Long-term Clinical and Angiographic Outcomes of the Mini-STAR Technique as a Bailout Strategy for Percutaneous Coronary Intervention of Chronic Total Occlusion

Background

A promising variant of the subintimal tracking and re-entry (STAR) technique, called “mini-STAR,” has been recently described as a successful rescue technique after revascularization failure by conventional techniques for coronary chronic total occlusion (CTO).

Methods

The current study enrolled patients with CTO who underwent successful revascularization by the mini-STAR technique as a bailout strategy. Two-year clinical follow-up and angiographic control procedures were performed.

Results

From March 2009-September 2011, 100 of 117 patients (mean age, 61.4 ± 10.9 years) underwent successful recanalization of CTO by the mini-STAR technique as a bailout strategy. Drug-eluting stents (DESs) were implanted in all cases. At 2-year follow-up, the major adverse cardiac events (MACE)-free survival was 89.2%, with a target lesion revascularization (TLR) rate of 6.5%. Angiographic follow-up was performed in 72% of patients. CTO target lesion restenosis was observed in 25% of patients, whereas the reocclusion rate was 12.5%. At multivariate Cox analysis, final thrombolysis in myocardial infarction (TIMI) flow < grade 3 was related to occurrence of MACE (hazard ratio, 5.9; 95% confidence interval [CI], 1.4-24.4; P = 0.013). Final TIMI flow < grade 3 (odds ratio [OR], 5.41; 95% CI, 1.05-27.73; P = 0.043) and CTO stent length (OR, 0.96; 95% CI, 0.93-0.99; P = 0.017) were independent predictors of reocclusion. The independent variables related to restenosis were first-generation DESs (OR, 4.10; 95% CI, 1.23-13.64; P = 0.022) and CTO stent length (OR, 0.97; 95% CI, 0.95-0.99; P = 0.027).

Conclusions

As bailout strategy for CTO revascularization, the mini-STAR technique shows low MACE and TLR rates at long-term follow-up.     

Association Between Drug-Eluting Stent Type and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention

Background

The comparative efficacy of first- vs second-generation drug-eluting stents (DESs) in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) is unknown.

Methods

A retrospective analysis of consecutive patients undergoing PCI at a tertiary PCI center from 2007-2011 was performed, with linkage to administrative databases for long-term outcomes. CKD was defined as creatinine clearance (CrCl) < 60 mL/min. Propensity matching by multivariable scoring method and Kaplan-Meier analyses were performed.

Results

Of 6481 patients with available CrCl values undergoing a first PCI during the study period, 1658 (25%) had CKD. First- and second-generation DESs were implanted in 320 (19.3%) and 128 (7.7%) patients with CKD, respectively. At 2 years, no significant differences were observed between first-generation (n = 126) and second-generation (n = 126) propensity-matched DES cohorts for the outcomes of death (19% vs 16%; P = 0.51), repeat revascularization (10% vs 10%; P = 1.00), and major adverse cardiovascular and cerebrovascular events (MACCE) (36% vs 37%; P = 0.90). The 2-year Kaplan-Meier survival was also similar (P = 0.77). In patients with CKD, second-generation DES type was not an independent predictor for death (P = 0.49) or MACCE (P = 1.00).

Conclusions

Although the use of first- and second-generation DESs was associated with similar 2-year safety and efficacy in patients with CKD, our results cannot rule out a beneficial effect of second- vs first-generation DESs owing to small sample size. Future studies with larger numbers of patients with CKD are needed to identify optimal stent types, which may improve long-term clinical outcomes.     

Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

Background

The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy and safety profile of polymer-free vs. durable polymer DES by a comprehensive meta-analysis of RCTs.

Methods

MEDLINE, Google Scholar, EMBASE and Cochrane databases were searched for RCTs comparing polymer-free to durable polymer DES. Safety endpoints at short-term (≤1 year) and long-term follow-up (>1-year) were: death, myocardial infarction (MI) and stent thrombosis (ST); main efficacy endpoints were: target lesion revascularization (TLR) and target vessel revascularization (TVR).

