Reduction In Target Lesion Revascularization Research Articles

Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies.

Clinical outcomes after successful revascularization of long chronic total occlusions using amphilimus-eluting polymer-free stent: a single center experience.

Chronic total occlusions (CTOs) are complex lesions that usually require stenting of long segments, and, therefore more prone to restenosis and/or thrombosis. Polymer-free stents to avoid chronic inflammatory response in the vessel wall are a potential solution to reduce target lesion revascularization. We, therefore, investigated the clinical outcomes following successful amphilimus-eluting polymer-free stent implantation in long CTOs. A total of 77 consecutive patients who underwent successful revascularization for long CTOs (lesion length ≥30 mm) using Cre8 stents were included. Baseline demographics, periprocedural characteristics, in-hospital events, and post-discharge long-term cardiovascular events were retrospectively screened for all patients. The Japanese CTO score was 1.58 ± 0.96, and the lesion length was 54.0 ± 9.89 mm. All cases were technically successful (n = 77, 100%), while procedural success was obtained in 74 patients (96.1%). Periprocedural complications were contrast-induced nephropathy (n = 4, 5.2%), coronary perforation (n = 3, 3.8%), residual dissection (n = 1, 1.3%), and femoral artery pseudoaneurysm (n = 1, 1.3%). Three patients (3.9%) presented periprocedural myocardial infarction requiring repeat percutaneous coronary intervention. At 25.0 ± 15.8 months follow-up, major adverse cardiac and cerebrovascular events were observed in 14 patients (18.1%). The Cre8 polymer-free drug- eluting stents seems safe and effective for percutaneous revascularization of long CTO lesions with a high success and low adverse event rate.

Single-Center Study Evaluating Long-Term Major Adverse Outcomes with the Use of Paclitaxel-Coated Balloons in Treating Infrainguinal Arterial Disease.

Paclitaxel drug-coated balloons (DCB) have been shown to reduce target lesion revascularization (TLR) rate, but recently an association between paclitaxel and an increase in mortality at 5-year was reported. We reviewed the 5-year mortality and freedom from TLR rates from a single center among patients that received DCB. Consecutive patients that received DCB from July 8, 2015 to November 27, 2019 with follow-up obtained from medical records and review of official death certificates were reviewed. The primary objective was total mortality and TLR rates with cumulative exposure to paclitaxel-coated balloons. Demographic, angiographic, clinical, and procedural variables were collected. Causes of mortality were classified according to death certificates. Descriptive analysis was performed on all variables. Kruskal-Wallis test was used to compare the total length of DCBs in those who were alive and those who died by the end of study. Kaplan-Meier (KM) was used to plot the freedom from mortality up to 5 years. A total of 91 symptomatic patients received the Lutonix balloon at index to treat femoropopliteal arterial disease and subsequently received either Lutonix or in.PACT during the follow-up phase for additional procedures. Age was 68.4 ± 10.8 years (56.0% males). Critical limb ischemia was present in 20.9%. There was no statistical difference in mortality between the median total number of balloons used among patients who were alive versus those who died (2.5 vs. 3.0, p -value = 0.89). Also, there was no statistical difference in the total length of DCB balloons used between those who were alive and those who died at the end of the study (p-value = 0.39). There were no in-hospital amputation or death. At 5-year follow-up KM freedom from TLR was 78.5%. A total of 13 patients died during follow-up. Of these 10 received only the Lutonix balloon and 3 did receive both Lutonix and In.PACT. The yearly KM freedom from mortality for the Lutonix only cohort were 92.7, 89.1, 85.5, 83.6, and 81.8% at 1, 2, 3, 4, and 5 years, respectively. Freedom from TLR and mortality at 5 years appears to be favorable with the use of DCB, predominantly Lutonix balloon in this cohort. This data needs to be supported prospectively by a larger number of patients.

