4-year Clinical Outcomes Research Articles

Laparoscopic resection for low rectal cancer: evaluation of oncological efficacy

Laparoscopic resection of low rectal cancer poses significant technical difficulties for the surgeon. There is a lack of published follow-up data in relation to the surgical, oncological and survival outcomes in these patients. The aim of this study is to evaluate the surgical, oncological and survival outcomes in all patients undergoing laparoscopic resection for low rectal cancer. Consecutive patients undergoing laparoscopic resection for low rectal cancers were included in the study. Clinical, pathological and follow-up data were recorded over a 4-year period. The mean follow-up was 25months A total of 53 patients were included in the study, 30 of whom were males. The mean age was 64.14years (range, 34-86years). The mean hospital stay was 8.2days (range, 4-42days). Fifty were completed laparoscopically and three were converted to an open procedure. Thirty-eight were anterior resections and 15 were abdominoperineal resections. Twenty-four patients received neoadjuvant chemoradiotherapy. The total mesorectal excision was optimal in 51 (98%) cases. There were no anastomotic sequelae and no surgical mortality. There was no local recurrence detected. The overall survival (mean follow-up, 25months) was 93.5%. Laparoscopic resection for low rectal cancers permits optimum oncological control. In our series, this technical approach is associated with excellent 4-year survival and clinical outcomes.

Four‐year clinical follow‐up of the XIENCE V everolimus‐eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT II trial

This report describes the 4-year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus-eluting stent (EES), or the TAXUS paclitaxel-eluting stent. At 4-year clinical follow-up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia-driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (EES 7.7% vs. paclitaxel-eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4-year follow-up, which is consistent with results from earlier follow-up.

Four‐year clinical outcome of sirolimus‐ and paclitaxel‐eluting stents compared to bare‐metal stents for the percutaneous treatment of stable coronary artery disease

There are limited data on the long-term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). We aimed to assess the 4-year clinical outcome in patients who received a bare-metal stent (BMS), sirolimus-eluting stent (SES), or a paclitaxel-eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000-2005. In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI-cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). At 4 years follow-up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47-0.81; HR = 0.67, 95% CI: 0.55-0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target-vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37-0.75; HR = 0.71, 95% CI: 0.62-0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow-up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI.

Costs and outcomes of noncardioembolic ischemic stroke in a managed care population

PurposeTo evaluate the clinical outcomes and incremental health care costs of ischemic stroke in a US managed care population.Patients and methodsA retrospective cohort analysis was done on patients (aged 18+ years) hospitalized with noncardioembolic ischemic stroke from January 1, 2002, through December 31, 2003, identified from commercial health plan administrative claims. New or recurrent stroke was based on history in the previous 12 months, with index date defined as first date of indication of stroke. A control group without stroke or transient ischemic attack (TIA) was matched (1:3) on age, sex, and geographic region, with an index date defined as the first medical claim during the patient identification period. Patients with atrial fibrillation or mitral value abnormalities were excluded. Ischemic stroke and control cohorts were compared on 4-year clinical outcomes and 1-year costs.ResultsOf 2180 ischemic stroke patients, 1808 (82.9%) had new stroke and 372 (17.1%) had a recurrent stroke. Stroke patients had higher unadjusted rates of additional stroke, TIA, and fatal outcomes compared with the 6540 matched controls. Recurrent stroke patients had higher rates of adverse clinical outcomes compared with new stroke patients; costs attributed to recurrent stroke were also higher. Stroke patients were 2.4 times more likely to be hospitalized in follow-up compared with controls (hazard ratio [HR] 2.4, 95% confidence interval [CI]: 2.2, 2.6). Occurrence of stroke following discharge was 21 times more likely among patients with index stroke compared with controls (HR 21.0, 95% CI: 16.1, 27.3). Stroke was also predictive of death (HR 1.8, 95% CI: 1.3, 2.5). Controlling for covariates, stroke patients had significantly higher costs compared with control patients in the year following the index event.ConclusionNoncardioembolic ischemic stroke patients had significantly poorer outcomes and higher costs compared with controls. Recurrent stroke appears to contribute substantially to these higher rates of adverse outcomes and costs.

