Ticagrelor monotherapy for acute coronary syndrome: an individual patient data meta-analysis of TICO and T-PASS trials.

BACKGROUND AND AIMS: In patients with acute coronary syndrome (ACS), dual antiplatelet therapy (DAPT) with aspirin and a potent P2Y12 inhibitor is recommended for 12 months after drug-eluting stent (DES) implantation. Monotherapy with a potent P2Y12 inhibitor after short-term DAPT is an attractive option to better balance the risks of ischaemia and bleeding. Therefore, this study evaluated the efficacy and safety of ticagrelor monotherapy after short-term DAPT, especially in patients with ACS. METHODS: Electronic databases were searched from inception to 11 November 2023, and for the primary analysis, individual patient data were pooled from the relevant randomized clinical trials comparing ticagrelor monotherapy after short-term (≤3 months) DAPT with ticagrelor-based 12-month DAPT, exclusively in ACS patients undergoing DES implantation. The co-primary endpoints were ischaemic endpoint (composite of all-cause death, myocardial infarction, or stroke) and bleeding endpoint [Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding] at 1 year. RESULTS: Individual patient data from two randomized clinical trials including 5906 ACS patients were analysed. At 1 year, the primary ischaemic endpoint did not differ between the ticagrelor monotherapy and ticagrelor-based DAPT groups [1.9% vs. 2.5%; adjusted hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.56-1.13; P = .194]. The incidence of the primary bleeding endpoint was lower in the ticagrelor monotherapy group (2.4% vs. 4.5%; adjusted HR 0.54; 95% CI 0.40-0.72; P < .001). The results were consistent in a secondary aggregate data meta-analysis including the ACS subgroup of additional randomized clinical trials which enrolled patients with ACS as well as chronic coronary syndrome. CONCLUSIONS: In ACS patients undergoing DES implantation, ticagrelor monotherapy after short-term DAPT was associated with less major bleeding without a concomitant increase in ischaemic events compared with ticagrelor-based 12-month DAPT. STUDY REGISTRATION: PROSPERO (ID: CRD42023476470).

Long-term effect of biodegradable vs durable polymer everolimus-eluting stents on neoatherosclerosis in ST-segment elevation myocardial infarction: the CONNECT trial.

BACKGROUND AND AIMS: Neoatherosclerosis is a leading cause of late (>1 year) stent failure following drug-eluting stent implantation. The role of biodegradable (BP) versus durable polymer (DP) drug-eluting stents on long-term occurrence of neoatherosclerosis remains unclear. Superiority of biodegradable against durable polymer current generation thin-strut everolimus-eluting stent (EES) was tested by assessing the frequency of neoatherosclerosis 3 years after primary percutaneous coronary intervention (pPCI) among patients with ST-segment elevation myocardial infarction (STEMI). METHODS: The randomized controlled, multicentre (Japan and Switzerland) CONNECT trial (NCT03440801) randomly (1:1) assigned 239 STEMI patients to pPCI with BP-EES or DP-EES. The primary endpoint was the frequency of neoatherosclerosis assessed by optical coherence tomography (OCT) at 3 years. Neoatherosclerosis was defined as fibroatheroma or fibrocalcific plaque or macrophage accumulation within the neointima. RESULTS: Among 239 STEMI patients randomized, 236 received pPCI with stent implantation (119 BP-EES; 117 DP-EES). A total of 178 patients (75%; 88 in the BP-EES group and 90 in the DP-EES group) underwent OCT assessment at 3 years. Neoatherosclerosis did not differ between the BP-EES (11.4%) and DP-EES (13.3%; odds ratio 0.83, 95% confidence interval 0.33-2.04, p=0.69). There were no differences in the frequency of fibroatheroma (BP-EES 9.1% vs DP-EES 11.1%, p=0.66) or macrophage accumulation (BP-EES 4.5% vs DP-EES 3.3%, p=0.68), and no fibrocalcific neoatherosclerosis was observed. Rates of target lesion failure did not differ between groups (BP-EES 5.9% vs DP-EES 6.0%, p=0.97). CONCLUSIONS: Use of BP-EES for primary PCI in patients presenting with STEMI was not superior to DP-EES regarding frequency of neoatherosclerosis at 3 years.

Clinical Implications of Acute Stent Mal-Apposition in the Left Main Coronary Artery.

