Giancarlo Vitrella

Early and Mid-Term Results of Drug-Eluting Stent Implantation in Unprotected Left Main

Background—The safety and efficacy of percutaneous coronary intervention in unprotected left main (ULM) coronary arteries are still a matter of debate. Methods and Results—All consecutive patients who had a sirolimus-eluting stent (Cypher, Cordis, Johnson and Johnson Co) or a paclitaxel-eluting stent (Taxus, Boston Scientific) electively implanted in de novo lesions on unprotected left main were analyzed. Patients treated with a drug-eluting stent (DES) were compared with the historical group of consecutive patients treated with bare metal stent (BMS). Eighty-five patients were treated with DES; 64 had BMS implantation. Patients treated with DES had lower ejection fractions (51.1±11% versus 57.4±13%, P=0.002) and were more often diabetics (21.2% versus 10.9%, P=0.12) with more frequent distal left main involvement (81.2% versus 57.8%, P=0.003). Furthermore, in the DES group, smaller vessels (3.33±0.6 versus 3.7±0.7 mm, respectively; P=0.0001) with more lesions (2.94±1.6 versus 2.25±1.3, P=0.004) and vessels (2.03±0.69 versus 1.8±0.72, P=0.05) were treated with longer stents (24.3±12 versus 15.8±8.6 mm, P=0.0001). Despite the higher-risk patients and lesion profiles in the DES group, the incidence of major cardiac events at a 6-month clinical follow-up was lower in the DES than in the BMS group (20.0% versus 35.9%, respectively; P=0.039). Moreover, cardiac deaths occurred in 3 DES patients (3.5%), as compared with 6 (9.3%) in the BMS group (P=0.17). Conclusions—In this early experience with DES in unprotected left main, this procedure appears safe with favorable and improved clinical results as compared with historical control subjects with a BMS. A randomized study comparing surgery appears justified at present.

New technique to seal a long giant coronary aneurysm with PTFE-covered stents: A case report

We report a case with a large aneurysm of right coronary artery (RCA) associated with coronary artery disease. The aneurysm was sealed with two PTFE‐covered stents using a sequential technique from proximal to distal to overcome the lack of long PTFE‐covered stents and existence of complex coronary anatomy. A bare metal stent was subsequently deployed to treat a lesion in the mid part of RCA. At 4‐month follow‐up, aneurysm was completely sealed and no restenosis occurred. Usage of sequential PTFE‐covered stents enables treatment of large coronary artery aneurysms.

Is overdilatation of 3.0 mm sirolimus-eluting stent associated with a higher restenosis rate?

We evaluated the safety and effectiveness of postdilating a 3.0 mm sirolimus‐eluting stents (SESs; six cells) with a 3.5–4.0 mm balloon. We identified 254 consecutive patients who underwent percutaneous coronary interventions using SESs with a nominal diameter of 3.0 mm (six cells). Patients were divided into two groups based on whether they were subsequently postdilated with a 3.0 mm (group 1: 168 patients, 251 lesions) or a 3.5–4 mm balloon (group 2: 86 patients, 102 lesions). There were no significant differences regarding the incidence of in‐hospital and long‐term follow‐up. Angiographic follow‐up was available in 72% and 74% of groups 1 and 2, respectively. The two groups had no significant differences regarding late lumen loss (0.51 ± 0.36 vs. 0.52 ± 0.33; P = 0.3) and binary restenosis rates (10.7% vs. 8.8%; P = 0.1). Six‐month clinical follow‐up was available in all patients. At long‐term follow‐up (mean: 10.6 ± 3.7 for group 1 and 11.3 ± 3.9 months for group 2), there were no significant differences between the two groups regarding major adverse cardiac events (8.9% vs. 9.2%; P = 0.9). Implantation of a 3.0 mm SES with postdilation with a 3.5–4 mm balloon did not result in any significant difference in complications, in‐hospital non‐Q‐wave myocardial infarction, binary restenosis, or target lesion revascularization. These data should lessen concern that overdilation may dilute the beneficial effects of SESs. Catheter Cardiovasc Interv 2005;64:129–133.

Results and follow-up after implantation of four or more sirolimus-eluting stents in the same patient

The aim of this study was to assess the safety and effectiveness of ≥4 sirolimus‐eluting stent (SES; Cypher, Cordis, Johnson and Johnson) implantation. The safety of implantation of ≥4 SESs in the same patient and setting has not been established. Furthermore, it has been hypothesized that sirolimus administration with the use of multiple stents may diminish the platelet inhibitory effects of clopidogrel and may trigger drug‐drug interactions. We identified 96 consecutive patients (96 procedures) who underwent implantation of ≥4 SESs in 365 lesions (438 stents) during the same procedure. All patients received aspirin indefinitely and clopidogrel or ticlopidine for at least 1 year postprocedure; 57% and 47% of the patients were on calcium channel blocker and statin therapy, respectively. All stents were successfully deployed and glycoprotein IIb/IIIa inhibitors were used in 50% of the procedures. There were no in‐hospital deaths, Q‐wave myocardial infarction (MI), urgent bypass surgery, or repeat percutaneous coronary intervention; 18 patients (19%) suffered non‐Q‐wave MI (defined as CK‐MB elevation >3 times the upper limit of normal). At 30‐day follow‐up, there was one (1%) subacute thrombosis resulting in target lesion revascularization. At mean follow‐up time of 15.4 ± 6.2 months, the frequency of target lesion revascularization, target vessel revascularization, and major adverse cardiac event rates were 12%, 16%, and 18%, respectively. No other notable clinical events that might have been attributed to the possible drug‐drug interactions or discontinuation of concomitant antithrombotic, statin, or calcium channel blocker therapy were reported. Multiple (≥4) SES implantation appears safe with no increase in major adverse cardiac events. Catheter Cardiovasc Interv 2005;64:436–439.