Carmelo Cernigliaro

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

Background Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. Methods and Results We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)‐covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30‐day and 6‐month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE‐covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30‐day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6‐month follow‐up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6‐month non‐Q‐wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). Conclusions The study did not demonstrate a difference in restenosis rate and 6‐month clinical outcome between the PTFE‐covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE‐covered stent. (Circulation. 2003;108:37‐42.)

Coronary rotational atherectomy in current practice: acute and mid-term results in high- and low-volume centers.

We conducted a prospective observational study to evaluate the indications, technique, in‐hospital and 9‐month results of consecutive patients treated with rotational atherectomy (RA) in 12 centers during 1 year, as well as their relationship with volume of RA activity. The study included 345 lesions in 289 patients treated (4.4% ± 2.6% of procedures at the participating centers). The lesions were mostly calcified (63%) and type B2 or C (74%). Procedural success was obtained in 94% of patients, with a major adverse cardiac event (MACE) rate of 4.5%. At 9 months, MACE occurred in 17.3%. Multivariate analysis identified multivessel disease and slow flow as negative predictors of procedural success, whereas balloon pressure ≤ 6 atm and hypercholesterolemia were associated with decreased MACE at 9 months. Center RA volume was not associated with in‐hospital or 9‐month outcome. We conclude that RA, even when used sporadically in selected complex lesions, can provide good immediate and mid‐term results. Catheter Cardiovasc Interv 2004;61:463–471.

Preventing Restenosis after Implantation of Bare Stents with Oral Rapamycin: A Randomized Angiographic and Intravascular Ultrasound Study with a 5-Year Clinical Follow-Up

Objectives: To establish the efficacy of oral rapamycin at a dose of 2 mg for 1 month at reducing the 6-month restenosis rate after the implantation of bare metal stents. Methods: A prospective, 1:1 randomized, single-blind, placebo-controlled study was conducted in 108 consecutive patients assigned immediately after stent implantation to oral rapamycin (4 mg loading dose followed by 2 mg daily for 30 days) or a placebo. Results: Rapamycin was maintained in 98% of patients. Angiographic in-stent binary restenosis was 14.3% in the rapamycin group versus 32.1% in the placebo group, with a relative risk (RR) of 0.45 (95% CI 0.24–0.84, p = 0.015). The rapamycin blood concentration at 15 days correlated with binary restenosis (p = 0.044). The volume obstructions found by intravascular ultrasound for the rapamycin and the placebo groups were 18.1±10.7 and 27.1±15.7% (p = 0.002), respectively. Major adverse cardiac events at a 5-year follow-up were 31.5% for the rapamycin group and 50.0% for the placebo group (RR 0.63, 95% CI 0.39–1.01, p = 0.078). Conclusions: Oral rapamycin significantly reduces the incidence of restenosis at follow-up compared to a placebo.We believe these findings deserve further testing in larger trials.

Early assessment of coronary artery bypass graft patency by high-dose dipyridamole echocardiography

Abstract To assess the role of high-dose (up to 0.84 mg/kg during 10 minutes) dipyridamole echocardiographic testing in the evaluation of coronary artery bypass graft patency early after surgery, 18 consecutive patients with angina underwent dipyridamole echocardiography and coronary angiography before and 7 to 10 days after bypass surgery-Coronary angiography showed 2- or 3-vessel disease in 7 and 11 patients, respectively. A total of 53 bypass grafts were performed. Before bypass surgery 14 patients had a positive and 4 a negative test result. No complication occurred during the test performed early after surgery. Of the 14 patients with positive dipyridamole echocardiographic results before surgery, 10 had negative and 4 had positive results after surgery. All 4 patients had negative results before and after surgery. In the 4 patients with positive results after dipyridamole echocardiographic testing before and after bypass surgery, dipyridamole time increased from 5.8 ± 5 to 9.3 ± 0.9 minutes (p = 0.3) after the procedure and wall motion score index at peak dipyridamole changed from 1.55 ± 0.2 to 1.28 ± 0.3 (p = 0.05). Forty-nine of 53 grafts were patent as seen on angiography. Dipyridamole echocardiographic results were positive in 4 of 5 patients who had at least 1 obstructed graft or native vessel obstructed distal to bypass graft insertion. The remaining patient had diagnostic electrocardiographic changes during dipyridamole infusion without wall motion abnormalities. Dipyridamole echocardiographic results were negative in all 13 patients who had complete revascularization. In the 4 patients with positive test results, the procedure correctly identified the localization of the diseased bypass graft. These data suggest that (1) dipyridamole echocardiography can be easily and safely performed after coronary artery bypass graft surgery, (2) there is an excellent correlation between the functional improvement assessed by dipyridamole echocardiography testing and anatomic results of coronary artery bypass surgery, and (3) it reliably detects and identifies diseased bypass grafts.

