French Ministry of Health prospective multicentre study using bio-active stents coated with titanium nitride oxide: the EVIDENCE registry.

BACKGROUND: Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents. AIMS: We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up. METHODS: Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy. RESULTS: Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients. CONCLUSIONS: In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.

Comparison of transradial and transfemoral approaches for coronary angiography and angioplasty in octogenarians (the OCTOPLUS study).

This prospective multicenter study was conducted to compare the incidence of significant vascular complications delaying hospital discharge after coronary angiography and percutaneous coronary intervention (PCI) between the radial approach (n = 192) and the femoral approach (n = 185) in octogenarians, a rapidly growing population with numerous risk factors for complications. By intention-to-treat analysis, the incidence of vascular complications was found to be significantly less in the radial group (1.6% vs 6.5%, p = 0.03), without any decrease in the efficacy of PCI and only a slight increase in procedure duration for coronary angiography. All vascular complications, except for 1, occurred in patients treated with the transfemoral approach.

Primary angioplasty in CADASIL.

We report an acute coronary event in a young patient suffering from cerebral autosomal dominant arteriopathy with sub-cortical infarcts and leucoencephalopathy (CADASIL) successfully treated by primary angioplasty and direct stenting. Coronary involvement and pathophysiology of this genetic disorder is discussed.

Less invasive PTCA of a gastroepiploic artery combining the transradial approach and 5 Fr guiding catheter: a case report.

The gastroepiploic artery has been successfully used as an arterial conduit in selected patients undergoing CABG with acceptable immediate and long-term results. Myocardial ischemia may occur during the follow-up period as a result of spasm, occlusion, or stenosis at the anastomosis site. Because of tortuosity and in order to avoid graft spasm and to obtain good extra backup support, we require low-profile wide-lumen guiding catheters for deep intubation and increased procedural success. In the case presented here, a gastroepiploic graft stenosis was treated by balloon angioplasty performed through a less invasive approach combining transradial access and use of 5 Fr guiding catheter.

Safety and feasibility of the radial approach for primary angioplasty in acute myocardial infarction during pregnancy.

Acute myocardial infarction during pregnancy, though rare, is nevertheless associated with a high mortality rate ranging from 37 50%. Primary angioplasty is the treatment of choice for acute myocardial infarction during pregnancy. There are reports of high vascular bleeding complications when using the transfemoral approach as well as increased morbidity, longer hospital stay and higher hospital cost. We present a case of successful primary angioplasty in acute myocardial infarction during pregnancy via the transradial approach without complications. The patient had an uncomplicated recovery with normal left ventricular function.

Stenting of bifurcation lesions using the Bestent: a prospective dual-center study.

Treatment of bifurcation lesions remains a technical challenge. Among 13 stents previously tested in a bench study, the Bestent seemed of particular interest in this indication as it provided good access to the side branch after stent implantation in the main branch associated with a satisfactory coverage of the lesion after kissing balloon inflation. The use of Bestent implanted in the main branch or both branches for treatment of bifurcation lesions involving a side branch > or = 2.2 mm in diameter was prospectively evaluated in a dual-center prospective study with a prospective 6-month clinical follow-up. All angiographic documents were analyzed by an independent corelab (CORISIS). Between 11 September 1997 and 21 February 1998, 96 patients were consecutively included (mean age, 63.7 +/- 11.4 years; 81.3% male; 58.3% with unstable angina and 6.3% acute myocardial infarction). The lesion involved the left anterior descending-diagonal coronary bifurcation in 55% of cases, left circumflex-marginal 23%, posterior descending-postero-lateral 12%, distal left main 6%, and others 4%. The main branch (proximal reference diameter: 3.43 +/- 0.45 mm) was stented in 98% of cases and the side branch (2.72 +/- 0.38 mm) in 38% (both branches in 34% of cases). T-stenting or provisional T-stenting was used in 88% of cases and final kissing balloon inflation was performed in 78% of cases. Procedural success was obtained in 100% of cases in the main branch and 98% in both branches. Major cardiac and cerebral events (MACCE) during hospitalization occurred in 4.2% of cases, non-Q-wave myocardial infarction (MI) in 3.1%, Q-wave MI in 1.0%, repeat PTCA in 2.1%; there were no major access site complication, no emergency coronary artery bypass grafting operation, no death. At 6-month follow-up, total MACCE rate was 14.6% (Q-wave MI, 3.1%; non-Q-wave MI, 3.1%; target vessel revascularization, 9.4%; death, 2.1%). Patients with target vessel revascularization (TVR) had restenosis of both branches in 22.2% of cases, main branch in 22.2%, and side branch in 55.6%. This study shows that using a simple strategy of provisional T-stenting of the side branch in the majority of cases, the Bestent can be used for treating bifurcation lesions with a high rate of success and an acceptable rate of TVR at 6-month follow-up.

Noncoronary transradial angioplasty with coronary equipment: a less invasive technique.

As the safety and feasibility of the transradial approach for percutaneous coronary interventions have already been established by many series, we evaluate the safety and feasibility of this approach in noncoronary interventions such as renal, celiac, mesenteric, and subclavian angioplasty procedures. We present here our preliminary experience of noncoronary interventions via the transradial approach using coronary equipment with 100% technical and clinical success. Nine noncoronary interventions were performed in seven patients (five renal, two celiac, one mesenteric and subclavian angioplasty each). The advantage of this approach is that it limits arterial wall damage as well as potential distal embolization by the use of small guiding catheters and 0.014" guidewires. The only limitation of this approach for noncoronary interventions is the guiding catheter length in tall patients and the unavailability of large coronary balloons for subclavian, celiac, and renal interventions. With the miniaturization of equipment and improvements in technique, this approach will also become an excellent alternative for noncoronary interventions.