Results

Eight RCTs including 6178 patients were included. No significant differences in mortality were observed between polymer-free and durable polymer DESs at both short- and long-follow up (OR [95% CI] = 0.79 [0.58–1.08], p = 0.14; and 0.80 [0.58–1.10], p = 0.17 respectively); polymer free and durable polymer DESs provided comparable short and long-term MI rates; at short-term: OR [95% CI] = 1.13 [0.83–1.54], p = 0.44 and at long-term: OR [95% CI] = 1.27 [0.87–1.85], p = 0.22. Similarly, these two different devices proved equally effective in regards to ST, TLR and TVR over the short and long follow-up period.

Conclusions

Polymer-free DESs are as safe and effective as durable polymer DES; however, there is no evidence of any additional benefits provided by this new technology.     

Meta-analysis of long-term outcomes of drug-eluting stent implantations for chronic total coronary occlusions

Background

In the treatment of chronic total occlusions (CTOs), some uncertainty exists regarding the effect of drug-eluting stents (DESs) compared with the effects of bare mental stents (BMSs). We reviewed outcomes of DES vs. BMS implantation for CTO lesions, to evaluate the risk-benefit ratio of DES implantation.

Methods

Relevant studies of long-term clinical outcomes or angiographic outcomes of both BMS and DES implantation were examined. The primary endpoint comprised major adverse cardiovascular events (MACEs), including all-cause deaths, myocardial infarctions (MIs), and target lesion revascularizations (TLRs). A fixed-effect model and random-effect model were used to analyze the pooling results.

Results

Ten studies were included according to the selection criteria. Eight were nonrandomized controlled trials, and two consisted of a randomized controlled comparison between DES and BMS implantation. No significant difference was evident for in-hospital MACE rates between the two groups (odds ratio [OR], 1.07; 95% confidence interval [CI], .53 to 2.13), but the long-term MACE rates in the DES group were significantly lower than in the BMS group (OR, .22; 95% CI, .13 to .38; P < .00001). The rates of stent restenosis and reocclusions were also significantly lower in the DES group (OR, .14; 95% CI, .09 to .20; and OR, .23; 95% CI, .12 to .41, respectively).

Conclusion

Implantation of the DES improves long-term angiographic and clinical outcomes compared with BMS in the treatment of CTO lesions.     

Stent thrombosis is not increased following percutaneous coronary intervention in patients with non-insulin dependent diabetes mellitus taking metformin

Objective

Recent studies have suggested that metformin may inhibit endothelialization following limus-eluting stent (LES) placement and may increase the risk of stent thrombosis. Therefore, we assessed the impact of metformin on stent thrombosis and major adverse cardiovascular events (MACE) in non-insulin-dependent diabetes mellitus (NIDDM) patients who receive drug-eluting stents (DES).

Methods

We assessed the impact of metformin and stent type on stent thrombosis, MACE, and death in NIDDM patients following DES placement. Of the 1201 patients included, 74.8% received LES, 25.2% received paclitaxel-eluting stents (PES), and 55% were taking metformin.

Results

There was no difference in stent thrombosis, regardless of stent type or metformin use. While Kaplan–Meier curves demonstrated reduced MACE (p = 0.007) and death (p = 0.006) with metformin use, multivariate analysis demonstrated that stent type and metformin use were not associated with outcome.

Conclusion

In NIDDM patients, metformin use or stent type following DES placement did not increase stent thrombosis and MACE rates.     

Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS)

Background

This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST is a rare, but potential life threatening event after coronary stent implantation. The etiology seems to be multifactorial.

Methods

124 patients with definite ST were assessed by IVUS during the acute ST event. The study was conducted in 15 high-volume percutaneous coronary intervention -centers in the Nordic–Baltic countries.

Results

In early or late ST there were no differences in ISA between DES and BMS. In very late ST, ISA was a more frequent finding in DES than in BMS (52% vs.16%; p = 0.005) and the maximum ISA area was larger in DES compared to BMS (1.1 ± 2.3 mm² vs. 0.1 ± 0.5 mm²; p = 0.004). Further, ISA was more prevalent in sirolimus-eluting than in paclitaxel-eluting stents (58% vs. 37%; p = 0.02). Stent fractures were found both in DES (16%) and BMS (24%); p = 0.28, and not related to time of stent thrombosis occurrence. For stents with nominal diameters ≥ 2.75 mm, 38% of the DES and 22% of the BMS had a minimum stent area of less than 5 mm²; p = 0.14.

