2nd Drug-eluting Stent Research Articles

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease intervention

Abstract Background DCB angioplasty is an emergent technology for the treatment of coronary artery disease. There is lack of data regarding the cost-effectiveness of DCB-only angioplasty for treatment of de novo coronary artery disease as compared with 2nd DES. We aimed to perform a cost analysis of drug coated balloon (DCB)-only angioplasty versus drug eluting stent (DES), for de novo disease of all vessel sizes and all clinical indications. Methods We compared total costs of patients treated with DCB or DES for first presentation of ST elevation myocardial infarction, non-ST elevation myocardial infarction or stable angina due to de novo disease between 1st January 2018 and 15th November 2019. The health economics analysis was undertaken from the National Health Service perspective, using the national annually published resource, the Personal Social Services Research Unit (PSSRU) and Unit Costs of Health and Social Care 2022. We defined total cost as the sum of 1) procedural devices-cost 2) procedural staff-cost 3) post-PCI hospital stay cost 4) antiplatelet regime cost. A cost minimisation analysis was performed to compare the costs of DCB and DES. Results We present 1952 all-comer, consecutive patients; 902 (1064 lesions) treated with DCB and 1050 (1186 lesions) treated with DES for de novo coronary artery disease. There were very few differences in terms of baseline clinical characteristics. The DCB group had more patients with history of stroke or heart failure while the DES group had more patients with history of smoking or chronic obstructive pulmonary disease. More scoring balloons were used in the DCB group while more intravascular imaging was used in the DES group. The average procedural duration was slightly shortened in the DCB group. The cost per patient was estimated to be £9.02 more expensive in the DCB group (£3153.00 versus £3143.98) (Fig 1). However, the cost per lesion treated was calculated to be £44.29 cheaper in the DCB group (£3007.56 versus £3051.85) (Fig 2). The results were consistent irrespective of duration of long-term antiplatelet medications. Apart from the deterministic analysis, the probabilistic sensitivity analysis showed that in terms of cost per lesion, DCB presents a 92.3% probability of being cost saving. Conclusion We have demonstrated for the first time that DCB-only angioplasty has similar cost to DES per patient and is cost-effective compared to DES in de novo coronary artery disease at the lesion level.DCB vs DES cost per patientDCB vs DES cost per lesion

Long-term outcomes of delayed percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction: A propensity score-matched retrospective study.

The best time window of percutaneous coronary intervention (PCI) is within 12 hours for ST-segment elevation myocardial infarction (STEMI). However, there is limited evidence about the proper time of PCI for delayed STEMI patients.From June 2014 to June 2015, a total of 268 patients receiving PCI with second-generation drug-eluting stent in a Chinese hospital after 3 days of STEMI onset were enrolled in this retrospective study, who were divided into the early group (3–14 days) and the late group (>14 days). A propensity score match was conducted to reduce the baseline difference. The primary endpoint of all-cause death and secondary endpoints of major adverse cardiac and cerebrovascular event (myocardial infarction [MI], stroke, emergent revascularization, and rehospitalization due to heart failure) were compared using survival analysis.At last, 182 cases were matched after propensity score match, with no statistical difference in baseline characteristics and PCI data. Kaplan-Meier survival curve demonstrated no difference in all-cause death of the 2 groups (P = .512). However, the early group presented a higher incidence of MI than the late group (P = .036). The multivariate Cox regression analysis also demonstrated that the early PCI was an independent risk factor for MI compared with late PCI (hazard ratio = 3.83, 95%CI [1.91–8.82], P = .001). There was no statistical difference in other major adverse cardiac and cerebrovascular event, including stroke, emergent revascularization, and rehospitalization due to heart failure.Using the 2nd drug-eluting stent, early PCI (3–14 days) and late PCI (>14 days) have comparable efficacy and outcomes. However, patients receiving early PCI are subjected to a relatively higher risk of recurrent MI.