Treatment Strategies for Coronary Bifurcation Lesions: Complexity and Risk

Treatment Strategies for Coronary Bifurcation Lesions: Complexity and Risk

Drug-Eluting versus Bare-Metal Stents in Saphenous Vein Grafts Compared to Native Coronary Vessels: The Norwegian Coronary Stent Trial Study

Background: Drug-eluting stents (DES) reduce target lesion revascularization (TLR) with no effect on mortality or myocardial infarction (MI) compared to bare-metal stents (BMS) in native vessels. Randomized stent studies in saphenous vein grafts (SVG) are few and the reported effects are ambiguous. The Norwegian Coronary Stent Trial study is the first to randomize lesions to percutaneous coronary intervention in native vessels and SVG. Aims: The aim of this study was to compare the rate of mortality, MI, and TLR across stent and vessel types. Methods: In this substudy, 6,087 patients with a single lesion in native vessels and 164 in SVG were followed for 5 years. Results: MI was more frequent in SVG (subdistributional hazard ratio [SHR] 4.95 (3.75–6.54, p < 0.001), but not affected by stent type. In the first 500 days, DES reduced TLR in native vessels (SHR 0.21 (0.15–0.30) p < 0.001) and SVG (SHR 0.18 (0.04–0.80) p = 0.02). Thereafter, DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23–8.94) p = 0.02). After 5 years, the TLR rate was still significantly lower for DES in native vessels (3.2% vs. 7.8%, p < 0.001) but not in SVG (21.4% vs. 18. 4%). Conclusion: In SVG, no difference in TLR between DES and BMS was observed after 5 years in contrast to persistent benefit in native vessels. The high rate of TLR and MI in SVG makes treatment of native vessels a preference whenever feasible and better treatment options for SVG are warranted.

Drug-Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta-Analysis of Randomized Controlled Trials.

BackgroundBoth drug‐coated balloon (DCB) angioplasty and conventional plain balloon angioplasty (PBA) can be implemented to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these 2 approaches by conducting a meta‐analysis of available randomized controlled trials.Methods and ResultsPubMed, Cochrane Library, and Embase databases were queried from establishment to January 2021. A total of 18 randomized controlled trials including 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta‐analysis. Target lesion primary patency, circuit patency, target lesion revascularization, and mortality were pooled. Odds ratios (ORs) were reported with 95% CIs. Publication bias was analyzed with funnel plot and Egger test. Target lesion primary patency was higher among patients who underwent DCB (OR, 2.93 [95% CI, 2.13–4.03], P<0.001 at 6 months; OR, 2.47 [95% CI, 1.53–3.99], P<0.001 at 1 year). Also, the DCB group had a higher dialysis circuit patency at 6 months (OR, 2.42; 95% CI, 1.56–3.77 [P<0.001]) and 1 year (OR, 1.91; 95% CI, 1.22–3.00 [P=0.005]). Compared with the PBA group, the DCB group had lower odds of target lesion revascularization during follow‐up (OR, 0.43 [95% CI, 0.23–0.82], P=0.001 at 6 months; OR, 0.74 [95% CI, 0.32–1.73], P=0.490 at 1 year). The OR of mortality was comparable between 2 groups at 6 months (OR, 1.18; 95% CI, 0.42–3.33 [P=0.760]) and 1 year (OR, 0.93; 95% CI, 0.58–1.48 [P=0.750]).ConclusionsBased on evidence from 18 randomized controlled trials, DCB angioplasty is superior to PBA in maintaining target lesion primary patency and circuit patency among patients with dialysis circuit stenosis. DCB angioplasty also reduces target lesion revascularization with a similar risk of mortality compared with PBA.

The Safety of Paclitaxel-Coated Devices for Patients with Peripheral Artery Disease.