Conclusions

Very late stent thrombosis was more prevalent and associated with more extensive ISA in DES than in BMS treated patients. Stent fracture was a common finding in ST after DES and BMS implantation.     

Long-term outcomes after percutaneous intervention of the internal thoracic artery anastomosis: the use of drug-eluting stents is associated with a higher need of repeat revascularization

Background

There is a lack of data and absence of clear recommendations regarding the optimal treatment of lesions located at the anastomosis of internal thoracic artery (ITA) grafts and native coronary arteries (CAs). The objective of this study was to assess the long-term outcomes of percutaneous coronary intervention (PCI) at the ITA anastomosis according to delivered treatment, namely deployment of a drug-eluting stent (DES), bare-metal stent (BMS), or balloon angioplasty only (POBA).

Methods

We used a prospective PCI registry at a large Canadian teaching hospital to identify all patients who underwent PCI at the ITA-CA anastomosis between June 2000 and June 2010. Our primary end point was repeat target lesion revascularization (TLR) at follow-up.

Results

Of the 53 patients included in the study (mean age 67.1 ± 10.7; 84.9% males), 45 (84.9%) underwent a successful PCI procedure. Of these, 23 patients (51.1%) received DES, 18 (40%) BMS, and 4 (8.9%) POBA. After a median follow-up of 29.2 months (interquartile range, 11.1-77.7 months), TLR was 47.8% with DES, 7.1% with BMS, and 50% with POBA (P = 0.032). Patients who underwent repeat revascularization were more likely to have longer stents than those who did not (18.2 mm vs 14.2 mm, P = 0.043).

Conclusions

Deployment of a DES for the treatment of ITA anastomotic lesions appears to be associated with a higher rate of repeat revascularization compared with BMS. Further studies will be necessary to evaluate if the present results might reflect different underlying pathophysiology in anastomotic and native coronary atherosclerotic lesions.     

One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: Results from the DiabEtic Argentina Registry (DEAR)

AimsPercutaneous coronary interventions (PCI) in patients with diabetes mellitus (DM) are associated with a high incidence of coronary restenosis, myocardial infarction (MI) and death. This study was to assess the potential role of a paclitaxel-eluting balloon (PEB) treatment in patients with DM with coronary lesions compared to those treated either with bare-metal stents (BMS) or drug-eluting stents (DES).Methods and ResultsThe Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomised, open-label study that enrolled 92 patients with diabetes mellitus in three centers from Buenos Aires, Argentina, between April 2009 and March 2011, to be treated with PEB. Results were compared with previous outcome data in all patients with DM treated with DES (n = 129 pts) or BMS (n = 96 pts) in clinical studies conducted at our institutions. At one-year follow-up, patients with DM who received PEB followed by BMS implantation (96%) had a significantly lower incidence of major adverse cardiac events (MACE) compared to the BMS group (BMS 32.3%, PEB 13.2%; P = .003). The incidence of target-vessel failure (TVF) was 30.2% (BMS) and 11% (PEB) (P = .003), that of target-vessel revascularization (TVR) was 22.9% (BMS) and 8.3% (PEB) (P = .005) and the composite of death/MI occurred in 13.5% (BMS) and in 2.2% for PEB (P = .05). These positive results are persistent even after subgroups analysis. When comparing with previous DES patients, TVF was 18.6% in DES vs. 11.0% in PEB (P = .13), MACE was 18.6% in DES vs. 13.2% in PEB (P = .29), TVR rate was 14.0% in DES vs. 8.3% in PEB (P = .14) and the composite death/MI was 9.3% in DES vs. 4.4% in PEB (0.18)ConclusionsDiabetic patients treated with PEB followed by BMS resulted in a significantly better outcome than BMS alone and appeared to be comparable to DES treatment.     

Comparison between imported versus domestic drug‐eluting stents in China: A large single‐center data

Background

In recent years, most drug‐eluting stents (DESs) were domestically produced in China, but how domestic DESs perform compared to imported DESs was still unknown.

Methods

A total of 9011 consecutive cases with DESs implantation in a single center throughout 2013 were prospectively collected. Two‐year clinical outcomes were evaluated between patients implanted with imported and domestic DESs.