Percutaneous Coronary Intervention With Drug Eluting Stents Versus Coronary Artery Bypass Graft Surgery in Patients With Advanced Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Το perform a systematic review and meta-analysis of the available literature comparing safety and efficacy outcomes between percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and coronary artery bypass grafting (CABG) in patients with chronic kidney disease (CKD). Eligible studies included patients with eGFR < 60 mL/min/1.73 m2 that underwent revascularization. Subgroup analyses according to DES generation and dialysis status were performed. A total of 7157 and 8156 patients were included in the CABG and PCI arms respectively across 16 studies eligible studies. Weighted mean age was 68.6 and 63.8 years for the CABG and PCI arms, respectively. Mean follow-up time was 3.2 and 2.9 years respectively. Compared to CABG, PCI was associated with increased risk for all-cause mortality (hazard ratio [HR]: 1.28, 95% confidence interval [CI]: 1.13, 1.46; P < 0.01), cardiac mortality (HR: 1.59, 95% CI: 1.13, 2.23; P = 0.01), myocardial infarction (MI) (HR: 1.89, 95% CI: 1.43, 2.49; P < 0.01), and repeat revascularization (HR: 2.97, 95% CI: 2.20, 3.97; P < 0.01). Risk for stroke was lower (HR: 0.64, 95% CI: 0.50, 0,81; P < 0.01) in the PCI group. These results were unchanged when 1st or 2nd DES were used. A subgroup analysis showed no difference in all-cause mortality for DES PCI vs CABG in dialysis patients (HR: 1.11, 95% CI: 0.71, 1.73; P = 0.65). In patients with CKD, PCI is associated with higher risk of mortality, MI, and repeat revascularization compared with CABG and regardless of DES generation. Risk of stroke is higher with CABG. Type of revascularization had no impact on survival of dialysis patients.

Long-term efficacy and safety of newer generation ultrathin strut drug-eluting stents: a systematic review and meta-analysis

Abstract Background Recent trials have demonstrated that short-term efficacy and safety of ultrathin strut drug-eluting stents (DES) were non-inferior to contemporary stents but long-term benefit remains uncertain. Purpose The main objective of this meta-analysis was to evaluate efficacy and safety of ultrathin strut DES with an extended follow-up in comparison to 2nd and 3rd generations DES. Methods A double-blind review of randomized controlled trials (RCT) comparing ultrathin strut DES to contemporary DES was performed from MEDLINE and CENTRAL databases and from cardiological congresses. The primary efficacy endpoint was target vessel failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) and the primary safety endpoint was occurrence of stent thrombosis (ST). Short (1 year) and long term (≥2 years) effects were estimated separately. This analysis was pre-specified in PROSPERO (CRD42019142206). Results The meta-analysis included 13 RCT including 19,490 patients. In short term, we found TLF decrease with ultrathin strut DES (RR 0.85, CI [0.75–0.97], p=0.01), driven by lower TV-MI (RR 0.83, CI [0.66–1.03], p=0.1) and TLR (RR 0.77, CI [0.58–1.01], p=0.1) rates, and a non-significant downward trend in ST (RR 0.85 CI [0.64–1.14]). In long term, from the 5 trials with extended follow-up, there was no significant difference between ultrathin strut DES and thicker strut stents in rate of TLF at the longest available follow-up (RR 0.90, CI [0.76–1.06], p=0.2), despite a numerically reduction of TV-MI (RR 0.81, CI [0.61–1.08], p=0.05) and TLR (RR 0.85, CI [0.69–1.04], p=0.1) in favor of ultrathin strut stents. However, we observed a persistent numerically reduction in ST (RR 0.79, CI [0.61–1.02], p=0.01). Conclusion Ultrathin strut DES was associated with a lower target lesion failure rate at one year but not beyond 2-years follow-up. Nevertheless, the safety of the ultrathin strut stents was sustained over time with a numerically reduction of ST. Funding Acknowledgement Type of funding source: None

Differences in lesion characteristics and patient background associated with the medium-term clinical outcomes of bare-metal and first-, second- and third-generation drug-eluting stents