Detection of moderate and severe coronary artery stenosis with technetium-99m tetrofosmin myocardial single-photon emission tomography

Abstract.The aim of this study was to determine the diagnostic accuracy of technetium-99m tetrofosmin myocardial imaging for the localization of coronary artery stenoses of different degrees of severity. Stress-rest single-photon emission tomography (SPET) was performed on separate days in 80 patients (64 males, 16 females; mean age 61 years; 43 patients with previous myocardial infarction; 18 patients with pharmacological stress), within 6 months of coronary angiography. Scintigraphic images were blindly and independently evaluated by three observers. Coronary stenosis was defined as a >50% narrowing in luminal diameter; severe stenosis was defined as a proximal stenosis of >75% or a peripheral stenosis of >90%. Coronary angiography revealed normal coronary arteries or insignificant coronary stenosis in 13 patients and significant coronary stenoses in 67 patients. The sensitivity and specificity of 99mTc-tetrofosmin SPET in respect of severely stenosed vessels were, respectively, 80% and 65% for the left anterior descending artery (LAD), 100% and 46% for the right coronary artery (RCA) and 58 and 78% for the left circumflex artery (LCx) territories. Considering all the significantly stenosed vessels, a significant decrease in sensitivity was observed for LAD territories (to 59%, P=0.05), and a nonsignificant decrease for RCA (88%) and LCx (47%) territories while specificity values remained essentially unchanged. No significant changes in sensitivity or specificity were observed when regions with previous myocardial infarction were excluded. In conclusion, the sensitivity of 99mTc-tetrofosmin SPET for the localization of individual stenosed vessels is only moderate when all significant stenoses are considered, but the ability of this technique to predict the location of severe coronary artery stenoses seems satisfactory, with the exception of the low specificity in respect of RCA territories.

ORAl iMmunosuppressive therapy to prevent in-Stent rEstenosiS (RAMSES) cooperation: A patient-level meta-analysis of randomized trials

OBJECTIVE The role of oral immunosuppressive therapy (OIT) to prevent restenosis after percutaneous coronary intervention (PCI) and stenting is still controversial. This study evaluates the impact of oral administration of prednisone or sirolimus to prevent restenosis. METHODS We conducted a meta-analysis of trials in which PCI-patients were randomized to bare metal stents (BMS) plus OIT (BMS + OIT group) versus BMS or drug-eluting stents alone (BMS/DES group). Primary endpoints were target lesion revascularization and death/myocardial infarction (MI). Secondary endpoints were death, MI, stent thrombosis and in-stent late lumen loss. Hazard ratio and weighted geometric mean difference [95% confidence intervals] served as summary statistics. RESULTS Individual data of seven trials (1246 patients [BMS + OIT, n = 608 versus BMS/DES, n = 638] with 1456 coronary lesions) were merged. At a median follow-up of 360 days, BMS + OIT versus BMS/DES significantly reduced the risk of revascularization (0.49 [0.24-0.98], P = 0.04). In particular, BMS + OIT reduced the risk of revascularization (0.38 [0.21-0.67], P < 0.001) and late lumen loss (-0.39 mm [-0.67, -0.11], P < 0.001) as compared with BMS alone. BMS + OIT versus BMS/DES showed a similar risk of death/MI (0.67 [0.29-1.53], P = 0.34), death (0.82 [0.25-2.69], P = 0.71), MI (0.58 [0.24-1.39], P = 0.22) and stent thrombosis (0.43 [0.10-1.87], P = 0.26). CONCLUSION In patients undergoing PCI the use of BMS and oral immunosuppressive therapy reduces the risk of revascularization as compared with BMS alone but not as compared with DES alone, while these therapies display a similar risk of death/MI. The advantage of adding oral immunosuppressive therapy to BMS is due to a lower risk of restenosis as compared with BMS alone.

Iopamidol in cardioangiography: a retrospective, multicenter study. Part I. Adult patients

To evaluate the occurrence of complications during diagnostic or interventional catheterization a retrospective analysis of catheterization procedures in 1.2 italian laboratories using the nonionic contrast medium (CM) iopamidol (370mgI/ml) was performed. Data obtained on 26,219 patients ≥ 14 years are presented. The overall complication rate was 1.89% (485/26,219). The overall mortality rate was 0.1% (27/26,219). Procedure related complications were 389 (1.48%) and CM related complications were 106 (0.4%). No death was attributed to CM. Ventricular fibrillation (VF) rate was 0.11% comparable to the low rate observed with nonionic CM in other studies and less than the rate observed in surveys concerning the use of ionic CM. Fifty-seven thrombotic events were recorded (0.22%), a rate comparable with other surveys with ionic and nonionic CM. The total complication rate (6.1%), the rates of coronary occlusion (1.34%), myocardial infarction (0.37%) and urgent coronary artery by-pass grafting (0.5%) in 1,348 coronary angioplasties were lower than those recorded in previous surveys.These data confirm a good tolerability and no increased risk of VF and thrombotic events with iopamidol in cardiac catheterization.

