Description of a Heart Team approach to coronary revascularization and its beneficial long-term effect on clinical events after PCI.

OBJECTIVE AND BACKGROUND: We present a first description of a Heart Team (HT)-guided approach to coronary revascularization and its long-term effect on clinical events after percutaneous coronary intervention (PCI). The HT approach is a structured process to decide for coronary bypass grafting (CABG), PCI or conservative therapy in ad hoc situations as well as in HT conferences. As a hypothesis, during the long-term course after a PCI performed according to HT rules, a low number of late revascularizations, especially CABGs, are expected (F-PCI study). METHODS: In this monocentric study, the HT approach to an all-comer population was first analyzed and described in general with the help of a database. Next the use of a HT approach was described for a more homogeneous subgroup with newly detected CAD (1.CAD). Those patients in whom the HT decision was PCI (which was a 1.PCI) were then studied with the help of questionnaires for clinical events during a very long-term follow-up. Events were CABG, PCI, diagnostic catheterization (DCath) and death. RESULTS: A significant number of patients were presented to HT conferences: 22 % out of all 11,174 catheterizations, 24 % out of all 7867 CAD cases and 35 % out of 3408 1.CAD cases. Most of these patients had multi-vessel disease (MVD). Conference decisions were isolated CABG in 46-66 %, PCI in 10-14 %, valvular surgery in 9-16 %, HTx in 10-21 % (Endstage heart failure candidates for surgery) and conservative therapy (Medical or no therapy, additional diagnostic procedures or no adherence to recommended therapy) in 2-3 %. However, most PCIs, ad hoc and elective, were performed under Heart Team rules, but without conference. During follow-up of 1.PCI patients (Kaplan-Meier analysis), CABG occurred in only 15 % of patients, PCI in 37 % and DCath in 65 %; mortality of any course was 51 %. Mortalities were similar in one-vessel disease and in a population of the same year, matched for age and sex (p < 0.057), but mortality was higher in 1.PCI patients with MVD (p < 0.001). Beyond 2 years, Kaplan-Meier curves were linear. CONCLUSION: The structured Heart Team approach is an effective tool for ad hoc and conference-based clinical decision-making with a sustained clinical benefit. This is demonstrated in low late CABG (and PCI) rates after a 1.PCI, without elevated mortality. The all-comer population supports the universal value of these data. Stable annual event rates late after PCI suggest a conversion to stable CAD. Heart Team conferences are also important tools in cases of valvular and end-stage heart disease.

Coronary stenting with the sirolimus-eluting stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry.

BACKGROUND: Treatment of restenosis following intracoronary brachytherapy (ICB) is still a challenging problem. Implantation of sirolimus-eluting stents (SES) in this setting may be an option to be evaluated. METHODS AND RESULTS: We analysed the prospective multicentre SES registry, the German Cypher Stent Registry. 7,445 patients treated with an SES during percutaneous coronary intervention (PCI) were registered. Out of these patients, 61 (0.8%) were treated for restenosis after ICB: 56 patients with completed follow-up could be evaluated. Median age was 65 years, with 80% male patients. 48% of patients had a prior myocardial infarction and 25% had already coronary bypass surgery (CABG). Type B2 lesion was present in 40% and type C lesion in 22.4%. Event rates from SES implantation until 6.6 months follow-up were death 0%, myocardial infarction 3.6%, stroke 2.1%. Target vessel revascularization rate (TVR) was 16.4%, and major adverse cardiovascular or cerebral events (MACCE) or TVR occurred in 17.9% of patients. This TVR rate was higher compared with that of other patients treated with an SES: 8.4% (P = 0.04). During 65 months follow-up MACCE or TVR occurred in 44.6% of patients. CONCLUSIONS: The treatment of lesions after ICB occurred in 0.8% out of all patients treated with an SES. Clinical event rates during early follow-up were low. However, the TVR rate was 16.4%, which was significantly higher when compared with other SES-treated patients (8.4%, P = 0.04). The treatment of restenosis after ICB with SES seems to be safe and reasonably effective; however, there might be a late catch-up phenomenon.

Coronary stenting with the sirolimus-eluting stent in clinical practice: final results from the prospective multicenter German Cypher Stent Registry.