Results

During 2‐year follow‐up, the rates of all‐cause death, cardiac death, myocardial infarction, stroke, and stent thrombosis were not significantly different between two groups. However, the rate of revascularization was significantly higher in domestic DES group, shown as higher rates of overall revascularization, target vessel revascularization (TVR), and target lesion revascularization (TLR) (9.7% vs 6.4%, P < 0.001; 5.6% vs 3.2%, P < 0.001; 4.5% vs 2.2%, P < 0.001, respectively). Accordingly, major adverse cardiac events (MACE) rate was significantly higher in domestic DES group (12.1% vs 8.5%, P < 0.001). Multivariable Cox regression analysis indicated that domestic DES was an independent risk factor of MACE (HR [95%CI]: 1.22 [1.05‐1.41]), overall revascularization (HR [95%CI]: 1.29 [1.09‐1.53]), TVR (HR [95%CI]: 1.54 [1.22‐1.94]), and TLR (HR [95%CI]: 1.85 [1.41‐2.42]). After propensity score matching, the rates of overall revascularization, TVR, and TLR were still significantly higher in domestic DES group, and domestic DES was still predictive of overall revascularization, TVR, and TLR in multivariate Cox regression analysis.

Conclusions

Domestic DESs showed the same safety as imported DESs in this real‐world cohort. But, patients implanted with domestic DESs had a higher risk of revascularization than imported DESs.

     

Long-term clinical outcomes of drug-eluting stents vs. bare-metal stents in Chinese geriatric patients

Background & Objective Little is known about the relative efficacies of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in elderly patients. The objective of this study was to evaluate the clinical outcome for geriatric patients who received either DES or BMS. Methods From January 2002 to October 2005, 199 consecutive Chinese geriatric patients (≥ 75 years old) underwent PCI with coronary DES or BMS implantation at our institution. We analyzed the major clinical end points that included all-cause mortality, cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, and bleeding complications. Results The three-year cumulative rates of all-cause mortality, cardiovascular death, and myocardial infarction were significantly lower in the DES group (6.3%, 3.6%, 5.4%) compared with the BMS group (16.2%, 11.5%, 14.9%; P < 0.05). No significant differences were found in the three-year cumulative rate for target lesion revascularization (6.3% vs. 4.6%, P = 0.61) or stent thrombosis (3.6% vs. 2.3%, P = 0.70). Likewise, there were no statistically significant differences in the cumulative rate for intracranial hemorrhage, or major and minor hemorrhage at three years. Conclusions DES-based PCI was associated with a significant reduction in the three-year cumulative rate of all-cause mortality, cardiovascular death, and myocardial infarction compared with BMS, without increased risk of TLR, stent thrombosis, or bleeding complications at three years in this group of Chinese geriatric patients.     

Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.     

Safety and Effectiveness of Drug-Eluting Versus Bare-Metal Stents in Saphenous Vein Bypass Graft Percutaneous Coronary Interventions : Insights From the Veterans Affairs CART Program

Background

Stenosis of saphenous vein grafts (SVGs) after coronary artery bypass grafting (CABG) is common and often requires percutaneous coronary interventions (PCI) for treatment. However, data for the effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) in SVG-PCI are unclear.

Objectives

This study sought to examine the association between DES versus BMS used during SVG PCI and clinical outcomes in the national Veterans Affairs integrated healthcare system.

Methods

We studied a national cohort of 2,471 post-CABG veterans undergoing SVG-PCI between 2008 and 2011 at all Veterans Affairs hospitals and compared clinical outcomes of between those receiving DES and BMS. Clinical outcomes included procedural complications, myocardial infarction (MI), and all-cause mortality. Comparisons were made in a propensity-matched cohort using Cox proportional hazards regression models.

Results

DES were used in 1,549 SVG-PCI patients (63%) and the use of DES increased progressively with each calendar year (50% in 2008 to 69% in 2011). Incidence of procedural complications was low and comparable in both groups (2.8% among BMS vs. 2.3% among DES patients; p = 0.54). During long-term (>2 years) follow-up, use of DES was associated with lower mortality than BMS (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.57 to 0.89) and similar rates of MI (HR: 0.94; 95% CI: 0.71 to 1.24) in the propensity-matched cohort.

