Impact of overlapping drug-eluting stents in patients undergoing percutaneous coronary intervention.

BACKGROUND: Sirolimus-eluting stent (SES) implantation for the treatment of single coronary lesions is proven to be effective and durable. However, the safety and efficacy of overlapping SES for the treatment of long lesions have not been well established. Objectives: We conducted a retrospective analysis to compare the clinical outcomes of overlapping versus nonoverlapping SES. METHODS: Fifty-five patients who received overlapping SES were compared with 39 patients who received nonoverlapping SES. RESULTS: The baseline clinical and angiographic characteristics were balanced between the two study groups. The in-hospital complications were similar between groups, except that non-Q-wave myocardial infarction was significantly higher in the Overlapping SES group when compared with the Nonoverlapping SES group (23.6% vs. 7.7%, P = 0.04). This higher rate of myonecrosis is due to periprocedural side branch compromises, including side branch narrowing, occlusion, and flow reduction. At 30 days and 6 months follow-up, all clinical outcomes were similar between the study groups. In addition, the event-free survival rate was similar between groups (P = 0.87). CONCLUSIONS: The implantation of overlapping SES for the treatment of long, native coronary lesions is feasible and effective but is associated with an increased rate of periprocedural myonecrosis. This phenomenon is caused primarily by side branch compromises, but does not have any adverse impact on late clinical events.     

Impact of sirolimus-eluting stents on outcomes of patients treated for acute myocardial infarction by primary angioplasty.

Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization.     

Impact of renal insufficiency on clinical and angiographic outcomes following percutaneous coronary intervention with sirolimus-eluting stents.

BACKGROUND: Sirolimus-eluting stents (SES) have been demonstrated to reduce restenosis. However, there have been few studies evaluating the impact of renal insufficiency on the angiographic as well as clinical outcomes after SES implantation. METHODS: This study was composed of 304 consecutive patients having 361 lesions who underwent percutaneous coronary intervention with SES. The patients were divided into 3 groups according to renal function (group 1 [n = 204]; creatinine clearance (Ccr) > or = 60 ml/min, group 2 [n = 69]; Ccr < 60 ml/min, group 3 [n = 31]; hemodialysis). Clinical and angiographic follow-up were evaluated at 8 months. RESULTS: Clinical follow-up was obtained in all patients and angiographic follow-up was obtained in 283 patients (93.1%). Patients in group 3 showed a higher incidence of previous coronary artery bypass graft surgery, and there were more female gender, hypertensive, and less hyperlipidemia in this group. Late lumen loss at 8 months was significantly different among the 3 groups (group 1; 0.16 +/- 0.46 mm, group 2; 0.44 +/- 0.62 mm, group 3; 0.81 +/- 0.88 mm, P < 0.0001). Major adverse cardiac events (MACE) were documented in 22 patients (10.8%) in group 1, 13 patients (18.8%) in group 2, and 12 patients (38.7%) in group 3, respectively (P = 0.0002). CONCLUSION: Neointimal growth following SES implantation is more pronounced in patients with renal insufficiency, especially those undergoing dialysis, compared with patients with normal renal function. Regardless of the beneficial effect of SES, the increased risk of MACE mainly due to high incidence of target vessel revascularization in the subgroup of patients with renal insufficiency should be taken into account.     

Outcomes of nonagenarians who undergo percutaneous coronary intervention with drug‐eluting stents

Background : Age is an important predictor of mortality after percutaneous coronary intervention (PCI). The safety and efficacy of PCI with drug‐eluting stents (DES) in nonagenarians have not been extensively studied. Methods : A retrospective analysis of 889 consecutive patients identified 28 (3.1%) nonagenarians who underwent PCI with DES from May 2003 to December 2005 at our institution. Results : The mean age was 92 ± 2 years, 39% were male, and 4% were diabetic. Sirolimus‐eluting stents were used in 79%. A mean of 1.5 ± 0.9 stents/patient were implanted with a total stent length of 31 ± 20 mm. Twenty‐nine percent presented with unstable angina and 39% with myocardial infarction. The angiographic success rate obtained was 100%. The 30‐day mortality rate was 21%. The 6 patients who died within 30 days included 3 patients who had cardiogenic shock and one patient with critical aortic stenosis who died due to complications during percutaneous aortic valvuloplasty. The cumulative survival rate for all nonagenarians at 1 year and 3 years was (68 ± 9)% and (61 ± 9)%. When the four patients who were in extremis on presentation were excluded, there were no in‐hospital deaths, the 30‐day mortality was 8%, and the 1 year and 3 year survival rate was (79 ± 8)% and (71 ± 9)% for the nonagenarians. No patient had definite stent thrombosis. Conclusions : The majority of the nonagenarians who underwent PCI with DES presented with acute coronary syndrome. Percutaneous coronary intervention with DES was safe in nonagenarians as there were no in‐hospital deaths and acceptable 3‐year survival rates when patients who were in extremis on presentation were excluded. The high‐risk profile of these patients and the expected attrition of nonagenarians may contribute to their mortality rates. © 2008 Wiley‐Liss, Inc.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

Objectives: We aim to explore the clinical outcome of drug‐eluting stents (DES) versus bare‐metal stents (BMS) implantation in diabetics versus nondiabetic patients. Background: Diabetic patients sustain worse long‐term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long‐term clinical benefits, such as myocardial infarction (MI) or mortality is scant. Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major‐adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42–0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55–0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56–0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69–1.13, P = 0.3). Conclusions: In a “real‐world,” unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population. © 2011 Wiley‐Liss, Inc.     

