12-month Target Lesion Revascularization Research Articles

Response to pre-dilatation with POBA can predict target lesion revascularization after DCB angioplasty for de novo small coronary artery lesions.

ObjectiveTo assess the determinants of target lesion revascularization (TLR) after drug-coated balloon (DCB) angioplasty for de novo small coronary artery lesions.MethodsThis retrospective study enrolled consecutive lesions from patients that were in a stable condition and had undergone successful DCB treatment for de novo small coronary artery lesions. The study endpoint was TLR and major adverse cardiac events at 12 months.ResultsA total of 68 patients with 83 lesions were enrolled in the study. Of these, 11 (13.3%) lesions required TLR. Mean ± SD pre-dilatation balloon diameters were similar in the non-TLR (2.33 ± 0.72 mm) and TLR (2.18 ± 0.36 mm) groups. A comparison of the two groups showed that post/pre-lumen area ratio during pre-dilatation (%) by plain old balloon angioplasty (POBA) was significantly and negatively associated with TLR and the optimal cut-off point was 170%. Cox proportional hazard and multivariate regression analyses showed that post/pre-lumen area ratio was the only independent predictor of TLR (hazard ratio 0.9318; 95% confidence interval 0.9001, 0.9645).ConclusionGreater pre-dilatation using POBA, assessed as the post/pre-lumen area ratio, may be independently associated with a lower 12-month TLR rate in patients undergoing DCB angioplasty for de novo small coronary lesions.

Drug-coated balloon angioplasty for failing haemodialysis access: meta-analysis of randomized clinical trials.

Arteriovenous fistulas, a major treatment for end-stage kidney disease, frequently require endovascular reinterventions to maintain haemodialysis function. Drug-coated angioplasty balloons (DCBs) were developed with the intention of reducing reintervention rates. The aim of this study was to perform a systematic review and meta-analysis of DCBs in the treatment of failing haemodialysis access. Electronic databases were searched systematically to identify all relevant RCTs and any follow-up studies from RCTs. Pooled estimates of dichotomous outcomes were calculated using the odds ratio (OR) and 95 per cent confidence interval. Effect data are presented as summary hazard ratio and 95 per cent confidence interval. Some 19 studies from 18 RCTs and comprising 1898 patients were included in the meta-analysis. Compared with plain balloon angioplasty (PBA), DCB use was associated with higher target-lesion primary patency (HR 0.60, 95 per cent c.i. 0.45 to 0.79), access-circuit primary patency (HR 0.67, 0.56 to 0.80), and less target-lesion revascularization (TLR) within 6 months (OR 0.33, 0.23 to 0.47). No difference was observed between DCB and PBA in 12-month TLR (OR 0.62, 0.28 to 1.37). Mortality after DCB use was similar to that associated with PBA use at 6 months (OR 1.20, 0.65 to 2.21) and 12 months (OR 0.99, 0.66 to 1.49), and was higher at 24 months (23.1 versus 16.6 per cent), although the difference was not statistically significant (OR 1.53, 0.92 to 2.53). Drug-coated balloon angioplasty of haemodialysis fistulas is associated with higher patency rates and lower rates of reintervention in the short to mid term. Although mortality rates appeared to be higher with drug-coated angioplasty at 24 months, this did not reach statistical significance.

Comparative effectiveness of endovascular treatment modalities for de novo femoropopliteal lesions in intermittent claudication: A network meta-analysis of randomized controlled trials

PurposeTo evaluate the most effective endovascular treatment modalities for de novo femoropopliteal lesions in intermittent claudication (IC) in terms of technical success, primary patency, target lesion revascularization (TLR) and all-cause mortality through network meta-analysis of randomized controlled trials. MethodsMedical databases were searched on December 3, 2020. 16 studies (3265 patients) and 7 treatments were selected. Outcomes were technical success, primary patency, TLR and mortality at 6 and/or 12 months. ResultsRegarding 6-month primary patency, drug-eluting stents (DES) was better than balloon angioplasty (BA; odds ratio [OR], 23.27; 95% confidence interval [CI], 12.57-43.06), drug-coated balloons (DCB; OR, 5.63; 95% CI, 2.26-14.03) and directional atherectomy (DA; OR, 31.52; 95% CI, 7.81-127.28), and bare nitinol stents (BNS) was better than BA (OR, 17.91; 95% CI, 7.22-44.48), DCB (OR, 4.33; 95% CI, 1.40-13.45) and DA (OR, 24.27; 95% CI, 5.16-114.11). Regarding 12-month primary patency, DES was better than BA (OR, 10.05; 95% CI, 4.56-22.16), DCB (OR, 3.70; 95% CI, 1.54-8.89) and DA (OR, 29.54; 95% CI, 7.26-120.26). DCB and combination of balloon and atherectomy were the most effective treatment regarding 12-month TLR and technical success (residual stenosis <30%), respectively. DES, BNS and DA with DCB (DA-DCB) were included in the best cluster in the clustered ranking plot combining 12-month primary patency and TLR. ConclusionsBalloon and atherectomy may confer advantages over other treatments for technical success; DCB may for TLR. Stent technologies confer substantial advantages regarding primary patency. Stent technologies and DA-DCB should be given priority in treating femoropopliteal lesions in IC.