Background: Intravascular ultrasound (IVUS) has been utilized to determine acute stent mal-apposition (ASM) after percutaneous coronary intervention (PCI) in the left main coronary artery (LMCA). However, the clinical consequences of this finding remain uncertain. This research aimed to evaluate the clinical implications of ASM in the LMCA using IVUS. Methods: In this study, 408 patients who underwent successful drug-eluting stent (DES) implantation in the LMCA were evaluated. We analyzed the prevalence and characteristics of ASM and its correlation with clinical outcomes. ASM is characterized by stent struts that are not in immediate proximity to the intimal surface of the vessel wall after initial stent deployment. Results: The observed incidence of LMCA-ASM post-successful PCI was 26.2%, both per patient and per lesion. Lesions with LMCA-ASM had a longer stent diameter, larger stent areas, and larger lumen areas compared to those without LMCA-ASM (4.0 ± 0.5 vs. 3.7 ± 0.4 mm, p < 0.001; 9.8 ± 2.0 vs. 9.0 ± 1.6 mm 2 , p < 0.001; 12.3 ± 1.9 vs. 10.1 ± 2.1 mm 2 , p < 0.001, respectively). The mean external elastic membrane (EEM) area (odds ratio (OR): 1.418 [95% confidence interval (CI): 1.295-1.556]; p < 0.001) emerged as an independent predictor of LMCA-ASM. During the observation period, LMCA-ASM did not display any association with device-oriented clinical endpoints (DoCE), which included cardiac death, target vessel-induced myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). Moreover, the DoCE incidence exhibited no significant disparity between patients with or without ASM (13.1 vs. 6.0%, p = 0.103). Conclusions: While LMCA-ASM was a not uncommon finding post-PCI, it did not correlate with adverse cardiac events in the present study.

Long-term outcomes of DCB and DES for the treatment of in-stent restenosis in relation to the vessel size.

BACKGROUND: Percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or drug-eluting stents (DES) are well-established treatments for in-stent restenosis, however little is known about the impact of vessel size on the outcomes. The study aimed to evaluate the efficacy and safety profile of DCB versus DES in DES in-stent restenosis depending on the vessel size. METHODS: Consecutive patients with DES in-stent restenosis who underwent PCI between January 2010 and February 2018 entered the registry with a long-term follow-up. Patients who received DCB at the index procedure were compared with those who received DES in three subgroups depending on the vessel size (≤2.5 mm; 2.5-3.5 mm; >3.5 mm). Data were analyzed using propensity score matching and Kaplan-Meier estimator plots. RESULTS: Among 1,374 patients with DES in-stent restenosis, 615 were treated with DES and 759 with DCB. After propensity score matching, we analyzed 752 patients in the DES and DCB groups at a long-term follow-up. The risk of DOCE did not differ significantly between the DES and DCB groups, both in the overall population (HR 0.85; 95%CI [0.58; 1.26], log-rank p = 0.41) and when divided into small (HR 0.84; 95%CI [0.36; 1.95], log-rank p = 0.70), medium-sized (HR 0.90; 95%CI [0.49; 1.65], log-rank p = 0.73), and large-sized (HR 0.81; 95%CI [0.42; 1.53], log-rank p = 0.50) coronary arteries. The incidence of all-cause death was significantly higher in the overall DES population (HR 4.03; 95%CI [2.40; 6.79], log-rank p < 0.001) and subgroup of small (HR 5.54; 95%CI [1.80; 17.02], log-rank p = 0.003), medium-sized (HR 4.37; 95%CI [1.92; 9.94], log-rank p = 0.009) and large-sized coronary arteries (HR 3.26; 95%CI [1.35; 7.86], log-rank p = 0.02). CONCLUSIONS: DES and DCB strategies are comparable methods of treating ISR regardless of the diameter of the treated vessel in a long-term follow-up.

Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.

BACKGROUND: We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined. METHODS: 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. RESULTS: At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. CONCLUSIONS: In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).

Comparison of thrombogenicity in different types of drug-eluting stents during transition from DAPT to SAPT.