Conclusions

In a national cohort of veterans, we observed widespread and increasing use of DES during SVG-PCI. In long-term follow-up, compared with BMS, DES use was safe and effective in SVG-PCI patients.     

Stent Thrombosis in New-Generation Drug-Eluting Stents in Patients With STEMI Undergoing Primary PCI : A Report From SCAAR

Background

Some concerns still have not been resolved about the long-term safety of drug-eluting stents (DES) in patients with acute STEMI.

Objectives

The aim of this study was to evaluate the stent thrombosis (ST) rate up to 3 years in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (n-DES) compared with bare-metal stents (BMS) and old-generation drug-eluting stents (o-DES) enrolled in the SCAAR (Swedish Coronary Angiography and Angioplasty Registry).

Methods

From January 2007 to January 2013, 34,147 patients with STEMI were treated by PCI with n-DES (n = 4,811), o-DES (n = 4,271), or BMS (n = 25,065). The risks of early/late (up to 1 year) and very late definite ST (after 1 year) were estimated.

Results

Cox regression landmark analysis showed a significantly lower risk of early/late ST in patients treated with n-DES (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.43 to 0.99; p = 0.04) and o-DES (HR: 0.60; 95% CI: 0.41 to 0.89; p = 0.01) compared with the BMS group. The risk of very late ST was similar between the n-DES and BMS groups (HR: 1.52; 95% CI: 0.78 to 2.98; p = 0.21), whereas a higher risk of very late ST was observed with o-DES compared with BMS (HR: 2.88; 95% CI: 1.70 to 4.89; p < 0.01).

Conclusions

Patients treated with n-DES have a lower risk of early/late ST than patients treated with BMS. The risk of very late ST is low and comparable between n-DES and BMS up to 3 years of follow-up, whereas o-DES treatment is associated with an increased risk of very late ST. The current STEMI guidelines might require an update in light of the results of this and other recent studies.     

Long‐Term Clinical Follow‐Up after Drug‐Eluting Stent Implantation for Bare Metal In‐Stent Restenosis

Objectives

We aimed to evaluate the long‐term safety and efficacy of drug‐eluting stent (DES) implantation in the treatment of diffuse bare metal stent (BMS) restenosis as compared to the treatment of de novo coronary lesions in high restenosis risk patient population.

Background

To date limited long‐term data are available about the treatment of BMS restenosis with DES.

Methods

Five hundred and fourteen consecutive patients who underwent DES implantation between January 2003 and October 2006 at our institute were studied: 201 patients received DES for treatment of BMS restenosis and 313 patients received DES for high restenosis risk de novo lesions. Outcomes were calculated using propensity score adjustment. Mean follow‐up length was 45.6 ± 21.5 months.

Results

The rates of acute coronary syndrome, three‐vessel disease, and diabetes were high in both restenosis and de novo groups: 44.8% versus 46.3%, 20.9% versus 28.7%, and 34.3% versus 38.9%, respectively. The incidence of ischemia‐driven target lesion revascularization (TLR) yielded similar results in the restenosis group and de novo group at 4 years (10.4% vs 12.4%, P = 0.490). All‐cause mortality was lower in the restenosis group at 4 years (7.4% vs 14.7%, P = 0.032); however, the incidence of definite and probable stent thrombosis did not differ (1.9% vs 1.6%, P = 0.708) between the 2 groups.

Conclusions

DESs are safe in the treatment of diffuse BMS restenosis and the rate of additional TLR is acceptable as compared to the use of DES in de novo lesions. (J Interven Cardiol 2013;26:271–277)

     

Long-Term Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusion in Patients Who Have Undergone Coronary Artery Bypass Grafting vs Those Who Have Not

Background

We aimed to investigate the procedural and long-term outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in patients who had undergone previous coronary artery bypass grafting (CABG) vs those who had not, and to evaluate the role of the Registry of CrossBoss and Hybrid procedures in France, the Netherlands, Belgium, and United Kingdom (RECHARGE) score in predicting acute and long-term outcomes.

Difference in Clinical Target Lesion Revascularization Between a Silicon Carbide-Coated and an Uncoated Thin Strut Bare-Metal Stent: The PRO-Vision Study

Background

Bare-metal stents trigger a foreign body reaction, resulting in neointima formation and restenosis. Silicon carbide (SiC) coating shields the metal from circulating blood and vessel wall, both potential sources of neointima smooth muscle cells.