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Excimer laser atherectomy in complex peripheral artery disease: a prospective European registry.

This study aimed to investigate performance, effectiveness, and safety of excimer laser atherectomy for the treatment of complex lower limb artery disease in a real-world setting. In our prospective, multicenter registry, consecutive patients with complex lower limb lesions underwent excimer laser atherectomy with optional standard balloon angioplasty, paclitaxel-coated balloon angioplasty, and bailout stenting. Primary outcome was technical success. Secondary outcomes were device performance of the excimer laser system, freedom from target lesion revascularization (TLR), peri-procedural complications, and amputation-free survival in patients with critical limb ischemia (CLI). A total of 294 patients were enrolled at 14 European centers (mean lesion length 109±103 mm, total occlusions 56.8% [167 of 294 lesions], CLI 47.3% [132 of 279 patients]. Adjuvant balloon angioplasty was conducted in 283 (96.3%), and complementary stent implantation in 98 patients (33.3%). Technical success was achieved in 95.3% of patients. Increasing lesion length was associated with decreased laser atherectomy performance (odds ratio [OR] per 10 mm: 0.94 [95% confidence interval [CI] 0.90 to 0.99], P=0.01). A total of 66 patients (22.4%) completed the 12-month follow-up. Freedom from TLR was 83.5% (95% CI: 74.9 to 92.1) at 12 months. Chronic total occlusions were associated with more TLR (OR 5.03 [95% CI: 1.01 to 25.1], P=0.049). Amputation -free survival in patients with CLI was 93.1% (95% CI: 83.9 to 100). Excimer laser atherectomy substantially contributed to technical success of endovascular treatment of complex infra-inguinal lesions. Freedom from 12-month TLR was reasonable.

Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

PurposeThe post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty.MethodsIn the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months.ResultsA total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI − 0.04 to 1.3], p = 0.06 and − 0.3 per 10 years [95% CI − 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: − 0.1 per 10 mm [95% CI − 0.1 to − 0.03], p = 0.001 and − 0.1 [95% CI − 1.7 to − 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).ConclusionDCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.

Comparative Effectiveness of Drug-Coated Balloon vs Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A Meta-analysis

Purpose: To compare the effectiveness and safety outcomes of drug-coated balloon angioplasty (DCBA) vs conventional balloon angioplasty (BA) for arteriovenous fistula (AVF) stenosis. Materials and Methods: A systematic review was conducted of PubMed and Embase databases from 1966 to May 2019 to identify English-language articles evaluating DCBA vs BA for the treatment of AVF stenosis. Data extracted from each study were synthesized to evaluate target lesion revascularization (TLR), technical success, and mortality for the 2 approaches. Meta-analyses were performed on these outcomes using random effects models to estimate the odds ratios (ORs) and 95% confidence intervals (CIs). Subgroup and sensitivity analyses were performed. Results: Twelve studies [6 randomized controlled trials (RCTs) and 6 cohort studies] comprising 979 patients were included in this meta-analysis. The pooled results showed that AVFs treated with DCBA had significantly fewer TLRs at 6 months (OR 0.31, 95% CI 0.14 to 0.69, p=0.004) and 12 months (OR 0.45, 95% CI 0.21 to 0.97, p=0.04) than BA. The 2 approaches had similar technical success rates (OR 0.22, 95% CI 0.03 to 1.43, p=0.11). Additionally, the pooled OR of 12-month mortality was 0.71 (95% CI 0.20 to 2.51, p=0.60), indicating no significant difference between DCBA and BA. Subgroup analysis based on study design showed the superiority of DCBA to BA in cohort studies but not RCTs, which had high heterogeneity. Significant publication bias was found in the cohort studies. Conclusion: In de novo or recurrent AVF stenosis, DCBA appears to be an effective procedure associated with lower 6- and 12-month TLR compared with BA. However, larger and randomized controlled studies are warranted to draw definitive conclusions.