Transradial approach for coronary angioplasty in the setting of acute myocardial infarction: a dual-center registry.

Although transradial angioplasty has been shown to have no major entry site-related complications, its clinical applicability for balloon angioplasty and stenting in acute myocardial infarction (AMI) is unclear. In order to assess the feasibility, safety, and clinical outcome of transradial access for coronary angioplasty (PTCA) and stenting during AMI, transradial angioplasty for AMI was registered on a prospective database at two European sites (A and B) with experience in the radial approach (RA); 6 Fr catheters with an inner lumen of at least 0.064" and low-profile rapid-exchange balloons were used. Primary success rates and procedural complications of 6 Fr RA were determined and compared to 6 Fr femoral approach (FA) procedures. A total of 1,224 AMI patients entered the registry. Study site A enrolled 185 RA patients (13.6% AMI) and study site B 92 RA patients (63.4%). Patient baseline demographics were similar in both study centers and showed no differences between RA and FA patients, except a more frequent use of abciximab in study site B compared to A. PTCA was successful in > 95% of both RA and FA patients. Total procedural time did not differ between RA and FA patients. Severe access site-related bleeding complications, however, were observed in FA patients only: study site A used closure devices routinely and found 2% severe bleedings; study site B used no closure device for FA patients and observed 7% severe bleedings. In selected patients and in experienced hands, transradial PTCA in AMI has a high success rate, is clinically safe, and could become an attractive alternative access site for patients being at high or even low risk for bleeding complications.

Triple vessel stenting for triple vessel coronary disease.

BACKGROUND: Randomized clinical trials have established the feasibility of implanting multiple coronary stents and, in selected patients, have measured survival after multiple stenting to be comparable to coronary artery bypass graft surgery (CABG). However, the proportion of candidates for this therapy is unclear. this prospective study was performed to measure the percentage of patients eligible for elective multiple stenting of triple vessel coronary artery disease and to examine their short- and intermediate-term outcomes. METHODS: Between January 1996 and January 1999, percutaneous coronary interventions (PCI) were performed in 6,810 consecutive patients, of whom 115 (1.7%) had triple vessel coronary artery disease treated with > or =3 stents. The mean age of these patients was 62.9 years (range, 35-85 years), 83% were men and 13 patients (11%) were diabetic. The treatment was performed in a single procedure in 80% of patients and 362 vessels were dilated, including the left anterior descending artery in 85%, the right coronary artery in 84%, the left circumflex in 49%, the left diagonal artery in 27%, the posterior descending artery in 8% and the posterior lateral artery in 4% of patients. RESULTS: A total of 483 stents were implanted, representing an average of 4.2 +/- 1.4 stents per patients (range, 3-10 stents). The total length of stents averaged 66.9 +/- 4.9 mm. In-hospital adverse events included 2 deaths (1.7%), 2 emergency CABG (1.7%) and 5 myocardial infarctions (4.3%). The mean hospitalization duration was 2.7 +/- 2.2 days. During a follow-up ranging between 1 and 36 months (mean, 16.7 months), 2 patients died (1.7%), 2 patients underwent CABG (1.7%) and 22 patients (19.1%) underwent further coronary artery dilatations. The 3-year event-free survival was 71.3%. In univariate analysis, patients who underwent additional target vessel revascularization were younger and were more likely to have stented segments > 80 mm in the index procedure. No other clinical, angiographic or procedural characteristic was predictive of adverse events. CONCLUSIONS: In this consecutive series of patients undergoing elective PCI, candidates for stenting of > or =3 arteries were few. Most eligible patients underwent uncomplicated and immediately successful procedures. The long-term outcome was comparable to controlled studies of CABG, except for a higher rate of repeat revascularization procedures due to restenosis.

A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction.

OBJECTIVES: We sought to determine whether direct stenting might prevent the adverse events associated with stent implantation during primary angioplasty and to compare it with conventional stent implantation in patients with acute myocardial infarction (AMI). BACKGROUND: No trial has demonstrated that stents favorably influence mortality rate. Recent studies have even suggested a negative impact of stents on coronary blood flow and clinical outcome. METHODS: Of 409 patients treated by primary angioplasty with stent implantation in our center, 206 (50%) were enrolled in this randomized, single-center trial and allocated to direct stent implantation (n = 102) or stent implantation after balloon pre-dilation (n = 104). The study end points included angiographic results (final corrected Thrombolysis In Myocardial Infarction [TIMI] frame count and a composite end point of slow and no-reflow or distal embolization), an electrocardiogram marker of myocardial reperfusion assessment (ST-segment resolution) and in-hospital clinical outcome (death and recurrent infarction). RESULTS: Direct stent implantation failed in eight patients but succeeded after pre-dilation in all. A non-significant increase in TIMI flow grade 3 was achieved after direct stenting (95.1% vs. 93.3%, p = 0.74) without significant difference in the corrected TIMI frame count (31.5 +/- 17 and 35.2 +/- 20 frames after direct and conventional stent, respectively, p = 0.42). The composite angiographic end point was significantly reduced by direct stent implantation (11.7% vs. 26.9%, p = 0.01). ST-segment resolution was also significantly improved after direct stent (no ST-segment resolution in 20.2% vs. 38.1% after direct and conventional stent, respectively, p = 0.01). Death and/or recurrent infarction occurred in six patients after conventional stent implantation and in two patients after direct stenting (p = 0.28). CONCLUSIONS: In selected patients with AMI, direct stenting can be applied safely and effectively. This strategy may result in a significant reduction of microvascular injury, as suggested by improved ST-segment resolution after reperfusion with major potential clinical consequences.