Methods

We investigated whether SiC-coated stents (PRO-Kinetic) have lower clinical target lesion revascularization (TLR) rates than do uncoated bare-metal stents (Vision). Stents were implanted in 2731 patients during 2 consecutive 18-month periods. Clinical TLR was evaluated at 1 year.

Results

In the PRO-Kinetic group, TLR was significantly higher (9.0% vs 5.6%; unadjusted odds ratio, 1.61; 95% confidence interval [CI], 1.24-2.08; P < 0.001) compared with the Vision group. After adjustment for postintervention minimal luminal diameter (adjusted odds ratio [AOR], 0.56; 95% CI, 0.42-0.73), total implanted stent length (AOR, 1.01; 95% CI, 1.00-1.02), non–ST-segment elevation myocardial infarction or unstable angina at initial presentation (AOR, 1.89; 95% CI, 1.41-2.54), and triple vessel stenting (AOR, 2.68; 95% CI, 1.02-7.05), the use of PRO-Kinetic stents remained an independent predictor for revascularization (AOR, 1.57; 95% CI, 1.18-2.10; P = 0.002). Because strut thickness is lower in 2.0- to 3.0-mm PRO-Kinetic stents, a subgroup analysis (n = 2382 lesions) was performed. Even in this subgroup, PRO-Kinetic implantation proved an independent predictor of TLR (AOR, 1.62; 95% CI, 1.17-2.23; P = 0.003).

Conclusion

In contrast to theoretical expectations, the SiC-coated PRO-Kinetic stent was associated with greater target lesion revascularization rates at 1 year compared with the uncoated Vision stent.     

Long-term outcomes of patients receiving zotarolimus-eluting stents in ST elevation myocardial infarction,non-ST elevation acute coronary syndrome,and stable angina: Data from the Resolute program

Background

Outcome data are limited in patients with ST-segment elevation acute myocardial infarction (STEMI) or other acute coronary syndromes (ACSs) who receive a drug-eluting stent (DES). Data suggest that first generation DES is associated with an increased risk of stent thrombosis when used in STEMI. Whether this observation persists with newer generation DES is unknown. The study objective was to analyze the two-year safety and effectiveness of Resolute™ zotarolimus-eluting stents (R-ZESs) implanted for STEMI, ACS without ST segment elevation (non-STEACS), and stable angina (SA).

Methods

Data from the Resolute program (Resolute All Comers and Resolute International) were pooled and patients with R-ZES implantation were categorized by indication: STEMI (n = 335), non-STEACS (n = 1416), and SA (n = 1260).

Results

Mean age was 59.8 ± 11.3 years (STEMI), 63.8 ± 11.6 (non-STEACS), and 64.9 ± 10.1 (SA). Fewer STEMI patients had diabetes (19.1% vs. 28.5% vs. 29.2%; P < 0.001), prior MI (11.3% vs. 27.2% vs. 29.4%; P < 0.001), or previous revascularization (11.3% vs. 27.9% vs. 37.6%; P < 0.001). Two-year definite/probable stent thrombosis occurred in 2.4% (STEMI), 1.2% (non-STEACS) and 1.1% (SA) of patients with late/very late stent thrombosis (days 31–720) rates of 0.6% (STEMI and non-STEACS) and 0.4% (SA) (P = NS). The two-year mortality rate was 2.1% (STEMI), 4.8% (non-STEACS) and 3.7% (SA) (P = NS). Death or target vessel re-infarction occurred in 3.9% (STEMI), 8.7% (non-STEACS) and 7.3% (SA) (P = 0.012).

Conclusion

R-ZES in STEMI and in other clinical presentations is effective and safe. Long term outcomes are favorable with an extremely rare incidence of late and very late stent thrombosis following R-ZES implantation across indications.     

The Effect of Percutaneous Coronary Intervention of Chronically Totally Occluded Coronary Arteries on Left Ventricular Global and Regional Systolic Function

Background

Percutaneous coronary intervention (PCI) is frequently attempted to open chronic total occlusions (CTOs) and restore epicardial coronary flow. Data suggest adverse outcomes in the case of PCI failure. We hypothesized that failure to open a CTO might adversely affect regional cardiac function and promote deleterious cardiac remodelling, and success would improve global and regional cardiac function assessed using cardiac magnetic resonance and velocity vector imaging.