Turbo-Power™ Laser Atherectomy Combined with Drug-coated Balloon Angioplasty is Associated with Improved One-Year Outcomes for the Treatment of Tosaka II and III Femoropopliteal In-stent Restenosis

BackgroundFemoropopliteal (FP) artery in-stent restenosis (ISR) is associated with high rates of re-intervention and occlusion. The combined use of laser atherectomy (LA) with balloon angioplasty (BA) is superior to conventional balloon angioplasty (BA). Drug-coated balloons (DCBs) when combined with LA have provided additional efficacy for the treatment of FP-ISR. The aim of this study was to investigate the combination of DCB + LA with the recently approved Turbo-Power™ (Spectranetics Inc., Colorado Springs, CO, USA) LA device. MethodsThis was a dual-center retrospective study enrolling 78 consecutive patients with Tosaka type II (n = 18) or III (n = 60) FP-ISR. The lesions were treated with either Turbo-Power™ LA followed by DCB (n = 27) or with other LA devices followed by plain BA (LA + BA; n = 51) from 2015 to 2017. A Cox regression analysis was performed to examine the association between the two groups in terms of target lesion revascularization (TLR) and occlusion rates over a follow up period of 12 months. Kaplan-Meier survival curves were estimated and compared with the log-rank test. ResultsThe overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™ + DCB: 7.4% vs LA + BA: 11.8%, p = .7). The 12-month KM estimates for freedom from TLR were 90.9% in the Turbo-Power™ + DCB group vs 55.7% in the LA + BA group (p = .005). Among Toasaka III lesions, the 12 m-KM survival estimates for freedom from TLR were 88.9% in the Turbo-Power™ + DCB group vs 54.2% in the LA + BA group (p = .009). The 12 m-KM estimates for freedom from re-occlusion were 89.0% in the Turbo-Power™ + DCB group vs 58.9% in the LA + BA group (p = .070). ConclusionsTurbo-Power™ laser atherectomy combined with DCB exerted synergistic mechanism of actions and improved 12-month TLR rates for the treatment of complex FP-ISR lesions.

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis

The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either predilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included postinterventional lumen gain and late lumen loss (LLL) at 6 months. The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs. 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs. NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs. 0.40 ± 0.46 mm, P = 0.468). Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis.

The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either pre-dilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post-interventional lumen gain and late lumen loss (LLL) at 6 months. The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468). Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

Drug-Coated Balloon Versus Plain BalloonAngioplasty for the Treatment ofFemoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials.

This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12months andat the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings. Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies. We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis. A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB. DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death.Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies.

Comparison of zotarolimus- and everolimus-eluting stents in patients with ST-elevation myocardial infarction and chronic kidney disease undergoing primary percutaneous coronary intervention

BackgroundChronic kidney disease (CKD) is associated with poor outcomes after percutaneous coronary intervention (PCI). The aim of the study was to compare zotarolimus- and everolimus-eluting stents used during primary PCI in patients with acute myocardial infarction (AMI) and CKD. MethodsWe selected 854 consecutive ST-elevation MI patients with CKD (estimated glomerular filtration rate <60mL/min/1.73m2) undergoing primary PCI who were followed up for 12 months. They were divided into two groups based on type of stents implanted: (1) zotarolimus-eluting stent (ZES) and (2) everolimus-eluting stent (EES). The study end point was the 12-month major adverse cardiac events (MACE) which included all-cause death, non-fatal MI, target lesion revascularization (TLR), and target vessel revascularization (TVR). ResultsThe average number of stents used per vessel was 1.4±0.7. A total of 433 patients received ZES and 421 patients received EES. There was no significant difference in the incidence of 12-month MI, TLR, or TVR. All-cause death was found to be borderline significant between two groups (2.8% in ZES vs 0.9% in EES, p=0.05). The incidence of 12-month MACE in ZES and EES was 5.7% and 2.6% respectively, p=0.022. Stent thrombosis did not differ between groups (p=0.677). Kaplan–Meier analysis did not show significant difference for 12-month MACE-free survival between groups (log-rank p=0.158). It remained the same even after propensity adjustment for multiple confounders in Cox model (p=0.326). ConclusionsImplantation of ZES or EES provided comparable clinical outcomes with similar risk of 12-month MACE and death in STEMI patients with CKD undergoing primary PCI.

