Device-oriented Composite Endpoint Research Articles

Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry.

Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR). We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR. Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR). A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES. Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

Five-year clinical outcomes of STEMI patients treated with a pre-specified bioresorbable vascular scaffold implantation technique: Final results of the BVS STEMI STRATEGY-IT

BackgroundData on Absorb bioresorbable vascular scaffold (BVS) use in patients presenting with ST-segment elevation myocardial infarction (STEMI) are limited. Furthermore, Absorb studies including STEMI patients lacked a prespecified implantation technique to optimize BVS deployment. This study examines the 5-year outcomes of BVS in STEMI patients using an optimized implantation strategy and the impact of prolonged dual antiplatelet therapy (DAPT). MethodsThe BVS STEMI STRATEGY-IT study is a prospective, non-randomized, single-arm multicenter trial (NCT02601781). It involved 505 STEMI patients undergoing primary percutaneous coronary intervention with a predefined BVS implantation protocol. Key endpoints were a 5-year device-oriented composite endpoint (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). The study also compared outcomes based on DAPT duration (36 months vs. shorter). Results502 (99.4 %) patients completed the 5-year follow-up. DOCE rate was 2.4 %. ID-TLR, TV-MI, and cardiac death rates were 1.6 %, 0.8 %, and 0.6 %, respectively. No DOCE occurred between three and five years. Scaffold thrombosis (ScT) was 1 %, all occurring within 24 months. Longer-term DAPT significantly reduced DOCE (1.3 % vs. 4.3 %; HR: 0.29; 95 % CI: 0.1–0.9; p = 0.03) driven by a lower rate of TV-MI (0 % vs. 2.2 %; p = 0.018) compared to shorter-term DAPT, as well as ScT (0 % vs 2.7 %, p = 0.007). ConclusionsThis study shows favorable 5-year outcomes for BVS in selected STEMI patients with an optimized implantation strategy. Prolonged DAPT further improved outcomes, emphasizing its role in reducing adverse events during scaffold resorption. Further research is needed to assess newer-generation bioresorbable devices.

Long-term outcomes following DCB vs. DES for ISR treatment

Abstract Background The-long term outcomes of patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. Purpose This study aims to investigate the outcomes of patients with drug-eluting stents (DES)-ISR presenting with CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. Methods Consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin-DES or paclitaxel-DCB for DES-ISR were enrolled. Primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint [DOCE: cardiac death, TLR or target vessel myocardial infarction (TV-MI)]. Propensity-score matching was used to adjust for baseline differences. Results A total of 846 patients were included in the pooled analysis, of whom 381 (45%) were treated with a thin-DES and 465 (55%) with paclitaxel-DCB. Patients who received thin-DES compared with those who received paclitaxel-DCB had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74], P&amp;lt;0.001) TVR (HR, 0.56 [95% CI, 0.39-0.86], P&amp;lt;0.001) and DOCE (HR, 0.63 [95% CI, 0.45-0.88], P=0.007).The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33–0.88], P=0.013), TVR (HR, 0.57 [95% CI, 0.41–0.80], P=0.009), and DOCE (HR, 0.65 [95% CI, 0.42–0.99], P=0.046) between the thin-DES and DCB group, respectively. Conclusions In long term observation in patients with CCS undergoing PCI of ISR, the use of thin-DES is associated with reduced rates of TLR, TVR and DOCE compared with patients treated with DCB.

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.

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 12months 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.

Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial

The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing. Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group. In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population. Xijing Hospital and Shenqi Medical. For the Chinese translation of the abstract see Supplementary Materials section.

Drug-Eluting Balloons and Drug-Eluting Stents in Diabetic Patients Undergoing Percutaneous Coronary Intervention Due to Restenosis-DM-Dragon Registry.

Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES), have been implemented. Patients with diabetes mellitus (DM) are burdened with a higher risk of ISR than the general population. Aims: DM-Dragon is aimed at evaluating the clinical outcomes of ISR treatment with DEBs vs. DES, focusing on patients with co-existing diabetes mellitus. Methods: The DM-Dragon registry is a retrospective study comprising data from nine high-volume PCI centers in Poland. A total of 1117 patients, of whom 473 individuals had DM and were treated with PCI due to ISR, were included. After propensity-score matching (PSM), 198 pairs were created for further analysis. The primary outcome of the study was target lesion revascularization (TLR). Results: In DM patients after PSM, TLR occurred in 21 (10.61%) vs. 20 (10.1%) in non-diabetic patients, p = 0.8690. Rates of target vessel revascularization (TVR), target vessel myocardial infarction, device-oriented composite endpoint (DOCE), and cardiac death did not differ significantly. Among diabetic patients, the risk of all-cause mortality was significantly lower in the DEB group (2.78% vs. 11.11%, HR 3.67 (95% confidence interval, CI) [1.01-13.3), p = 0.0483). Conclusions: PCI with DEBs is almost as effective as DES implantation in DM patients treated for ISR. In DM-Dragon, the rate of all-cause death was significantly lower in patients treated with DEBs. Further large-scale, randomized clinical trials would be needed to support these findings.

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

BackgroundPercutaneous 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 designThe 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.DiscussionThe 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 registrationRegistered on clinicaltrial.gov (NCT04561739).

Long-term outcomes following paclitaxel-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in chronic coronary syndrome (CCS Dragon-Registry).

The long-term outcomes for patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. We aimed to investigate the outcomes for patients with drug-eluting stents (DES)-ISR and CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. A total of 846 consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin (strut thickness <100 μm) strut-DES (381 [45%]) or paclitaxel-DCB (465 [55%]) for DES-ISR were enrolled between February 2008 and October 2021. The median follow-up was 1006 (IQR 426-1770) days. The primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE: cardiac death, TLR, or target vessel myocardial infarction [TV-MI]). Patients who received DES, compared with those who received DCB, had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74]; P <0.001), TVR (HR, 0.56 [95% CI, 0.39-0.86]; P <0.001), and DOCE (HR, 0.63 [95% CI, 0.45-0.88]; P = 0.007). The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33-0.88]; P = 0.013), TVR (HR, 0.57 [95% CI, 0.41-0.80]; P = 0.009) and DOCE (HR, 0.65 [95% CI, 0.42-0.99]; P = 0.046) between the DES and DCB groups, respectively. In long-term follow-up of CCS patients undergoing PCI of ISR, the use of DES was associated with reduced rates of TLR, TVR, and DOCE compared with patients treated with DCB.

Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry.

The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR. Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial. A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001). The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.

Long-term intracoronary imaging and physiological measurements of bioresorbable scaffolds and untreated atherosclerotic plaques

BackgroundBioresorbable scaffolds (BRS) provide the prospect of restoring the anatomic and physiologic characteristics of the vascular wall. ObjectiveThis study sought to examine the long-term outcomes of BRS-based coronary intervention in a young population with diffuse and severe coronary atherosclerotic disease (CAD) and to compare the long-term evolution of treated segments versus the natural progression of untreated non-flow limiting stenoses. MethodsObservational, single-center cohort study that prospectively included patients that underwent percutaneous coronary intervention with implantation of ABSORB BRS (Abbott Vascular). The clinical endpoint was the incidence of device-oriented composite endpoint (DoCE) up to 5 years follow-up. A subgroup of patients with baseline intracoronary imaging assessment of long lesions and/or multivessel disease underwent elective angiographic (70 patients, 129 lesions) and intracoronary imaging (55 patients, 102 lesions) follow-up. Paired intravascular ultrasound (IVUS) and quantitative flow reserve (QFR) were analyzed. ResultsBetween 2012 and 2017, 159 patients (mean age 54.0 ± 11.1) with native CAD were treated with BRS on 247 lesions. Patients were mainly at their first cardiac event, mostly acute coronary syndromes (86.5%). At the median follow-up time of 56 months [41–65], DoCE occurred in 15/159 (9.4%) patients, while non-target vessel-oriented composite endpoint occurred in 16 patients (10.4%). A significant atherosclerotic progression was detected on residual non-flow limiting plaques as per IVUS and QFR assessment, while no significant change was detected in the treated segment. ConclusionsMild-to-moderate asymptomatic CAD progressed significantly at 5-year despite OMT. BRS-treated segments had a less aggressive progression at 5-year despite more severe and symptomatic CAD at baseline.

Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing PCI

BackgroundOver the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DesignThe PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SummaryThe PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI.