BACKGROUND: During the transition from dual antiplatelet therapy (DAPT) to single antiplatelet therapy (SAPT), previous studies have raised concerns about a rebound effect. We compared platelet and inflammatory cell adhesion on different types of stents in the setting of clopidogrel presence and withdrawal. METHODS: In Experiment 1, three pigs were administered with DAPT, that is, clopidogrel and acetylsalicylic acid (ASA), for 7 days. Each animal underwent an extracorporeal carotid arteriovenous shunt model implanted with fluoropolymer-coated everolimus-eluting stent (FP-EES), biodegradable-polymer sirolimus-eluting stent (BP-SES), and biodegradable-polymer everolimus-eluting stents (BP-EES). In Experiment 2, two pigs were administered DAPT, clopidogrel was then withdrawn at day 7, and SAPT with ASA was continued for next 21 days. Then flow-loop experiments with the drawn blood from each time point were performed for FP-EES, BioLinx-polymer zotarolimus-eluting stents (BL-ZES), and BP-EES. The rebound effect was defined as the statistical increase of inflammation and platelet adhesion assessed with immunohistochemistry on the stent-strut level basis from baseline to day-14 or 28. RESULTS: Both experiments showed platelet adhesion value was highest in BP-EES, while the least in FP-EES during DAPT therapy. There was no increase in platelet or inflammatory cell adhesion above baseline values (i.e., no therapy) due to the cessation of clopidogrel on the stent-strut level. Monocyte adhesion was the least for FP-EES with the same trend observed for neutrophil adhesion. CONCLUSIONS: No evidence of rebound effect was seen after the transition from DAPT to SAPT. FP-EES demonstrated the most favorable antithrombotic and anti-inflammatory profile regardless of the different experimental designs.

Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent.

BACKGROUND: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up. AIMS: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. METHODS: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan-Meier methods, applying the log-rank test for between-group comparison. RESULTS: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75-1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24-0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39-0.93], plog-rank = 0.023). CONCLUSIONS: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.

Percutaneous coronary intervention for unprotected left main distal bifurcation lesions in elderly people.

BACKGROUND: In the elderly people with unprotected left main distal bifurcation lesions (ULMD), percutaneous coronary intervention (PCI) is often selected as first choice treatment strategy because of perioperative high risk of coronary artery bypass graft surgery due to their large number of comorbidities. Also, some recent papers reported that geriatric nutritional risk index (GNRI) is also strongly associated with clinical outcomes after interventional procedures in elderly patients. OBJECTIVES: We assessed clinical outcomes after PCI for ULMD and the impact of GNRI in elderly patients. METHODS: We identified 669 non dialysis patients treated with current generation drug-eluting stent for ULMD from MITO registry. We divided the patients to the following 2 groups; elderly group (n = 240, age ≥75) and young group (n = 429, age <75). Additionally, we could calculate GNRI and divided elderly group into 2 group based on the median value of the GNRI. The primary endpoint was all-cause mortality. RESULTS: All-cause mortality was significantly higher in elderly group [adjusted hazard ratio (HR) 2.37; 95% confidence interval (CI), 1.40-4.02; p = 0.001]. All-cause mortality was significantly higher in low GNRI elderly group compared to other 2 groups (Adjusted HR of elderly with low GNRI: 3.56, 95%CI (1.77-7.14), p < 0.001). Cardiovascular mortality was comparable between two groups. TLR rate was significantly lower in elderly group (adjusted HR 0.57; 95% CI, 0.34-0.97; p = 0.035). CONCLUSIONS: The elderly had higher all-cause mortality after PCI for ULMD compared to young people. Especially, the elderly with low GNRI were extremely associated with poorer outcomes.

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

PURPOSE: Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. METHODS: This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. RESULTS: A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). CONCLUSIONS: This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. CLINICAL IMPACT: One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results.

BACKGROUND: Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. MATERIALS AND METHODS: Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. RESULTS: After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). CONCLUSION: In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). CLINICAL IMPACT: The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Nationwide Study of the Outcome of Treatment of Lower Extremity Atherosclerotic Lesions With Endovascular Surgery With or Without Drug Eluting Methods in Patients With Diabetes.

CLINICAL IMPACT: This retrospective observational registry trial combines national registries for vascular surgical procedures and diabetes mellitus to clarify results of drug eluting technology in treating diabetic subjects with intermittent claudication or chronic limb threatening ischemia compared to treatment of non-diabetic subjects. As earlier proposed and showed in this trial, there may be an implication for a beneficial treatment efficacy with drug eluting therapy in the diabetic population with PAD compared to the non-diabetic population. A finding worth further exploration.

Impact of 12-Month Angioscopic Thrombi and Yellow Plaque After Drug-Eluting Stent Implantation.