Comparison of Drug-Eluting Stents in Acute Myocardial Infarction Patients with Chronic Kidney Disease

Background/AimsTo determine which drug-eluting stents are more effective in acute myocardial infarction (MI) patients with chronic kidney disease (CKD).MethodsThis study included a total of 3,566 acute MI survivors with CKD from the Korea Acute Myocardial Infarction Registry who were treated with stenting and followed up for 12 months: 1,845 patients who received sirolimus-eluting stents (SES), 1,356 who received paclitaxel-eluting stents (PES), and 365 who received zotarolimus-eluting stents (ZES). CKD was defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m2 calculated by the modification of diet in renal disease method.ResultsAt the 12-month follow-up, patients receiving ZES demonstrated a higher incidence (14.8%) of major adverse cardiac events (MACEs) compared to those receiving SES (10.1%) and PES (12%, p = 0.019). The ZES patients also had a higher incidence (3.9%) of target lesion revascularization (TLR) compared to those receiving SES (1.5%) and PES (2.4%, p = 0.011). After adjusting for confounding factors, ZES was associated with a higher incidence of MACE and TLR than SES (adjusted hazard ratio [HR], 0.623; 95% confidence interval [CI], 0.442 to 0.879; p = 0.007; adjusted HR, 0.350; 95% CI, 0.165 to 0.743; p = 0.006, respectively), and with a higher rate of TLR than PES (adjusted HR, 0.471; 95% CI, 0.223 to 0.997; p = 0.049).ConclusionsOur findings suggest that ZES is less effective than SES and PES in terms of 12-month TLR, and has a higher incidence of MACE due to a higher TLR rate compared with SES, in acute MI patients with CKD.

Paclitaxel-Eluting Stents Compared With Bare Metal Stents in Diabetic Patients With Acute Myocardial Infarction

Background— In the prospective, randomized Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, implantation of paclitaxel-eluting stents (PES) safely reduced the rates of ischemic target lesion revascularization (TLR) compared with bare metal stents (BMS) in patients with ST-segment–elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention. Diabetes mellitus is a known predictor of adverse outcomes after percutaneous intervention in STEMI. We therefore sought to assess the impact of PES in diabetic patients with STEMI from the HORIZONS-AMI trial. Methods and Results— A total of 478 patients with diabetes and 2527 without diabetes were randomly assigned to receive PES versus BMS. The 12-month rates of ischemic TLR were significantly reduced by PES compared with BMS in both diabetic (11.2% versus 5.2%; hazard ratio [95% confidence interval]=0.45 [0.21 to 0.93]; P =0.03) and nondiabetic (6.8% versus 4.3%, hazard ratio [95% confidence interval]=0.63 [0.44 to 0.92]; P =0.02) patients. In patients with insulin-treated diabetes, PES compared with BMS reduced the 12-month TLR rate from 21.4% to 7.3% (hazard ratio [95% confidence interval]=0.35 [0.12 to 1.03]; P =0.046). Angiographic late loss and binary restenosis at 13 months were also significantly reduced in PES-treated diabetic patients. There were no significant differences between the BMS and PES groups in the 12-month rates of death, reinfarction, stroke, or stent thrombosis in either diabetic or nondiabetic patients. Conclusions— In the large-scale, prospective, randomized HORIZONS-AMI trial, implantation of PES compared with BMS in patients with STEMI and diabetes mellitus resulted in significant reductions in ischemia-driven TLR and angiographic restenosis at 1 year, with comparable safety outcomes, including stent thrombosis. These results suggest that PES can safely be used to reduce restenosis in high-risk diabetic patients presenting with STEMI. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00433966.