Efficacy of Percutaneous Coronary Intervention With Synergy Stents in Patients Aged ≥75 Years: 1-Year Clinical Outcomes from the Synergy Elderly Registry

Data regarding the clinical outcomes of older patients after Synergy everolimus-eluting stent (S-EES) implantation are limited. This study investigated the 12-month clinical outcomes of older patients who underwent percutaneous coronary intervention with new-generation drug-eluting stents according to ischemic risks. This prospective multicenter study targeted patients aged ≥75years who underwent S-EES implantation. The primary and secondary end points included 12-month device-oriented composite end point (DOCE) (cardiovascular death, target vessel myocardial infarction, or target lesion revascularization) and major adverse cardiac and cerebrovascular events (MACCEs; all-cause death, myocardial infarction, target vessel revascularization, stent thrombosis, or stroke), respectively. A stratified analysis was conducted according to high-ischemic risk (HIR), defined as complex coronary intervention (number of stents implanted ≥3, total stented length >60mm, chronic total occlusion, left main, or bifurcation), diabetes, or chronic kidney disease. In total, 650 enrolled patients aged ≥75years were categorized into HIR (n=425) and non-HIR groups (n=225). In the total population, the 1-year incidence of DOCEs was 2.5%. The rates of DOCEs were not significantly different between the HIR and the non-HIR groups, whereas the MACCE rate was higher in the HIR (9.4%) than the non-HIR group (4.9%, p=0.035), and the DOCE and MACCE components did not differ significantly in the occurrence between the groups. The independent predictors for the DOCEs or MACCEs included age, anemia, or left ventricular ejection fraction <40%. In conclusion, in older patients, S-EES implantation demonstrated favorable device-related outcomes, regardless of procedural complexity or co-morbidities. However, it requires careful attention because older patients with HIR are associated with worse clinical outcomes.

Impact of acute and persistent stent malapposition after percutaneous coronary intervention on adverse cardiovascular outcomes.

The association of coronary stent malapposition (SM) and adverse clinical outcomes after percutaneous coronary intervention (PCI) remains unclear. We aimed to perform a systematic review and meta-analysis of randomized and observational studies to assess the association between acute and persistent SM detected using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) and adverse cardiovascular outcomes. Available studies were identified through a systematic search of PubMed, reference lists of relevant articles, and Medline. Main efficacy outcomes of interest were: device-oriented composite endpoint (DoCE, including cardiac death, myocardial infarction [MI], target lesion revascularization [TLR], and stent thrombosis [ST]), major safety events (MSE, including cardiac death, MI and ST), TLR, and ST. A sensitivity analysis regarding the impact of major malapposition was also performed. A total of 9 studies enrolling 6497 patients were included in the meta-analysis. After a mean follow up of 24±14 months, overall acute and/or persistent malapposition was not significantly associated with the occurrence of all the outcomes of interest, including DoCE (risk ratio [RR] 1.00, 95% confidence interval [CI, 0.79-1.26], P=0.99), MSE (RR 1.42, 95%CI [0.81-2.50], P=0.22), TLR (RR 0.84, 95%CI [0.59-1.19], P=0.33), and ST (RR 1.16, 95%CI [0.48-2.85], P=0.74). In the sensitivity analysis, we found a significant increase of MSE in patients with major malapposition (RR 2.97, 95%CI [1.51-5.87], P=0.001). Acute and persistent SM were not overall associated with adverse cardiovascular clinical outcomes at follow-up. However, major malapposition was associated with an increased risk of major safety events, including cardiac death, MI and ST. These findings should be taken into account during stent implantation and PCI optimization.

Characteristics and Pattern of Calcified Nodule and/or Nodular Calcification Detected by Intravascular Ultrasound on the Device-Oriented Composite Endpoint (DoCE) in Patients with Heavily Calcified Lesions Who Underwent Rotational Atherectomy-Assisted Percutaneous Coronary Intervention.