Peripheral artery disease (PAD) is a common, debilitating disease that impacts 8.5 million Americans and carries a poor prognosis. The most common manifestation of lower extremity PAD is claudication-a condition which significantly reduces quality of life and functional status. Paclitaxel-coated balloons and stents (PCBs and PESs) represented a breakthrough in the ability to treat medication-refractory patients relative to bare metal stents (BMSs) and percutaneous transluminal angioplasty (PTA) because they improve primary patency rates, reduce target lesion revascularization (TLR), and minimize late-lumen loss for femoropopliteal lesions. As a result, paclitaxel-coated devices (PCDs) were swiftly established as the standard of care for revascularization of femoropopliteal artery disease. A recent meta-analysis of summary-level data demonstrated a late mortality signal for patients treated with paclitaxel-coated devices relative to uncoated devices. This has had a major impact on the vascular community and for the treatment of patients with PAD. Herein, we provide a detailed review of the available data on the late mortality signal associated with paclitaxel. In December of 2018, Katsanos et al. J Am Heart Assoc 7: e011245, 2018) published data from randomized-controlled trials (RCTs) that demonstrated an increase in mortality at 2 and 5 years in patients treated with PCDs involving the femoropopliteal arterial segment relative to patients treated with uncoated devices. As a result of this analysis, randomized trials were stopped and the FDA sent a letter to healthcare providers recommending restriction of use of these devices to patients at the highest risk of restenosis. As additional data emerged supporting the safety of these devices, the FDA organized an advisory committee meeting to review the available data and to determine a pathway forward. The FDA concluded that there were insufficient data to make a final decision regarding the safety of PCDs. They allowed these devices to remain on the market, but with revised safety labeling and updated their letter to healthcare providers to continue to restrict use to patients at highest risk of reintervention. The FDA also called for additional long-term data, including from RCTs and real-world data. To date, an updated patient-level meta-analysis of clinical trial data, RCTs with longer-term follow-up, and large observational studies have been conducted. While meta-analyses conducted using overlapping clinical trial data have found a persistent increase in mortality for those treated with PCDs, individual industry-sponsored RCTs and large observational studies have consistently failed to detect a corresponding mortality increase. To date, no mechanism linking paclitaxel to mortality has been observed. We are currently at an impasse for drawing definitive conclusions regarding the long-term safety of paclitaxel-coated devices. As we await enrollment in ongoing clinical trials, we must proceed with making reasonable decisions for our patients' care from the available data, as these devices have important clinical implications for our patients. A critical lesson that can be learned from this controversy is that, for future device trials, committing to long-term follow-up is crucial.

Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial.

Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients. The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months. A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, -1.2%; Pnoninferiority<0.001). The key secondary end point, device-oriented composite outcome, occurred less frequently in the DP-DES group (DP-DES vs BP-DES, 2.6% vs 3.9%; hazard ratio, 0.67 [95% CI, 0.46-0.98]; P=0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; P=0.513 and 0.1% versus 0.4%; P=0.174, respectively). In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov; Unique identifier: NCT02193971.

Comparison of coronary bifurcation lesions stenting techniques- a network meta-analysis

Abstract Background Coronary bifurcations lesions (CBL) are account for 15–20% of all percutaneous coronary interventions (PCI) and constitute a major challenge for interventionists in terms of procedural success rate and long-term cardiac events. Based on data from multiple randomized trials and registries, current guidelines advocate the use of provisional side branch (SB) stenting strategy for the majority of CBL's. However, for true or complex CBL's (long side branches lesions, difficult side branches access or high risk of side branches compromise), which account for up to 25% of CBL's, this strategy may by unsafe and ineffective due to a potential risk of intraprocedural or long-term occlusion of a significant side branch and a two-stenting technique may be needed in order to achieve optimal results. Up to date, the optimal two- stenting technic for CBL remains in debate. Accordingly, our aim was to compare different stenting techniques in coronary bifurcation lesions. Methods We performed a MEDLINE search for randomized controlled trials (RCT) and observational studies comparing stenting techniques in CBL's with reported clinical outcomes. Mixed treatment comparison model generation was performed to directly and indirectly compare culotte, T and protrusion (TAP), crush and provisional techniques Results A total of 13 RCT and 12 observational studies were identified including 6806 patients, among whom 1,201 were treated with cullotte, 2,731 with crush, 797 with TAP and 2077 with provisional stenting. The Bayesian hierarchical random-effects model demonstrated a significant reduction in target lesion revascularization (TLR) rate with crush techniques compared with provisional technique (OR 0.64 95% CI 0.42–0.97) along with a trend for reduction in major adverse cardiovascular (MACE) events (OR 0.75, 95% CI 0.55–1.02). TAP and culotte techniques did not show similar results. Equality of other endpoints, including mortality, myocardial infarction and re-stenosis was found between all CBL's techniques (Figure 1). Discussion Our findings suggest improved outcomes with crush technique compared to other double stenting techniques in terms of TLR with a trend towards MACE reduction. Further research is required to determine the optimal stenting technique for coronary bifurcations lesions along with the utility of imaging and physiology in this complex subset. Figure 1. Comparison of double stentin techniques Funding Acknowledgement Type of funding source: None