A Randomized, Double-Blind, Multicenter Comparison Study of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy to Reduce Restenosis After Drug-Eluting Stent Implantation in Long Coronary Lesions: Results From the DECLARE-LONG II (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions) Trial

The purpose of this study was to determine whether cilostazol reduces intimal hyperplasia in patients undergoing long zotarolimus-eluting stent implantation (stent length: ≥ 30 mm) for native long coronary lesions (length: ≥ 25 mm). Restenosis after drug-eluting stent implantation remains a significant clinical problem in long coronary lesions. Patients (n = 499) were assigned randomly to triple (aspirin, clopidogrel, and cilostazol, triple group: n = 250) or dual antiplatelet therapy (aspirin and clopidogrel and placebo, dual group: n = 249) for 8 months after long zotarolimus-eluting stent implantation. The primary end point was in-stent late loss at the 8-month angiography according to the intention-to-treat principle. The 2 groups had similar baseline characteristics. The in-stent (0.56 ± 0.55 mm vs. 0.68 ± 0.59 mm, p = 0.045) and in-segment (0.32 ± 0.54 mm vs. 0.47 ± 0.54 mm, p = 0.006) late loss were significantly lower in the triple versus dual group, as were 8-month in-stent restenosis (10.8% vs. 19.1%, p = 0.016), in-segment restenosis (12.2% vs. 20.0%, p = 0.028), and 12-month ischemic-driven target lesion revascularization (5.2% vs. 10.0%, p = 0.042) rates. At 12 months, major adverse cardiac events including death, myocardial infarction, and ischemic-driven target lesion revascularization tended to be lower in the triple group than the dual group (7.2% vs. 12.0%, p = 0.07). Percent intimal hyperplasia volume by volumetric intravascular ultrasound analysis was reduced from 27.1 ± 13.2% for the dual group to 22.1 ± 9.9% for the triple group (p = 0.017). Patients receiving triple antiplatelet therapy after long zotarolimus-eluting stent implantation had decreased extent of late luminal loss, percent intimal hyperplasia volume, and angiographic restenosis, resulting in a reduced risk of 12-month target lesion revascularization compared with patients receiving dual antiplatelet therapy. (Triple Versus Dual Antiplatelet Therapy after ABT578-Eluting Stent; NCT00589927).

Five‐year clinical outcomes of sirolimus‐eluting versus paclitaxel‐eluting stents in high‐risk patients

First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients. The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years. A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44-0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80-1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02-1.34; P = 0.12). In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES.

Selection Criteria for Drug-Eluting Versus Bare-Metal Stents and the Impact of Routine Angiographic Follow-Up: 2-Year Insights From the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial

We sought to identify patients with ST-segment elevation myocardial infarction most likely to benefit from drug-eluting stents (DES), and to evaluate the impact of routine angiographic follow-up on the apparent differences between stent types. DES might have greatest utility in patients who would benefit most from their antirestenotic properties. We randomly assigned 3,006 patients with ST-segment elevation myocardial infarction to paclitaxel-eluting stents (PES) or to bare-metal stents (BMS). Events were assessed at 12 months and 24 months, with a subset undergoing routine angiographic follow-up at 13 months. Using well-known risk factors for restenosis and target lesion revascularization (TLR), risk groups were formed to examine the absolute differences between PES and BMS. Compared with BMS, PES reduced TLR at 12 months from 7.4% to 4.5% (p = 0.003). Insulin-treated diabetes mellitus (hazard ratio: 3.12), reference vessel diameter ≤3.0 mm (hazard ratio: 2.89), and lesion length ≥30 mm (hazard ratio: 2.49) were independent predictors of 12-month TLR after BMS. In patients with 2 or 3 of these baseline risk factors, PES compared with BMS markedly reduced 12-month TLR (19.8% vs. 8.1%, p = 0.003). In patients with 1 of these risk factors, the 12-month rates of TLR were modestly reduced by PES (7.3% vs. 4.3%, p = 0.02). The 12-month TLR rates were low and similar for both stents in patients with 0 risk factors (3.3% vs. 3.2%, p = 0.93). Routine 13-month angiographic follow-up resulted in a marked increase in TLR procedures (more so with BMS) so that the absolute incremental benefit of PES compared with BMS doubled from 2.9% at 12 months to 6.0% at 24 months, a difference evident in all risk strata. Patients at high risk for TLR after BMS in ST-segment elevation myocardial infarction for whom DES are of greatest benefit may be identified. Conversely, DES may be of less clinical benefit for patients at lower risk for TLR after BMS. Routine angiographic follow-up increases the perceived clinical benefits of DES, and must be avoided to accurately estimate absolute treatment effects. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).