BACKGROUND: Coronary angioscopy (CAS) has 2 unique abilities: direct visualization of thrombi and plaque color. However, in the recent drug-eluting stent (DES) era, serial CAS findings after DES implantation have not been fully elucidated. We investigated the impact of CAS findings after implantation of a polymer-free biolimus A9-coated stent (PF-BCS) or durable polymer everolimus-eluting stent (DP-EES).Methods and Results: We investigated serial CAS and optical coherence tomography (OCT) findings at 1 and 12 months in 99 patients who underwent PF-BCS or DP-EES implantation. We evaluated factors correlated with angioscopic thrombi and yellow plaque, and the clinical impact of both thrombi and yellow plaque at 12 months (BTY). The BTY group included 17 (22%) patients. The incidence and grade of thrombi and yellow plaque decreased from 1 to 12 months. Although no patients had newly appearing thrombi at 12 months, 2 DP-EES patients had newly appearing yellow plaque at 12 months. Multivariable analysis revealed HbA1c, minimum stent area, and adequate strut coverage were significant factors correlated with 12-month angioscopic thrombi, and DP-EESs were significantly correlated with 12-month yellow plaque. However, BTY was not correlated with clinical events. CONCLUSIONS: The management of diabetes, stent area, and adequate stent coverage are important for intrastent thrombogenicity and polymer-free stents are useful for stabilizing plaque vulnerability.

Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds.

BACKGROUND: Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions. METHODS AND RESULTS: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. CONCLUSIONS: No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.

One-Month Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy After Biodegradable Polymer Drug-Eluting Stent Implantation　- The REIWA Region-Wide Registry.

BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain. METHODS AND RESULTS: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.

Self-expanding intracranial drug-eluting stent system in patients with symptomatic intracranial atherosclerotic stenosis: initial experience and midterm angiographic follow-up.

BACKGROUND: Symptomatic intracranial atherosclerotic stenosis (ICAS) is a major cause of ischemic stroke worldwide. In patients undergoing endovascular treatment for ICAS, in-stent restenosis (ISR) is associated with ischemic stroke recurrence. OBJECTIVE: Intracranial drug-eluting self-expanding stent systems (COMETIU; Sinomed Neurovita Technology Inc., CHN) are new devices for treating ICAS. This study evaluated the perioperative experience and medium-term outcomes of COMETIU in 16 patients. METHODS: We prospectively analyzed 16 patients with ICAS (≥ 70% stenosis) who underwent intravascular therapy between September 4, 2022, and February 1, 2023. The primary outcome was the incidence of ISR at 6 months postoperatively. The secondary efficacy outcomes were device and technical success rates. The secondary safety outcomes included stroke or death within 30 days after the procedure and the cumulative annual rate of recurrent ischemic stroke in the target-vessel territory from 31 days to 6 months and 1 year. RESULTS: A total of 16 patients with 16 intracranial atherosclerotic lesions were treated with 16 COMETIUs. All procedures were performed under general anesthesia with 100% device and technical success rates, with no cases of periprocedural stroke or death. The mean radiographic follow-up duration was at least 6 months postoperatively, and all patients presented for radiographic and clinical follow-up. There were no reported ischemic or hemorrhagic strokes. Angiographic follow-up for all patients revealed no cases of ISR. CONCLUSION: COMETIU is safe and effective for treating ICAS, with minimal risk during the procedure and a low rate of ISR during medium-term follow-up.

Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design.

BACKGROUND: Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain. STUDY DESIGN: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. DISCUSSION: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting. TRIAL REGISTRATION: Registered on clinicaltrial.gov (NCT04561739).

Different drugs in drug-eluting stents for peripheral artery disease: a systematic evaluation and Bayesian meta-analysis.

Drug-eluting stents (DESs) have become the first-line treatment for symptomatic peripheral arterial disease (PAD). Currently, there are many types of DESs on the market. The same type of DESs has different concentrations, and various drugs in them show uneven efficacy. The selection of DESs remains controversial. This study was aimed at comparing the long-term real-world outcomes of different DESs in the treatment of peripheral arterial occlusive disease (PAOD). The databases including Cochrane Library, Embase, and PubMed were searched with a time frame until March 25, 2023. The primary patency (PP) and target lesion revascularization (TLR) at 6 months were used as the primary endpoints. A total of 32 studies (5467 patients) were eligible. At the six-month follow-up, DES-Evero 1 ug/mm2 ranked first in terms of PP, with a significant difference from BMSs (RR [95% CI] = 1.6). DES-Siro 0.9 ug/mm2, DES-Siro 1.4 ug/mm2, DES-Siro 1.95 ug/mm2, DES-PTX 0.167 ug/mm2, DES-PTX 1 ug/mm2 and covered stents (CSs) showed significantly better PPs than BMSs. In terms of TLR, DES-Siro 0.9 ug/mm2 (0.31) ranked first, and DES-Evero 1 ug/mm2 ranked last. Among the treatment modalities for PAD, different DESs showed overall encouraging results in improving PP and TLR compared with BMSs. DES-Evero 1 ug/mm2 showed the best PP, but it had the highest reintervention rate at 6 months. Sirolimus-eluting stents were not always more effective with higher concentrations of sirolimus. Among various DESs, sirolimus-eluting stents and everolimus-eluting stents were superior to paclitaxel-eluting stents.