Percutaneous coronary intervention with drug-eluting stents in octogenarians: characteristics, clinical presentation, and outcomes.

OBJECTIVES: We aimed to compare clinical outcomes of octogenarians > or =80 years of age after coronary drug-eluting stent (DES) implantation. BACKGROUND: Although octogenarians constitute a fast-growing portion of cardiovascular patients, they are not adequately represented in current clinical revascularization trials. METHODS: We analyzed the data of 3,166 consecutive patients who underwent percutaneous coronary intervention (PCI) and DES implantation since March 2003. Periprocedural events, 1- and 6-month clinical outcomes were compared between octogenarians (n = 339) and patients <80 years of age (n = 2,827). RESULTS: Baseline characteristics revealed a higher prevalence of females (P < 0.001), Caucasians (P = 0.004), chronic renal failure (P < 0.001), heart failure (P < 0.001), number of diseased vessels (P = 0.009), and lower ejection fraction (P = 0.03) in octogenarians. Patients <80 years showed more positive family history (P < 0.001), hyperlipidemia (P = 0.006), smoking (P < 0.001), and obesity (P < 0.001). Clinical presentation and procedural success were similar in both groups as were death, myocardial infarction (MI), and repeat revascularization in-hospital. At 6 months, restenosis rates were low and comparable. In the subgroup of octogenarians who presented with acute coronary syndrome, mortality (15% vs. 3%, P < 0.001) and Q-wave MI occurred more often. Multivariate analysis revealed age >80 (P = 0.008), cardiogenic shock (P < 0.001), Q-wave MI at presentation (P = 0.003), and length of hospital stay (P = 0.003) to be independent predictors of mortality. CONCLUSIONS: PCI with DES in octogenarians results in a similar reduction of restenosis rates when compared to patients <80 years. Yet in octogenarians who presented with acute coronary syndrome, incidence of mortality and Q-wave MI at 6 months was higher as compared to younger patients.     

Use of sirolimus-eluting coronary stents in routine clinical practice.

Restenosis has long remained the major limitation of intracoronary stenting, but several randomized trials have recently shown that the use of drug-eluting stents appear to reduce markedly the risk of recurrence following treatment of de novo lesions. To evaluate whether the results of randomized trials can be generalized to routine clinical practice, all patients receiving at least one sirolimus-eluting stent (SES) in two Swiss hospitals were entered into a prospective registry. Only target vessels with a reference diameter > 3.5 mm were excluded. Clinical follow-up was obtained after 6 months. A total of 183 patients were included. The procedural success was 97.8% and the incidence of in-hospital MACE was 2.2%. At 7 +/- 2 months, 95.6% of the patients were event-free, and target lesion revascularization was required in only three patients (1.6%). The excellent medium-term results obtained with the SES in randomized trials can be replicated in routine clinical practice.     

Selective versus exclusive use of sirolimus-eluting stent implantation in multivessel coronary artery disease.

Sirolimus-eluting stents (SESs; Cypher) have demonstrated a significant reduction in restenosis rates when compared to bare metal stents (BMSs). The purpose of this study was to evaluate the strategy of exclusive use of two SESs versus the combination of one BMS and one SES for two-vessel coronary artery disease (CAD). It was found that the selective use of one SES combined with one BMS in patients undergoing percutaneous coronary intervention that requires more than one stent is safe, feasible, and associated with favorable procedural, 30-day, and 6-month clinical outcomes when compared to the exclusive use of SESs.     

Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: A randomized PIPA trial

Objectives : To compare the safety and efficacy of the new Coroflex? Please stents with conventional Taxus? Liberte stents in patients with coronary artery lesions. Background : The Coroflex? Please stent is a new version of paclitaxel‐eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first‐generation stents. However, it has not been directly compared with the early generation paclitaxel‐eluting stents in a multicenter, prospective, and randomized study. Methods : We randomly assigned 319 patients to receive Coroflex? Please stents (159 patients; 198 lesions) or Taxus? Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in‐segment late luminal loss at 9 months. Results : Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex? Please and Taxus? Liberte stents showed similar in‐segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in‐segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow‐up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target‐lesion revascularization (7.5% vs. 7.5%, P = 0.99). Conclusions : The Coroflex? Please stent resulted in similar angiographic and clinical outcomes as the Taxus? Liberte stent in patients with coronary artery lesions. © 2012 Wiley Periodicals, Inc.     