We investigated the lesion characteristics and patient background factors associated with the medium-term incidence of major adverse cardiac events (MACEs) for bare-metal stents (BMS) and 1st-, 2nd- and 3rd-generation drug-eluting stents (DES) using the PCI-Registry (FU-Registry). Between January 2003 and March 2016, 2967 cases/3508 lesions for which percutaneous coronary intervention was performed at Fukuoka University Hospital and related facilities were enrolled. Patients were divided into BMS and 1st-, 2nd- and 3rd-generation drug-eluting stent (DES) groups. The incidence of MACEs in the BMS group (26.2%) was significantly higher than those in the 1st, 2nd and 3rd DES groups (18.0%, 12.5%, and 11.0%, respectively). The incidence of MACEs in the BMS group was strongly associated with insulin use, hemodialysis, low high-density lipoprotein cholesterol, stent minimum lesion diameter, stent length, severe calcification and a small vessel diameter of less than 2.5mm. Some of these factors showed no association with MACEs among the drug-elution groups, and only hemodialysis, arteriosclerosis obliterans and severe calcification showed a strong correlation in the 2nd DES group. In the 3rd DES group, none of the factors considered were associated with MACEs. In conclusion, in stent implantation, the number of factors associated with MACEs has gradually decreased as the stent generation increased.

Design and Rational for a Prospective Randomized Study of Safety Outcomes Treated with Edoxaban in Patients with Stable Coronary Artery Disease and Atrial Fibrillation (PRAEDO AF Study)

Background: In non-valvular atrial fibrillation (NVAF) patients with coronary artery disease (CAD), using antiplatelet drugs in addition to anticoagulants for stroke prevention may further increase the bleeding risk. Several guidelines have recommended an oral anticoagulant (OAC) monotherapy in patients with stable CAD one year after percutaneous coronary intervention (PCI). When considering early neointima healing of current 3rd generation drug-eluting stents (DESs), the duration of the de-escalation from a single antiplatelet drug plus an OAC to an OAC alone therapy can be shortened by less than one year after PCI. The data on the clinical acceptability of short durations for de-escalation to an edoxaban monotherapy in those patients are still lacking. Methods: A multicenter, prospective, randomized, open-label, parallel group study has been established to investigate the safety outcomes of an edoxaban monotherapy in NVAF patients with stable CAD for over at least 6 months after PCI (PRAEDO AF study). From 7 institutions in Japan, approximately 200 participants will be randomized to receive either edoxaban monotherapy or edoxaban plus clopidogrel. All patients will be followed-up at least 1 year after enrollment. The primary endpoint is the percentage of serious bleeding complications and clinically significant bleeding combined events according to the ISTH criteria for edoxaban alone and edoxaban plus an antiplatelet agent. Conclusions: This will be the first study to assess the safety of edoxaban monotherapy in NVAF patients with stable CAD over 6 months after the 3rd generation DES and over 12 months after 1st or 2nd DES implantations.

P2696Clinical characteristics of late catch-up phenomenon after implantation of 2nd generation drug eluting stent

Abstract Introduction Late catch-up phenomenon (LCU) of 1st generation drug eluting stent (DES) has been increasing yearly despite the rate of restenosis in 1 year has reduced compared with bare metal stent (BMS). 2nd generation DES was more improved than 1st generation DES and suggested more benefits about clinical outcome. Purpose To investigate the incidence and predictor of LCU after implantation of 2nd generation DES and to evaluate the association between LCU phenomenon and adverse events. Methods Between August 2012 and July 2013, a total of 1665 consecutive patients (1956 lesions with elective/urgent PCI) were enrolled in SHINANO 5 years Registry (a prospective observational multicenter cohort study) from 13 institutions in Nagano, Japan. 711 patients that were treated with 2nd generation DES and 576 patients with BMS were selected. Exclusion criterias were cases of 1st DES, only POBA, only aspiration and chronic total occulusion. Results There were significant difference about patients background between BMS and 2nd generation DES groups. Those groups were matched with propensity score. After matching, 822 patients (BMS group 411 patients, 2nd generation group 411 patients) were analyzed. The rates of 2nd DES and BMS restenosis 5 years after initial PCI were 9.2% and 8.5% (p=0.572), those of LCU were 2.6% and 5.6% (p=0.043) by 1 year landmark analysis. Cox proportional hazards analysis revealed that the DES in-stent restenosis (ISR) lesion and higher HbA1c were independent predictors for LCU from 1year to 5year (HR 5.304, p=0.009, HR 1.254, p=0.015), but 2nd generation DES was not. Kaplan Meier curve showed no association between LCU phenomenon and all cause death (p=0.446). Cox regression analysis showed LCU was not independent predictor for all cause death (p=0.414). Conclusions Implantation to DES-ISR lesion with 2nd generation DES was associated with higher LCU. Despite of more complex lesions with 2nd generation DES, there were no differences of LCU incidence between 2nd generation DES and BMS. Acknowledgement/Funding None