This study aimed to determine characteristics and pattern of a calcified nodule (CN) and/or nodular calcification (NC) detected by intravascular ultrasound (IVUS) on the device-oriented composite endpoint (DoCE) in patients with calcified lesions who underwent rotational atherectomy (RA)-assisted percutaneous coronary intervention (PCI). The characteristics and pattern of a CN and/or NC on clinical outcome remain unknown. We retrospectively enrolled patients who underwent RA-assisted PCI at Siriraj Hospital during August 2016 to April 2020. Preprocedural IVUS imaging was mandatory. CN/NC was defined as convex shape of luminal surface and luminal side of calcium with protrusion into the coronary artery lumen as assessed by IVUS. The primary outcome was cumulative of DoCE, defined as the composite of cardiovascular death, myocardial infarction, and clinically-driven target lesion revascularization. Two hundred patients were included. Primary outcome occurred in 14%. The cumulative DoCE was significantly higher in the CN/NC group than that in the non-CN/NC group (20.7% vs. 8.8%, p = 0.022). CN/NC (p = 0.023) and MSA ≤ 5.5 mm2 (p = 0.047) were correlated with a significantly higher cumulative DoCE. CN/NC was the independent predictor for the cumulative DoCE (HR = 2.96, 95% CI 1.08-8.11, p = 0.035). Pattern and characteristic of CN/NC have a prognostic value. Patients with an eccentric CN/NC had a significantly higher cumulative DoCE compared to those CN/NC with concentric calcification (p = 0.014). The presence of a CN/NC in patients with heavily calcified lesions who underwent RA-assisted PCI was found to be associated with increased cumulative 5 year DoCE, especially in patients with an eccentric CN/NC. The clinical trial is registered with TCTR20210616001.

The standard versus prolonged dual antiplatelet therapy after the XINSORB bioresorbable scaffold implantation (SPARTA) trial: study protocol for a randomized controlled trial

BackgroundDual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care after coronary stenting, including coronary stenting involving bioresorbable scaffolds (BRSs). Current clinical guidelines recommend at least 12 months of DAPT after BRS implantation. However, the correlation between prolonged DAPT and net clinical benefits remains unknown.MethodsThe SPARTA trial is designed to be a prospective, randomized, parallel-group, clinical trial. It aims to compare the benefits and risks of DAPT applied for either 12 or 36 months after XINSORB BRS implantation. The primary endpoints are the incidence of the composite endpoint of major adverse cardiac events (MACEs), including all-cause death, any myocardial infarction (MI), and all revascularizations, as well as Bleeding Academic Research Consortium Definition (BARC) type 3 or 5 bleeding events. The secondary endpoints of the study include the device-oriented composite endpoint of target lesion failure (defined as cardiac death, target vessel-related MI, or ischemia-driven target lesion revascularization), target vessel failure (defined as cardiac death, MI, or ischemia-driven target vessel revascularization), scaffold thrombosis, and minor bleeding events. This trial will enroll 2106 subjects treated with the XINSORB BRS only. All subjects will receive DAPT after the index procedure for 12 (± 1) months. Subjects without MACEs or major bleeding will be randomized to receive either 24 additional months of DAPT or aspirin alone.DiscussionThis trial is designed to investigate the impact of extending the duration of DAPT up to 3 years after XINSORB BRS implantation by investigating the balance of risks and benefits in a broad population of treated patients.Trial registrationClinicalTrials.gov NCT04501900. Registered on 6 August 2020.

Comparisons of Drug-Eluting Balloon versus Drug-Eluting Stent in the Treatment of Young Patients with Acute Myocardial Infarction.

The incidence of acute myocardial infarction (AMI) in the younger population has been increasing gradually in recent years. The objective of the present study is to investigate the safety and effectiveness of drug-eluting balloons (DEBs) in young patients with AMI. All consecutive patients with AMI aged ≤ 45 years were retrospectively enrolled. The primary endpoint was a device-oriented composite endpoint (DOCE) of cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR). The secondary study endpoints included heart failure and major bleeding events. A total of 276 young patients presenting with AMI were finally included. The median follow-up period was 1155 days. Patients treated with DEBs had a trend toward a lower incidence of DOCEs (3.0% vs. 11.0%, p = 0.12) mainly driven by the need for TLR (3.0% vs. 9.1%, p = 0.19) than those treated with DESs. No significant differences between the two groups were detected in the occurrence of cardiac death (0.0% vs. 0.5%, p = 0.69), MI (0.0% vs. 1.4%, p = 0.40), heart failure (0.0% vs. 1.9%, p = 0.39), or major bleeding events (1.5% vs 4.8%, p = 0.30). Multivariate regression analysis showed that DEBs were associated with a trend toward a lower risk of DOCEs (HR 0.13, 95% CI [0.02, 1.05], p = 0.06). The findings of the present study suggested that DEBs might be a potential treatment option in young patients with AMI. A larger scale, randomized, multicenter study is required to investigate the safety and effectiveness of DEBs in this setting.

