Compared with CCS patients, ACS patients had a higher risk ofall-cause death and nTVR in the first year, but comparable risk thereafter. In addition, ACS patients had a higher risk of MI [adjusted hazard ratio 1.21, 95% confidence interval (1.04-1.41)] and definite ST [adjusted hazard ratio 1.48, 95% confidence interval (1.14-1.92)], while the risk of TLR and TVR was not significantly different up to 10-year follow-up. Compared to CCS patients, ACS patients treated with PCI and DES implantation have an increased risk of all-cause death and repeat revascularization of remote vessels up to 1 year, with no significant differences thereafter and up to 10-year follow-up. ACS patients have a consistently higher risk of MI and definite ST. Whether these differences persist with current antithrombotic and secondary prevention therapies requires further investigation.

Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial.

Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events. Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events. A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; P=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; Pnoninferiority=0.07). In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501.

TCT-445 Three-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small Coronary Arteries: A Systematic Review and Meta-Analysis

TCT-445 Three-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small Coronary Arteries: A Systematic Review and Meta-Analysis

TCT-431 Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents in Acute Coronary Syndrome Patients With High Ischemic Risk: Three-Year Post Hoc Analysis of the HOST-REDUCE-POLYTECH-ACS Trial

TCT-431 Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents in Acute Coronary Syndrome Patients With High Ischemic Risk: Three-Year Post Hoc Analysis of the HOST-REDUCE-POLYTECH-ACS Trial

Dual antiplatelet therapy duration and stent type in patients with high bleeding risk: A systematic review and network meta-analysis

BackgroundIt is uncertain whether the efficacy and safety of dual antiplatelet therapy (DAPT) in patients with high bleeding risk (HBR) vary according to DAPT duration and stent type (e.g., durable polymer drug-eluting stents (DP-DESs), biodegradable polymer DESs (BP-DESs), or polymer-free drug-coated stents (PF-DCSs)). We aimed to study the stent type and DAPT duration appropriate for patients with HBR. MethodsPubMed and EMBASE were searched until October 2023. Randomized controlled trials (RCTs) involving patients with HBR that compared standard DAPT (6-12 months) with DP- or BP-DES versus short DAPT (≤3 months) with DP- or BP-DES or PF-DCS or bare-metal stent (BMS) were identified. The primary efficacy outcome was major adverse cardiovascular events (MACEs), defined as cardiovascular death, myocardial infarction (MI), and stroke. The primary safety outcome was major bleeding. Secondary outcomes included MI and stent thrombosis (ST). We performed a network meta-analysis using a random effects model. ResultsThirteen RCTs with a total of 19,418 patients with HBR were included. Compared to standard DAPT with DP-DES, short DAPT with BMS was associated with a higher risk of MACE and MI. For major bleeding, short DAPT strategies were associated with a lower risk than standard DAPT strategies (e.g. short DAPT with DP-DES versus standard DAPT with DP-DES; HR[95% CI]: 0.48[0.28-0.82]). Interestingly, the use of BP-DES was associated with a higher risk of ST than DP-DES (e.g. standard DAPT with BP-DES versus short DAPT with DP-DES; HR[95% CI]: 2.65[1.03-6.79]). ConclusionsIn patients with HBR who underwent percutaneous coronary intervention, a short DAPT strategy with DP-DES should be used since it offers the best combination of efficacy and safety.

Comparative Study between Immediate and Mid-Term Results of Coronary Angioplasty Using Two Different Types of Drug-Eluting Stents

Comparative Study between Immediate and Mid-Term Results of Coronary Angioplasty Using Two Different Types of Drug-Eluting Stents

TCT-261 Comparison of Clinical Outcomes Between First- and Second-Generation Drug-Eluting Stents in Single-Vessel Disease Patients: Up to 10-Year Follow-up Results

TCT-261 Comparison of Clinical Outcomes Between First- and Second-Generation Drug-Eluting Stents in Single-Vessel Disease Patients: Up to 10-Year Follow-up Results

TCT-416 Impact of Total Stent Length on Long-Term Clinical Outcomes With Newer-Generation Drug-Eluting Stents in ST-Segment Elevation Myocardial Infarction: A Subgroup Analysis From the Biostemi ES Randomized Trial

TCT-416 Impact of Total Stent Length on Long-Term Clinical Outcomes With Newer-Generation Drug-Eluting Stents in ST-Segment Elevation Myocardial Infarction: A Subgroup Analysis From the Biostemi ES Randomized Trial

TCT-433 Five-Year Clinical Results of Patients Treated With Angiolite Drug-Eluting Stents: Real Life Registry (Epic02-Rango Study)

TCT-433 Five-Year Clinical Results of Patients Treated With Angiolite Drug-Eluting Stents: Real Life Registry (Epic02-Rango Study)

Clinical Outcomes After Percutaneous Coronary Intervention for Left Main Coronary Artery Disease in Patients of Diverse Race/Ethnicity

Data on percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease in patients of diverse race/ethnicity is scant. The aim of the study was to assess the impact of race/ethnicity on clinical outcomes at 12-month follow-up of patients with LMCA disease undergoing PCI with drug-eluting stent implantation. All patients undergoing PCI for LMCA disease between 2010 and 2019 at a tertiary care center were prospectively enrolled. Clinical outcomes were assessed per each race/ethnic group. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12 months. A total of 774 consecutive patients with known race/ethnicity were prospectively enrolled, 62.1% (n=481) Caucasians, 17.2% (n=133) Hispanics, 12.7% (n=98) Asians and 8.0% (n=62) African Americans. Compared with Caucasians, the hazard rate of the primary endpoint tended to be lower in Asian patients (6.1% vs 14.2%; hazard ratio [HR]: 0.41; 95% confidence interval [CI]: 0.16-1.03), and similar in African American (13.7% vs 14.2%; HR: 0.93; 95% CI: 0.40-2.16) and Hispanic patients (14.2% vs 14.2%; HR: 1.02; 95% CI: 0.58-1.78). Hazard rates of target vessel or lesion revascularization were comparable in the four groups. Cox multivariable regression adjustment confirmed consistent findings and revealed higher hazard rate of post-discharge bleeding in African Americans vs. Caucasians (HR: 5.89; 95% CI: 1.00-34.5). In conclusion, within a racially/ethnically diverse cohort of patients undergoing PCI for LMCA disease, when compared with Caucasians, Asians are at lower risk of all-cause death, MI or stroke, while African Americans are at increased risk of post-discharge bleeding.

TCT-424 Pathologic Analysis of Fibrin Deposition Around Stent Struts Within 1 Month After Placement of Circumferentially Coated Durable Polymer Drug-Eluting Stents and Abluminally Coated Biodegradable Polymer Drug-Eluting Stents for Acute Coronary Syndrome

TCT-424 Pathologic Analysis of Fibrin Deposition Around Stent Struts Within 1 Month After Placement of Circumferentially Coated Durable Polymer Drug-Eluting Stents and Abluminally Coated Biodegradable Polymer Drug-Eluting Stents for Acute Coronary Syndrome