P2688A novel risk factor of stent restenosis after drug-eluting stent implantation; Involvement of triglyceride deposit cardiomyovasculopathy, coronary atherosclerosis with triglyceride deposition

Abstract Background Triglyceride deposit cardiomyovasculopathy (TGCV) is a novel disease concept characterized by the excessive accumulation of triglyceride in cardiomyocytes and vascular smooth muscle cells, leading to coronary artery disease (CAD), heart failure, and arrhythmia. However, it is rarely known whether TGCV contributes to the increased risk of vascular failure after drug eluting stent (DES) implantation. Purpose The aim of this study was to evaluate vascular failure after 2nd generation DES implantation in patients with TGCV. Methods Among 637 consecutive patients suspected of having CAD who underwent both coronary angiography and iodine-123-β-methyliodophenyl-pentadecanoic acid (BMIPP) scintigraphy between 2010 and 2018, we analyzed the data from 92 patients who met the inclusion criteria (shown in Table and Figure). Ninety-two patients were allocated to the presence (TGCV group, 11 patients) or absence (control group, 81 patients) of TGCV. All of 92 patients were implanted 2nd generation DES and underwent planned follow up coronary angiography. Control patients were diagnosed of diabetes mellitus. Binary restenosis (ISR), defined as angiographic luminal diameter ≥50% by quantitative coronary angiography, target lesion revascularization (TLR), In-stent late loss and restenosis morphology were assessed in 23 stents of TGCV group and 120 stents of control group. Results There were no significant differences in baseline characteristics between the two groups except for the prevalence of hypertension. In-stent late loss was greater in TGCV than in control (0.45 (−0.04 to 3.33) vs. 0.15 (−0.18 to 2.75), p=0.ehz748.10067), resulting in greater incidence of ISR and TLR in TGCV than in control (34.8% vs. 10.0%, p=0.0017; 21.7% vs. 6.7%, p=0.021, respectively). On multivariable logistic regression analysis, TGCV was found to be a significant and independent predictor for ISR after 2nd generation DES implantation. Regarding restenosis morphology, diffuse and occlusive pattern of ISR, were more frequently observed in TGCV than control (87.5% and 33.3%, Fisher's exact test p=0.028). Table 1.The 4th edition diagnostic criteria for TGCV Items Clinical findings 2 points I) BMIPP scintigraphy Wash-Out Rare &lt;10% II) Diffuse narrowng coronary arteries 1 point III) Jordans anomaly in peripheral blood smear IV) Diabetes Decision 4 points or more → Definite TGCV Figure 1 Conclusion Patients with TGCV showed the greater incidence of vascular failure even after 2nd generation DES implantation, contributing to the novel risk factor for coronary intervention even in the 2nd DES era.

P2813The improvement of chronic local coagulative response according to the progress of drug eluting stent