Three years performance of Biodegradable Polymer Sirolimus Eluting Stent in all comer patients undergoing Percutaneous Coronary Intervention.

Introduction: Contemporary evidence suggest the comparable performance of biodegradable polymer sirolimus eluting stents (BPSES) with that of second generation durable polymer drug eluting stents. This study was done to evaluate the performance of BPSES in all comer patients undergoing percutaneous intervention (PCI) in real world setting over a period of three years. Materials &amp; Methods: This was a prospective observational study, wherein all comer consecutive patients undergoing PCI with BPSES (Yukon Choice Elite stent by Translumina Therapeutics, India) were enrolled and followed up for 3 years. The study's primary endpoint was the Device Oriented Composite Endpoint (DOCE), which included cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR); the co-primary endpoint was the Patient-Oriented Composite Endpoint (POCE), which included all-cause mortality, any MI , and any repeat revascularization and the secondary endpoint was definite or probable stent thrombosis (DST &amp; PST). Results: 301 patients with 502 lesions were treated with 485 BP-SES. Mean age of the study cohort was 61.6± 9.3 yrs and males were 79.1%. 18.6% patients were diabetic, 29.6% had ejection fraction less than 40% and 73.1% patients presented with acute coronary syndrome (ACS). Majority of the patient had triple vessel disease (TVD) (51.8%), multivessel PCI was done in 15.6% and complex PCI in 26.2% patients. A mean of 1.6 ±0.8 stents per patient with mean diameter 3.0 ± 0.3 mm and mean length of 27.2 ± 0.8 mm were placed. DOCE &amp; POCE occurred in 7.9% (cardiac death-4.8%, TLR-2.6% &amp; target vessel MI-0.4%) and 12.8% (All deaths-9.7%, any MI- 0.4% and any revascularisation-2.6%) patients respectively at three years follow-up. DST &amp; PST rate was 0.9% and 0.4% respectively in the study cohort. All the cases of stent thrombosis occurred within 30 days. Kaplan Meier analysis revealed that diabetes mellitus, low ejection fraction (EF), acute coronary syndrome (ACS), long stents and complex intervention had no impact on occurrence of DOCE &amp; POCE while using BP-SES in all-comer patient population. Conclusion: Present study showed favourable long term safety and efficacy profile of BP-SES for all-comer patients undergoing PCI.

Bioresorbable scaffolds vs. drug-eluting stents for patients with myocardial infarction: A systematic review and meta-analysis of randomized clinical trials

To compare the efficacy and safety of bioresorbable scaffolds (BRS) with drug-eluting stents (DES) in patients with myocardial infarction undergoing percutaneous coronary interventions (PCI). We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing BRS with DES on clinical outcomes with at least 12 months follow-up. Electronic databases of PubMed, CENTRAL, EMBASE, and Web of Science from inception to 1 March 2022 were systematically searched to identify relevant studies. The primary outcome of this study was the device-oriented composite endpoint (DOCE) consisting of cardiac death, target-vessel myocardial infarction, and target lesion revascularization. Secondary outcomes were a composite of major adverse cardiac events (MACE, all-cause death, target-vessel myocardial infarction, or target vessel revascularization) and the patient-oriented composite endpoint (POCE, defined as a composite of all-cause death, myocardial infarction, or revascularization). The safety outcomes were definite/probable device thrombosis and adverse events. Four randomized clinical trials including 803 participants with a mean age of 60.5 ± 10.8 years were included in this analysis. Patients treated with BRS had a higher risk of the DOCE (RR 1.62, 95% CI: 1.02-2.57, P = 0.04) and MACE (RR 1.77, 95% CI: 1.02-3.08, P = 0.04) compared with patients treated with DES. No significant difference on the POCE (RR 1.33, 95% CI: 0.89-1.98, P = 0.16) and the definite/probable device thrombosis (RR 1.31, 95% CI: 0.46-3.77, P = 0.61) were observed between BRS and DES. No treatment-related serious adverse events were reported. BRS was associated with a higher risk of DOCE and MACE compared with DES in patients undergoing PCI for myocardial infarction. Although this seems less effective in preventing DOCE, BRS appears as safe as DES. [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=321501], identifier [CRD 42022321501].

Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.

The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain. The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial. This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee. Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.