AIMS: Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice. METHODS AND RESULTS: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 +/- 0.41 SES were implanted with a mean length of 21.1 +/- 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery. CONCLUSIONS: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters.

Cobalt-chrome MULTI-LINK VISION-stent implantation in diabetics and complex lesions: results from the DaVinci-Registry.

AIMS: Restenosis in bare-metal stents is in part related to stent design and material. Optimized strut design of cobalt-chrome (CoCr) stents may yield nearly comparable results to drug-eluting stents (DES) in selected lesions. The prospective multicenter DaVinci registry investigates the clinical outcome of a CoCr coronary stent (MULTI-LINK VISION), particularly in terms of patients with diabetes and complex lesions (B1, B2, C). METHODS AND RESULTS: The prospective internet-based registry included 1,344 patients (76% males, aged 66 +/- 10 years) undergoing stent implantation (n = 1,642) in 32 centres from July 2003 to June 2004. Follow-up data (median 9 +/- 1 months) of this cohort were available for 1,289 patients (98.1%). Of these patients 327 (26.2%) were diabetics. In total, 1,429 de-novo lesions (A 11.9%, B1 47.7%, B2 31.6%, C 8.8%) were treated with the CoCr stent. The predefined primary endpoint was defined as a composite of death, Q-wave myocardial infarction (STEMI), non-STEMI (NSTEMI), target vessel revascularization (TVR) by coronary bypass graft (CABG) or PCI at 270 days (target vessel failure, TVF). Secondary endpoints include death, time to the first myocardial infarction, TVR and CABG. The cumulative incidence of major adverse cardiac events (MACE) was 12.4% with 0.8% deaths, 1.5% non-fatal MI, and 9.7% TVR. TVF in the overall cohort was documented in 137 (10.8%) patients. For diabetics and complex lesions TVF was 13.8% (95% CI 4.2-18) and 11.4% (95% CI 2.0-13.3), respectively. CONCLUSION: This large registry confirms good acute and long-term success of CoCr stents making this strategy valuable, particularly in a special cohort (diabetics and complex lesions) as long as late stent thrombosis with DES plays a role and short-term antiplatelet therapy is favoured.

Sirolimus-eluting stent treatment at high-volume centers confers lower mortality at 6-month follow-up: results from the prospective multicenter German Cypher Registry.

BACKGROUND: Studies continue to identify percutaneous coronary intervention procedural volume both at the institutional level and at the operator level as being strongly correlated with outcome. High-volume centers have been defined as those that perform >400 percutaneous coronary intervention procedures per year. The relationship between drug-eluting stent procedural volume and outcome is unknown. We investigated this relationship in the German Cypher Registry. METHODS AND RESULTS: The present analysis included 8201 patients treated with sirolimus-eluting stents between April 2002 and September 2005 in 51 centers. Centers that recruited >400 sirolimus-eluting stent patients in this time period were considered high-volume centers; those with 150 to 400 patients were considered intermediate-volume centers; and those with <150 patients were designated as low-volume centers. The primary end point was all death, myocardial infarction, and target-vessel revascularization at 6 months. This end point occurred in 11.3%, 12.1%, and 9.0% of patients in the low-, intermediate-, and high-volume center groups, respectively (P=0.0001). There was no difference between groups in the rate of target-vessel revascularization (P=0.2) or cerebrovascular accidents (P=0.5). The difference in death/myocardial infarction remained significant after adjustment for baseline factors (odds ratio 1.85, 95% confidence interval 1.31 to 2.59, P<0.001 for low-volume centers; odds ratio 1.69, 95% confidence interval 1.29 to 2.21, P<0.001 for intermediate-volume centers). Patient and lesion selection, procedural features, and postprocedural medications differed significantly between groups. CONCLUSIONS: The volume of sirolimus-eluting stent procedures performed on an institutional level was inversely related to death and myocardial infarction but not to target-vessel revascularization at 6-month follow-up. Safety issues are better considered in high-volume centers. These findings have important public health policy implications.

In-hospital outcomes after elective and non-elective percutaneous coronary interventions in hospitals with and without on-site cardiac surgery backup.