Five-year major adverse cardiac and cerebrovascular events of patients with lipid core abutting lumen (LCAL) on integrated-backscatter intravascular ultrasound undergoing PCI with current DES

Abstract Background Percutaneous Coronary Intervention (PCI) using the new generation drug-eluting stent (DES) has been extremely reduced target lesion revascularization (TLR) in recent years. However, a high incidence of non-target lesion-related cardiovascular events in patients undergoing PCI is an important problem to be solved. According to the previous findings, patients with vulnerable plaques particularly have a high recurrence of cardiovascular events. Little studies, however, has been done to examine the relationship between plaque characteristics on intravascular imaging in a target lesion and non-target lesion-related cardiovascular events. Purpose The main objective of this study is to investigate the five-year major adverse cardiac and cerebrovascular events (MACCE) of patients with lipid core abutting lumen (LCAL) on integrated backscatter intravascular ultrasound (IB-IVUS) in a target lesion undergoing PCI with current DES. Methods and results Between February 2010 and September 2013, in total 780 patients with ischemic heart disease undergoing PCI, 166 target lesions in 166 consecutive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) and stable angina pectoris (SAP) undergoing IVUS-guided PCI were studied. Plaque characteristics in all target lesions were analyzed by three-dimensional IB-IVUS system using the mechanical IVUS catheter. Our previous study has found that LCAL which is defined as a lipid pool directly in contact with the lumen visualizes the thin fibrous cap of less than 75μm on optical coherence tomography (OCT). On the basis of this data, LCAL at minimal lumen area (MLA) site was identified. In total, 39 patients had lesions with LCAL at MLA site (LCAL(+)), and 127 patients had those without LCAL (LCAL(−)). The primary endpoint was defined as MACCE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-TLR for the new lesion during a median follow up of five years. The MACCE occurred significantly higher in the LCAL(+) than in the LCAL(−) (38.5% vs. 17.3%; p&amp;lt;0.005). And the Kaplan-Meier estimates have shown that the cumulative incidence of MACCE was significantly higher in the LCAL(+) than in the LCAL(−) (log rank test, p=0.041). Additionally, after adjustment for confounders, gender, prior PCI and LCAL was the independent predictors for the MACCE of patients undergoing PCI with current DES. Furthermore, after adding LCAL to a baseline model with established factors consisting of age, gender, diabetes mellitus, prior PCI and percentage lipid volume on IB-IVUS, the net reclassification (p&amp;lt;0.002) and integrated discrimination improvement (p&amp;lt;0.004) significantly improved compared to baseline model alone. Conclusions In this study, it has become clear that LCAL on IB-IVUS is likely to be a surrogate marker of MACCE in patients undergoing PCI with current DES. Funding Acknowledgement Type of funding source: None

Clinical Outcomes Following Coronary Bifurcation PCI Techniques: A Systematic Review and Network Meta-Analysis Comprising 5,711 Patients

ObjectivesThe aim of this study was to compare clinical outcomes of different bifurcation percutaneous coronary intervention (PCI) techniques. BackgroundDespite several randomized trials, the optimal PCI technique for bifurcation lesions remains a matter of debate. Provisional stenting has been recommended as the default technique for most bifurcation lesions. Emerging data support double-kissing crush (DK-crush) as a 2-stent technique. MethodsPubMed and Scopus were searched for randomized controlled trials comparing PCI bifurcation techniques for coronary bifurcation lesions. Outcomes of interest were major adverse cardiovascular events (MACE). Secondary outcomes of interest were cardiac death, myocardial infarction, target vessel or lesion revascularization, and stent thrombosis. Summary odds ratios (ORs) were estimated using Bayesian network meta-analysis. ResultsTwenty-one randomized controlled trials including 5,711 patients treated using 5 bifurcation PCI techniques were included. Investigated techniques were provisional stenting, T stenting/T and protrusion, crush, culotte, and DK-crush. Median follow-up duration was 12 months (interquartile range: 9 to 36 months). When all techniques were considered, patients treated using the DK-crush technique had less occurrence of MACE (OR: 0.39; 95% credible interval: 0.26 to 0.55) compared with those treated using provisional stenting, driven by a reduction in target lesion revascularization (OR: 0.36; 95% credible interval: 0.22 to 0.57). No differences were found in cardiac death, myocardial infarction, or stent thrombosis among analyzed PCI techniques. No differences in MACE were observed among provisional stenting, culotte, T stenting/T and protrusion, and crush. In non–left main bifurcations, DK-crush reduced MACE (OR: 0.42; 95% credible interval: 0.24 to 0.66). ConclusionsIn this network meta-analysis, DK-crush was associated with fewer MACE, driven by lower rates of repeat revascularization, whereas no significant differences among techniques were observed for cardiac death, myocardial infarction, and stent thrombosis. A clinical benefit of 2-stent techniques was observed over provisional stenting in bifurcation with side branch lesion length ≥10 mm.