TCT-559: A 4-Year Clinical Outcome after Implantation of Titanium-nitride-oxide-coated Stents and Paclitaxel-eluting Stents in an Unselected Population

TCT-559: A 4-Year Clinical Outcome after Implantation of Titanium-nitride-oxide-coated Stents and Paclitaxel-eluting Stents in an Unselected Population

TCT-361: Selective Use of Drug-Eluting Stent In High Risk Versus Bare Metal Stent in Low Risk Patients According to Predefined Clinical Score Confers Similar 4-Year Long-Term Clinical Outcomes

TCT-361: Selective Use of Drug-Eluting Stent In High Risk Versus Bare Metal Stent in Low Risk Patients According to Predefined Clinical Score Confers Similar 4-Year Long-Term Clinical Outcomes

Surgical regenerative treatment of peri‐implantitis lesions using a nanocrystalline hydroxyapatite or a natural bone mineral in combination with a collagen membrane: a four‐year clinical follow‐up report

The present case series aimed at investigating the 4-year clinical outcomes following surgical regenerative therapy of peri-implantitis lesions using either a nanocrystalline hydroxyapatite (NHA) or a natural bone mineral in combination with a collagen membrane (NBM+CM). Twenty patients suffering from moderate peri-implantitis (n=20 intrabony defects) were randomly treated with (1) access flap surgery (AFS) and the application of NHA (n=9), or with AFS and the application of NBM+CM (n=11). Clinical and radiographic (R) parameters were recorded at baseline (R) and after 36 and 48 (R) months of non-submerged healing. One patient from the NBM+CM group was discontinued from the study due to severe pus formation at 36 months. Compared with NHA, the application of NBM+CM resulted in higher mean PD reductions (NBM+CM: 2.5 +/- 0.9 mm versus NHA: 1.1 +/- 0.3 mm) and clinical attachment-level gains (NBM+CM: 2.0 +/- 1.0 mm versus NHA: 0.6 +/- 0.5 mm) at 48 months. A radiographic bone fill was observed for five sites in the NHA group, and eight sites in the NBM+CM group. While the application of NBM+CM resulted in clinical improvements over a period of 4 years, the long-term outcome obtained with NHA without barrier membrane must be considered as poor.

Sustained benefit over four years from an initial combined antiplatelet regimen after coronary stent placement in the ISAR trial

Combined antiplatelet therapy after coronary stent placement is superior to anticoagulation with respect to early outcome. It is unclear if this benefit is maintained during long-term follow-up. This study reports on the 4-year clinical outcome of patients randomized in the Intracoronary Stenting and Antithrombotic Regimen trial. In the Intracoronary Stenting and Antithrombotic Regimen trial, 517 patients were randomized after successful placement of Palmaz-Schatz stents: 257 to aspirin and ticlopidine, and 260 to aspirin and phenprocoumon. Ticlopidine and phenprocoumon were given for 4 weeks. At 30 days, patients with ticlopidine had significantly fewer adverse cardiac events (1.6% vs 6.2%; p = 0.007), nonfatal myocardial infarction (0.8% vs 3.5%; p = 0.034), and target vessel revascularization procedures (1.2% vs 5.4%; p = 0.007). At 4 years, rates for any adverse cardiac events were 22.6% versus 28.5% (p = 0.078), for nonfatal myocardial infarction 0.9% versus 5.8% (p = 0.003), and for target vessel revascularization 18.3% versus 22.7% (p = 0.21). The absolute difference in event rates (4.6% after 30 days) was maintained after 4 years (5.9%). Event rates beyond day 30 were not significantly different (21.1% vs 22.5%; p = 0.78), nor were the rates beyond the first year, which were very low (5.2% vs 3.6%; p = 0.50). This study shows that the benefit of combined antiplatelet therapy evident after 30 days is maintained after 4 years. Independent of the initial regimen, rates of adverse cardiac events are low beyond the first year.