BACKGROUND: Guidelines recommend on-site surgery backup (SB) when elective percutaneous coronary intervention (PCI) is performed. The evidence for this recommendation is however weak. OBJECTIVES: The objective of the present study was to compare clinical outcomes in patients undergoing PCI in hospitals with SB or without surgery backup (non-SB). METHODS: Prospective German PCI registry in 36 hospitals throughout Germany. Consecutive procedures were collected and analyzed centrally. RESULTS: In 2006, a total of 23,148 patients were included; 12,465 patients (53.8%) in 11 hospitals with SB and 10,683 patients (46.2%) in 25 hospitals without on-site cardiac SB. Both patient groups were well-balanced with regard to age and gender. SB hospitals had more patients with ACS (OR 1.29; 95%CI 1.23-1.36) and less patients with stable angina (OR 0.78; 95%CI 0.74-0.82) than non-SB hospitals. There was no indication of a clinically relevant differential outcome for in-hospital death, MACE, non-fatal MI, non-fatal stroke/TIA, or emergency CABG between SB and non-SB hospitals for neither patients with ACS nor stable angina except for emergency CABG in ACS patients (more frequent in SB hospitals, OR 2.29; 95%CI 1.02-5.13). CONCLUSIONS: There was no evidence of an excess risk associated with PCI-procedures performed in non-SB hospitals.

Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry.

AIMS: Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine. METHODS AND RESULTS: The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03). CONCLUSION: This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.

Prognostic value of the modified American College of Cardiology/American Heart Association lesion morphology classification for clinical outcome after sirolimus-eluting stent placement (results of the prospective multicenter German Cypher Registry).

The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification scheme has prognostic impact for early and late outcomes when bare-metal stents are used. Its value after drug-eluting stent placement is unknown. The predictive value of this lesion morphology classification system in patients treated using sirolimus-eluting stents included in the German Cypher Registry was prospectively examined. The study population included 6,755 patients treated for 7,960 lesions using sirolimus-eluting stents. Lesions were classified as type A, B1, B2, or C. Lesion type A or B1 was considered simple (35.1%), and type B2 or C, complex (64.9%). The combined end point of all deaths, myocardial infarction, or target vessel revascularization was seen in 2.6% versus 2.4% in the complex and simple groups, respectively (p = 0.62) at initial hospital discharge, with a trend for higher rates of myocardial infarction in the complex group. At the 6-month clinical follow-up and after adjusting for other independent factors, the composite of cumulative death, myocardial infarction, and target vessel revascularization was nonsignificantly different between groups (11.4% vs 11.2% in the complex and simple groups, respectively; odds ratio 1.08, 95% confidence interval 0.8 to 1.46). This was also true for target vessel revascularization alone (8.3% of the complex group, 9.0% of the simple group; odds ratio 0.87, 95% confidence interval 0.72 to 1.05). In conclusion, the modified ACC/AHA lesion morphology classification system has some value in determining early complications after sirolimus-eluting stent implantation. Clinical follow-up results at 6 months were generally favorable and cannot be adequately differentiated on the basis of this lesion morphology classification scheme.

Implantation of sirolimus-eluting stents in saphenous vein grafts is associated with high clinical follow-up event rates compared with treatment of native vessels.

AIMS: The clinical effectiveness of sirolimus-eluting stents (SES) for treatment of patients with saphenous vein graft disease is not well defined. This analysis sought to evaluate the clinical follow-up after treatment of stenotic saphenous vein grafts using SES in a large patient registry. Patients treated with SES for saphenous vein graft disease were compared with patients receiving SES in native vessel disease. METHOD: This is a subanalysis from the prospective multicenter German Cypher Stent Registry. Only patients with completed 6 months clinical follow-up were included. The analysis comprises 344 patients with 353 lesions in saphenous vein grafts treated with 400 SES (Cypher, Cordis Inc., Cordis Corp., Warren, New Jersey, USA) and 6411 patients with 7607 native coronary artery lesions treated with 8725 SES. RESULTS: Mean SES length per lesion was 22.6+/-11.7 mm and mean stent diameter 3.0+/-0.3 mm in saphenous vein graft lesions. Target vessel revascularization rate was 18.1% and major adverse cardiovascular events (MACE) rate was 23.8% at 6-month follow-up after SES implantation for saphenous vein graft lesions. Even after adjustment for different baseline characteristics, target vessel failure and MACE rate were significantly higher after SES implantation for saphenous vein graft lesions than for native coronary vessel stenosis [odds ratio: 2.10 (95% confidence interval: 1.40-3.13), P<0.001] and [odds ratio: 2.15 (95% confidence interval: 1.49-3.09), P<0.001], respectively. CONCLUSION: Treatment of saphenous vein graft disease is associated with high target vessel revascularization and MACE rates also with the use of SES if applied to unselected patients. Target vessel revascularization and MACE rates remain significantly higher after SES for saphenous vein graft lesions than after SES in native vessel disease.