Meta-Analysis Comparing Endovascular Treatment Modalities for Femoropopliteal Peripheral Artery Disease

Endovascular interventions are commonly utilized for treatment of femoropopliteal peripheral artery disease. The relative efficacy of these interventions remains unclear. A Bayesian network meta-analysis was performed comparing 5 endovascular treatment modalities: balloon angioplasty (BA), bare metal stent (BMS), covered stent (CS), drug-coated balloon (DCB), drug-eluting stent (DES) for femoropopliteal peripheral artery disease. The primary efficacy end points were freedom from target lesion revascularization (TLR) and primary patency at 12 months. BA was the reference treatment. Twenty-two trials including 4,381 participants provided data on TLR. Sixteen trials including 3,691 participants provided data on primary patency. Point estimates for DCB suggested that it was the most efficacious treatment for freedom from TLR (odds ratio [OR] 4.23; 95% credible intervals [CrI] 2.43 to 7.66) followed by CS (OR 3.65; 95% CrI 1.11 to 12.55), DES (OR 2.64; 95% CrI 0.72 to 9.77), and BMS (OR 2.3; 95% CrI 1.11 to 4.76). Similarly, point estimates for primary patency were highest with DES (OR 8.93; 95% CrI 3.04, 27.14) followed by CS (OR 3.91; 95% CrI 1.18, 13.84), DCB (OR 3.32; 95% CrI 1.8, 6.25), and BMS (OR 3.5; 95% CrI 1.58, 7.99). In conclusion, DCB has the lowest need for TLR whereas DES has the highest primary patency rate. DCB, CS, and BMS were associated with significant reductions in TLR compared with BA, whereas DCB, DES, CS, and BMS were associated with significantly improved primary patency compared with BA.

The Effect of Drug-Eluting Stents on Target Lesion Revascularization in Native Coronary Arteries: Results from the NORSTENT Randomized Study

Background: The NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS) with 5-year follow-up. No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularizations, which were reduced by DES. We report the occurrence of target lesion revascularization (TLR) in time and across demographic and clinical subgroups in patients with lesions in native coronary arteries (n = 8,782). Results: Clinically driven TLR was performed on 488 (5.6%) of the 8,782 patients during 5 years of follow-up. Male gender, older age, visible thrombus in the lesion, and larger stent diameter were associated with less TLR; multivessel disease and longer stents were associated with a higher risk of TLR. There was a substantial and highly significant reduction of the risk of any TLR after 5 years in the DES group (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.36–0.52], p < 0.001). The effect of DES on TLR was limited in time to the first 2 years in the study with no evidence of a later rebound effect. The reduction in TLR after DES insertion was consistent across subgroups defined by gender, age, diabetes status, renal function, and lesion and stent characteristics. The number needed to treat with DES (vs. BMS) to prevent 1 TLR ranged from 4 to 110 across clinically relevant subgroups. Conclusion: DES have a time-limited effect on the rate of TLR, but with a substantial and highly significant reduction in the first 2 years after the procedure. This effect was found to be consistent across all important clinical subgroups.