Abstract Background We have previously reported local persistent hypercoagulation after sirolimus-eluting stent (SES) implantation by measuring local plasma prothrombin fragment 1+2 (F1+2) levels. The aim of this study is to examine chronic local coagulative response after each generation- drug eluting stent (DES) implantation. Methods Ninety-five patients who were treated about eight months earlier with coronary angioplasty, with no evidence of restenosis, were studied [1stgeneration durable polymer (DP)-DES {SES; Cypher®: 26pts, paclitaxel-eluting stent (PES); Taxus®:16pts}, 2ndgeneration DP-DES {everolimus-eluting stent (EES); Xience®:15pts, zotarolimus-eluting stent (ZES); Endeavor®:15pts}, and 3rdgeneration biodegradable polymer (BP)-DES {BP-biolimus-eluting stent (BES); Nobori®: 11pts and BP-SES; Ultimaster®: 12pts}]. We measured plasma levels of F1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V). The transcardiac gradient (Δ) was defined as CS level minus V level. Results No significant differences were observed in the percent diameter stenosis among 1st, 2nd, and 3rd DES groups (12.5±15.5 vs 16.1±12.9 vs 13.1±11.9%). The ΔF1+2 was significantly lower in the 2nd and 3rd DES groups than in the 1st DES group (9.0±15.4 and 10.0±17.4 vs 27.3±23.8pmol/l, p&lt;0.05, respectively). The ΔF1+2 was significantly lower in the BP-DES groups (BP-BES and BP-SES) than in the DP-DES groups (DP-SES, DP-PES, DP-ZES, and DP-EES) (10.0±17.4 vs 18.1±19.5pmol/l, p&lt;0.05). The ΔF1+2 was significantly lower in the thin strut-DES groups (BP-SES, DP-ZES, and DP-EES) than in the thick strut-DES groups (DP-SES, DP-PES, and BP-BES) (8.4±15.4 vs 21.7±18.5pmol/l, p&lt;0.05). In the BP-DES groups, the ΔF1+2 was lower in the BP-SES group than in the BP-BES group (8.0±16.1 vs 12.7±18.1pmol/l, p=0.08). Conclusions The improvement of chronic local coagulative response was observed according to the progress of DES. These findings might be associated with lower strut thickness and faster polymer resorption in the newer-generation DES.

Second-generation drug-eluting stenting versus coronary artery bypass grafting for treatment of coronary chronic total occlusion

BackgroundLimited data are available regarding the long-term clinical outcomes of percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DESs) versus coronary artery bypass grafting (CABG) for the treatment of coronary artery disease (CAD) with chronic total occlusion (CTO). We compared the clinical outcomes of patients with multivessel CAD including CTO lesions treated with PCI using DESs versus CABG. MethodsWe analyzed data from 423 consecutive patients who underwent successful revascularization for CTO between March 2008 and February 2012. Death or myocardial infarction (MI) and major adverse cardiac and cerebrovascular events (MACCE) were compared between patients treated with PCI using second-generation DESs (n=232, 2nd DES group) versus those treated with CABG (n=191, CABG group). To reduce selection bias according to treatment strategy and other potential confounding factors, inverse probability of treatment weighting (IPTW) was also performed. ResultsDuring a median follow-up duration of 32 months, there was no significant difference in death or MI [hazard ratio (HR): 0.69; 95% confidence interval (CI): 0.29–1.63; p=0.399] or MACCE (HR: 1.32; 95% CI: 0.74–2.35; p=0.341) between the 2nd DES group and the CABG group based on multivariable analysis. After IPTW adjustment, the incidences of death or MI (HR: 0.72; 95% CI: 0.26–1.95; p=0.518) and MACCE (HR: 1.49; 95% CI: 0.76–2.91; p=0.244) remained similar in the two groups. In subgroup analysis, the effect of second-generation drug-eluting stenting was comparable to that of CABG across various subgroups without a significant p-value for the interaction. ConclusionsThe efficacy of PCI using second-generation DES was comparable to that of CABG in CTO patients with multivessel CAD.

Frequency and predictors of bleeding events after 2nd generation drug-eluting stent implantation differ depending on time after implantation

BackgroundAntiplatelet therapy is required after drug-eluting stent (DES) implantation, but bleeding events occur unexpectedly. We aimed to assess whether bleeding event predictors after 2nd generation DES (2nd DES) implantation differed by time after implantation. MethodsWe studied 1912 consecutive patients who underwent successful 2nd DES implantation (70±10 years, 72% male). Bleeding events were recorded as early (≤1 year) and late (>1 year). Major bleeding events were defined as a composite of type 5, 3, and 2 bleeding in the Bleeding Academic Research Consortium criteria. Predictors were assessed using a Cox proportional hazard model. ResultsBleeding event rates were 3.3%, 5.1%, and 6.7% at 1, 2, and 3 years, respectively, with the highest 1-year rate in year 1 (p<0.001). Cause and severity of bleeding events were similar between early and late bleeding events. Prior history of gastrointestinal bleeding, non-steroidal anti-inflammatory drug use, and triple antithrombotic therapy [adjusted risk ratio (RR): 3.68, 3.21, 4.57, respectively; p<0.01] were independent predictors of early bleeding events. Age >80 years and severe renal dysfunction (adjusted RR: 2.27, 2.02, respectively; p<0.01) were independent predictors of late bleeding events. Survival rate was significantly lower in patients with bleeding events compared with patients without bleeding events (82.4% vs 90.1%; p<0.001). ConclusionFrequency and predictors of bleeding events after 2nd DES implantation differ by time after implantation. Treatment strategies corresponding to individual patients are required.

