Bioresorbable Scaffold vs. Second Generation Drug Eluting Stent in Long Coronary Lesions requiring Overlap: A Propensity-Matched Comparison (the UNDERDOGS study).

BACKGROUND: Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions. METHODS: From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37-3.55, p=0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p=0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p=0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97-1.2, p=0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p=0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p=0.001, p=0.001 and p=0.01, respectively). CONCLUSIONS: Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1year if compared to second generation DES. Further and larger studies are on demand to confirm our findings.

One-year mortality in elderly adults with non-ST-elevation acute coronary syndrome: effect of diabetic status and admission hyperglycemia.

OBJECTIVES: To determine whether type 2 diabetes mellitus and hyperglycemia on admission should be considered independent predictors of mortality in elderly adults with acute coronary syndrome (ACS). DESIGN: Prospective cohort study. SETTING: Twenty-three hospitals in Italy. PARTICIPANTS: Individuals aged 75 and older with non-ST-elevation ACS (NSTEACS) (mean age 82, 47% female) (N = 645). MEASUREMENTS: Diabetic status and blood glucose levels were assessed on admission. Hyperglycemia was defined as glucose greater than 140 mg/dL. Multivariable Cox proportional hazard regression was used to assess the potential confounding effect of major covariates on the association between diabetic status, admission glucose, and 1-year mortality. RESULTS: A history of diabetes mellitus was found in 231 participants (35.8%), whereas 257 (39.8%) had hyperglycemia. Hyperglycemia was found in 171 participants with diabetes mellitus (70%) and 86 (21%) without diabetes mellitus. Participants with diabetes mellitus were significantly (P < .05) more likely to have had prior myocardial infarction and stroke and had lower ejection fraction and blood hemoglobin. Hyperglycemia was associated with lower (P < .05) ejection fraction and estimated glomerular filtration rate (eGFR). Diabetic status and hyperglycemia were associated with greater 1-year mortality according to univariate analysis (54 participants with diabetes mellitus died (23.4%), versus 66 (15.9%) without diabetes mellitus (hazard ratio (HR) = 1.5 95% confidence interval (CI) = 1.0-2.1), and 60 participants with hyperglycemia died (23.3%), versus 60 (15.5%) without hyperglycemia (HR=1.6; 95% CI = 1.1-2.2), but this association was not statistically significant after adjustment for ejection fraction, age, blood hemoglobin, and eGFR. CONCLUSION: In elderly adults with NSTEACS, diabetes mellitus and hyperglycemia on admission are associated with higher mortality, mostly because of preexisting cardiovascular and renal damage.

Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial.

OBJECTIVES: This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. METHODS: A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. RESULTS: During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). CONCLUSIONS: The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).

Comparison of primary angioplasty in rural and metropolitan areas within an integrated network.

AIMS: To compare reperfusion times and in-hospital outcome of patients with STEMI treated with primary percutaneous coronary intervention (PCI) in a teaching hospital (TH) with or without inter-hospital transfer and in community hospitals. METHODS AND RESULTS: We performed a retrospective analysis of 536 patients with STEMI treated between January 2005 and December 2006 with primary PCI. Three groups were identified. A: 207 patients presented to the TH. B: 121 patients transferred to TH from metropolitan area hospitals (MAH). C: 208 patients presented in two rural area hospitals (RAH) with primary PCI capability. Baseline characteristics were similar. Door-to-balloon (DtB) times were significantly (p<0.001) higher in group B (median 120, range 90-180 min) both compared to group A (median 60, range 45-90 min) and C (median 73, range 55-99 min). In group B 79,5% of patients present a DtB > 90 min. In-hospital mortality was 4.9%, 3.3% and 4.3% respectively in group A, B and C without significant differences. CONCLUSIONS: The expansion of primary PCI to RAH achieves reperfusion delays similar to that of patients admitted to TH. Transferred patients present very higher DtB when compared to patients treated on-site. In-hospital outcome are similar but further studies are warranted.

Oxaliplatin hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: a phase I-II clinical study.

Oxaliplatin is a new drug active in the treatment of advanced colorectal cancer. Hepatic arterial infusion chemotherapy is under evaluation because of the high target dose and low general toxicity. Twelve patients with liver metastases from colorectal cancer were enrolled, all pretreated with evidence of progressive disease: three after a partial remission induced by oxaliplatin, folinic acid and 5-FU, three patients after a partial remission induced by irinotecan, folinic acid and 5-FU and six patients after failing a 5-FU and folinic acid regimen. They received hepatic arterial infusion chemotherapy with oxaliplatin as 30-min infusion on an outpatient basis every 3 weeks. Dose-limiting toxicity was observed at 175 mg/m2/cycle and consisted of obliteration of the hepatic artery in one patient, abdominal pain requiring morphine in one patient and severe hypotension requiring plasma expander in a third. Following phase 1, all patients received 150 mg/m2 for six cycles. We reported four cases of partial remission (33%) lasting 24, 15, 12 and 10+ weeks, respectively, 2 stabilisation of disease (17%) lasting more than 12 weeks and six progressions (50%). Six patients (50%) presented CEA reduction of > 30% and five patients (41%) showed an increase of > 8% of body weight. The median survival was 13 months (range 6-19). Oxaliplatin did not present significant toxicity for liver parenchyma and biliary tree. We advise that further studies be undertaken with oxaliplatin 150 mg/m2.

Irinotecan hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: a phase II clinical study.

AIMS AND BACKGROUND: The advantage of delivering chemotherapy by hepatic arterial infusion is the acquisition of a high concentration of the drug in the target. Irinotecan (CPT-11) is active for the treatment of advanced colorectal cancer. In phase I studies, doses of 20 mg/m2/d for 5 days given every 4 weeks as continuous infusion or 200 mg/m2 as a short 30-min infusion given every 3 weeks is recommended for phase II studies. METHODS AND STUDY DESIGN: Twelve patients with a median liver substitution of 30% (20-50%) were enrolled, 6 progressed after a FOLFOX-induced partial response and 6 progressed after 5-fluorouracil and folinic acid. All patients had a surgically (n = 6) or angiographically placed port (n = 6). They received hepatic arterial infusion chemotherapy with CPT-11 (200 mg/m2) on an out-patient basis, every 3 weeks as a short 30-min infusion for six cycles. RESULTS: Four partial responses were observed (33%) lasting 24, 15, 12 and 8+ weeks, 3 stable disease (25%) lasting more than 12 weeks, and 5 progressions (41%). Six patients (50%) presented a >30% reduction in CEA. Toxicity was G2 diarrhea in 5 patients (41%) and G2 myelosuppression in 6 (50%); one patient had abdominal right upper quadrant pain requiring analgesics. CONCLUSIONS: CPT-11 is active as hepatic arterial infusion chemotherapy in liver metastases from colorectal cancer and can rescue systemically pretreated patients. Our schedule seems safe, feasible and well accepted on an out-patient basis.