Impact of thinner strut design on current generation drug-eluting stent in all-comers.

Current thin-strut 2nd generation drug eluting stents (DES) are considered as optimal standard of care for revascularization of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). Ultrathin (≤ 70 μm strut thickness) strut DES have recently been shown to reduce target lesion failure (TLF) compared to thin-strut DES. Therefore, in order to assess the validity of improved outcomes associated with ultrathin-strut DES, we conducted an updated meta-analysis that includes recently published follow-ups of previously conducted randomized controlled trials (RCTs). MEDLINE and Scopus were queried from their inception to May 2024 to identify studies comparing outcomes between ultrathin and current thin-strut 2nd generation DES groups. A random-effects meta-analysis was conducted to derive risk ratios (RR) from dichotomous data. The primary endpoint was long-term TLF defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR). The secondary outcome was target-vessel failure (TVF) defined as a composite of cardiac death, TV-MI and clinically driven target-vessel revascularization (CD-TVR). A total of 17 RCTs (n=22141) with a mean follow-up of 34 months were included. The risk of TLF was significantly lowered in the ultrathin DES group in comparison to thin-strut DES. A significant decrease was also noted in rates of TVF, CD-TLR and CD-TVR in the ultrathin DES vs thin-strut DES group. The results of our analysis demonstrate a significantly reduced risk of TLF in the ultrathin DES group in comparison with thin-strut DES. Ultrathin DES was also associated with a significantly decreased risk of TVF, CD-TLR and CD-TVR.

<i>Circulation</i> Editors’ Picks

Comparison of Effectiveness of Bare Metal Stents Versus Drug-Eluting Stents in Large (≥3.5 mm) Coronary Arteries

Percutaneous revascularization of left main coronary artery (LMCA) disease has remained controversial for more than 25 years, since LMCA balloon angioplasty was first performed by Andreas Gruentzig in 1978. Summarizing his experience, Gruentzig concluded, “We have not been too successful with dilating left main stems…although the procedure is relatively simple, the potential complications are both sudden and serious.”1 Following the evolution of percutaneous catheter-based therapies to include both bare metal stent and, more recently, drug-eluting stent (DES) platforms in conjunction with advances in periprocedural and postprocedural adjunctive pharmacotherapies, interest in percutaneous LMCA revascularization, particularly unprotected left main, has been renewed. Although studies performed with bare metal stents demonstrated a low rate of in-hospital mortality, the incidence of late coronary restenosis remained high.2–6 In the Unprotected Left Main Trunk Intervention Multi-Center Assessment (ULTIMA) registry, which enrolled 279 patients with unprotected LMCA disease who had percutaneous coronary revascularization (69% bare metal stent), mortality at a 1-year follow-up was proportional to clinical risk stratification (40% in high-risk versus 3.5% in low-risk patient cohorts), and repeated revascularization was required in 34% of cases.6 The experience gleaned from these studies continued to support the American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations that in reasonable surgical candidates with LMCA disease, coronary bypass surgery is the preferred therapeutic option.7 After the introduction of DES, several small clinical series demonstrated the feasibility and short-term safety of LMCA stenting, while late clinical/angiographic outcomes appeared favorable as compared with historical (nonrandomized) patient cohorts treated with bare metal stents.3,8–11 The cumulative experience with DES treatment for LMCA demonstrated an apparent marked reduction in major adverse cardiovascular events, including target vessel revascularization, during 6 to 12 months of follow-up as compared with the precedent experience after bare metal stent deployment. Article p 2542 The clinical …