Sirolimus-eluting stent treatment for unprotected versus protected left main coronary artery disease in widespread clinical routine: 6-month and 3-year clinical follow-up results from the prospective multicentre German Cypher Registry.

BACKGROUND: Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery. OBJECTIVE: To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry. SETTING AND PATIENTS: The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point. RESULTS: One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2). CONCLUSION: Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.

Incidence and predictors of target vessel revascularization after sirolimus-eluting stent treatment for proximal left anterior descending artery stenoses among 2274 patients from the prospective multicenter German Cypher Stent Registry.

BACKGROUND: Involvement of the proximal LAD is considered an indication for coronary artery bypass graft (CABG) surgery due to the high restenosis rates associated with this location after percutaneous coronary interventions (PCI). This seems to be different, however, when using sirolimus-eluting stents, a finding if proven to be true could have a major impact on clinical decision making regarding the optimal revascularization strategy for these patients. METHODS: We analyzed 2274 patients treated for proximal LAD stenoses using SES from the German Cypher Stent Registry. The incidence of TVR and other major clinical adverse events were determined and independent predictors of TVR were specified using a multiple logistic regression model. RESULTS: Event-free survival was achieved in 89.5% of patients. TVR was performed in 179 patients (7.9%) and the combined incidence of all cause death, myocardial infarction and TVR was 10.5% (231 patients). Independent predictors of TVR were multivessel disease (OR 1.74, 95% CI 1.16-2.62, p = 0.008), stent diameter < or = 2.75 mm (OR 1.61, 95% CI 1.10-2.40, p = 0.02) and the administration of GP IIb/ IIIa antagonists (OR 1.60, 95% CI 1.05-2.60, p = 0.03). TVR rate was as high as 11.2% for 2.5 mm SES and as low as 4.0% for 3.5 mm SES (p < 0.001 for trend test). CONCLUSION: TVR among patients treated with SES for proximal LAD stenoses is low and is related in part to operator dependent factors. Treatment with SES should be considered as an effective treatment for these patients.

The sirolimus-eluting coronary stent in clinical practice: impact of direct stenting versus stenting with balloon pre-dilatation.

AIMS: When using bare metal stents (BMS), direct stenting (DS) has become an established method for percutaneous coronary interventions (PCI). If drug-eluting stents are used, DS is currently not recommended. METHODS AND RESULTS: We analysed the data of the German Cypher Stent Registry to evaluate current use and outcome of DS using the sirolimus-eluting stent (SES). 4,437 patients at 122 hospitals who received a single SES for one lesion and completed follow-up, were included. DS was performed in 1,727 (38.9%) of these patients. However, there was a wide range from 0% to 77.8% within the centres. The following factors were independently associated with the use of DS: degree of stenosis (per 10%) (p<0.0001), type C lesion (p<0.0001), three vessel disease (p<0.0001), age (per decade) (p<0.0001), target vessel = LAD (p=0.0029), diabetes mellitus (p=0.0222) and renal insufficiency (p=0.0260). There were no higher event rates for DS compared to predilatation from admission until the end of follow-up: death rates were 1.4% versus 1.9%, p=0.1854, TVR rates 7.9% versus 8.7%, p=0.3388 and TVR or MACCE rates 10.8% versus 12.1%, p=0.2088. This was confirmed after correction for confounding factors. CONCLUSIONS: In current clinical practice DS with the SES is performed within a very wide range at the different hospitals. Further predictors for the use of DS with the SES are similar to those known from BMS. DS with the SES in such selected patients seems to be safe and effective.

Predictors of death or myocardial infarction during follow-up after coronary stenting with the sirolimus-eluting stent. Results from the prospective multicenter German Cypher Stent Registry.