Methods

Thirty patients referred for PCI to a CTO underwent cardiac magnetic resonance examination before and after the procedure. Left ventricular function and transmural extent of infarction was assessed in these patients. Regional cardiac function using Velocity Vector Imaging version 3.0.0 (Siemens) was assessed in 20 patients.

Results

Successful CTO opening (thrombolysis in myocardial infarction 3 flow) occurred in 63% of patients. Left ventricular ejection fraction significantly increased after successful PCI (50 ± 13% to 54 ± 11%; P < 0.01). Global longitudinal strain (GLS) fell significantly in the failed group (Δ = −25 ± 17%; P = 0.02) in contrast with successful PCI in which GLS did not change (Δ 20 ± 32%; P = 0.17). GLS rate followed a pattern similar to GLS (failed, Δ −30 ± 17%; P < 0.01 vs success Δ 25 ± 48%; P = 0.34). In contrast, radial and circumferential strain/strain rate were not different between groups after success/failed PCI.

Conclusions

Regional cardiac function assessment using velocity vector imaging showed a significant decline in GLS and GLS rate in patients in whom PCI failed to open a CTO, with no change in global measures of cardiac function.     

Long-term outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries

Background

Long-term (> 3 years) outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries were not conclusive. In addition, large coronary vessels were defined using a wide size range (≥ 3.0 mm) in previous studies. The aim of this study was to assess the long-term efficacy of DES versus BMS in subgroups of different vessel sizes.

Methods

A total of 1096 patients (1342 lesions) who underwent either DES or BMS implantation in large coronary vessels was followed for a mean duration of 4.5 years. Patients were divided into 4 subgroups by the reference vessel diameters (Q1: 3.0–3.25 mm, Q2: 3.26–3.50 mm, Q3: 3.51–3.75 mm, and Q4: 3.76–4.50 mm). The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. The propensity score-adjusted Cox regression method was applied.

Results

In the 3 subgroups with smaller vessel sizes, the adjusted risk of MACE in DES recipients was reduced by 82% in Q1 (hazard ratio [HR]: 0.18, 95% confidence interval [CI]: 0.09–0.38), 49% in Q2 (HR: 0.51, 95% CI: 0.26–0.98), and 67% in Q3 (HR: 0.33, 95% CI: 0.15–0.73). However, in the largest vessel subgroup (> 3.75 mm), all clinical outcomes were not significantly different irrespective of the stent type used.

Conclusions

The incidence of MACE in 3.0–3.75 mm vessels was significantly reduced by the use of DES than by the use of BMS during a long-term follow-up. However, DES lost its benefit in > 3.75 mm vessels.     

Long-term outcomes of biodegradable polymer versus durable polymer drug-eluting stents in patients with diabetes a pooled analysis of individual patient data from 3 randomized trials

Background

There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).

Methods

We pooled individual patient-level data from 3 randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4 and LEADERS) comparing biodegradable polymer DES with durable polymer SES. Clinical outcomes out to 4 years were assessed. The primary end point was the composite of cardiac death, myocardial infarction and target-lesion revascularization. Secondary end points were target lesion revascularization and definite or probable stent thrombosis.

Results

Of 1094 patients with diabetes included in the present analysis, 657 received biodegradable polymer DES and 437 durable polymer SES. At 4 years, the incidence of the primary end point was similar with BP-DES versus SES (hazard ratio = 0.95, 95% CI = 0.74–1.21, P = 0.67). Target lesion revascularization was also comparable between the groups (hazard ratio = 0.89, 95% CI = 0.65–1.22, P = 0.47). Definite or probable stent thrombosis was significantly reduced among patients treated with BP-DES (hazard ratio = 0.52, 95% CI = 0.28–0.96, P = 0.04), a difference driven by significantly lower stent thrombosis rates with BP-DES between 1 and 4 years (hazard ratio = 0.15, 95% CI = 0.03–0.70, P = 0.02).

Conclusions

In patients with diabetes, biodegradable polymer DES, compared to durable polymer SES, were associated with comparable overall clinical outcomes during follow-up to 4 years. Rates of stent thrombosis were significantly lower with BP-DES.