Cost‐effectiveness of percutaneous coronary intervention with cobalt‐chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta‐analysis of randomized trials

• The diagnosis, surveillance, and management of infrapopliteal critical limb ischemia remain inconsistent among clinicians.
• This study demonstrates that using an absolute ankle pressure of >73 mm Hg or an absolute toe pressure increase of 1 mm Hg or greater post endovascular intervention in patients with infrapopliteal critical limb ischemia may be predictive of a reduction in target limb revascularization, amputation, and death.
• This study highlights the need for vascular societies to come together to promote standardized screening, surveillance, and treatment paradigms for this complex population.

     

Randomized clinical trial of abluminus DES+ sirolimus-eluting stent versus everolimus-eluting DES for percutaneous coronary intervention in patients with diabetes mellitus: An optical coherence tomography study

Background

Diabetic patients are at higher risk of recurrent adverse events following percutaneous coronary intervention (PCI) than the nondiabetics. Despite the introduction of new generation drug-eluting stents, their efficacy in the diabetics is still limited.

Aims

To evaluate the efficacy of the Abluminus DES+ biodegradable polymer sirolimus-eluting stent in reducing neointimal hyperplasia in diabetic patients, compared to a durable polymer everolimus-eluting stent (DP-EES).

Methods

A total of 131 patients with diabetes and coronary artery disease were enrolled in six Italian centers and randomized in a 2:1 fashion to PCI with Abluminus DES+ or DP-EES: 85 were assigned to Abluminus DES+ and 46 to DP-EES. The primary endpoint was optimal coherence tomography (OCT)-derived neointimal volume at 9–12 months. Secondary endpoints included OCT-derived neointimal area, neointimal volume obstruction and adverse clinical events.

Results

The primary endpoint, neointimal volume, did not differ between Abluminus DES+ and DP-EES (29.11 ± 18.90 mm³ vs. 25.48 ± 17.04 mm³, p = 0.40) at 9–12-month follow-up. This finding remained consistent after weighing for the sum of stents lengths (1.14 ± 0.68 mm³ vs. 0.99 ± 0.74 mm³ for Abluminus DES+ and DP-EES, respectively, p = 0.38). Similarly, other OCT-derived and clinical secondary endpoints did not significantly differ between the two groups. Rate of target lesion failure was high in both groups (21.2% for Abluminus DES+ and 19.6% for DP-EES).

Conclusions

This preliminary study failed to demonstrate the superiority of the Abluminus DES+ over the DP-EES in diabetic patients in terms of neointimal proliferation.     

Two-year clinical outcome after coronary stenting of small vessels using 2.25-mm sirolimus- and paclitaxel-eluting stents: insight into the RESEARCH and T-SEARCH registries.

OBJECTIVES: To evaluate long-term outcomes after drug-eluting stents (DES) implantation in small coronary vessels. BACKGROUND: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been reported to improve both the angiographic and clinical outcomes compared with bare metal stents even in 'real world' settings. Currently, no data is available on long-term outcomes after DES implantation in small vessels. METHODS: Since April 2002, our institution has implanted DES, either SES or PES, as a default strategy in all patients irrespective of their clinical presentation. Between October 2002 and September 2003, 197 consecutive patients were enrolled: 107 consecutive patients received at least one 2.25-mm SES (SES group) and 90 consecutive patients received at least one 2.25-mm PES (PES group). RESULTS: The two cohorts presented with high-risk characteristics. At 2 years, the cumulative incidence of major adverse cardiac events (MACE) in the SES group was significantly lower than that in the PES group (10.3% vs. 23.3%, P=0.02). There were two subacute angiographic stent thromboses in the PES group and none in the SES group. By multivariate analysis, PES utilization (HR 2.37, 95% CI 1.07-5.26), presentation with acute coronary syndromes (ACS) (HR 3.34, 95% CI 1.44-7.70) and multi-vessel disease (MVD) (HR 3.91, 95% CI 1.27-12.0) were identified as independent predictors of MACE. CONCLUSIONS: In an unselected population treated for small vessel disease, SES were associated with significantly better 2-year clinical outcomes than PES. The use of PES and the presentation with ACS and MVD were identified as independent predictors of MACE.     

Late thrombosis of sirolimus-eluting stents following noncardiac surgery.

We describe two patients with in-stent thrombosis occurring 4 and 21 months after implantation of sirolimus-eluting stents. Both cases occurred following noncardiac surgery. In both cases, aspirin had been stopped prior to surgery. Both patient sustained a severe myocardial infarction; one died. The occurrence of late thrombosis of sirolimus-eluting stents is of concern.