Utility of the HAS-BLED Score in Risk Stratifying Patients on Dual Antiplatelet Therapy Post 12 Months After Drug-Eluting Stent Placement.

Current guidelines recommend continuation of dual anti-platelet therapy (DAPT) for 12 months after percutaneous coronary intervention (PCI). Recent studies have shown benefit in continuing DAPT beyond 12 months but at the risk of increase bleeding. To date, there has been little data on risk stratifying patients to determine who can continue DAPT beyond 12 months at minimal bleeding risk. All patients who underwent drug-eluting stent (DES) placement from January 1, 2013 to September 30, 2014 were reviewed. Patients who had follow-up for at least 12 months, placement of 2nd generation everolimus-coated DES, and were on DAPT for at least 12 months were included. Patients with a history of atrial fibrillation, follow-up time less than 12 months, or were on concurrent oral anticoagulation therapy were excluded. Five hundred thirty-one patients were analyzed as described above. Two hundred two patients included in our study with 7 patients in the bleeding cohort and 195 patients in no-bleed cohort. The HAS-BLED score in patients who had a bleeding episode vs. those who did not was 3.29 vs. 2.24 (P value of 0.0009). Although not statistically significant, patients who had a bleeding episode were more likely to have renal dysfunction, alcohol use, be on prasugrel, and be on 325mg of aspirin. The study shows that the HAS-BLED score can be of utility in risk stratifying patients in determining who can continue DAPT beyond 12 months. Furthermore, a HAS-BLED score of less than 2 may help guide extended DAPT beyond 12 months at minimal bleeding risk. © 2016 Wiley Periodicals, Inc.

Impact of ultra‐long second‐generation drug‐eluting stent implantation

This study investigated the safety and prognosis of ultra-long second DES (UL-2nd DES) implantation in real-world practice. Long stenting is a widely known predictor of stent thrombosis (ST) or target lesion revascularization (TLR) in first-generation drug-eluting stents (DES). Participants were 1,669 patients (2,763 lesions) who had undergone successful second DES implantation; they were assigned to one of three groups: ultra-long 2nd DES (UL-DES; >50 mm, 166 patients, 259 lesions), long second DES (L-DES; 20-50 mm, 758 patients, 1,212 lesions), or short second DES (S-DES; <20 mm, 745 patients, 1,292 lesions). The primary endpoint was TLR, and secondary endpoints were ST, cardiac death, and major adverse cardiac events (MACE; composite of TLR, ST and cardiac death). A Cox proportional hazards model was used to identify independent predictors of TLR. Patient characteristics including dual antiplatelet therapy duration were similar across groups. Follow-up data were obtained from hospital charts, by contacting patients. Target lesion characteristics in the UL-DES group showed higher right coronary artery and chronic total occlusion lesion rates. TLR rates (23.1 ± 13.2 months) were significantly higher in the UL-DES group relative to other groups during follow up (P < 0.001). TLR rate was similar between S-DES and L-DES (P = 0.30). The incidence of ST was similar across groups (P = 0.40). MACE was significantly higher in the UL-DES group relative to other groups due to higher TLR rates (P = 0.01). In a Cox proportional hazard model, hemodialysis (RR: 2.53, 95% CI: 1.69-3.67, P < 0.001) and total stent length of >50 mm (RR: 1.67, 95% CI: 1.07-2.55, P = 0.02) were independent predictors of TLR. Ultra-long DES implantation was associated with higher TLR rates but did not increase ST, while long DES implantation up to 50 mm was safe and acceptable.