Differences in vascular tissue response after stent implantation between biolimus-eluting and everolimus-eluting stents: a sub-study of the NEXT study.

NEXT [NOBORI biolimus-eluting stent (BES) versus XIENCE/PROMUS everolimus-eluting stent (EES) trial] was a multicenter, randomized, prospective trial that included 3235 patients with 8-12 months of follow-up imaging at 18 centers. IB-IVUS images were analyzed at an interval of 0.5 mm using a motorized pull-back system in each plaque that required stent implantation. We analyzed seven cross-sections at the site of minimal lumen area and ten cross-sections in proximal and distal peripheral sites prior to the procedure, after stent implantation and after 8 months. We averaged the relative blue volume, relative green volume, relative yellow volume, and relative red volume across seven cross-sections using the manufacturer's default setting. Fifty-four lesions in 50 patients were analyzed. There were 28 lesions in 25 patients in the EES group and 26 lesions in 25 patients in the BES group. The patient characteristics did not differ significantly between the two groups except high-density lipoprotein cholesterol. There were no significant differences before and after stent implantation after 8 months in relative red volume, relative yellow volume, relative green volume or relative blue volume. Although the present study was likely underpowered for statistical analyses and larger populations are needed to confirm the conclusions, the vascular response regarding tissue characterization was similar between EES and BES, even though the thickness and releasing materials differed between the stents.

Clinical outcomes of percutaneous coronary intervention for severely calcified lesions: comparison between the morphologies of severely calcified coronary lesions.

Existing studies evaluating the comparison of clinical outcome of percutaneous coronary intervention (PCI) for severe calcified coronary lesions are limited, and the clinical outcomes of PCI for different morphologies of calcified lesions are controversial. Overall, consecutive 576 lesions with severe calcification that were treated with PCI from 2010 to 2021 at Nagoya Heart Center were investigated. All lesions were assessed using invasive coronary angiogram (CAG) or computed tomography-CAG at 12 months after DES implantation. We divided the patients into three groups based on the results of intravascular ultrasound (IVUS) imaging (concentric calcified lesion [CC] n = 273, eccentric calcified lesion [EC] n = 217, calcified nodule [CN] n = 86). The clinical and angiographic outcomes of each group were investigated retrospectively to compare the prognosis between the three groups and identify predictive factors for the device-oriented composite end points (DoCE). There were no differences in patient characteristics among the three groups, except that there were significantly more patients on dialysis in the CN group. The incidence of DoCE was significantly higher in the CN group than in the other groups (CC; 18.3% vs. EC; 23.5% vs. CN; 36.0%; Log-Rank test; p = 0.001). Cox regression analysis showed that the independent predictors of DoCE were CN, insulin use, hemodialysis, right coronary artery lesions, and calcium cracks. The incidence of DoCE was significantly higher in the CN group. Calcium cracks are crucial for improving outcomes in severely calcified lesions, being key predictors of DoCE.

Systematic Review on Role of Drug Eluting Stent (DES) Versus Drug-Coated Balloon (DCB) in Small Vessel Coronary Artery Disease.

PURPOSE OF REVIEW: This review aims to explain the current advancements in the treatment modalities for small vessel coronary artery disease (SVCAD) and de novo lesions post-percutaneous coronary intervention (PCI), focusing on drug-coated stents (DES) and drug-coated balloons (DCB). Its goal is to address the lack of standards in the management of these lesions and to assess the potential of DCB as a preferential treatment strategy over DES in the long term. RECENT FINDINGS: Technological advancements have improved drug-eluting stents (DES) and drug-coated balloons (DCB) which offer a more promising avenue for managing SVCAD. According to new data, DCBs, initially recognized for their efficacy in preventing restenosis within three to five years of stent placement, may offer superior outcomes compared to DES in certain clinical scenarios. This review shows that DCBs have a favorable therapeutic profile in the treatment of SVCAD, and they could be considered as an alternative to DES. Although the initial data is compelling, definitive conclusions cannot be met without further large-scale, long-term clinical trials. The implication of these findings suggests a shift in the future of SVCAD management and requires additional research to substantiate the long-term benefits of DCB use in SVCAD. Should ongoing and future studies corroborate the current evidence, DCB could emerge as the standard of care for SVCAD, significantly influencing clinical practices and future research.