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Objectives The aim of the DAPT-DRAGON registry was to asses long-term outcomes and the length of dual antiplatelet therapy (DAPT) in patients treated with percutaneous coronary intervention (PCI) due to drug-eluting stent in stent restenosis (DES-ISR) with drug-eluting balloons (DEB) or thin-DES. Background Data regarding the duration of DAPT in patients with DES-ISR treated with PCI is still undergoing research and observation, and the adequate duration of DAPT in this group of patients is not unambiguously sanctioned. Methods Overall, 1,367 consecutive patients with DES-ISR who underwent PCI with DEB or DES, were entered into the multi-center DAPT-DRAGON Registry (Fig. 1). The mean age was 66.7±9 years (70.5% males). The median follow-up was 3.3 years. There were 34.1% patients with chronic coronary syndrome, 35.2% with unstable angina, 2.9% with ST segment elevation myocardial infarction and 27.7% with non-ST segment elevation myocardial infarction (MI). We assessed selected study endpoints according to the duration of DAPT (≤3 vs. &amp;gt;3 months and ≤6 vs. &amp;gt;6 months), before and after propensity score matching (PSM): stroke, target lesion revascularization (TLR), target vessel revascularization (TVR), MI, death and device-oriented composite endpoints (DOCE). Results Among predictors of increased DOCE rate before PSM, we demonstrated: PCI with DEB vs. DES (p&amp;lt;0.001), recurrent ISR (p=0.002), treatment with glycoprotein IIb/IIIa inhibitor during PCI (p&amp;lt;0.001), lower left ventricle ejection fraction (p=0.004) and extent of stenosis (p&amp;lt;0.001). Pairwise contrast analysis considering type of PCI (thin-DES vs. DEB) and duration of DAPT (≤6 vs. &amp;gt;6 months) before PSM revealed superiority of thin-DES+DAPT &amp;gt;6 months vs. DEB+DAPT &amp;gt;6 months for DOCE (p&amp;lt;0.001), TVR (p=0.02) and TLR (p=0.01). After PSM analysis, the length of DAPT (≤3 vs. &amp;gt;3 months) had no significant influence on assessed long-term outcomes, while the percentage of stroke free survival was significantly lower in the group of patients with DAPT ≤6 months vs. &amp;gt;6 months (p=0.01; Fig. 2). Conclusions Long-term treatment with DAPT (&amp;gt;6 months) in patients with DES-ISR with DES implantation is related to better long-term outcomes in terms of lower rate of DOCE, TVR and TLR compared to PCI with DEB. DAPT &amp;gt;6 months is related to a greater rate of strokes, independently of the type of treatment (thin-DES and DEB) compared to DAPT ≤6 months. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated With Drug-Eluting Stents: From the NHLBI Dynamic Registry

We sought to investigated the outcomes of patients with chronic kidney disease (CKD) and drug-eluting stent (DES)-in-stent restenosis (ISR) undergoing percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) or thin strut drug-eluting stent (thin-DES). Consecutive patients with DES-ISR who underwent PCI with a thin-DES or a paclitaxel-coated DCB for DES-ISR were enrolled. The primary outcome was target lesion revascularization (TLR), while the secondary was target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE). The pooled analysis included 1,317 patients, with 585 (44.42%) treated using a thin-DES and 732 (55.58%) by DCB. In the crude analysis of CKD patients (n = 286) undergoing PCI for ISR, thin-DES vs. DCB showed similar outcomes for TLR (hazard ratio [HR]=0.94, 95% confidence interval [CI]=0.44-2.00; p = 0.873), TVR (HR = 0.82, 95% CI = 0.44-1.55; p = 0.542), MI (HR = 0.71, 95% CI = 0.34-1.46; p = 0.348) and DOCE (HR = 0.71, 95% CI = 0.36-1.40; p = 0.325). After propensity score matching (n = 184), the HRs remained non-significant for TLR (0.52, 95% CI = 0.21-1.29; p = 0.159), TVR (0.54, 95% CI = 0.24-1.01; p = 0.134), MI (0.56, 95% CI = 0.24-1.32; p = 0.183), TV-MI (0.56, 95% CI = 0.09-3.39; p = 0.528), cardiac death (0.63, 95% CI = 0.10-3.81; p = 0.615), and DOCE (0.45, 95% CI = 0.19-1.04; p = 0.062). In conclusion, in CKD patients undergoing PCI for ISR, thin-DES treatment was associated with a numerical reduction in TLR, TVR, and DOCE compared with DCB. However, these differences did not achieve statistical significance in the crude or propensity score-matched analyses.

We sought to investigated the outcomes of patients with chronic kidney disease (CKD) and drug-eluting stent (DES)-in-stent restenosis (ISR) undergoing percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) or thin strut drug-eluting stent (thin-DES). Consecutive patients with DES-ISR who underwent PCI with a thin-DES or a paclitaxel-coated DCB for DES-ISR were enrolled. The primary outcome was target lesion revascularization (TLR), while the secondary was target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE). The pooled analysis included 1,317 patients, with 585 (44.42%) treated using a thin-DES and 732 (55.58%) by DCB. In the crude analysis of CKD patients (n = 286) undergoing PCI for ISR, thin-DES vs. DCB showed similar outcomes for TLR (hazard ratio [HR]=0.94, 95% confidence interval [CI]=0.44–2.00; p = 0.873), TVR (HR = 0.82, 95% CI = 0.44–1.55; p = 0.542), MI (HR = 0.71, 95% CI = 0.34–1.46; p = 0.348) and DOCE (HR = 0.71, 95% CI = 0.36–1.40; p = 0.325). After propensity score matching (n = 184), the HRs remained non-significant for TLR (0.52, 95% CI = 0.21–1.29; p = 0.159), TVR (0.54, 95% CI = 0.24–1.01; p = 0.134), MI (0.56, 95% CI = 0.24–1.32; p = 0.183), TV-MI (0.56, 95% CI = 0.09–3.39; p = 0.528), cardiac death (0.63, 95% CI = 0.10–3.81; p = 0.615), and DOCE (0.45, 95% CI = 0.19–1.04; p = 0.062). In conclusion, in CKD patients undergoing PCI for ISR, thin‐DES treatment was associated with a numerical reduction in TLR, TVR, and DOCE compared with DCB. However, these differences did not achieve statistical significance in the crude or propensity score-matched analyses.

