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Background and Objectives: Paclitaxel-coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in-stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel-eluting Coroflex™ Please stent in coronary artery lesions. Methods: One-hundred and twenty-nine patients (66.2 ± 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post-PTCA restenotic coronary lesions.The mean reference diameter was 2.84 ± 0.43 mm, the lesion length 12.51 ± 4.6 mm, and the minimal lumen diameter 0.75 ± 0.29 mm. Follow-up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. Results: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in-stent late loss and the late-loss index were 0.27 ± 0.59 mm and 0.17 ± 0.40 resulting in binary in-stent restenoses in 16/120 (13.3%) subjects and in-segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow-up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. Conclusion: The data of the Paclitaxel-eluting Coroflex™ Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel-eluting stent. (J Interven Cardiol 2010;23:160-166)

In a prospective, randomized, and double-blinded protocol, the effect of oral diltiazem (180 mg) over placebo on the restenosis rate was assessed in 189 consecutive patients (150 males. 39 females, 57.6 ± 8.4 years) eligible for follow-up angiography after 3.6 ± 0.6 months (diltiazem 90.4%, placebo 89.6%). Pre-PTCA stenoses were similar in both groups (diltiazem 83.9%; placebo 84.4%). Immediately after PTCA, the remaining stenoses were identical in both groups (22.6% vs 22.8%). At follow-up angiography there was a highly significant difference (P 50% stenosis or loss of > 50% of the initial gain) was significantly (P < 0.03) reduced by diltiazem (18 [21.4%] of 84 patients) compared to placebo (33 [38.4%] of 86 patients). Diltiazem was superior to placebo in all vessels: (1) left anterior descending coronary artery: 21.6% vs. 32.7%, (2) right coronary artery: 25% vs 46.7%; and (3) left circumflex. 16.7% vs 36%. The benefit of diltiazem was most pronounced in calcified plaques (33.3% vs 47.1%), in diabetics (15% vs 46.2%), in hypercholesterolemia (20.4% vs 44.2%, P < 0.05), in the age range of 41–50 years (21.4% vs 44.4%), and in patients with CCS Class 2 (11.1% vs 64%, P < 0.01). In stratified analysis, the effect was apparent in both sexes, independent from concomitant therapy, regardless of whether or not coronary artery disease had progressed in segments other than the dilated ones. Thus, in this limited series of patients, diltiazem significantly reduced the number and extent of restenosis. Confirmation in a larger cohort is necessary.

We report about the 6-month follow-up of 28 consecutive patients treated with a new tantalum stent (Wiktor¿ stent, Medtronic, Inc.). Indication for stenting was the prevention of restenosis in eight patients (restenosis group), and threatening or acute closure after PTCA in 20 patients (acute closure group). Twenty-eight of 30 stents were successfully positioned in 27 of 28 patients (96%), whereas implantation failed twice in one patient. Immediate stent occlusion developed in two patients in the acute closure group (7.4%) Subacute stent occlusion was observed in three patients (11%), one in the restenosis group, two in the acute closure group, between 3 and 5 days after implantation. Coronary bypass surgery had to be performed in four patients (15%): one patient after failed stent placement, two after acute, and one after subacute stent thrombosis. Major bleeding complications related to the anticoagulative drug regimen occurred in nine patients (33%). Three patients (11%) died for reasons most probably not related to stent implantation. A 6-month angiographic follow-up revealed restenosis in two of 19 patients (11%), one patient in each group. Sixteen of the 27 stented patients (59%) reached 6-month follow-up without death, acute or subacute stent thrombosis, or restenosis. It is concluded that the Wiktor stent can be placed with a high rate of success. It may also reduce the risk of restenosis. The stent also offers the possibility to circumvent emergency bypass surgery in case of PTCA related vessel occlusion. Acute and subacute stent occlusion still remains an unsolved topic.

Stents coated with hypothrombogenic silicon carbide (a-SiC:H) exhibited low restenosis rates in the rabbit and in an observational study in humans. Thus, the clinical and angiographic outcome was assessed in a large multicenter study.Four hundred and ninety-seven patients (63.4 +/- 9.8 years) were randomized to either receive the a-SiC:H-coated Tenax stent or the stainless steel Nir stent. Lesions (diameteror = 2.8 mm, length20 mm) were covered with one single stent.Fifty-one of 497 (10.3%) patients were excluded for protocol violation. Three hundred and forty-two of 446 (76.7%) patients presented for scheduled angiographic follow-up after 4.7 +/- 1.2 months and 29 of 446 (6.5%) prematurely. In-hospital complications comprised two deaths (0.8%) (P0.99) and one (0.4%) (P0.99) CK-elevation in each group, target lesion revascularization in 5 of 250 (2%) of the Tenax and 4 of 244 (1.6%) of the Nir sample (P0.99), and subacute thrombosis in 2 of 250 (0.8%) of the Tenax patients (P = 0.5). In the Tenax/Nir patients mean percent diameter stenosis decreased from 82.3 +/- 9.1%/80.7 +/- 8.4% (P = 0.49) to 17.6 +/- 5.5%/17.6 +/- 5.5% (P = 0.99) postprocedure and increased to 34.5 +/- 21.5%/34.2 +/- 23.1% (P = 0.90) at follow-up.Thus, there appears to be no advantage of the silicon carbide coated stent over a stainless steel stent after 4.7 +/- 1.2 months with regard to clinical and angiographic restenosis rates.