CRT-100.35 Comparison of Biodegradable-Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent—a Meta-Analysis of Randomized Trials

Newer-generation drug-eluting stents (DES) reduce mortality and late stent thrombosis compared with bare metal stents and early generation DES. Recent randomized controlled trials (RCT) showed reduction in target lesion revascularization with ultrathin biodegradable-polymer (BP) stents but similar

P3589New generation stents for primary percutaneous coronary intervention in patients with acute myocardial infarction: evidence from an individual patient data network meta-analysis of randomized clinical

Abstract Background Drug-eluting stents have shown their superiority in primary percutaneous intervention in patients with ST-segment elevation myocardial infarction (STEMI). No specific stent type has fully proven its superiority over others. Purpose We sought to compare the safety and efficacy of coronary artery stents in STEMI patients undergoing primary PCI through comprehensive network meta-analysis (NMA). Methods We performed an individual patient data (IPD) NMA of dedicated randomized trials in STEMI patients treated with coronary stents. The primary endpoint of interest was the composite outcome of cardiac death, any myocardial infarction (MI) or target lesion revascularization (TLR). Secondary outcomes were the individual component of the primary endpoint and definite or probable stent thrombosis. Outcomes were analyzed at the longest available follow-up. The primary analysis was performed using a one-stage random-effects meta-analysis. Results IPD from 15 randomized trials in STEMI patients were obtained including a total of 10,979 patients. Six different stent types were studied including bare metal stents (BMS), durable-polymer paclitaxel-eluting stents (DP-PES), durable-polymer sirolimus-eluting stents (DP-SES), durable-polymer zotarolimus-eluting stents (DP-ZES), durable-polymer everolimus-eluting stents (DP-EES) and biodegradable-polymer biolimus-eluting stent (BP-BES). Mean patient age was 60.7±11.9 years; 22.7% were female and 16.1% were diabetic. Median symptom onset to balloon time was 210 min. At a median follow-up of 3 years (interquartile range 2–4.9 years), patients treated with second-generation (DP-EES and BP-BES) or first-generation DES (DP-PES, DP-SES and DP-ZES) had significantly lower risk of the primary endpoint than patients treated with BMS (BMS vs. second-generation DES; HR 0.69, 95% CI 0.57–0.82, BMS vs. first-generation DES; HR 0.70, 95% CI 0.61–0.80). The differences were driven by the significant reduction of TLR associated with first- and second-generation DES compared with BMS. A trend towards lower risk of MI with second-generation DES compared with BMS or first-generation DES was observed (BMS vs. second-generation DES; HR 0.79, 95% CI 0.58–1.06, first- vs. second-generation DES; HR 0.75, 95% CI 0.54–1.03). Second-generation DES was associated with a significantly lower risk of definite or probable stent thrombosis compared with BMS (HR 0.62, 95% 0.40–0.97) and first-generation DES (HR 0.55, 95% CI 0.34–0.91). DP-EES and BP-BES had a similar risk of the primary endpoint, individual components of the primary endpoint, and definite or probable stent thrombosis. Conclusions In this larger-scale IPD NMA in STEMI patients, second-generation DES were superior to BMS with respect to long-term efficacy and safety outcomes. Second-generation DES were associated with a significant reduction of stent thrombosis compared with BMS and first-generation DES. Similar long-term outcomes were observed between DP-EES and BP-BES. Acknowledgement/Funding This study was funded by Biosensors International

Intravascular ultrasound-guided stent implantation reduces cardiovascular mortality - Updated meta-analysis of randomized controlled trials

BackgroundThe use of intravascular ultrasound (IVUS) guidance to facilitate stent implantation has been demonstrated to reduce major adverse cardiovascular events (MACE), predominantly due to a reduction in target lesion revascularization (TLR). The objectives of our meta-analysis are to assess the effect of IVUS on clinical outcomes, including cardiovascular mortality. MethodsRCTs comparing drug-eluting stent (DES) implantation using IVUS plus angiography versus angiography alone were identified from a comprehensive search in PubMed, Embase, and Cochrane library. Pooled relative risks (RR) were obtained using DerSimonian and Laird estimator for the random effects model. ResultsThe search yielded 10 RCTs (5007 participants) in which the relevant data were available. Two trials were performed in patients with chronic total occlusion (CTO), whereas other trials included patients that either had stable ischemic heart disease (22–64%) or presented as an acute coronary syndrome (ACS) (36–78%). Routine use of IVUS was effective in reducing TLR (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.44, 0.80; p < 0.01), target vessel revascularization (TVR) (RR 0.59, 95% CI 0.43, 0.81; p < 0.01), and MACE (RR 0.63, 95% CI 0.51, 0.77; p < 0.01). Cardiovascular mortality was also significantly reduced (RR 0.51, 95% CI 0.27, 0.96; p = 0.04). ConclusionDuring DES implantation, the routine use of IVUS in addition to angiography improves clinical outcomes, including cardiovascular mortality. These findings reinforce the need for a broader implementation of IVUS-guidance during PCI. Since a significant proportion of patients studied presented as ACS, future trials should assess the benefit of IVUS-guidance in a more focused presentation setting.