A Randomized Comparison of the Endeavor Zotarolimus-Eluting Stent Versus the TAXUS Paclitaxel-Eluting Stent in De Novo Native Coronary Lesions: 12-Month Outcomes From the ENDEAVOR IV Trial

The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES). First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results. This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (p(noninferiority) < or = 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).

TAXUS Liberté Attenuates the Risk of Restenosis in Patients With Medically Treated Diabetes Mellitus: Results From the TAXUS ATLAS Program

The aim of this study was to assess the relative efficacy and safety of the second-generation TAXUS Liberté paclitaxel-eluting stent (PES) in patients with and without diabetes mellitus. Diabetic patients suffer from accelerated atherosclerosis and increased risk of restenosis after coronary interventions; however, prior data suggest that PES might blunt this effect, providing equal benefit in diabetic and nondiabetic patients. A pooled analysis of all 4 TAXUS ATLAS studies was conducted that included 413 diabetic and 1,116 nondiabetic subjects treated with the TAXUS Liberté stent for de novo coronary lesions. Angiographic and intravascular ultrasound outcomes at 9 months and clinical outcomes at 9 and 12 months were compared in patients with and without diabetes. Propensity score and multivariate adjustments were performed to correct for baseline differences. In-stent angiographic restenosis (13.0% vs. 9.6%, p = 0.12), late luminal loss (0.40 mm vs. 0.38 mm, p = 0.58), and intimal hyperplasia (14.8% vs. 13.4%, p = 0.29) were similar for diabetic and nondiabetic subjects. After propensity adjustment, 12-month target lesion revascularization rates were similar for diabetic and nondiabetic subjects (6.4% vs. 4.7%, p = 0.18), with no differences in mortality, myocardial infarction, or stent thrombosis. However, the rate of target vessel revascularization (TVR) was higher for diabetic subjects due to increased TVR outside the target lesion (TVR Remote). Similar clinical, angiographic, and intravascular ultrasound outcomes were observed for both diabetic and nondiabetic subjects treated with TAXUS Liberté, suggesting that this PES attenuates the effect of diabetes on restenosis after percutaneous coronary intervention, yielding comparable efficacy and safety in diabetic and nondiabetic patients. (TAXUS ATLAS; NCT00371709, NCT00371423, NCT00371748, and NCT00371475).

A Randomized Controlled Trial of Angiography Versus Intravascular Ultrasound-Directed Bare-Metal Coronary Stent Placement (The AVID Trial)

AVID (Angiography Versus Intravascular ultrasound-Directed stent placement) is a multicenter, randomized controlled trial designed to assess the effect of intravascular ultrasound (IVUS)-directed stent placement on the 12-month rate of target lesion revascularization (TLR). After elective coronary stent placement and an optimal angiographic result (<10% stenosis), 800 patients were randomized to Angiography- or IVUS-directed therapy. Blinded IVUS was performed in the Angiography group without further therapy. In the IVUS group, IVUS criteria for optimal stent placement (<10% area stenosis, apposition, and absence of dissection) were applied. Final minimum stent area was 6.90+/-2.43 mm(2) in the Angiography group and 7.55+/-2.82 mm(2) in the IVUS group (P=0.001). In the IVUS group, only 37% with inadequate expansion (<90%) received further therapy. The 12-month TLR rate was 12.0% in the Angiography group and 8.1% in the IVUS group (P=0.08, 95% confidence level [CI], [-8.3% to 0.5%]). When vessels with a distal reference diameter <2.5 mm by core laboratory angiography measurement were excluded from analysis, the 12-month TLR rate was 10.1% in the Angiography group and 4.3% in the IVUS group (P=0.01, 95% CI, [-10.6% to -1.2%]). With a pre-stent angiographic stenosis of > or =70%, the TLR rate was lower in the IVUS group compared with the Angiography group (3.1% versus 14.2%; P=0.002; 95% CI, [-18.4% to -4.2%]). IVUS-directed bare-metal stent placement results in larger acute stent dimensions without an increase in complications and a significantly lower 12-month TLR rate for vessels > or =2.5 mm by angiography and for vessels with high-grade pre-stent stenosis. However, for the entire sample analyzed on an intention-to-treat basis, IVUS-directed bare-metal stent placement does not significantly reduce the 12-month TLR rate when compared with stent placement guided by angiography alone. In addition, IVUS evaluation of adequate stent expansion is underutilized by experienced operators.