Oral Rapamycin to Reduce Intimal Hyperplasia After Bare Metal Stent Implantation - A Prospective Randomized Intravascular Ultrasound Study

Coronary artery disease is a major health problem throughout the world. Important advances in diagnosis and treatment of atherosclerotic disorders have been made over the last five decades. Coronary angiography, introduced by Mason Sones in 1958 has been very effective on expanding the diagnosis and treatment of coronary lesions. The introduction of conventional balloon percutaneous transluminal coronary angioplasty (PTCA) by Andreas Gruntzig in 1977, represented an innovative and quite efficient non surgical treatment of angina pectoris and acute myocardial infarction. This procedure was however frequently complicated by an abrupt vessel closure, coronary dissections and a high incidence of restenosis (up to 40 – 50 % of cases) (Gruntzig et al., 1979). In 1986 the first coronary Wallstent was implanted in Toulouse by Jacques Puel and Ulrich Sigwart (Sigwart et al., 1987) and in 1994 Palmaz-Schatz stents were approved by FDA in the United States. Coronary stents improved the immediate and long-term results of coronary angioplasty, reducing immediate complications of the procedure like coronary dissection and abrupt closure and the incidence of restenosis. However, despite technical advances in stent delivery systems and design the rate of restenosis after stent implantation remained 20-30% especially in the high risk patients subsets (Serruys et al., 1994; Fischman et al., 1994). To overcome the problem of restenosis the drug eluting stents Cypher and Taxus were approved in 2003 and 2004 respectively. The initial studies with these stents demonstrated a marked major advance in reducing restenosis (Bailey, 1997; Serruys et al., 2002). Later studies however confirmed that despite these advances, in the real world, stent thrombosis (acute, subacute and late) and instent restenosis still remain a great clinical challenge (Daemen et al., 2007). The process of restenosis is complex. Restenosis may ensue mainly because of: a) patients-related factors (diabetes, restenosis after PTCA, chronic renal insufficiency, high serum PCR etc), b) vessel factors (chronic occlusion, vessel involved e.g. LAD, SVG etc, vessel 30 mm, bifurcation lesion, ostial lesion), c) procedure factors (post-stent MLD < 3mm, multiple stents, stent underexpansion or malapposition, stent fracture).

Single vs multivessel treatment during primary angioplasty: Results of the multicentre randomized HEpacoat™ for cuLPrit or multivessel stenting for Acute Myocardial Infarction (HELP AMI) Study (Acute Cardiac Care (2004) 6 (128-133))

It addresses the management of acute coronary syndromes (ACS) with an emphasis on evidence-based pharmacological management, cardiac emergencies (cardiac arrest ...

Early assessment of coronary artery bypass graft patency by high dose dipyridamole echocardiography

To assess the role of high-dose (up to 0.84 mg/kg during 10 minutes) dipyridamole echocardiographic testing in the evaluation of coronary artery bypass graft patency early after surgery, 18 consecutive patients with angina underwent dipyridamole echocardiography and coronary angiography before and 7 to 10 days after bypass surgery. Coronary angiography showed 2- or 3-vessel disease in 7 and 11 patients, respectively. A total of 53 bypass grafts were performed. Before bypass surgery 14 patients had a positive and 4 a negative test result. No complication occurred during the test performed early after surgery. Of the 14 patients with positive dipyridamole echocardiographic results before surgery, 10 had negative and 4 had positive results after surgery. All 4 patients had negative results before and after surgery. In the 4 patients with positive results after dipyridamole echocardiographic testing before and after bypass surgery, dipyridamole time increased from 5.8 +/- 5 to 9.3 +/- 0.9 minutes (p = 0.3) after the procedure and wall motion score index at peak dipyridamole changed from 1.55 +/- 0.2 to 1.28 +/- 0.3 (p = 0.05). Forty-nine of 53 grafts were patent as seen on angiography. Dipyridamole echocardiographic results were positive in 4 of 5 patients who had at least 1 obstructed graft or native vessel obstructed distal to bypass graft insertion. The remaining patient had diagnostic electrocardiographic changes during dipyridamole infusion without wall motion abnormalities. Dipyridamole echocardiographic results were negative in all 13 patients who had complete revascularization. In the 4 patients with positive test results, the procedure correctly identified the localization of the diseased bypass graft.(ABSTRACT TRUNCATED AT 250 WORDS)