BACKGROUND: Drug-eluting coronary stents are the most recent "breakthrough" technology in interventional cardiology. Whereas risk factors influencing restenosis and need for target vessel revascularization are well known, risk factors for dying or developing a myocardial infarction (MI) after drug-eluting coronary stent implantation need to be evaluated yet. METHODS: We evaluated data from the German Cypher Stent Registry. RESULTS: From April 2002 to December 2004, 7445 patients at 122 hospitals, who received at least one sirolimus-eluting stent during percutaneous coronary intervention, were included. Complete follow-up at a median of 6.6 months (quartiles 6.1-8.1 months) was available in 6755 patients (91%). Death occurred in 1.8% (120/6755) of patients, nonfatal MI in 2.3% (156/6635), and death or MI in 4.1% (276/6755) of patients. Independent predictors of death or MI were initial presentation with ST-elevation MI or non-ST-elevation MI (OR [odds ratio] 2.21, 95% CI 1.66-2.95, P < .0001), cardiogenic shock (OR 3.05, 95% CI 1.67-5.55, P = .0003), renal insufficiency (OR 1.74, 95% CI 1.24-2.44, P = .0017), reduced left ventricular function (OR 1.74, 95% CI 1.21-2.50, P = .0027), age (per decade) (OR 1.19, 95% CI 1.05-1.36, P = .0058), diabetes mellitus (OR 1.39, 95% CI 1.05-1.84, P = .0183), 3-vessel disease (OR 1.32, 95% CI 0.99-1.77, P = .043), and prior MI (OR 1.35, 95% CI 1.01-1.80, P = .0468), whereas interventional and lesion characteristics showed no significant association. CONCLUSIONS: These results demonstrate that the most powerful predictors of death or MI after sirolimus-eluting stent implantation during percutaneous coronary intervention are presentation with an acute coronary syndrome, impaired left ventricular ejection fraction, and conventional risk factors for coronary heart disease. Interventional and lesion characteristics do not play a major role.

Incidence and predictors of target vessel revascularization and clinical event rates of the sirolimus-eluting coronary stent (results from the prospective multicenter German Cypher Stent Registry).

Randomized trials have demonstrated the ability of drug-eluting stents to decrease the risk of restenosis after coronary stent implantation. However, the incidences of major cardiovascular/cerebral adverse events (MACCEs) and target vessel revascularization (TVR) during follow-up in a routine clinical setting remain to be determined. We analyzed data of the multicenter German Cypher Stent Registry. From April 2002 to March 2003, 1,726 patients at 93 hospitals who received >/=1 sirolimus-eluting coronary stent were included. Median follow-up was 6.7 months. During follow-up, death occurred in 1.2% of patients (20 of 1,726), nonfatal myocardial infarction in 2.5% (43 of 1,706), and nonfatal stroke in 0.5% (7 of 1,469). TVR was performed in 8.6% of patients, with percutaneous coronary intervention in 7.3% and coronary artery bypass grafting in 1.5%. The overall rate of MACCEs or TVR was 10.8% (186 of 1,726). Independent predictors of TVR were the target vessel being a bypass graft (odds ratio [OR] 2.43, 95% confidence interval [CI] 1.41 to 4.18, p = 0.001), management of >1 lesion during the same intervention (OR 1.75, 95% CI 1.04 to 2.96, p = 0.035), 2- or 3-vessel disease (OR 1.69, 95% CI 1.05 to 2.72, p = 0.030), and age (per decade; OR 0.82, 95% CI 0.69 to 0.98, p = 0.025). These data confirm the safety and effectiveness of using the sirolimus-eluting stent in daily clinical practice. The management of bypass grafts and multiple lesions in 1 session and the presence of multivessel disease were predictors of MACCEs or TVR.

[Safety and current indications during "real life" use of sirolimus-eluting coronary stents in Germany. Results from the prospective multicenter German Cypher Registry]. / Aktuelle Indikationsstellung und Sicherheit beim Einsatz des koronaren Sirolimus-Stents im klinischen Alltag in Deutschland. Ergebnisse des deutschen prospektiven multizentrischen Cypher-Registers.

BACKGROUND: Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs. METHODS: The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002. RESULTS: From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs. CONCLUSION: In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.