The objective of this prospective, multicenter, observational trial was to evaluate the procedural results and longterm outcomes of the flexible AVE GFX coronary stent in native coronary lesions. The trial included 137 consecutive patients (111 [81%] men, age 63.1 +/- 9.2 years) with one vessel disease (n = 76 [55.5%]), two vessel disease (n = 31 [22.6%]), and three vessel disease (n = 30 [21.9%]) with ischemia secondary to a significant denovo lesion (diameter > or = 3 mm, length < or = 18 mm) in a native coronary artery. Stent deployment was successful in 97.8% (134/137) of patients. Angiographic follow-up at 6.1 +/- 1.2 months was available in 111 (82.8%) of 134 patients. All angiographic images were analyzed by an independent core lab. The primary end point was the binary restenosis rate. In-hospital major cardiac events occurred in 3.7%. No postdischarge major adverse cardiac events occurred, except for one abrupt closure (0.7%). Angiographic restenosis was documented in 22 (19.8%) of 111 patients. The GFX stent is easy to handle with high success and low restenosis rates in patients with simple lesions in native coronary arteries and, thus, compares favorably with other sophisticated stents.

From 1988 to 1990 chronic coronary occlusions were treated with a newly developed slowly rotating angioplasty system (ROTACS), which is designed for atraumatic passage of arterial obstructions. In all 152 patients (mean age 55 years, ranging from 29 to 78 years) attempts to recanalize the coronary occlusion with conventional guidewire systems had failed. In 74/152 patients the age of the occlusion could be estimated because of a previous angiogram or clinical event. It ranged from 1–192 months (median 6 months, mean value 14 months; in 20% of patients it was 1–3, in 37% 4–6, in 28% 7–12, and in 15% > 12 months). The occlusion was localized in the right coronary artery (RCA) in 86 cases, in the left anterior descending coronary artery (LAD) in 37 cases, and in the circumflex branch of the left coronary artery in 17 cases. Eleven bypass occlusions were treated. One patient had a LAD and RCA occlusion. Out of 152 patients 84 could be recanalized. The success rate rose with experience from 30% to 60%. It was 55% in the LAD, 52% in the RCA, 70% in the circumflex branch, and 63% in bypass grafts. The success rate in relation to the age of the occlusion was 93% in occlusions of 1–3 month duration, 74% in occlusions of 4–6 months duration, 52% in occlusions of 6–12 months duration, and 8% in occlusions older than 12 months. Seventy-six of the successfully treated patients underwent follow-up angiography after 4 months. In 56/76 (74%) the vessel remained open. Twenty-two patients (29%) had restenosis that was successfully dilated in 21 patients. Twenty patients (26%) had reocclusion. Thus, the angiographically determined long-term success rate was 72%. Emergency operation was necessary in two patients in whom reopening of the LAD was attempted although the occlusion was located directly at the take-off of the LAD from the left main. Since this type of occlusion was consequently considered a contraindication, no further serious complications occurred. There was one myocardial infarction, no death, no vessel wall perforation or other complications in the 152 patients. It is concluded that low speed ROTACS is a safe technique that can be applied in chronic coronary occlusions even if the duration of occlusion exceeds 6 months. (J Interven Cardiol 1991; 4:15–165)

Following successful application in chronic peripheral artery occlusions, rotational angioplasty was refined and miniaturized for application in patients with chronic coronary artery occlusions. The new catheter system comprises a motor-driven rotating inner steel catheter made up of several steel coils providing maximum elasticity and complete torque control with an olive-like rounded tip (1.0–1.7 mm). The catheter has a lumen for contrast injection and a shielding plastic tube. It is introduced through a conventional 8 Fr guiding catheter. The slowly rotating (200 RPM) catheter passes nontraumatically through the occlusions, thus creating a new channel with smooth contours in a “remodeling” fashion. Once the channel (diameter 1–1.5 mm) is confirmed angiographically, balloon angioplasty is performed over an exchange wire in conventional technique. The new technique was applied to patients with chronic coronary occlusions. Reopening was first attempted with conventional guidewire technique. If the occlusion could be probed with the guidewire, patients were excluded from the study. Twenty patients in whom the occlusion could not be probed with a wire were studied: 1 ACVB, 2 LAD, and 17 RCA. Average duration of occlusion was 7.4 months; it exceeded 3 months in 15/20 and 6 months in 12/20 patients. Successful reopening was achieved in 9/20 (3 from the first 10, 6 from the second 10 patients). No vessel wall perforation or any other severe complication was encountered. Residual stenosis diameter ranged from 30%–70%. Duration of occlusion was similar among patients from the successful and unsuccessful group. It is concluded that with low speed rotational angioplasty reopening of chronic coronary artery occlusions can be achieved in a considerable part of patients in whom conventional technique is unsuccessful. (J Interven Cardiol 1989:2:3)