INTRAVASCULAR ULTRASOUND-GUIDED STENT IMPLANTATION IMPROVES MORTALITY: LATEST EVIDENCE FROM RANDOMIZED CONTROLLED TRIALS

Improvement in MACE (major adverse cardiovascular events) from the use of intravascular ultrasound (IVUS) guidance for stent implantation has been attributed to the reduction in target lesion revascularization (TLR). We performed a comprehensive meta-analysis of randomized controlled trials (RCT) to

Meta-analysis of drug eluting stents compared with bare metal stents in high bleeding risk patients undergoing percutaneous coronary interventions.

To determine the efficacy and safety of drug-eluting stents (DESs) and bare metal stents (BMSs) when used with short or tailored dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. DES have been shown to reduce target lesion revascularization (TLR) as well as stent thrombosis (ST) compared to BMS in patients undergoing percutaneous coronary intervention (PCI). However, patients at HBR continue to receive BMS given the fear of bleeding or ST from premature discontinuation of DAPT in patients receiving DES. We performed a meta-analysis of randomized controlled trials by performing systematic search for studies comparing DES with BMS in HBR patients using PUBMED, MEDLINE, and Cochrane Central, reported until March 1, 2018. Three randomized controlled studies met the inclusion criteria with total of 4,460 patients; 50% received DES. Major adverse cardiovascular event (MACE); composite of death, myocardial infarction (MI), and TLR, at 1 year was significantly lower (RR = 0.63, 95% CI 0.50-0.80) in DES group compared to BMS. This difference was primarily driven by lower TLR (RR = 0.46, 95% CI 0.35-0.61) in DES group. Definite or probable ST (RR = 0.59, 95% CI = 0.32-1.08) and major (RR = 0.94, 95% CI = 0.74-1.20) bleeding were similar. DES was associated with lower MACE without increased risk of bleeding or ST compared to BMS when used with short or tailored DAPT in patients with HBR.

40 Years of Percutaneous Coronary Intervention: History and Future Directions

The field of interventional cardiology has evolved significantly since the first percutaneous transluminal coronary angioplasty was performed 40 years ago. This evolution began with a balloon catheter mounted on a fixed wire and has progressed into bare-metal stents (BMS), first-generation drug-eluting stents (DES), second- and third-generation biodegradable polymer-based DES, and culminates with the advent of bioabsorbable stents, which are currently under development. Each step in technological advancement has improved outcomes, while new persisting challenges arise, caused by the stent scaffolds, the polymers employed, and the non-selective cytostatic and cytotoxic drugs eluted from the stents. Despite the promising technological advances made in stent technology, managing the balance between reductions in target lesion revascularization, stent thrombosis, and bleeding remain highly complex issues. This review summarizes the evolution of percutaneous coronary intervention with a focus on vascular dysfunction triggered by the non-selective drugs eluted from various stents. It also provides an overview of the mechanism of action of the drugs currently used in DES. We also discuss the efforts made in developing novel cell-selective drugs capable of inhibiting vascular smooth muscle cell (VSMC) proliferation, migration, and infiltration of inflammatory cells while allowing for complete reendothelialization. Lastly, in the era of precision medicine, considerations of patients’ genetic variance associated with myocardial infarction and in-stent restenosis are discussed. The combination of personalized medicine and improved stent platform with cell-selective drugs has the potential to solve the remaining challenges and improve the care of coronary artery disease patients.

TCT-228 Outcomes After Treatment of Coronary In-Stent Restenosis With Drug-Coated Balloon Versus Drug-Eluting Stent According to the Presence or Absence of Diabetes Mellitus: A Prespecified Analysis of the DAEDALUS Study.

Drug-coated balloon (DCB) and drug-eluting stent (DES) have emerged as the most effective treatments for coronary in-stent restenosis (ISR). The main analysis of the DAEDALUS study showed that DES reduces target lesion revascularization (TLR) at long-term follow-up compared with DCB. The DAEDALUS