ObjectiveTo compare the efficacy and safety of bioresorbable scaffolds (BRS) with drug-eluting stents (DES) in patients with myocardial infarction undergoing percutaneous coronary interventions (PCI).MethodsWe 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.ResultsFour 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.ConclusionBRS 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.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=321501], identifier [CRD 42022321501].

“Does it make economic sense to completely abandon a therapy that works well for 85% to 90% of the population for a new therapy costing four times as much to treat a transient health condition with no impact on either death or myocardial infarction?” J.M. Brophy and L.J. Erickson1 Since Andreas Gruntzig performed the first percutaneous coronary intervention (PCI) in 1977,2 the cost-effectiveness of this procedure has engendered major controversy. Debates have erupted over the clinical value and cost-effectiveness of each new device or therapy that has become available. Controversies have arisen regarding the cost of atherectomy, bare metal stents (BMS), brachytherapy, distal protection devices, glycoprotein IIb/IIIa inhibitors, and intravascular ultrasound.3–6 Drug-eluting stents (DES) are the most recent devices to have their cost scrutinized.7–12 Response by Ryan and Cohen p 1754 Balloon angioplasty is associated with restenosis rates of 30% to 40%, whereas PCI with BMS is associated with rates of 20% to 30%,13,14 and PCI with DES is associated with rates in the single digits.15,16 My colleagues and I pooled the results of 11 DES trials involving >5000 patients using a hierarchical Bayesian random-effects model.17 We found that, compared with BMS, DES reduce angiographic restenosis from 29.3% to 8.9% (Table 1 and Figure 1). There was no difference between DES and BMS in terms of mortality (0.9% versus 0.9%, respectively) or myocardial infarction (2.7% versus 2.9%, respectively). There was a suggestion that restenosis was less with sirolimus-eluting stents (SES) compared with polymeric paclitaxel-eluting stents (PES) (6.2% for SES versus 36.9% for BMS; 7.1% for PES versus 23.5% for BMS), a finding that was subsequently identified in another meta-analysis.18 View this table: TABLE 1. Clinical Events and Restenosis Rates in Randomized Clinical Trials Investigating DESs Figure 1. Forest plot comparing rates of angiographic restenosis for …

Guiding-extension catheters (GECs) provide enhanced support to guiding catheter (GC) during complex percutaneous coronary intervention (PCI). However, by reducing the inner cross-sectional diameter, they can create high friction between the GEC and the drug-eluting stents (DES), potentially causing abrasion and damage to the abluminal struts. This study aims to compare the performances of the Amphilimus Cre8 EVO polymer-free DES with all the other surface-coated DES. The abluminal grooves of this polymer-free DES, which contain the drug and avoid any risk of its abrasion and detachment (abluminal reservoir technology), may offer a protective effect during stent advancement within the GEC. Between January 2019 and April 2024, 218 patients who underwent complex PCI procedures with the insertion of a DES and the use of GEC were enrolled in the study. They were divided into Group A (39 patients) received the Amphilimus polymer-free DES, while Group B (179 patients) received other types of DES. To evaluate the efficacy and safety of the DES used, a device-oriented composite endpoint (DoCE) was assessed at one year of follow-up. This composite endpoint included Cardiovascular Death, Target Vessel Myocardial Infarction, and Clinically and Physiologically indicated Target Lesion Revascularization. At the one-year follow-up, the primary endpoint demonstrated a statistically significant difference between the two groups. Event-free survival from DoCE was 97.4% in Group A compared to 85.5% in Group B (Log rank = 0.027). Additionally, there was a significant difference in mean stent length between the groups: Group A had a longer mean stent length of 52.4 ± 38.6 mm, while Group B had a mean length of 40.4 ± 22.6 mm, with a p-value of 0.01. All other clinical and procedural variables were similar between the two groups. Our findings suggest that the polymer-free DES tested in this study appears to be the most effective option when using GECs, as it may help prevent negative interactions between the inner surface of GEC and the abluminal struts of the DES.

Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited. The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization. At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent (P=0.55). Rates of cardiac death (3.9% versus 3.8%; P=0.88), target vessel myocardial infarction (3.2% versus 2.5%; P=0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%; P=0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%; P=0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%; P=0.34). In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.

[Figure: see text].

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.